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4週前
Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical CancerJune 8, 2026 8:34 PM
Business Wire - TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China - TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy, including in an exploratory subpopulation of patients in China. The NMPA approval follows regulatory approvals in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China), underscoring the broad global clinical evidence supporting TIVDAK availability in China. The indication statement for TIVDAK differs slightly by region. “Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer,” said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. “Coupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options.” Results from the Phase 3 innovaTV 301 clinical trial, including data from the China subpopulation of this study that Zai Lab conducted, supported global approval of TIVDAK: In the global study, the trial met its primary endpoint of OS in the intention-to-treat (ITT) population of the global study (HR=0.70; 95% CI: 0.54–0.89; two-sided p=0.0038). The China subpopulation showed consistent results, with a clinically meaningful improvement in OS (HR: 0.55, 95% CI: 0.27- 1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy.1 54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure.2 There were no new safety signals identified among patients in the China subpopulation who received TIVDAK. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).1 The most common Grade ≥3 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%).2 “Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs,” said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. “Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy.” Zai Lab will leverage the company’s extensive experience and expanding presence in the Chinese gynecologic oncology community, as well as commercial synergies with its ZEJULA® team, to bring TIVDAK to patients in China. About Cervical Cancer in China An estimated 150,000 new cases of cervical cancer occur annually in China3. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients. About Tisotumab Vedotin Tisotumab vedotin (approved under the brand name TIVDAK® in the EU, U.K., U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. TIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, and U.S. approval was first secured in September 2021 under the accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval has also been received in Japan, European Union, Macau (China), and Hong Kong (China) for the same indication. Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). Zai Lab is solely responsible for the development, supply, and commercialization of TIVDAK in Greater China. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Greater China, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. References: 1. Vergote I, et al. N Engl J Med. 2024 Jul 4;391(1):44-55. 2. 2025 Chinese Society of Clinical Oncology (CSCO) Meeting, Tisotumab Vedotin versus Chemotherapy in Recurrent or Metastatic Cervical Cancer with Disease Progression on or after Systemic Therapy: Prespecified China Subpopulation Analysis of Phase 3 innovaTV. 3. Bingfeng Han et al., "Cancer incidence and mortality in China, 2022" Journal of the National Cancer Center, 2024. DOI: 10.1016/j.jncc.2024.01.006. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608963481/en/ Investor Relations:
Christine Chiou
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christine.chiou1@zailaboratory.com Media:
Shaun Maccoun / Xiaoyu Chen
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shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Original: Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer
US Market News
1月前
Zai Lab Announces Changes to Senior Leadership TeamMay 21, 2026 6:09 PM
Business Wire Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced changes to its senior leadership team aimed at strengthening operational performance and efficiency. As part of these changes, the Board has made the decision that Josh Smiley, President and COO, will no longer be with the Company, effective Friday, May 22. "I want to thank Josh for his contributions to Zai Lab over the past three and a half years and wish him well in his future endeavors," said Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. Zai Lab anticipates multiple clinical data readouts in 2026 for its lead global investigational therapies, including zoci in first-line ES-SCLC and extrapulmonary NECs, and ZL-1503 (IL-13/IL-31Ra), with a first-in-human data readout from the global Phase 1/1b study. The company is also preparing for the launch of COBENFY™ in China and for multiple anticipated regional regulatory approvals and expected data readouts. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20260521314535/en/ For more information, please contact: Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media:
Shaun Maccoun / Xiaoyu Chen
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shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Original: Zai Lab Announces Changes to Senior Leadership Team
US Market News
3月前
Zai Lab Presents New Preclinical Data Suggesting ZL-1503, an IL-13/IL-31Ra Bispecific Antibody, Provides Rapid Itch Relief and Reduction in Inflammation in Atopic DiseasesApril 18, 2026 9:00 AM
Business Wire
-Efficacy and safety data shared at IMMUNOLOGY2026 reinforce potential of ZL-1503 as a first-in-class treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases
-Strong inhibition of both inflammatory and pruritic pathways over 112 days following a single dose of ZL-1503, together with a favorable preclinical safety profile, supports potential for less frequent dosing than current biologics
-Zai Lab initiated first-in-human Phase 1/1b studies of ZL-1503 in December 2025; clinical data expected in 2H 2026
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced new data from a preclinical study of ZL-1503, demonstrating that the company’s internally developed IL-13/IL-31Ra bispecific antibody may lead to sustained suppression of intense pruritus (itch) and inflammation caused by atopic diseases. The findings, featured in a poster presentation at the IMMUNOLOGY2026 conference in Boston, MA, reinforce the potential of ZL-1503 to be a first-in-class treatment option for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases.
IL-13 and IL-31 are key mediators in atopic disease. IL-13 promotes Type 2 inflammation and tissue changes, while IL-31 drives itch and amplifies local immune responses. Together, these cytokines perpetuate the itch-scratch-inflammation cycle that underlies the development and persistence of atopic dermatitis and related conditions, highlighting the need for therapies that effectively target both pathways simultaneously. ZL-1503 was engineered to disrupt this cycle by blocking both IL-13 and IL-31Ra-mediated signaling concurrently.
“The breadth of activity across pruritus and atopic disease models in this study, including sustained suppression of symptoms from a single dose over 112 days, reinforces our belief that dual targeting of IL-13 and IL-31 pathways represents a compelling therapeutic approach,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “These data support our conviction that ZL-1503 has the potential to make a meaningful difference for patients and collectively support its clinical advancement.”
In the preclinical study presented today, researchers evaluated the ability of ZL-1503 to inhibit IL-31-induced scratching and IL-13-dependent signaling (pSTAT6), and its efficacy in models of asthma, allergic conjunctivitis, and rhinitis triggered by a controlled allergen challenge.
Key study results presented at IMMUNOLOGY2026 include:
Efficacy
A single intravenous dose of ZL-1503 (0.3, 3, 10 mg/kg) produced sustained, dose-dependent inhibition of both IL-31-induced scratching and IL-13-dependent pSTAT6 signaling over a 112-day observation period, demonstrating durable pathway suppression.
A single dose of 10 mg/kg also significantly improved lung function, reduced airway inflammation in asthma, and alleviated symptoms of allergic rhinitis and conjunctivitis.
Transcriptomic and histopathological analyses further demonstrated broad suppression of T helper 2 (TH2)-related inflammatory pathways, immune cell infiltration, and mast-cell activation across lung, nasal mucosa, and conjunctival tissues, providing mechanistic evidence of ZL-1503’s effects at the site of inflammation.
Safety: ZL-1503 demonstrated a favorable nonclinical safety profile across all studies, supporting its advancement into human clinical trials.
In December 2025, Zai Lab initiated Phase 1/1b first-in-human studies of ZL-1503 in healthy volunteers and adult patients with moderate-to-severe atopic dermatitis in Australia, New Zealand, and China.
Details of the ZL-1503 poster presentations at IMMUNOLOGY2026:
Title: ZL-1503: A Bispecific Antibody Targeting IL-13 and IL-31Ra Sustains Suppression of Pruritus and Atopic Disease in Non-Human Primates
Presenter: Henry Wu
Session Title: Immediate and Delayed Hypersensitivity Exhibit Hall
Date/Time: Saturday, April 18, 2026, from 2:30 p.m. – 3:30 p.m. ET
Location: Thomas M. Menino Convention & Exhibition Center, Boston, MA
Poster Board Number: 194
About ZL-1503
ZL-1503 is a potential first-in-class bispecific antibody targeting IL-13 and IL-31Ra engineered by Zai Lab’s in-house discovery engine to simultaneously suppress both inflammatory and pruritogenic (itch-causing) pathways implicated in AD and other IL-13 and IL-31-driven diseases, potentially offering faster onset of action and superior efficacy compared to single-pathway inhibition.
ZL-1503 is currently being evaluated in the ongoing global Phase 1/1b clinical trial evaluating its safety, tolerability, pharmacokinetics, and efficacy. This clinical advancement is supported by preclinical studies in which ZL-1503 demonstrated the ability to simultaneously suppress inflammatory and pruritogenic pathways implicated in AD.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing ZL-1503, the potential benefits of ZL-1503, and the potential treatment of atopic dermatitis and other type 2 helper T-cell (TH2)-driven diseases. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260418529898/en/
Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com
Media:
Shaun Maccoun / Xiaoyu Chen
+1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Original: Zai Lab Presents New Preclinical Data Suggesting ZL-1503, an IL-13/IL-31Ra Bispecific Antibody, Provides Rapid Itch Relief and Reduction in Inflammation in Atopic Diseases
US Market News
3月前
Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer with Brain Metastases and Promising Activity in Other Neuroendocrine CarcinomasApril 17, 2026 3:01 PM
Business Wire
Zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, showed a 53.7% confirmed intracranial objective response rate (iORR) for small cell lung cancer (SCLC) with brain metastases; at 1.6 mg/kg dose, the confirmed iORR was 62.5% (10/16), including complete responses
Encouraging activity was observed in extrapulmonary neuroendocrine carcinomas (NECs), with a 38.2% confirmed objective response rate
Global Phase 3 trial ongoing in second-line-plus SCLC; first-line SCLC and neuroendocrine carcinoma programs advancing toward registrational phase in 2026
Investor conference call and webcast to discuss data being presented at AACR Annual Meeting 2026 and clinical trial plans scheduled for Monday, April 20, at 5:30 a.m. PT / 8:30 a.m. ET / 8:30 p.m. HKT
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced clinical data indicating zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (ADC), provides rapid and robust intracranial responses in patients with previously treated extensive stage small cell lung cancer (ES-SCLC) and brain metastases as measured by independent assessment using modified Response Assessment in Neuro-Oncology for Brain Metastases (mRANO-BM) criteria, as well as promising data in patients with other neuroendocrine carcinomas (NECs). These findings, as well as preclinical data evaluating ZL-6201 (LRRC15 ADC) and ZL-1222 (PD-1/IL-12), will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego.
Results from an ongoing, global Phase 1 trial (NCT06179069) demonstrate that treatment with zoci results in significant intracranial lesion regression and reduced tumor size among patients with ES-SCLC whose cancer metastasized to the brain, a population with poor survival and limited effective treatment options.
“For patients with extensive stage small cell lung cancer who develop brain metastases, a frequent and clinically significant driver of disease progression, the prognosis is poor and existing therapeutic options delays systemic therapy and offer limited efficacy,” said Luis Paz-Ares, M.D. Ph.D., senior investigator and Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center) in Madrid, Spain. “The data from these ongoing zoci clinical trials are encouraging, demonstrating not only rapid and robust responses across multiple dose cohorts, but also notable activity in patients regardless of prior intracranial radiotherapy. These findings suggest the potential for zoci to provide a novel treatment option for difficult-to-treat cancers with limited therapies, addressing significant unmet needs in this patient population."
Additionally, researchers will share preliminary data from a Phase 1b/2 clinical trial of zoci (NCT06885281) in patients with extrapulmonary neuroendocrine carcinomas (epNECs) and other selected solid tumors. These data indicate that zoci has antitumor activity, with an objective response rate (ORR) of 38.2% in an additional patient population with aggressive malignancies, poor prognosis, and limited treatment options. Notably, there are no approved standard therapies in previously treated epNEC and no targeted therapies in this disease.
Abstract title: Intracranial activity of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer and baseline brain metastasis: Analysis of a Phase 1 trial
Patients with ES-SCLC and baseline brain metastasis were enrolled in a clinical trial with zoci monotherapy administered intravenously every three weeks at varying doses (0.8, 1.2, 1.6, 2, 2.4, or 2.8 mg/kg). The data presented had a median follow-up of 7.9 months. Systemic efficacy was measured with RECIST v1.1 by investigator assessment and intracranial efficacy was assessed with mRANO-BM by blinded independent radiologic committee review.
Among 136 treated patients, 36% had baseline brain metastases.
In all patients with brain metastases and the opportunity to finish at least two post-baseline scans, intracranial objective response rate (iORR) among patients who received zoci was 53.7% (22/41), including seven complete responses. At the 1.6 mg/kg dose, confirmed iORR was 62.5% (10/16), including four complete responses. Fourteen patients were censored after a median follow-up of 9.2 months.
Intracranial tumor reductions occurred across multiple dose levels and responses were observed in both patients with (50%, 13/26) and without (60%, 9/15) prior radiotherapy.
Zoci demonstrated a manageable safety profile, with most treatment emergent adverse events (TEAEs) reported as low grade with minimal discontinuation. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6mg/kg. The most common grade ≥3 TRAEs included: neutropenia (9.6%, 13/136), anemia (8.8%, 12/136), thrombocytopenia (3.7%, 5/136), lymphopenia (2.9%, 4/136), and leukopenia (2.9%, 4/136). No intracranial metastasis complications or treatment-related neurologic serious adverse events were reported.
Abstract title: Preliminary results from the Phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and other selected solid tumors
In another important analysis for patients with high unmet need due to aggressive malignancies with limited treatment options, preliminary results from the multicenter Phase 1b/2 study of zoci in patients with NECs demonstrated clinically meaningful responses. Researchers administered zoci intravenously at 1.6 mg/kg every three weeks until disease progression or unacceptable toxicity, with a data cutoff date of February 18, 2026, representing a median follow up of 3.7 months in the Phase 1b portion of the study. Tumor response was evaluated by investigator-assessed RECIST v1.1 with additional assessments for some NECs.
Of the 46 patients who were pretreated with prior platinum-based chemotherapy and other prior systemic therapies, treatment with zoci decreased tumor sizes within multiple epNEC subtypes with confirmed responses in pretreated patients.
Among response evaluable patients, the overall response rate was 38.2% (13/34) across study cohorts and the overall disease control rate was 55.9% (19/34).
Zoci demonstrated a manageable safety profile; neutrophil count decrease (5.2%, 3/58) was the only Grade ≥3 TRAE occurring in more than one patient.
These findings highlight the potential for zoci across a broad range of DLL3-expressing NECs.
“The zoci data that we will present at AACR, alongside our ZL-6201 and ZL-1222 preclinical data, highlight the breadth, diversity and potential of our global oncology pipeline,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The rapid progression of zoci into pivotal development, with three registration-enabling studies planned by the end of this year, is a prime example of our strategy to deliver our first global oncology launch. This accelerated progress is made possible by our unique integrated U.S.-China infrastructure, which allows us to evolve drug discovery into life-changing medicines with a focus on speed and quality."
Data from two additional Zai Lab internally developed investigational oncology therapies will also be presented at AACR. Researchers will share promising findings from preclinical studies of ZL-6201, a leucine-rich repeat-containing protein 15 (LRRC15) targeting ADC for the treatment of sarcoma and epithelial tumors with LRRC15 expressing cancer-associated fibroblasts; and, ZL-1222, a potential next generation anti-PD-1 and interleukin-12 (IL-12) signaling attenuated mutein agonist immunocytokine for cancer immunotherapy.
Details regarding the webcast and conference call are as follows:
Date/Time: Monday, April 20, 2026, at 5:30 a.m. PT / 8:30 a.m. ET / 8:30 p.m. HKT
Registration available at:
Webcast presentation (preferred): https://edge.media-server.com/mmc/p/8v9n78fj/
Dial-in: https://register-conf.media-server.com/register/BId10f18579c7947b29fda2857a99f26b9
Presenters: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab; Luis Paz-Ares, M.D. Ph.D., Chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre and Head of the Lung Cancer Unit at the CNIO (Spanish National Cancer Research Center), Madrid, Spain; Rohit Thummalapalli, M.D., gastrointestinal medical oncologist, Memorial Sloan Kettering Cancer Center
About Zocilurtatug Pelitecan (Zoci, ZL-1310)
Zoci targets DLL3, a validated therapeutic target for small cell lung cancer that is overexpressed in many neuroendocrine tumors and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across 2L+ SCLC, 1L SCLC and extrapulmonary neuroendocrine carcinomas by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage small cell lung cancer, as well as a backbone DLL3-targeting antibody drug conjugate in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.
About ZL-6201
Zai Lab is evaluating ZL-6201 as a potential first-in-class LRRC15-targeting antibody drug conjugate for the treatment of multiple solid tumors. LRRC15 is a type I transmembrane protein and an attractive target for cancer therapy because it is overexpressed in various mesenchymal tumors, such as sarcoma, glioblastoma and melanoma, as well as in cancer associated fibroblasts across many other tumor types.
About ZL-1222
Zai Lab is evaluating ZL-1222 as a potential next-generation bispecific immunocytokine comprising anti-PD-1 and attenuated IL-12 for cancer immunotherapy across multiple indications, with potential to combine potent antitumor activity with improved systemic safety. Previously, interleukin-12 therapies have shown potential benefit across a range of cancer types; however, narrow therapeutic windows and toxicity concerns have limited the utility of this therapeutic class.
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing zocilurtatug pelitecan (zoci), ZL-6201 and ZL-1222, the potential benefits of zoci, ZL-6201 and ZL-1222, and the potential treatment of small cell lung cancer, neuroendocrine carcinomas, and solid tumors. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260417034173/en/
For more information, please contact:
Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com
Media:
Shaun Maccoun / Xiaoyu Chen
+1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Original: Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer with Brain Metastases and Promising Activity in Other Neuroendocrine Carcinomas
US Market News
3月前
Zai Lab Announces Global Clinical Trial Collaboration and Supply Agreement to Evaluate Novel DLL3 ADC, Zocilurtatug Pelitecan, in Combination with a Bispecific T-cell Engager TherapyApril 1, 2026 7:30 AM
Business Wire
- Collaboration with Amgen to explore the clinical potential of Zai Lab’s DLL3-targeting ADC, zocilurtatug pelitecan, in combination with Amgen’s IMDELLTRA®
- Amgen to sponsor and lead global Phase 1b study; Zai Lab to retain full ownership of zocilurtatug pelitecan
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced a global clinical trial collaboration with Amgen Inc. (NASDAQ: AMGN) to evaluate Zai Lab’s investigational delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), zocilurtatug pelitecan (zoci, formerly ZL-1310), in combination with Amgen’s IMDELLTRA® (tarlatamab-dlle), a DLL3-targeting Bispecific T-cell Engager (BiTE®) therapy in patients with extensive-stage small cell lung cancer (ES-SCLC).
As part of this collaboration agreement, Amgen will sponsor a global Phase 1b study to evaluate the safety and efficacy of zoci in combination with IMDELLTRA® in patients with ES-SCLC. Zai Lab will retain full ownership of zoci and will supply Amgen with the study drug.
“In combination, this dual-targeting strategy has the potential to increase the rate and deepen responses both systemically and, in the brain, address resistance pathways, and unlock new treatment paradigms for patients with small cell lung cancer,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “These two approaches leverage complementary mechanisms — our ADC delivers a potent cytotoxic payload directly to DLL3-expressing tumor cells, while the T-cell engager is designed to activate T-cells by binding the same antigen and eliciting an immune response against the tumor.”
Zoci is a DLL3-targeting ADC for small cell lung cancer. Zai Lab has presented data from a Phase 1/2 clinical trial of zoci at the EORTC-NCI-AACR (ENA) Symposium 2025 and the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, demonstrating a high response rate in heavily pretreated SCLC patients, including strong intracranial activity, and a tolerable safety profile. Amgen’s IMDELLTRA® received FDA approval and is currently marketed in the U.S. for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Please see full Prescribing Information, including Boxed Warnings, for IMDELLTRA®.
About Zocilurtatug Pelitecan (zoci, formerly ZL-1310)
Zoci is a novel ADC in Zai Lab’s global oncology pipeline targeting DLL3, an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. Zoci comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.
Zoci is being evaluated in a global development program, which includes DLLEVATE, a pivotal trial to further evaluate the safety and efficacy of zoci compared to investigator’s choice single agent therapy in patients with relapsed ES-SCLC; a phase 1b/2 trial evaluating zoci in selected solid tumors including extrapulmonary neuroendocrine carcinoma; and a phase 1a/1b trial evaluating zoci as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC.
Zoci’s safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential as a backbone ADC in first-line combination regimens, including those that reduce the burdens of chemotherapy. Zoci received FDA Orphan Drug Designation and FDA Fast Track Designation for the treatment of SCLC.
About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and lethal solid tumors, accounting for ~15% of approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Two-thirds of all SCLC patients are diagnosed at extensive stage3, which is associated with high rates of relapse and poor prognosis. The outcomes of the patients with ES-SCLC are dismal, with median survival of approximately 12 months following initial therapy4 and a ~5-10% overall five-year survival rate5. Treatment options have historically been limited once a patient progresses. IMDELLTRA® is the first DLL3-targeting bispecific T-cell engager therapy to demonstrate an overall survival benefit in this patient population. The combination of zocilurtatug pelitecan and IMDELLTRA® has the potential to build on these gains by further improving efficacy while maintaining manageable safety6.
References:
1
J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America.
2
WHO Globocan 2022.
3
Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561.
4
Phase 3 IMpower133 (atezolizumab) and CASPIAN study (durvalumab).
5
National Cancer Institute. www.cancer.gov. Accessed October 15, 2024.
6
Mountzios et al, NEJM 2025
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including zocilurtatug pelitecan, the potential benefits of zocilurtatug pelitecan, and the potential treatment of SCLC and other neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401769229/en/
For more information:
Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com
Media:
Shaun Maccoun/ Xiaoyu Chen
+1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Original: Zai Lab Announces Global Clinical Trial Collaboration and Supply Agreement to Evaluate Novel DLL3 ADC, Zocilurtatug Pelitecan, in Combination with a Bispecific T-cell Engager Therapy
US Market News
4月前
Zai Lab to Present New Data on Three Internally Developed Oncology Candidates at AACR 2026, Including Zocilurtatug Pelitecan, a DLL3-Targeting Antibody-Drug Conjugate (ADC)March 17, 2026 4:35 PM
Business Wire
- Zoci data show intracranial response in small-cell lung cancer (SCLC) with brain metastases, as well as activity in other neuroendocrine carcinomas
- ZL-6201 will be highlighted in a poster presentation showcasing its potential as an innovative ADC for the treatment of sarcoma and other LRRC15-positive solid tumors
- ZL-1222, a PD-1/IL-12, will also be featured in a poster presentation highlighting its potential as a next-generation immunocytokine therapy for the treatment of solid tumors
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced three of the Company’s internally-developed investigational oncology therapies will be presented across four poster sessions at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17-22 in San Diego, California. These next-generation candidates include: zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (ADC) for small cell lung cancer (SCLC); ZL-6201, a leucine-rich repeat-containing protein 15 (LRRC15) ADC for the treatment of sarcoma and epithelial tumors with LRRC15 expressing cancer-associated fibroblasts (CAFs); and, ZL-1222, a PD-1 and interleukin-12 (IL-12) signaling attenuated mutein agonist immunocytokine for cancer immunotherapy.
“The breadth and profile of our global oncology pipeline, highlighted by zoci, ZL-6201, and ZL-1222, underscore our commitment to developing innovative therapies for cancers that remain difficult to treat with current standards of care,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Leveraging our integrated U.S.-China development model, we are advancing these programs with speed and quality, and the data we will present at AACR reinforces our confidence in these compounds.”
Zoci targets DLL3, a validated therapeutic target for SCLC that is overexpressed in many neuroendocrine tumors and is generally associated with poor clinical outcomes. Zoci is on track to become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated ES-SCLC, as well as a backbone ADC in first line combination regimens, including those that reduce the burdens of chemotherapy. Studies with other combinations and lines of therapies are planned.
LRRC15 is a type I transmembrane protein and an appealing target for cancer therapy because it is overexpressed in various mesenchymal tumors, such as sarcoma, glioblastoma and melanoma, as well as in CAFs across many other tumor types. Zai Lab is evaluating ZL-6201 as a potential first-in-class LRRC15-targeting ADC for the treatment of multiple solid tumors.
Interleukin-12 treatments have shown potential therapeutic benefit across a range of cancer types; however, narrow therapeutic windows and toxicity concerns have limited the utility of this therapeutic class. Zai Lab is evaluating ZL-1222 as a potential next-generation PD-1 and attenuated IL-12 immunocytokine bispecific protein for cancer immunotherapy across multiple indications, potentially combining potent antitumor activity with improved systemic safety.
Details regarding the Zai Lab poster presentations at AACR 2026 are as follows:
Title: Discovery of ZL-6201, a novel LRRC15-targeting antibody drug conjugate (ADC) for the treatment of sarcomas and epithelial solid tumors
Session Title: Antibodies, Antibody-Drug Conjugates, and Nucleic Acids
Date/Time: Monday, April 20, 2026, from 9:00 a.m. - 12:00 p.m. PT
Location: San Diego Convention Center, Poster Section 38
Poster Board Number: 7
Publish Abstract Number: 2399
Title: ZL-1222, a PD-1-targeted potency-reduced IL-12 immunocytokine, overcomes PD-1 resistance and enhances antitumor immunity with an accepted safety profile
Session Title: Monoclonal Antibodies and Antibody-Cytokine Platforms
Date/Time: Tuesday, April 21, 2026, from 9:00 a.m. - 12:00 p.m. PT
Location: San Diego Convention Center, Poster Section 9
Poster Board Number: 2
Publish Abstract Number: 4331
Title: Intracranial activity of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer and baseline brain metastasis: Analysis of a phase 1 trial
Session Title: Phase 1 Clinical Trials
Date/Time: Tuesday, April 21, 2026, from 9:00 a.m. - 12:00 p.m. PT
Location: San Diego Convention Center, Poster Section 50
Poster Board Number: 15
Publish Abstract Number: CT193
Title: Preliminary results from the phase 1b/2, open-label, multi-center study of ZL-1310, a DLL3-targeted ADC, in patients with neuroendocrine carcinomas and other selected solid tumors
Session Title: Phase 1 Clinical Trials
Date/Time: Tuesday, April 21, 2026, from 9:00 a.m. - 12:00 p.m. PT
Location: San Diego Convention Center, Poster Section 50
Poster Board Number: 11
Publish Abstract Number: CT189
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing zocilurtatug pelitecan (ZL-1310), ZL-6201 and ZL-1222, the potential benefits of zocilurtatug pelitecan (ZL-1310), ZL-6201 and ZL-1222, and the potential treatment of small cell lung cancer, neuroendocrine carcinomas, and solid tumors. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260317815099/en/
For more information, please contact:
Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com
Media:
Shaun Maccoun / Xiaoyu Chen
+1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Original: Zai Lab to Present New Data on Three Internally Developed Oncology Candidates at AACR 2026, Including Zocilurtatug Pelitecan, a DLL3-Targeting Antibody-Drug Conjugate (ADC)
US Market News
5月前
$207B Market Shift: The Race for Fast Track Approval in OncologyFebruary 5, 2026 9:35 AM
PR Newswire (Canada)
Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Feb. 5, 2026 /CNW/ -- USANewsGroup.com News Commentary – The FDA isn't just approving drugs; they are completely reshaping the landscape. In 2025 alone, the agency issued over 50 oncology approvals[1], but the real story is the aggressive pivot toward targeted therapies for high-unmet-need solid tumors. That momentum has accelerated in 2026 with a sudden flurry of expedited designations[2] for RAS inhibitors and rare malignancies. This regulatory velocity creates a clear validation framework, positioning Oncolytics Biotech Inc. (NASDAQ: ONCY), Relay Therapeutics (NASDAQ: RLAY), MAIA Biotechnology (NYSE-A: MAIA), Zai Lab (NASDAQ: ZLAB), and Arrivent BioPharma (NASDAQ: AVBP) directly at the convergence of urgent unmet medical need and commercial opportunity.
This is projected to be a $326.82 billion market opportunity by 2031[3], fueled by a robust expansion in antibody-drug conjugates and biomarker-driven regimens. But in biotech, time is the ultimate currency. Data confirms that Breakthrough Therapy Designation can slash late-stage development time by 30%[4]. For companies demonstrating clinical efficacy in difficult-to-treat populations, these expedited pathways are no longer just a bonus: they are the primary value drivers for scalable growth.Oncolytics Biotech Inc. (NASDAQ: ONCY) just received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.The designation is based on clinical data showing pelareorep combined with standard chemotherapy achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually."Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:Relay Therapeutics (NASDAQ: RLAY) has announced FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following progression on CDK4/6 inhibitor treatment. The designation was supported by clinical data from the ReDiscover trial with 600mg BID fasted and 400mg BID fed doses showing comparable exposures across all PIK3CA mutations."This Breakthrough Therapy designation underscores the FDA's recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date," said Don Bergstrom, President of R&D at Relay Therapeutics.Initial Phase 1/2 data of zovegalisib plus fulvestrant at the 400mg BID fed Phase 3 dose in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16. Relay Therapeutics developed zovegalisib as the first known allosteric, pan-mutant, and isoform-selective PI3Ka inhibitor designed to overcome limitations of traditional orthosteric inhibitors.MAIA Biotechnology (NYSE-A: MAIA) has advanced its ateganosine program as the first and only telomere-targeting anticancer agent in clinical development, securing FDA Fast Track designation for the treatment of non-small cell lung cancer (NSCLC). The company initiated a pivotal Phase 3 trial in third-line NSCLC and expanded its Phase 2 trial with a $2.3 million NIH grant while establishing agreements with Roche and BeOne Medicines for checkpoint inhibitor combinations."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, CEO of MAIA Biotechnology. "Our statistical assessments of ateganosine imply a high probability of technical success in our concurrent Phase 3 and Phase 2 trials."The company targets potential commercial approval within 18 to 24 months, with 2026 milestones including interim Phase 3 efficacy data and Phase 2 trial conclusion. MAIA Biotechnology raised approximately $17.6 million in 2025 with board participation in nearly all transactions.Zai Lab (NASDAQ: ZLAB) announced that China's National Medical Products Administration has approved the supplemental New Drug Application for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval marks the second indication in China for the next-generation tyrosine kinase inhibitor, which demonstrated robust and durable efficacy and manageable safety in the pivotal Phase 1/2 TRIDENT-1 study."We are pleased with the NMPA's approval of AUGTYRO for patients with NTRK-positive solid tumors," said Rafael Amado, President, Head of Global Research and Development at Zai Lab. "This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population."The approval represents the first in China to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors. Zai Lab has an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China, following their acquisition of Turning Point Therapeutics.Arrivent BioPharma (NASDAQ: AVBP) announced first patient dosing in the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant non-small cell lung cancer. The oral, once-daily, brain-penetrant therapy demonstrated 16-month median progression-free survival and 68% confirmed objective response rate in the FURTHER trial, supporting selection of the 240 mg dose for pivotal development."Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, CEO of Arrivent BioPharma. "With a well-characterized safety profile and broad clinical systemic and central nervous system activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations."The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. Arrivent BioPharma estimates the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicinehttps://www.mordorintelligence.com/industry-reports/solid-tumor-therapeutics-markethttps://pmc.ncbi.nlm.nih.gov/articles/PMC12758617/Logo : https://mma.prnewswire.com/media/2838876/5764584/USA_News_Group_Logo.jpg
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Original: $207B Market Shift: The Race for Fast Track Approval in Oncology
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