Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX:
1877; SSE: 688180), a leading innovation-driven biopharmaceutical
company dedicated to the discovery, development, and
commercialization of novel therapies, and its wholly-owned
subsidiary TopAlliance Biosciences Inc. (TopAlliance Biosciences),
announce that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has given a positive
opinion for the marketing authorization application (MAA) for
toripalimab (European trade name: LOQTORZI®). The CHMP recommends
approval for toripalimab for two indications:
- Toripalimab in combination with cisplatin and gemcitabine for
the first-line treatment of adult patients with recurrent, not
amenable to surgery or radiotherapy, or metastatic nasopharyngeal
carcinoma (NPC);
- Toripalimab in combination with cisplatin and paclitaxel for
the first-line treatment of adult patients with unresectable
advanced, recurrent, or metastatic oesophageal squamous cell
carcinoma (ESCC).
The European Commission will take into
account the CHMP’s positive opinion when making the final decision
on the marketing application for toripalimab. The decision will be
applicable to all 27 member states of the European Union, plus
Iceland and Norway. If approved, toripalimab would become the first
and only drug for the treatment of NPC and the only first-line
treatment for advanced or metastatic ESCC regardless of PD-L1
status in Europe.
“As a leading innovative
pharmaceutical company in China,” Dr. Jianjun ZOU, General Manager
and CEO of Junshi Biosciences, said, “Junshi Biosciences is
dedicated to addressing the clinical needs of local patients while
offering novel therapies that provide survival benefits to patients
globally. Currently, patients with NPC and ESCC in Europe receive
limited clinical benefits from existing treatments. Toripalimab has
the potential to improve their treatment options. The positive
opinion from the CHMP brings us one step closer to this goal. We
will continue communicating with local regulatory authorities so
that our innovative therapy can benefit more European patients as
soon as possible.”
“The CHMP’s positive opinion is based
on the robust and clinically important benefits with the addition
of toripalimab to first-line chemotherapy in patients with
metastatic or recurrent NPC or ESCC, not amenable to local
therapy,” Dr. Patricia Keegan, CMO of TopAlliance Biosciences,
said. “Adding toripalimab to chemotherapy has shown significantly
and meaningful improvements in overall survival in both tumor
types. This positive opinion suggests that our innovative product,
already launched in China and the United States, is likely to reach
Europe as well.”
NPC is a malignant tumor that occurs
in the epithelium of the nasopharynx and is one of the most common
types of head and neck cancers globally. According to GLOBOCAN 2022
statistics, the number of newly diagnosed NPC cases in 2022
exceeded 120,000 worldwide. Due to the location of the primary
tumor, surgery is rarely an option. The latest European Society for
Medical Oncology (ESMO) Guidelines recommend immunotherapy combined
with chemotherapy as the first-line treatment for recurrent or
metastatic NPC.
The CHMP’s positive opinion on the NPC
indications is primarily based on the results from JUPITER-02, a
randomized, double-blind, placebo-controlled, multinational,
multi-center Phase III clinical study (NCT03581786). Notably, the
results of the JUPITER-02 study were presented in an oral report
during the Plenary Session of the 2021 annual meeting of the
American Society of Clinical Oncology (ASCO) (#LBA2) and were
subsequently featured on the cover of Nature Medicine. The results
were also published in full in the Journal of the American Medical
Association (JAMA).
Esophageal Cancer (EC) is one of the
most common malignant tumors in the digestive tract. According to
GLOBOCAN 2022 statistics, EC was the 11th most commonly diagnosed
cancer and the seventh leading cause of cancer death worldwide,
with over 511,000 new cases and over 445,000 deaths in 2022. ESCC
and esophageal adenocarcinoma are the two main histological
subtypes of esophageal cancer. The ESMO Guidelines recommend PD-1
blocking antibodies combined with chemotherapy for the first-line
treatment of patients with advanced or metastatic ESCC with PD-L1
positive status.
The CHMP’s positive opinion on the
ESCC indications is primarily based on the results from JUPITER-06,
a randomized, double-blinded, placebo-controlled, multi-center
Phase III clinical study (NCT03829969), which were first presented
in an oral session during the ESMO Congress 2021, and later
published in Cancer Cell and Journal of Clinical Oncology, two
leading international oncology journals.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for
its ability to block PD-1 interactions with its ligands, PD-L1 and
PD-L2, and for enhanced receptor internalization (endocytosis
function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes
the immune system’s ability to attack and kill tumor cells.
More than forty company-sponsored toripalimab clinical studies
covering more than fifteen indications have been conducted globally
by Junshi Biosciences, including in China, the United States,
Southeast Asia, and Europe. Ongoing or completed pivotal clinical
trials evaluating the safety and efficacy of toripalimab cover a
broad range of tumor types, including cancers of the lung,
nasopharynx, esophagus, stomach, bladder, breast, liver, kidney,
and skin.
In the Chinese mainland, toripalimab was the first domestic
anti-PD-1 monoclonal antibody approved for marketing (approved in
China as TUOYI®). Currently, there are ten approved indications for
toripalimab in the Chinese mainland:
- unresectable or metastatic melanoma after failure of standard
systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma (NPC) after
failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed
platinum-containing chemotherapy or progressed within 12 months of
neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as the first-line
treatment for patients with locally recurrent or metastatic
NPC;
- in combination with paclitaxel and cisplatin in first-line
treatment of patients with unresectable locally advanced/recurrent
or distant metastatic esophageal squamous cell carcinoma
(ESCC);
- in combination with pemetrexed and platinum as the first-line
treatment in EGFR mutation-negative and ALK mutation-negative,
unresectable, locally advanced or metastatic non-squamous non-small
cell lung cancer (NSCLC);
- in combination with chemotherapy as perioperative treatment and
subsequently with monotherapy as adjuvant therapy for the treatment
of adult patients with resectable stage IIIA-IIIB NSCLC;
- in combination with axitinib for the first-line treatment of
patients with medium to high risk unresectable or metastatic renal
cell carcinoma (RCC);
- in combination with etoposide plus platinum for the first-line
treatment of extensive-stage small cell lung cancer (ES-SCLC);
- in combination with paclitaxel for injection (albumin-bound)
for the first-line treatment of recurrent or metastatic
triple-negative breast cancer (TNBC).
The first six indications have been included in the National
Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the
only anti-PD-1 monoclonal antibody included in the NRDL for the
treatment of melanoma. In April 2024, the Drug Office at the
Department of Health in the Government of the Hong Kong Special
Administration Region (DO) accepted the NDA for toripalimab in
combination with cisplatin and gemcitabine for the first-line
treatment of adults with metastatic or recurrent locally advanced
NPC, and for toripalimab, as a single agent, for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
In the United States, the US FDA has approved the Biologics
License Application for toripalimab in combination with cisplatin
and gemcitabine for the first-line treatment of adults with
metastatic or recurrent locally advanced NPC, and for toripalimab,
as a single agent, for the treatment of adults with recurrent,
unresectable, or metastatic NPC with disease progression on or
after platinum-containing chemotherapy in October 2023. The FDA has
granted toripalimab 2 Breakthrough Therapy designations for the
treatment of NPC, 1 Fast Track designation for the treatment of
mucosal melanoma, and 5 Orphan Drug designations for the treatment
of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma,
and small cell lung cancer (SCLC).
In Europe, marketing authorization applications (MAA) were
accepted by the European Medicines Agency (EMA) and the MHRA for 1)
toripalimab combined with cisplatin and gemcitabine for the
first-line treatment of patients with locally recurrent or
metastatic NPC and 2) toripalimab combined with paclitaxel and
cisplatin for the first-line treatment of patients with
unresectable locally advanced/recurrent or metastatic ESCC, in
December 2022 and February 2023.
In Australia, the new chemical entity (NCE) application was
accepted by the Australia Therapeutic Goods Administration (TGA) in
November 2023. The TGA has also granted toripalimab an Orphan Drug
designation for the treatment of NPC.
In Singapore, the NDA application was accepted by the Singapore
Health Sciences Authority (HSA) in January 2024. The HSA has also
granted priority review designation for the NDA.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE:
688180) is an innovation-driven biopharmaceutical company dedicated
to the discovery, development and commercialization of innovative
therapeutics. The company has established a diversified R&D
pipeline comprising over 50 drug candidates, with five therapeutic
focus areas covering cancer, autoimmune, metabolic, neurological,
and infectious diseases. Four of the company’s innovations have
already reached the Chinese or international markets, one of which
is toripalimab, China’s first domestically produced and
independently developed anti-PD-1 monoclonal antibody, approved in
China and the US. Additionally, more than 30 drugs are currently in
clinical development. During the COVID-19 pandemic, Junshi
Biosciences actively shouldered the social responsibilities of a
Chinese pharmaceutical company through its involvement in
developing etesevimab, MINDEWEI®, and other novel therapies for the
prevention and treatment of COVID-19.
With a mission of “providing patients with world-class,
trustworthy, affordable, and innovative drugs”, Junshi Biosciences
is “In China, For Global.” At present, the company boasts
approximately 3,000 employees in the United States (San Francisco
and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou,
etc.). For more information, please visit:
http://junshipharma.com.
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800