Elevar Therapeutics Granted Orphan Medicinal Product Designation by the European Medicines Agency for First-Line Systemic Therapy for Unresectable Hepatocellular Carcinoma
2024年8月1日 - 10:48PM
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co.,
Ltd., today announced the European Medicines Agency (EMA) granted
Orphan Medicinal Product Designation for rivoceranib in combination
with camrelizumab as a first-line treatment option for Unresectable
Hepatocellular Carcinoma (uHCC).
“This significant designation by the EMA underscores the ongoing
unmet need for new liver cancer therapies. Orphan designation
further supports Elevar’s mission to bring a novel first-line
systemic treatment option to patients in the EU diagnosed with
hepatocellular carcinoma, a leading cause of cancer death in the EU
and worldwide,” commented Chris Galloway, M.D., senior vice
president of clinical and medical affairs.
About EMA Orphan Designationi
To qualify for Orphan designation by EMA, a medicine must meet a
number of criteria:
- it must be intended for the treatment, prevention or diagnosis
of a disease that is life-threatening or chronically
debilitating;
- the prevalence of the condition in the EU must not be
more than 5 in 10,000 or it must be unlikely that marketing of the
medicine would generate sufficient returns to justify the
investment needed for its development;
- no satisfactory method of diagnosis, prevention or treatment of
the condition concerned can be authorized, or, if such a method
exists, the medicine must be of significant benefit to
those affected by the condition.
The European Union (EU) offers a range of incentives for
medicines that have been granted an orphan designation by
the European Commission, including access to a centralized
authorization resulting in a single opinion and a single decision
from the European Commission valid in all EU Member States.
Additionally, authorized orphan medicines benefit from 10
years of protection from market competition with similar
medicines with similar indications once they are approved.ii
About Hepatocellular CarcinomaMore than
800,000 people worldwide are diagnosed with liver
cancer each year. Liver cancer is a leading cause of cancer
accounting for more than 700,000 deaths annually.iii Hepatocellular
Carcinoma (HCC) is the most common type of primary liver cancer. It
most frequently develops in people with chronic underlying liver
inflammation which may be from viral and non-viral causes. HCC
typically has a poor prognosis with limited treatment options and
continues to be a diagnosis with an ongoing urgent medical
need.
About Rivoceranib Rivoceranib, a small-molecule
tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of
vascular endothelial growth factor receptor (VEGFR), a primary
pathway for tumor angiogenesis. VEGFR inhibition is a clinically
validated target to limit tumor growth and disease progression.
Rivoceranib is currently being studied as a monotherapy and in
combination with chemotherapy and immunotherapy in various solid
tumor indications. Ongoing clinical studies include uHCC (in
combination with camrelizumab), gastric cancer (as a monotherapy
and in combination with paclitaxel), adenoid cystic carcinoma (as a
monotherapy) and colorectal cancer (in combination with Lonsurf®).
Rivoceranib was the first TKI approved in gastric cancer in China
(November 2014). It is also approved in China in combination with
camrelizumab as a first-line treatment for uHCC (January 2023). The
drug has been studied in more than 6,000 patients worldwide and was
well tolerated in clinical trials with a comparable safety profile
to other TKIs and VEGF inhibitors. Orphan drug designations have
been granted in gastric cancer (U.S., EU and South Korea), in
adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar
Therapeutics, Inc. holds the global rights (excluding China) to
rivoceranib and has partnered for its development and marketing
with HLB-LS in South Korea. Rivoceranib, under the name apatinib,
is also approved in China for advanced gastric cancer and in
second-line advanced HCC by the Chinese -territory license-holder,
Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma),
under the brand name Aitan®.
About Camrelizumab Camrelizumab (SHR-1210) is a
humanized monoclonal antibody that binds to the programmed death-1
(PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a
therapeutic strategy showing success in a wide variety of solid and
hematological cancers. Camrelizumab is developed by Hengrui Pharma
and has been studied in more than 5,000 patients. Currently, 50
clinical trials are underway in a broad range of tumors (including
liver cancer, lung cancer, gastric cancer, and breast cancer, etc.)
and treatment settings. Camrelizumab, under the brand name
AiRuiKa®, is currently approved for eight indications in China,
including monotherapy for the treatment of HCC (second-line), in
combination with rivoceranib as a treatment for uHCC (first-line),
relapsed/refractory classic Hodgkin’s lymphoma (third-line),
esophageal squamous cell carcinoma (second-line) and nasopharyngeal
carcinoma (third-line or further) and in combination with
chemotherapy for the treatment of non-small cell lung cancer
(non-squamous and squamous), esophageal squamous cell carcinoma and
nasopharyngeal carcinoma in the first-line setting. The U.S. Food
and Drug Administration granted Orphan Drug Designation to
camrelizumab for advanced HCC in April 2021.
In October 2023, Elevar licensed camrelizumab, an anti-PD-1
antibody, for commercialization from Jiangsu Hengrui
Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding
Greater China and Korea.
About Elevar TherapeuticsElevar Therapeutics,
Inc. is a fully integrated biopharmaceutical company built on the
promise of elevating treatment experiences and outcomes for
patients who have limited or inadequate therapeutic options. With
expertise rooted in oncology, Elevar is focused on identifying and
developing promising medicines for complex yet under-treated health
conditions. Elevar’s lead proprietary drug candidate is
rivoceranib. Elevar is headquartered in New Jersey, with offices in
South Korea. Additional information is available at
ElevarTherapeutics.com.
Media Contact: Jeanette BressiHead, Corporate
Communications, Elevar
Therapeuticsjbressi@elevartherapeutics.com609-439-3997
Investor Contact:Wade SmithChief Financial
& Business Officer, Elevar Therapeutics
wsmith@elevartherapeutics.com
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i Orphan designation: Overview | European Medicines Agency
(europa.eu)ii Orphan incentives | European Medicines Agency
(europa.eu)iii Key Statistics About Liver Cancer | American Cancer
Society