Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and
Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX:
1877; SSE: 688180) announced today that the United States Food and
Drug Administration ("FDA") has granted Orphan Drug Designation
(“ODD”) for toripalimab, a PD-1 inhibitor, for the treatment of
small cell lung cancer (“SCLC”). ODD is granted to drugs intended
to treat rare diseases with a patient population less than 200,000
in the United States. The designation provides incentives to
advance development and commercialization of drugs that have the
potential to provide benefit to patients with rare diseases.
SCLC is an aggressive tumor characterized by rapid
disease progression, low expression of PD-L1 and low levels of
tumor infiltrating immune cells, as well as a high degree of
immunosuppression. Efficacy of cancer immunotherapy has been
limited in SCLC. No PD-1 inhibitors are currently approved in the
United States for SCLC. Prognosis for SCLC patients is poor, with
five year survival rates of approximately 20% and less than 5% for
patients with extensive stage SCLC.
The JUPITER-08 study (NCT04012606) is an ongoing,
randomized, double-blind, placebo-controlled, multi-center Phase 3
clinical trial evaluating PD-1 inhibitor toripalimab in combination
with chemotherapy (cisplatin or carboplatin + etoposide) compared
to placebo in combination with chemotherapy as the first-line
treatment of extensive stage SCLC. Enrollment in this trial has
been completed. The co-primary endpoints of the study are overall
survival and progression free survival as assessed by the
investigator.
“Toripalimab in combination with chemotherapy has
demonstrated robust antitumor immunity and survival benefit in
multiple tumor types including in tumors with low PD-L1 expression.
This differentiated clinical activity may result from toripalimab’s
unique binding epitope and internalization properties,” said Dr.
Theresa LaVallee, Chief Development Officer at Coherus. “SCLC
patients have a particularly poor prognosis, and new and better
treatment options are clearly needed for patients with this
aggressive cancer. We are pleased to be working closely with our
partner, Junshi Biosciences, to evaluate toripalimab in this
underserved patient population and look forward to topline data
from the pivotal first line SCLC clinical trial expected later this
year.”
“Lung cancer is the second most prevalent malignant
tumor and has the highest mortality rate. However, there is a
disparity in the development of new treatments for different
subtypes of lung cancer, non-small cell lung cancer (“NSCLC”) and
SCLC. For NSCLC without oncogenic mutations, multiple
immuno-oncology drugs, including toripalimab, have been shown to
improve survival when added to chemotherapy as compared to
chemotherapy alone, whereas treatment options for SCLC patients are
limited to chemotherapy with one of two PD-L1 inhibitors,” said Dr.
Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “We
appreciate the FDA’s recognition of our endeavors to develop new
therapies for SCLC patients and, based on experience in other
cancers, are hopeful that toripalimab may provide a significant
advance over chemotherapy in the JUPITER-08 study.”
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 thirty 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 European
countries. 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 China, toripalimab was the first domestic
anti-PD-1 monoclonal antibody approved for marketing (approved
in China as TUOYI®). Currently, there are four approved
indications for toripalimab in China:
- 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.
The first three indications have been included in
the National Reimbursement Drug List (“NRDL”) (2021 Edition).
Toripalimab is the only anti-PD-1 monoclonal antibody included in
the NRDL for melanoma and NPC.
In addition, two supplemental New Drug Applications
(“NDAs”) for toripalimab are currently under review by
the National Medical Products Administration (“NMPA”)
in China:
- in combination with
chemotherapy as the first-line treatment of patients with advanced
or metastatic ESCC.
- in combination with
chemotherapy as the first-line treatment of patients with advanced
or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA has granted
priority review for the toripalimab BLA for the treatment of
recurrent or metastatic NPC, an aggressive head and neck tumor
which has no FDA-approved immuno-oncology treatment options. The
FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target
action date for April 2022 for the toripalimab BLA. The
FDA granted Breakthrough Therapy designation for toripalimab in
combination with chemotherapy for the first-line treatment of
recurrent or metastatic NPC in 2021 as well as for toripalimab
monotherapy in the second or third-line treatment of recurrent or
metastatic NPC in 2020. Additionally, the FDA has granted Fast
Track designation for toripalimab for the treatment of mucosal
melanoma and Orphan Drug Designation for the treatment of
esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and
SCLC. In 2021, Coherus in-licensed rights to develop and
commercialize toripalimab in the United
States and Canada. Coherus and Junshi Biosciences plan to
file additional toripalimab BLAs with the FDA over the next three
years for multiple other cancer types.
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.
Junshi Biosciences was the first Chinese pharmaceutical company
that obtained marketing approval for anti-PD-1 monoclonal antibody
in China. Its first-in-human anti-BTLA monoclonal antibody for
tumors was the first in the world to be approved for clinical
trials by the FDA and NMPA and has since entered Phase Ib/II trials
in both China and the US. Its anti-PCSK9 monoclonal antibody was
the first in China to be approved for clinical trials by the
NMPA.
In the face of the COVID-19 pandemic, Junshi
Biosciences responded swiftly and strongly, joining forces with
Chinese and international scientific research institutions and
enterprises to develop an arsenal of drug candidates to combat
COVID-19, taking the initiative to shoulder the social
responsibility of Chinese pharmaceutical companies by prioritizing
and accelerating COVID-19 R&D. Among the many drug candidates
is JS016 (etesevimab), China’s first neutralizing fully human
monoclonal antibody against SARS-CoV-2 and the result of the
combined efforts of Junshi Biosciences, the Institute of
Microbiology of the Chinese Academy of Science and Lilly. JS016
administered with bamlanivimab has been granted Emergency Use
Authorizations (“EUA”) in over 15 countries and regions worldwide.
Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug
designed to hinder virus replication, is in global Phase III
clinical trials. The JS016 and VV116 programs are a part of the
company’s continuous innovation for disease control and prevention
of the global pandemic.
Junshi Biosciences has more than 2,800 employees in
the United States (San Francisco and Maryland) and China (Shanghai,
Suzhou, Beijing and Guangzhou). For more information, please visit:
http://junshipharma.com.
About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical
company building a leading immuno-oncology franchise funded with
cash generated by its commercial biosimilar business. In 2021,
Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the
United States and Canada. A biologics license application for
toripalimab for the treatment of metastatic or recurrent
nasopharyngeal carcinoma is currently under priority review by the
FDA with a target action date of April 2022. Toripalimab is also
being evaluated in pivotal clinical trials for the treatment of
cancers of the lung, breast, liver, skin, kidney, stomach,
esophagus, and bladder.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a
biosimilar of Neulasta® in the United States, and expects to launch
the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in
the United States in 2023. The FDA is currently reviewing the
biologics license application for CHS-201, a biosimilar of
Lucentis® (ranibizumab), with a target action date of August 2022.
Coherus is also developing CHS-305, a biosimilar of Avastin®
(bevacizumab).
Forward-Looking Statements
Except for the historical information contained
herein, the matters set forth in this press release are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding Coherus’
ability to build its immuno-oncology franchise to achieve a leading
market position; Coherus’ ability to generate cash; Coherus’
investment plans; Coherus’ expectations for the launch date of
YUSIMRY™ and other products; Coherus’ plans to file additional BLAs
for toripalimab; beliefs about toripalimab’s ability to enhance
treatment of patients in combination with chemotherapy; beliefs
about the need for new treatment options for SCLC; and expectations
for the timing of any clinical data from the Phase 3 study
evaluating toripalimab for SCLC.
Such forward-looking statements involve substantial
risks and uncertainties that could cause Coherus’ actual results,
performance or achievements to differ significantly from any future
results, performance or achievements expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the risks and uncertainties inherent in the clinical
drug development process; risks relating to the COVID-19 pandemic;
risks related to our existing and potential collaboration partners;
risks of the drug development position of Coherus’ competitors; the
risks and uncertainties of the regulatory approval process,
including the speed of regulatory review, international aspects of
Coherus’ business, the need to schedule inspections in China and
the timing of Coherus’ regulatory filings; the risk of FDA review
issues; the risk of Coherus’ execution of its change in strategy
from a focus on biosimilars to a strategy using cash from its
portfolio to fund an immuno-oncology franchise; the risk that
Coherus is unable to complete commercial transactions and other
matters that could affect the availability or commercial potential
of Coherus’ drug candidates; and the risks and uncertainties of
possible litigation. All forward-looking statements contained in
this press release speak only as of the date of this press release.
Coherus undertakes no obligation to update or revise any
forward-looking statements. For a further description of the
significant risks and uncertainties that could cause actual results
to differ from those expressed in these forward-looking statements,
as well as risks relating to Coherus’ business in general, see
Coherus’ Annual Report on Form 10-K for the year ended December 31,
2021, filed with the Securities and Exchange Commission on February
23, 2022, including the section therein captioned “Risk Factors”
and in other documents Coherus files with the Securities and
Exchange Commission.
UDENYCA®, YUSIMRY™ and CIMERLI™, whether or not
appearing in large print or with the trademark symbol, are
trademarks of Coherus, its affiliates, related companies or its
licensors or joint venture partners, unless otherwise noted.
Trademarks and trade names of other companies appearing in this
press release are, to the knowledge of Coherus, the property of
their respective owners.
Coherus Contact Information:
IR Contact:
McDavid Stilwell
Chief Financial Officer
Coherus BioSciences, Inc.
IR@coherus.com
Media Contact:
Brian Grancagnolo
Brian.Grancagnolo@hkstrategies.com
+1 (212) 885-0449
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300
Goby Global
Bob Ai
bai@gobyglobal.com
+ 1 646-389-6658
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
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