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 for the treatment of esophageal cancer.
Orphan drug designation is granted to drugs and biologics intended
to treat rare diseases with a patient population less than 200,000
in the U.S. The designation provides incentives to advance
development and commercialization of rare disease drugs.
Esophageal cancer (“EC”) is a malignant tumor originating in the
inner lining of the esophagus. Esophageal squamous cell carcinoma
(“ESCC”) and adenocarcinoma are the two main subtypes of esophageal
cancer. EC is rare in the United States, with approximately 19,000
newly diagnosed cases and 15,000 deaths annually, according to
estimates from the American Cancer Society. The prognosis of
patients with advanced EC is poor, with five-year survival rates of
less than 20%.
“Esophageal squamous cell carcinoma is an aggressive cancer, and
patients need new and better treatment options. We plan to work
closely with our partner, Junshi Biosciences, to submit a BLA
supplement for toripalimab for this indication in 2022,” said Denny
Lanfear, CEO of Coherus.
In September, Coherus and Junshi Biosciences announced results
of the Phase 3 clinical trial, JUPITER-06, a randomized, double
blind, placebo-controlled study evaluating toripalimab in
combination with chemotherapy as a first-line therapy for patients
with advanced or metastatic ESCC. The study met the co-primary
endpoints with statistically significant and clinically meaningful
improvements in progression free survival (PFS) and overall
survival (OS) for patients treated with the toripalimab and
chemotherapy combination, compared to chemotherapy alone. In 2022,
Coherus and Junshi Biosciences are planning to submit a biologics
license application (“BLA”) supplement to the FDA for toripalimab
in combination with platinum-based chemotherapy for the first-line
treatment of advanced or metastatic ESCC. A BLA for toripalimab for
advanced recurrent or metastatic nasopharyngeal carcinoma is
currently under priority review by the FDA with a target action
date of April 2022.
About ToripalimabToripalimab 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 is thought to recharge 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, 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®). On December 17, 2018,
toripalimab was granted a conditional approval by the National
Medical Products Administration (NMPA) for the second-line
treatment of unresectable or metastatic melanoma. In December
2020, toripalimab was successfully included in the updated National
Reimbursement Drug List. In February 2021, the NMPA granted a
conditional approval to toripalimab for the treatment of patients
with recurrent or metastatic nasopharyngeal carcinoma ("NPC") after
failure of at least two lines of prior systemic therapy. In April,
the NMPA granted a conditional approval to toripalimab for the
treatment of patients with locally advanced or metastatic
urothelial carcinoma who failed platinum-containing chemotherapy or
progressed within 12 months of neoadjuvant or adjuvant
platinum-containing chemotherapy. In addition, two
supplemental NDAs, one for toripalimab in combination with
chemotherapy for the first-line treatment of patients with
advanced, recurrent or metastatic NPC, and the other for the
first-line treatment of patients with advanced or metastatic
esophageal squamous cell carcinoma, were accepted by the NMPA for
review in February and July 2021, respectively.
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 currently
has no FDA-approved immuno-oncology treatment options. Earlier, the
FDA granted Breakthrough Therapy designation for toripalimab in
combination with chemotherapy for the 1st line treatment of
recurrent or metastatic NPC as well as for toripalimab monotherapy
in the second or third-line treatment of recurrent or metastatic
NPC. Additionally, the FDA has granted Fast Track designation for
toripalimab for the treatment of mucosal melanoma and orphan drug
designation for esophageal cancer, NPC, mucosal melanoma and soft
tissue sarcoma. Earlier 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 Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the
mission to increase access to cost-effective medicines that can
have a major impact on patients’ lives and to deliver significant
savings to the health care system. Coherus’ strategy is to build a
leading immuno-oncology franchise funded with cash generated by its
commercial biosimilar business. For additional information, please
visit www.coherus.com.
Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United
States and through 2023 expects to launch toripalimab, an anti-PD-1
antibody, as well as biosimilars of Lucentis®, Humira®, and
Avastin®, if approved.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech,
Inc.
Humira® is a registered trademark of AbbVie Inc.
About Junshi BiosciencesFounded
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 45 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 antibody for solid tumors was the first in the world to
be approved for clinical trials by the FDA and NMPA and its
anti-PCSK9 monoclonal antibody was the first in China to
be approved for clinical trials by the NMPA. In early 2020, Junshi
Biosciences joined forces with the Institute of Microbiology
of Chinese Academy of Science and Eli Lilly to co-develop
JS016 (etesevimab), China’s first neutralizing fully human
monoclonal antibody against SARS-CoV-2. JS016 administered with
bamlanivimab has been granted Emergency Use Authorizations (EUA) in
15 countries and regions worldwide. The JS016 program is a part of
our continuous innovation for disease control and prevention of the
global pandemic. Junshi Biosciences has over 2,500 employees in the
United States (San Francisco and Maryland) and China (Shanghai,
Suzhou, Beijing and Guangzhou). For more information, please visit:
http://junshipharma.com.
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, Coherus’ ability to generate cash flow from its
UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to
co-develop toripalimab, and Coherus’ ability to commercialize
toripalimab, or any other drug candidates developed as part of its
collaboration with Junshi Biosciences in the licensed territory;
Coherus’ ability to expand a late-stage pipeline into the rapidly
growing checkpoint inhibitor market; any market size expectation
for checkpoint inhibitor therapeutic agents in the United
States; the expected filing of a BLA supplement seeking approval
for toripalimab for ESCC in 2022; the ability for ex-US clinical
trial data from a single country to support an approval by the FDA;
the potential for toripalimab to gain approval in the United
States for nasopharyngeal carcinoma, esophageal squamous cell
carcinoma, lung cancer, or any indication; Coherus’ and Junshi
Biosciences’ plans to file additional toripalimab BLAs with the FDA
over the next three years for other clinical indications; Coherus’
plans to invest the cash generated by its biosimilar commercial
business to build a focused immuno-oncology franchise; Coherus’
ability to prepare for projected launches through 2023 of
biosimilars of Humira®, Avastin® and Lucentis®, if approved.
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; the risks and uncertainties of the
regulatory approval process, including the speed of regulatory
review and the timing of Coherus’ regulatory filings; the risk of
FDA review issues; 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 patent litigation. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Coherus undertakes no
obligation to update or revise any forward-looking statements. For
a further description of the 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, 2020, filed with the Securities and
Exchange Commission on February 25, 2021,its Quarterly Report on
Form 10-Q for the three and nine months ended June 30, 2021, filed
with the Securities and Exchange Commission on November 8, 2021 and
its future periodic reports to be filed with the Securities and
Exchange Commission. Results for the quarter ended September 30,
2021 are not necessarily indicative of our operating results for
any future periods.
Coherus Contact Information:IR Contact:McDavid
StilwellCoherus BioSciences, Inc.IR@coherus.com
Media Contact:Cheston TurbyfillCoherus BioSciences,
Inc.Cturbyfill@coherus.com
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-2250 0300
Solebury TroutBob Aibai@soleburytrout.com+ 1 646-389-6658
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800
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