Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”,
“Junshi”, HKEX: 1877; SSE: 688180) and Coherus BioSciences,
Inc. (“Coherus”, Nasdaq: CHRS) announced today that the U.S.
Food and Drug Administration (“FDA”, “the Agency”) has issued a
complete response letter (“CRL”) for the Biologics License
Application (“BLA”) for toripalimab in combination with gemcitabine
and cisplatin in the first-line treatment of patients with advanced
recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for
toripalimab monotherapy in the second-line or later treatment of
recurrent or metastatic NPC after platinum-containing chemotherapy.
The CRL requests a quality process change that Coherus and
Junshi Biosciences believe is readily addressable. Coherus and
Junshi Biosciences plan to meet with the FDA directly and expect to
resubmit the BLA by mid-summer 2022. The Agency also communicated
in the CRL that the review timeline for the BLA resubmission would
be six months, as required onsite inspections have been hindered by
travel restrictions related to the COVID-19 pandemic in China.
“We will continue to work closely with our partner, Junshi
Biosciences, to facilitate the completion of the FDA’s review of
the toripalimab BLA. In late April, we responded quickly to an FDA
request for a quality process change and implemented required
actions,” said Denny Lanfear, CEO of Coherus. “We plan to first
meet with the FDA and directly thereafter to resubmit the BLA. The
FDA has indicated that the existing toripalimab clinical data are
supportive of the BLA submission, and we eagerly await scheduling
and completion of the required inspections in China that have been
impeded to date by COVID-related travel restrictions. We believe
toripalimab addresses an important unmet need for patients with NPC
for whom there are currently no approved immunotherapies in the
United States, and the FDA has stated that this indication warrants
regulatory flexibility with respect to the sufficiency of single
country clinical data.”
“Junshi Biosciences is dedicated to the discovery, development
and commercialization of innovative new drugs on a global scale,”
said Dr. Ning Li, CEO of Junshi Biosciences. “Toripalimab, our PD-1
inhibitor, has demonstrated a compelling clinical profile in
studies across multiple tumor types and is currently approved in
China for four indications. We fully support our partner, Coherus,
in its efforts to seek toripalimab approval in the United States
for advanced nasopharyngeal carcinoma, as well as in the subsequent
commercial launch, if approved. Our respective teams are working
diligently together in a well coordinated effort to achieve these
goals as partners.”
About Nasopharyngeal Carcinoma (NPC)
NPC is a type of aggressive cancer that starts in the
nasopharynx, the upper part of the throat behind the nose and near
the base of skull. Due to the location of the primary tumor,
surgery is rarely an option, and patients with localized disease
are treated primarily with radiation and chemotherapy. In the
United States, there are presently no immunotherapies approved for
the treatment of NPC.
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 granted Breakthrough Therapy
designation for toripalimab in combination with chemotherapy for
the first-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. Coherus and Junshi Biosciences plan
to resubmit a BLA for toripalimab for advanced NPC by mid-summer
2022. 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 several 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. Coherus plans to resubmit a BLA for
toripalimab for the treatment of advanced NPC by mid-summer 2022.
Toripalimab is also being evaluated in pivotal clinical trials for
the treatment of rare and highly prevalent cancers.
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;
expectations about the success and timing of the toripalimab BLA
resubmission and the associated BLA review; and Coherus’
expectations about being able to overcome COVID-19-related travel
restrictions to finish required onsite inspections for
toripalimab.
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® and YUSIMRY™, 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 StilwellChief Financial OfficerCoherus BioSciences,
Inc.IR@coherus.com
Media Contact:Brian
GrancagnoloBrian.Grancagnolo@hkstrategies.com+1 (212)
885-0449
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-2250 0300
Goby GlobalBob Aibai@gobyglobal.com+ 1 646-389-6658
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800
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