SUZHOU, China, May 31, 2020 /PRNewswire/ -- Innovent
Biologics, Inc. (Innovent) (HKEX: 01801), a world-class
biopharmaceutical company that develops, manufactures and
commercializes high quality medicines, jointly announced with Eli
Lilly and Company (Lilly) (NYSE: LLY) the research results of
TYVYT® (sintilimab injection) ORIENT-1 study for the
treatment of relapsed or refractory classic Hodgkin's lymphoma (r/r
cHL), at the 56th Annual Meeting of the American Society
of Clinical Oncology (ASCO) (Abstract # 8034, Poster # 367,
8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).
The ORIENT-1 study is a multicenter, single-arm, Phase 2
clinical trial, assessing the efficacy and safety of sintilimab in
r/r cHL. Subjects received 200 mg of sintilimab every three weeks
in this study until disease progression. A total of 96 subjects
with r/r cHL were enrolled, and the study's primary endpoint was
objective response rate (ORR) assessed by an independent imaging
assessment committee (IRRC). In addition, the complete response
(CR) rate was a secondary endpoint in the ORIENT-1 study.
As of the data cutoff on September 30,
2019, the ORR was 85.4% (82/96) based on IRRC review, of
which 41 patients (42.7%) achieved complete response (CR).
Professor Yuan-kai Shi, Associate Dean from the Cancer Hospital of
the Chinese Academy of Medical Sciences and Director of the
Department of Oncology, said: "Treatment options for patients with
r/r cHL remain limited, and new drugs with long-lasting efficacy
and good safety are urgently needed. The results of long-term
follow-up of the ORIENT-1 study showed that sintilimab can bring
relatively more long-term benefits to r/r cHL patients."
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection), an innovative drug
developed with global quality standards jointly developed by
Innovent and Lilly in China, has
been granted marketing approval by the National Medical Products
Administration (NMPA) for relapsed or refractory classic Hodgkin's
lymphoma after second-line or later systemic chemotherapy, and
included in the 2019 Guidelines of Chinese Society of Clinical
Oncology for Lymphoid Malignancies. TYVYT® (sintilimab
injection) is the only PD-1 inhibitor that has been included in the
new Catalogue of the National Reimbursement Drug List (NRDL) in
November 2019.
TYVYT® (sintilimab injection) is a type of
immunoglobulin G4 monoclonal antibody, which binds to PD-1
molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1
(PD-L1) pathway and reactivates T-cells to kill cancer cells.
Innovent is currently conducting more than 20 clinical studies with
TYVYT® (sintilimab injection) to evaluate its
safety and efficacy in a wide variety of cancer indications,
including more than 10 registration or pivotal clinical trials.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through
Action," Innovent's mission is to develop, manufacture and
commercialize high-quality biopharmaceutical products that are
affordable to ordinary people. Established in 2011, Innovent is
committed to developing, manufacturing and commercializing high
quality innovative medicines for the treatment of oncology,
autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main
Board of the Stock Exchange of Hong Kong Limited with the stock
code: 01801.HK.
Since its inception, Innovent has developed a fully integrated
multifunctional platform which includes R&D, CMC (Chemistry,
Manufacturing, and Controls), clinical development and
commercialization capabilities. Leveraging the platform, the
company has built a robust pipeline of 23 valuable assets in the
fields of oncology, autoimmune, metabolic diseases and other major
therapeutic areas, with 17 in clinical development, five in Phase 3
or pivotal clinical trials, four under NDA reviews by the NMPA
(three under priority review status), while TYVYT®
(sintilimab injection), officially approved for marketing in
China in 2018, has been the only
PD-1 inhibitor included in the NRDL, since 2019.
Innovent has built an international team of advanced talents in
high-end biological drug development and commercialization,
including many overseas experts. The company has also entered into
strategic collaborations with Eli Lilly and Company, Adimab,
Incyte, MD Anderson Cancer Center, Hanmi and other international
partners. Innovent strives to work with all relevant parties to
help advance China's
biopharmaceutical industry, improve drug availability to ordinary
people and enhance the quality of the patients' lives. For more
information, please visit: www.innoventbio.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.com.
About Innovent Biologics' strategic cooperation with Eli
Lilly and Company
Innovent entered into a strategic collaboration with Lilly
focusing on biological medicine in March
2015 – a groundbreaking partnership between a Chinese
pharmaceutical company and a multinational pharmaceutical company.
Under the agreement, Innovent and Lilly are co-developing and
commercializing oncology medicines, including TYVYT®
(sintilimab injection) in China.
In October 2015, the two companies
announced the extension of their existing collaboration to include
co-development of three additional antibodies targeting oncology
indications. In August 2019, Innovent
entered into an additional licensing agreement with Lilly to
develop and commercialize a potentially global best-in-class
diabetes medicine in China. Its
collaboration with Lilly indicates that Innovent has established a
comprehensive level of cooperation between China's innovative pharmaceuticals sector and
the international pharmaceuticals sector in fields such as R&D,
CMC, clinical development and commercialization.
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SOURCE Innovent Biologics, Inc.