PR93199

CStone Pharmaceuticals and Jiangsu Hengrui Pharmaceuticals announce strategic partnership and exclusive licensing agreement on anti-CTLA-4 monoclonal antibody CS1002 in Greater China

SUZHOU, China, Nov. 21, 2021 /PRNewswire=KYODO JBN/ --

- CStone granted the exclusive rights to Hengrui for research, development,

registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in

the Greater China region

- CStone will retain the rights to develop and commercialize anti-CTLA-4 mAb

CS1002 outside of Greater China

- CStone and Hengrui will partner respective R&D and commercial expertise to

accelerate the development and commercialization of anti-CTLA-4 mAb CS1002, a

backbone immuno-oncology asset, to fully unleash its commercial value

CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical

company focused on the research, development, and commercialization of

innovative immuno-oncology therapies and precision medicines, and Jiangsu

Hengrui Pharmaceuticals ("Hengrui", SHSE: 600276) today announced a strategic

partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the

Greater China region. This strategic partnership marks another milestone in

CStone's mission to introduce innovative oncology therapies in China after the

commercial launch of two first-in-class drugs this year.

Under the terms of the agreement, CStone will be eligible for an upfront

payment and potential milestone payments up to $200 Mn in addition to

double-digit royalties. Hengrui will obtain the exclusive rights for research,

development, registration, manufacturing, and commercialization of anti-CTLA-4

mAb CS1002 in Greater China. CStone will retain the rights to develop and

commercialize of CS1002 outside of Greater China.

Cytotoxic T lymphocyte associated antigen 4 (CTLA-4) is one of the few

clinically validated targets for IO combination therapies. There is only one

anti-CTLA-4 monoclonal antibody approved globally, and it is also approved in

China. According to EvaluatePharma, the annual global revenue of the product in

2020 was approximately $1.69 billion. CS1002 is an investigational anti-CTLA-4

monoclonal antibody being developed by CStone currently in clinical

development. Results from the ongoing Ph1a/1b study showed that differentiated

dosing schedules of CS1002 in combination with CS1003 (anti-PD-1) were

well-tolerated and demonstrated very encouraging efficacy in

anti-PD-(L)1-refractory melanoma, anti-PD-(L)1-refractory hepatocellular

carcinoma, and anti-PD-(L)1-naïve, pretreated microsatellite instability

high/deficient mismatch repair (MSI-H/dMMR) tumors.

Dr. Frank Jiang, Chairman and CEO of CStone, said, "We are happy to reach the

partnership with Hengrui. As a leading global China pharmaceutical company with

an extensive oncology pipeline and strong integrated capabilities in

commercialization, we are very confident that Hengrui will bring the full

potentialities of CS1002 into the Greater China market. Through this

collaboration, we believe we will join forces to bring forward more

high-quality innovative oncology therapies to patients."

Dr. Lianshan Zhang, Member of the Board, Senior Vice President and President of

global R&D of Hengrui, said, "We are happy to enter into this collaboration

with CStone on the backbone immune-oncology asset of CS1002. With its

combination therapy potential, CS1002 will further synergize our pipeline,

enrich the oncology portfolio and strengthen our competitiveness. As a leading

Chinese biopharmaceutical company, CStone has demonstrated its outstanding

research and development capabilities with impressive early-stage clinical data

and differentiated dosing schedules of CS1002. We have full confidence in the

future development of it to provide more innovative drugs for Chinese patients."

About CS1002 (anti-CTLA-4 antibody)

CS1002 is an investigational anti-CTLA-4 monoclonal antibody being developed by

CStone. CS1002 is differentiated from prior CTLA-4 targeting drug in its dosing

schedules that have been tested in early development and the encouraging

efficacy and safety in three indications providing proof-of-concept for CS1002

as a potential backbone for IO combinations. Cytotoxic T lymphocyte associated

antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by

the CTLA-4 gene that can down-regulate the activity of T cells when binding

with its ligand, B7, a pathway also used by tumor cells to avoid T lymphocyte

attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell

activation and proliferation to induce or enhance anti-tumor immune responses.

CTLA-4 provides a new immuno-therapeutic approach to a number of human cancers.

About CStone

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on

researching, developing, and commercializing innovative immuno-oncology and

precision medicines to address the unmet medical needs of cancer patients in

China and worldwide. Established in 2015, CStone has assembled a world-class

management team with extensive experience in innovative drug development,

clinical research, and commercialization. The company has built an

oncology-focused pipeline of 15 drug candidates with a strategic emphasis on

immuno-oncology combination therapies. Currently, CStone has received three

drug approvals in Greater China, including two in Mainland China and one in

Taiwan. CStone's vision is to become globally recognized as a world-renowned

biopharmaceutical company by bringing innovative oncology therapies to cancer

patients worldwide.

For more information about CStone, please visit: www.cstonepharma.com.

About Hengrui

Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a leading global pharmaceutical

company based in China with a focus on research, development, manufacturing and

commercialization of innovative and high–quality healthcare products.

Innovation is the core development strategy. Hengrui Pharma has 8 innovative

products marketed, more than 50 innovative candidates in the R&D stage, more

than 20 innovative products under clinical development around the world.

Hengrui Pharma ranked 21st among the top 1,000 global pharma companies

announced by the Torreya in 2020. Hengrui Pharma has been on the Pharma Exec's

annual listing of the top global pharmaceutical companies for the third

consecutive year, rising from 47th in 2019 to 38th in 2021.

Forward-looking statement

The forward-looking statements made in this article only relate to events or

information as of the date when the statements are made in this article. Except

as required by law, we undertake no obligation to update or publicly revise any

forward-looking statements, whether as a result of new information, future

events or otherwise, after the date on which the statements are made or to

reflect the occurrence of unanticipated events. You should read this article

completely and with the understanding that our actual future results or

performance may be materially different from what we expect. All statements in

this article are made on the date of publication of this article and may change

due to future developments.

SOURCE: CStone Pharmaceuticals