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CStone Pharmaceuticals, a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative immuno-oncology therapies and precision medicine, and Jiangsu Hengrui Pharmaceuticals today announced a strategic partnership and exclusive license agreement for the anti-CTLA-4 mAb CS1002 in the Greater China region. This strategic partnership is another milestone in CStone’s mission to bring innovative oncology therapies to China, following the launch of two first-in-class drugs this year.

Under the agreement, CStone will receive an upfront payment and potential milestone payments of up to $200 million, as well as double-digit royalties. Hengrui will receive exclusive rights to research, develop, register, manufacture, and commercialize the anti-CTLA-4 mAb CS1002 in Greater China. CStone retains rights to develop and commercialize 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 worldwide, and it is also approved in China. According to EvaluatePharma, annual global sales of the product were approximately $1.69 billion in 2020. CS1002 is an anti-CTLA-4 monoclonal antibody being developed by CStone and is currently in clinical development. Results from the ongoing Ph1a/1b trial demonstrated that differentiated dosing regimens of CS1002 in combination with CS1003 (anti- PD -1) were well tolerated and very encouraging efficacy in anti- PD -(L)1-refractory melanoma, anti- PD -(L)1-refractory hepatocellular carcinoma, and anti- PD -(L)1-naive pretreated tumors with high microsatellite instability/deficient mismatch repair (MSI-H/dMMR).

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 integration 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.”