CStone Pharmaceuticals announced a strategic partnership and exclusive licensing agreement with Shenyang Sunshine Pharmaceutical Co. Ltd., a subsidiary of 3SBio Inc., for nofazinlimab (anti-PD-1 antibody) in mainland China on November 1, 2023. This strategic partnership marks another milestone in CStone's mission to introduce innovative oncology therapies in mainland China.

Key Highlights: CStone to grant 3SBio exclusive rights for the development, registration, manufacturing, and commercialization of nofazinlimab (anti-PD-1 antibody) in mainland China. CStone to retain the rights to nofazinlimab outside mainland China; This partnership will combine the strengths of CStone and 3SBio in research and development, manufacturing, and commercialization, thus accelerating the clinical development and commercialization of nofazinlimab and benefitting more patients in mainland China; The global multi-regional Phase III study CS1003-305 of nofazinlimab in combination with lenvatinib versus placebo in combination with lenvatinib as first-line treatment for advanced hepatocellular carcinoma has completed patient enrollment and been making steady progress. Disclosure of the topline results is expected in the first quarter of 2024; Proof-of-concept data reported at the 2022 American Society of Clinical Oncology annual meeting indicated that the combination of nofazinlimab and lenvatinib achieved robust and durable efficacy and manageable safety profile as the first-line treatment of advanced HCC.

Data from the first-in-human ("FIH") trial of nofazinlimab (CS1003-101), published in the British Journal of Cancer in September 2023, indicated that nofazinlimab monotherapy was well tolerated without observing dose-limiting toxicities and demonstrated preliminary anti-tumor activity in multiple tumor types. Under the terms of the agreement, CStone will receive an upfront payment of RMB60 million, development and registration milestone payments reaching approximately RMB 100 million, and additional payments for future sales-based milestones and tiered sales royalties. 3SBio will obtain the exclusive rights for the development, registration, manufacturing, and commercialization of nofazinlimab in mainland China.

CStone retains the rights to nofazinlimab outside mainland China and is actively looking for partners.