SUZHOU - CStone Pharmaceuticals ('CStone', HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today announced that early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR), has been granted by the United States Federal Trade Commission in connection with the licensing agreement between CStone and EQRx.
The licensing agreement has now become effective.
As previously announced, CStone has entered into an agreement to out-license ex-Greater China rights for two key late-stage immuno-oncology assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx. Under the terms of the agreement, CStone will receive an upfront payment of US$150 million and up to US$1.15 billion in milestone payments for both drugs as well as separate tiered royalties, as previously referenced in CStone's Oct. 27, 2020 press release. EQRx obtains exclusive rights to lead global development and commercialization, excluding Mainland China, Taiwan, Hong Kong and Macau. CStone retains rights to CS1003 in Greater China, where it can continue to pursue development as a monotherapy or as part of its combination strategy for this drug.
About Sugemalimab (PD-L1)
Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. China's National Medical Products Administration (NMPA) has accepted the company's New Drug Application (NDA) for sugemalimab. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.
Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and Phase 1b of the study, sugemalimab showed good antitumor activity and tolerability in multiple tumor types.
Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 bridging study in the U.S., the clinical program in China includes one multi-arm Phase 1b study for several tumor types, one Phase 2 registrational studies for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV NSCLC, gastric cancer, and esophageal cancer. The phase III clinical trial of sugemalimab in the treatment of stage IV non-small cell lung cancer reached the primary endpoint.
About CS1003 (PD-1)
CS1003 is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed for immunotherapy of various tumors. Compared to most of the monoclonal antibodies that bind human and monkey PD-1 (either already approved or in clinical stage), CS1003 demonstrates comparable high binding affinities across species against human, cynomolgus monkey and mouse PD-1, and is developed to disrupt the interaction of PD-1 with its ligands PD-L1 and PD-L2.
About CStone
CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 16 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become a world-renowned biopharmaceutical company that is leading the way to conquering cancer.
About EQRx
EQRx is committed to making innovative medicines at dramatically lower prices for the benefit of people and society. By bringing together stakeholders from across the healthcare system and utilizing the latest advances in science and technology, the company seeks to discover, develop and deliver high-quality, patent-protected medicines more efficiently and cost-effectively than ever before. Headquartered in Cambridge, Massachusetts, the company is backed by GV, ARCH Venture Partners, Andreessen Horowitz, Casdin Capital, Section 32, Nextech, and Arboretum Ventures.
Forward-looking Statement
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Contact:
Tel: + 86-0512-8718-6550
Email: cstone@cstonepharma.com
CSTONE PHARMACEUTICALS 
