Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
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
The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals
According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of ALK-mutant NSCLC in China is estimated to grow at a CAGR of 5.3% from 22,725 in 2021 to 31,902 in 2029
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