CStone Pharmaceuticals announced today (October 31) that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab combined with platinum-containing chemotherapy for patients without EGFR sensitive mutations, or without ALK, ROS1, First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with RET genomic tumor variants.

This is the second marketing authorization application approval for sugalimab in overseas markets, following the approval by the European Commission. The approval was mainly based on the results of a multi-center, randomized, double-blind Phase III clinical study - GEMSTONE-302. Sugemalimab combined with chemotherapy can significantly extend the progression-free survival and overall survival of patients with newly treated metastatic NSCLC compared with placebo combined with chemotherapy. The research data has been published in The Lancet Oncology and Nature Cancer, and has been presented in oral and poster presentations at many international academic conferences.

CStone Pharmaceuticals has reached a strategic cooperation with Ewopharma for the commercialization of sugalimab in Central and Eastern Europe and Switzerland, and is expected to reach more commercial cooperation agreements in Western Europe, Latin America, the Middle East, Southeast Asia and other regions in the near future. According to the press release, sugemalimab is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. The development of sugemalimab is based on the OmniRat® transgenic animal platform licensed and introduced by the American company Ligand.

Currently, NMPA has approved sugalimab for 5 indications: first-line treatment of patients with metastatic squamous and non-squamous NSCLC in combination with chemotherapy; treatment of unresectable, stage III NSCLC that has not progressed after concurrent or sequential chemoradiotherapy. Patients; treatment of patients with relapsed or refractory extranodal NK/T cell lymphoma; combination of fluorouracil and platinum chemotherapy drugs as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; combination of fluorouracil and platinum Pharmacological chemotherapy is used as first-line treatment for unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 (composite positive score [CPS] ≥5).

The European Commission (EC) has approved sugemalimab combined with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC without EGFR-sensitizing mutations or ALK, ROS1, or RET genomic tumor mutations. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitizing mutations or ALK, ROS1, or RET genomic tumor mutations.

What other layouts are there? CStone Pharmaceuticals, established in 2015, is an innovation-driven biopharmaceutical company focusing on the research and development of anti-tumor drugs. So far, CStone Pharmaceuticals has successfully launched 4 innovative drugs, and has been approved for 15 new drug applications (NDA) and 9 indications. The current R&D pipeline is evenly equipped with 16 drug candidates, including potentially first-in-class or best-in-class antibody drug conjugates (ADCs), multispecific antibodies, immunotherapy and precision therapy drugs.

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