CStone Pharmaceuticals, an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), which is one of the largest cancer indications and a leading cause of cancer death in the world. Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, also making CStone the very first biopharmaceutical company in China to potentially launch a domestic anti-PD-L1 mAb in ex-China markets.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of CStone’s sugemalimab, an anti-PD-L1 monoclonal antibody (mAb), for first-line treatment of metastatic non-small cell lung cancer (NSCLC).
SUZHOU, China, June 1, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), which is one of the largest cancer indications and a leading cause of cancer death in the world. Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, also making CStone the very first biopharmaceutical company in China to potentially launch a domestic anti-PD-L1 mAb in ex-China markets.
Suzhou-based CStone Pharmaceuticals’ checkpoint inhibitor sugemalimab has proved effective in a trial as a first-line therapy for oesophageal cancer, setting up a regulatory filing in China.
EQRx – a focused on expanding access to innovative medicines – has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a marketing authorisation application (MAA) for sugemalimab.
A Pfizer cancer drug partner in China is considering a sale as the biotech’s commercial path in the U.S. looks uncertain and competition in its home country intensifies. CStone Pharmaceuticals is exploring strategic options including a sale, Bloomberg reports, citing people familiar with the company.
A combination of EQRx and CStone’s PD-(L)1 drug sugemalimab and chemotherapy significantly prolonged patients’ lives over placebo in patients with newly diagnosed stage IV non-small cell lung cancer, according to updated data from the Phase III GEMSTONE-302 study unveiled Tuesday evening.