CStone developed sugemalimab, the first Chinese PD-L1 antibody approved in Europe, and brought pralsetinib, avapritinib and ivosidenib to China.
CStone Pharmaceuticals, based in Suzhou and Shanghai, founded in 2015 and listed in Hong Kong as 2616.HK, developed sugemalimab, the first Chinese PD-L1 antibody approved in Europe, and brought pralsetinib, avapritinib and ivosidenib to China. Sugemalimab, sold as Cejemly, was approved in China in 2021 and in the European Union in 2024 on the GEMSTONE-302 trial, the company holds Greater China rights to the three in-licensed drugs, and its pipeline includes ADCs and a PD-L1 by VEGF by CTLA-4 trispecific. OnCo links it to all four drugs and to GEMSTONE-302. The record describes it as a capital-constrained example of the 2015 biotech wave that relied on in-licensing plus one internal asset. Whether a European approval for a PD-L1 antibody can be turned into revenue in a crowded class is the open question.
Sugemalimab is CStone's PD-L1 antibody, approved in China for first-line lung cancer with chemotherapy and after chemoradiotherapy in stage III disease, and the first China-developed PD-L1 antibody to win European approval.
Pralsetinib is the second selective RET pill for lung cancer, less used than selpercatinib after a change of owner and label.
Avapritinib is the first drug for GIST driven by the PDGFRA D842V mutation, which resists every other kinase inhibitor; it is also approved for systemic mastocytosis.
The first drug to block a mutant metabolic enzyme in cancer. With azacitidine it tripled survival in IDH1-mutated AML that could not take intensive chemotherapy.
Shares Pralsetinib, Ivosidenib.