CStone Pharmaceuticals·Healthcare

Rapid Advancement Across Core R&D Pipeline The global, multicenter Phase I/II clinical trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) is actively enrolling patients in Australia and China, and the Phase II IND application has been approved in the US. CS2009 demonstrates an excellent safety profile with a ≥Grade 3 TRAE rate of 23% , along with broad-spectrum anti-tumor activity.

Key Highlights: Excellent Safety Profile: As of mid-March 2026, 113 heavily pretreated patients with solid tumors have been enrolled in the Phase I trial of CS2009, with a median follow-up of approximately 6 months. The more mature data continue to show a favorable safety profile, with 23% incidence of Grade ≥3 Treatment-Related Adverse Events (TRAEs).

Following approval by the European Commission (EC), sugemalimab has received a new indication approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for stage III non-small cell lung cancer (NSCLC). This marks the second indication approved for the product in the UK.
CStone Pharmaceuticals, a biopharmaceutical company, researches, develops, and commercializes immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and internationally. It offers Sugemalimab, a monoclonal antibody against programmed death (PD) ligand 1; GAVRETO, an RET inhibitor for the treatment of patients with advanced or metastatic RET-mutant medullary and RET fusion-positive thyroid cancers; and avapritinib, a KIT/PDGFRA inhibitor to treat adults with unresectable or metastatic gastrointestinal stromal tumors harboring a PDGFRA exon 18 mutation. The company's product pipeline includes Nofazinlimab, a PD-1 antibody for the treatment of patients with hepatocellular carcinoma; Ivosidenib, an isocitrate dehydrogenase 1 (IDH1) inhibitor to treat adults with relapsed or refractory acute myeloid leukemia with an IDH1 mutation; and Fisogatinib, an FGFR4 inhibitor to treat hepatocellular carcinoma. Its products also comprise CS1002, CS2006, CS3002, CS3005, CS2007, CS2008, and CS500 for solid tumors; and CS5001 for solid tumors and hematologic malignancies. The company was incorporated in 2015 and is headquartered in Shanghai, China.
Healthcare
Biotechnology
135
2020-09-14
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