CStone Pharmaceuticals
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in mil. unless spec.Company Description
- CEO
- Jian Xin Yang
- Full Time Employees
- 93
- Sector
- Health technology
- Industry
- Pharmaceuticals: major
- Address
- C1 Building Shanghai China 215123
- IPO Date
- Feb 26, 2019
- Website
- cstonepharma.com
- Similar Companies
- Business
- CStone Pharmaceuticals (HKEX: 2616), founded in 2015 and headquartered in Suzhou, China, is an innovation-driven biopharmaceutical company that researches, develops and commercializes immuno-oncology, precision medicines and antibody-drug conjugates (ADCs) targeting oncology, autoimmune and inflammatory diseases for patients primarily in China and globally. The company offers CEJEMLY (sugemalimab), a fully human anti-PD-L1 monoclonal antibody approved in China for five indications including first-line stage IV non-small cell lung cancer (NSCLC), stage III NSCLC, relapsed/refractory extranodal NK/T-cell lymphoma, esophageal squamous cell carcinoma and gastric/gastroesophageal junction adenocarcinoma, as well as approved in the EU and UK for first-line metastatic NSCLC; AYVAKIT (avapritinib), a KIT/PDGFRA inhibitor for unresectable or metastatic gastrointestinal stromal tumors harboring PDGFRA exon 18 mutations including D842V; GAVRETO (pralsetinib), a RET inhibitor for RET fusion-positive NSCLC, medullary thyroid cancer and thyroid cancer; nofazinlimab (CS1003), a PD-1 antibody in phase III for hepatocellular carcinoma; CS1002, a CTLA-4 antibody for solid tumors; and a Pipeline 2.0 featuring 16 candidates including CS5001 (ROR1 ADC) in phase Ib for lymphomas and solid tumors, CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in global phase I for solid tumors, plus preclinical ADCs such as CS5007 (EGFR/HER3), CS5005 (SSTR2), CS5008 (DLL3/SSTR2), CS5006 (ITGB4) and bispecifics for autoimmune diseases, supported by an in-house ADC platform with proprietary linkers. Recent developments include new NDA approvals for sugemalimab in gastric cancer in China and NSCLC in the EU/UK in 2024; strategic commercialization partnerships for sugemalimab with Ewopharma (Central/Eastern Europe and Switzerland, May 2024), Pharmalink (MENA and South Africa, November 2024) and SteinCares (Latin America, January 2025), with further deals anticipated in Western Europe, Southeast Asia and Canada; NMPA approval for localized manufacturing of AYVAKIT in 2024 with full transition expected in 2025 and exclusive promotion rights granted to Hengrui Pharmaceuticals in July 2024; ongoing regulatory review for GAVRETO manufacturing localization; phase Ib advancement and compelling data for CS5001 at ASCO/ASH 2024 showing objective response rates up to 100% in Hodgkin lymphoma; global phase I initiation for CS2009 with first patient dosed in March 2025; and preclinical expansion into autoimmune therapies. CStone operates through subsidiaries with commercial partnerships including Pfizer in China for sugemalimab, Allist for GAVRETO and Hengrui for AYVAKIT, focusing on greater China while expanding ex-China presence across Europe, Middle East, Africa, Latin America and beyond.
Company News
CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum
CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum
CStone Pharmaceuticals Enters into Exclusive Commercialization Agreement with Arrotex for Sugemalimab across Australia and New Zealand
ASCO 2026 | CStone Presents Updated Clinical Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody), Reinforcing Triple-Target Synergy and Delivering Strong Proof-of-Concept
CStone Presented Preclinical Data for Three Novel or Differentiated ADCs at AACR 2026, Including CS5007 (EGFR/HER3)
CStone Announces 2025 Annual Results: Accelerated Expansion of Global Commercial Footprint and Efficient Advancement of Innovation Pipeline 2.0
CStone Updated Clinical Progress and Key Phase I/II Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)
CStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial