CStone Presented Preclinical Data for Three Novel or Differentiated ADCs at AACR 2026, Including CS5007 (EGFR/HER3)
SUZHOU, China, April 19, 2026 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, today announced that the Company pr...
CStone Announces 2025 Annual Results: Accelerated Expansion of Global Commercial Footprint and Efficient Advancement of Innovation Pipeline 2.0
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...
CStone Updated Clinical Progress and Key Phase I/II Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)
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, with23% i...
CStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
* 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 Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
* CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA)to initiate a Phase II clinical trial inpatients with advanced solid tumors. This marks a significant milestone in the global development of thi...
ACAAI 2025 | CS2015 (OX40L/TSLP Bispecific Antibody) Makes International Debut
SUZHOU, China, Nov. 6, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced that the Company will ...
ESMO 2025: CStone Discloses Phase I Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)
SUZHOU, China, Oct. 19, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced the first disclosure...
CStone Presents Preclinical Results of CS2011 (EGFR/HER3 bispecific antibody), CS5007 (EGFR/HER3 bispecific ADC), CS5005 (SSTR2 ADC) and CS5006 (ITGB4 ADC) at 2025 AACR
SUZHOU, China, May 6, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on anti-cancer therapies, announced today that poster presentations of preclinical data of CS2011 (EGFR/HER3 bispecific antibody), CS5007 (EGFR/HER3 bis...
CStone Pharmaceuticals Announces 2024 Annual Results and Recent Business Progress
Financial Performance: Strong Year-over-Year Improvement - Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income. - Net Loss Reduction: 71.5% year-over-year improvement. Key Product Advancements - Sugemalimab (Anti-PD-L1 mAb) - Regulatory...
CStone to Showcase Five Latest Research Achievements at AACR 2025
SUZHOU, China, March 25, 2025 /PRNewswire/ -- From April 25 to 30, 2025, the American Association for Cancer Research (AACR) Annual Meeting will take place inChicago. CStone will showcase its latest preclinical studies on five internally developed innovative candidates, including the trispecific ...
CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer
SUZHOU, China, March 23, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab. T...
CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL
* Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. * CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor...
CStone Announces First Patient Dosed in Global Multicenter Phase I Clinical Trial of CS2009, a PD-1/VEGF/CTLA-4 Trispecific Antibody
SUZHOU, China, March 3, 2025 /PRNewswire/ --CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced thatthe first patient has been successfully dosed in the global multicenter P...
CStone Announces Publication of GEMSTONE-303 Study Results for Sugemalimab (Cejemly®) in JAMA
* Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for the treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The GEMSTONE-303 study results supportsugemalimab in combination with chemotherapy as a new standard first-line treatmentfor patients wit...
CStone Announces Inclusion of Cejemly® (sugemalimab) as a First-Line Combination Therapy for NSCLC in ESMO Guideline
SUZHOU, China, Feb. 9, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that its key product, Cejemly® (sugemalimab), has been included in the Europe...
CStone Partners with SteinCares to Market Sugemalimab in Latin America
* CStone will receive upfront, regulatory and commercial milestone payments, and book revenue from SteinCares through the supply of sugemalimab in 10 Latin American (LATAM) countries. * This marks CStone's third major global commercialization partnership for sugemalimab, with additional deals...
CStone Announces Submission of Clinical Trial Application in Australia for CS2009, an Innovative PD-1/VEGF/CTLA-4 Trispecific Antibody
SHANGHAI, Dec. 22, 2024 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced today the submission of clinical trial application inAustralia for CS2009 (PD-1/VEGF/CT...
Encouraging Efficacy and Safety: CStone Presents Latest Clinical Data on CS5001 for Advanced Lymphoma at the 66th ASH Annual Meeting
* CS5001 is so far the first anti-ROR1 ADC known to show clinical anti-tumor activity in both solid tumors and lymphomas. The data presented at ASH highlighted the latest safety and efficacy of CS5001 as a monotherapy for patients with advanced lymphomas. * CS5001 is well tolerated in heavily...
CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC) in the UK
* This approval marks the second international marketing authorization for sugemalimab outside ofChina, following its recent approval by the European Commission. * The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination...
CStone Reports 2024 Interim Results and Recent Corporate Updates
* Total revenue of RMB 254.2 million for 2024 H1; achieving first-time profitability with cash reserve atRMB 814 million as of June 30, 2024. * NDA approval of sugemalimab (PD-L1) for Stage IV NSCLC in EU, marking the first successful international approval of aChina domestic anti-PD-L1 mAb. ...
