CStone announced two key phase 3 registrational clinical trials of sugemalimab completed patient enrollment
* Both trials investigate first-line treatment with sugemalimab combined with chemotherapy in patients with metastatic gastric adenocarcinoma (GC)/gastro-esophageal junction (GEJ) adenocarcinoma or esophageal squamous cell carcinoma (ESCC) * A significant milestone in our pipeline development...
CStone announces the clinical data from registrational study of Sugemalimab in stage III non-small cell lung cancer published in The Lancet Oncology
SUZHOU, China, Jan. 15, 2022 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the registrational clinical...
CStone announces the registrational clinical study results of sugemalimab in stage IV non-small cell lung cancer published in The Lancet Oncology
SUZHOU, China, Jan. 15, 2022 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that results of the GEMSTONE-302...
CStone announces phase 2 GEMSTONE-201 trial met primary endpoint of objective response rate (ORR) in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL)
* Sugemalimab has the potential to become the world's first immunotherapy to be approved for patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) * The National Medical Products Administration (NMPA) of China has granted the Breakthrough Therapy Designati...
CStone Pharmaceuticals announced the IND approval of CS5001, a potential global best-in-class ROR1-targeting ADC by the U.S. Food and Drug Administration
SUZHOU, China, Jan. 3, 2022 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the investigational new ...
CStone announced new drug approval of precision therapy AYVAKIT® (avapritinib) in Hong Kong, China for the treatment of PDGFRA D842V mutant gastrointestinal stromal tumors (GIST)
* AYVAKIT is the first precision therapy approved in Hong Kong, China for the treatment of patients with PDGFRA D842V mutant GIST * This is CStone's fifth NDA approval in Greater China this year SUZHOU, China ,Dec. 28, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leadi...
CSTONE ANNOUNCED NEW DRUG APPROVAL OF CEJEMLY® (SUGEMALIMAB) IN CHINA TO POTENTIALLY RESHAPE THE LANDSCAPE OF IMMUNO-ONCOLOGY THERAPY IN LUNG CANCER
SUZHOU, China, Dec. 21, 2021 /PRNewswire/ -- CStone Pharmaceuticals (the " Company" or "CStone") is pleased to announce that the National Medical Products Administration ("NMPA") of China has approved the new drug application ("NDA") of anti-PD-L1 monoclonal antibody Cejemly® (sugemalimab) in comb...
Phase 3 Data Show That TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine Significantly Improves Event-Free Survival and Overall Survival in Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia
* TIBSOVO in combination with azacitidine compared to placebo plus azacitidine also demonstrated significant improvement in complete remission rate, complete remission and complete remission with partial hematologic recovery rate and objective response rate * Safety profile was favorable and ...
CStone Pharmaceuticals and Jiangsu Hengrui Pharmaceuticals announce strategic partnership and exclusive licensing agreement on anti-CTLA-4 monoclonal antibody CS1002 in Greater China
SUZHOU, China, Nov. 21, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals ("Hengru...
CStone Pharmaceuticals and Jiangsu Hengrui Pharmaceuticals announce strategic partnership and exclusive licensing agreement on anti-CTLA-4 monoclonal antibody CS1002 in Greater China
SUZHOU, China, Nov. 21, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals ("Hengru...
CStone Pharmaceuticals and DotBio sign a global discovery collaboration and option agreement to expand emerging portfolio of next-generation innovative therapeutics
* The two sides will jointly develop up to three preclinical first-in-class or best-in-class next-generation antibody therapies, for which CStone would lead the design of the target combination based on the intended mechanism of action and DotBio will lead the design and engineering of the mole...
CStone received China NMPA IND acceptance for lorlatinib in Chinese patients with ROS1-positive advanced NSCLC
SUZHOU, China, Oct. 20, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that the investigational new drug (...
CStone presents research data of CS5001 (ROR1 ADC) at the 33rd AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2021
SUZHOU, China, Oct. 8, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the data on the preclini...
CStone presents ARROW study data for GAVRETO® (pralsetinib) in Chinese patients with RET-mutant medullary thyroid cancer (MTC) for the first time in a late breaking oral abstract session at the 90th Annual Meeting of the American Thyroid Association 2021
* Primary efficacy results showed GAVRETO had robust and durable anti-tumor activity in the Chinese patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC), with a confirmed objective response rate (ORR) of 73.1%. And the 9-month duration of response (DOR) rate was 100% ...
CStone presents clinical data from the China registrational bridging study on ivosidenib in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with a susceptible IDH1 mutation at the 2021 ESMO Congress
* The data showed that ivosidenib demonstrated clinical efficacy in the treatment of Chinese adults with R/R AML with a susceptible IDH1 mutation. And ivosidenib was well tolerated and had a manageable safety profile * In August 2021, the National Medical Products Administration (NMPA) of Chin...
CStone presents preliminary results from a phase Ib study of the anti-CTLA-4 monoclonal antibody (mAb) CS1002 in combination with the anti-PD-1 mAb CS1003 in patients with advanced solid tumors at ESMO 2021
SUZHOU, China, Sept. 19, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative cancer immunotherapies and precision medicines, today announced the preliminary results from t...
CStone will present registrational clinical study data of Sugemalimab in patients with stage III non-small cell lung cancer in an oral presentation at ESMO Congress 2021
* Sugemalimab is the world's first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival (PFS) in patients withstage III non-small cell lung cancer (NSCLC) without disease progression after concurrent or sequential chemoradiotherapy * The data showed that suge...
CStone received China NMPA IND approval for CS2006/NM21-1480, a PD-L1/4-1BB/HSA multi-specific antibody, marking further expansion of its Pipeline 2.0
SUZHOU, China, Sept. 15, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the investigational ne...
CStone presents updated data from registrational clinical study of sugemalimab in patients with stage IV NSCLC in an oral presentation at IASLC 2021 WCLC
* Data with the longer follow-up showed that sugemalimab plus chemotherapy continued to demonstrate improvement in progression-free survival (PFS), after the primary efficacy endpoint was met at an interim PFS analysis last year * The updated data showed that the risk of disease progression or...
CStone presents registrational bridging study data for GAVRETO® (pralsetinib) highlighting efficacy and safety in Chinese patients with advanced RET fusion-positive non-small cell lung cancer at IASLC WCLC 2021
SUZHOU, China, Sept. 9, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines, today announced that efficacy and safety data from a...
