CStone Announces the NDA Approval of GAVRETO® (pralsetinib) for the Treatment of RET Fusion-Positive treatment-naïve (first-line) and pretreated Non-Small Cell Lung Cancer (NSCLC) in Hong Kong, China
* GAVRETO is the first highly selective rearranged during transfection (RET) inhibitor approved inHong Kong, China for the treatment of RET fusion-positive metastatic non-small cell lung cancer * GAVRETO is CStone's second therapy approved in Hong Kong, China * GAVRETO is CStone's ninth NDA ...
CStone presents pre-specified overall survival data of sugemalimab for first-line treatment of stage IV non-small cell lung cancer at ASCO 2022
* Sugemalimab is the world's first PD-L1 monoclonal antibody to show the statistically significant and clinically meaningful overall survival improvement in combination with chemotherapy for patients with treatment-naïve stage IV non-small cell lung cancer across both squamous and non-squamous ...
CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
* The National Medical Products Administration approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy * Sugemalimab became the first anti-PD-...
CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
* The National Medical Products Administration approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy * Sugemalimab became the first anti-PD-...
CStone presents updated results of anti-PD-1 antibody nofazinlimab in combination with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (HCC) at ASCO 2022
* Nofazinlimab in combination with lenvatinib as first-line treatment for unresectable hepatocellular carcinoma demonstrated an objective response rate of 45.0%. The median duration of response was not yet reached as of the data cutoff date (4.2 to 18.7+ months). The median progression free sur...
CStone presents clinical results of sugemalimab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma via an oral abstract session at ASCO 2022
* GEMSTONE-201 is the largest registrational clinical study of an anti-PD-(L)1 antibody reported so far in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). * Results on the primary endpoint showed that sugemalimab significantly improved objective res...
CStone Pharmaceuticals Reports 2021 Annual Results and Recent Business Highlights
SUZHOU, China, June 1, 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 reported 2021 full-year financial results a...
CStone announces final PFS analysis of a registrational study of sugemalimab in patients with stage III NSCLC further demonstrates its robust efficacy and significant clinical benefits shown in interim analysis
* Sugemalimab is the world's first anti-PD-(L)1 monoclonal antibody to significantly improve progression-free survival (PFS) in patients with stage III non-small cell lung cancer (NSCLC) without disease progression following concurrent or sequential chemoradiotherapy * The National Medical Pr...
CStone to present the latest clinical results of anti-PD-L1 antibody sugemalimab and anti-PD-1 antibody nofazinlimab at ASCO 2022
* Results from GEMSTONE-201 study of sugemalimab, the first successful registrational clinical study to date evaluating an anti-PD-(L)1 antibody targeting patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, will be presented in an oral abstract session * The protoc...
CStone Announces Results From Phase 3 AGILE Data of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia Published in the New England Journal of Medicine
* Results from the trial present a significant advancement for patients dealing with previously untreated IDH1-mutated AML * Global Phase 3 trial of TIBSOVO (ivosidenib tablets) met its primary endpoint of event-free survival and all key secondary endpoints, complete remission rate, overall s...
CStone Announces Presentation of Preclinical data on a Multi-Specific Antibody-based Therapeutic Candidate CS2006/NM21-1480 at the American Association for Cancer Research (AACR) Annual Meeting 2022
* Results from pharmacokinetic/pharmacodynamic modeling demonstrated that binding affinity optimization of CS2006/NM21-1480 allowed optimal PD-L1 blockade and 4-1BB stimulation concomitantly, at a broad dose range thereby and facilitating dose-finding in the clinic * CS2006/NM21-1480 was effi...
CStone announces first patient enrollment in the U.S. in the Phase 1 clinical trial of CS5001, a potential global best-in-class ROR1-targeting ADC
* Commencement of the first-in-human clinical trial of CS5001 marks another key milestone for CStone's Pipeline 2.0 * Global development of CS5001 is conducted in the form of a multi-regional clinical trial, with sites initiated in the US andAustralia, and an IND application accepted by the ...
CStone Pharmaceuticals Announces the Acceptance of New Drug Application (NDA) for Pralsetinib for the Treatment of RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) in Hong Kong, China
SUZHOU, China, March 18, 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, announced today that the new drug application (...
CStone announced the global multi-regional registration trial of anti-PD-1 antibody nofazinlimab in combination with lenvatinib as first-line treatment for patients with advanced hepatocellular carcinoma successfully reached the prespecified enrollment target
SUZHOU, China, March 18, 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 global multi-regional ...
CStone announces the NMPA approval of GAVRETO (pralsetinib) for the treatment of Advanced or Metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer
* GAVRETO is the first and only selective rearranged during transfection (RET) inhibitor approved inChina for the treatment of RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer (TC) * The labeled indications of GAVRETO have been expanded after it was approved by...
CStone Pharmaceuticals Announces the Acceptance of New Drug Application (NDA) for Pralsetinib for the Treatment of RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) and RET-Altered Thyroid Cancers in Taiwan, China
SUZHOU, China, Feb. 17, 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 Taiwan Food and Drug A...
CStone announced new drug approval of China's first IDH1 inhibitor TIBSOVO® (ivosidenib tablets) as a new precision therapy for patients with acute myeloid leukemia
* TIBSOVO®, a first-in-class drug, is approved for adult patients with relapsed/refractory acute myeloid leukemia (R/R AML) who have a susceptible IDH1 mutation * Clinical study data showed that TIBSOVO® had robust clinical efficacy and a well-tolerated and manageable safety profile in Chines...
CStone announces the GEMSTONE-302 study of sugemalimab met the endpoint of overall survival in the first-line treatment of metastatic non-small cell lung cancer patients
* Sugemalimab is the world's first PD-L1 monoclonal antibody that when administered along with chemotherapy improved overall survival of first-line metastatic squamous and non-squamous non-small cell lung cancer patients in a statistically significant and clinically meaningful manner * Surviv...
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...
