HongKong:2616

CStone announces positive GAVRETO® (pralsetinib) registrational study data for first-line treatment of advanced RET fusion-positive non-small cell lung cancer and plans to submit a new indication application

* Key efficacy data showed that GAVRETO demonstrated deep and durable clinical activity in Chinese patients with RET fusion-positive non-small cell lung cancer (NSCLC) * CStone plans to submit new indication application to the China National Medical Products Administration for GAVRETO as a fi...

2021-06-24 08:05 5715

CStone announces first prescriptions of precision therapy GAVRETO® (pralsetinib) issued across China for the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer after platinum-based chemotherapy

SUZHOU, China, June 21, 2021 /PRNewswire/ -- GAVRETO® (pralsetinib), a precision therapy discovered by CStone Pharmaceuticals' partner Blueprint Medicines, had the first batch of prescriptions issued at Guangdong Province People's Hospital and around 100 other hospitals acrossChina. GAVRETO is al...

2021-06-21 13:06 2569

CStone Announces the First-in-Class Registrational Clinical Trial of Sugemalimab Met its Primary Endpoint in Stage III NSCLC and Plans to Submit a New Drug Application

* Sugemalimab becomes the world's first anti-PD-1/PD-L1 monoclonal antibody to successfully improve progression-free survival (PFS) in patients with stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent or sequential chemoradiotherapy * Sugemalimab is also t...

2021-05-28 08:10 7314

CStone Announces Acceptance of New Drug Application in Hong Kong for Avapritinib for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumor

SUZHOU, China, May 12, 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 the acceptance of the company's new ...

2021-05-12 14:09 2523

CStone Announces NMPA Acceptance of New Drug Application of Selective Inhibitor GAVRETO(R) (Pralsetinib) with Priority Review Designation for the Treatment of Advanced or Metastatic RET-Altered Thyroid Cancer Patients

SUZHOU, China, April 26, 2021 /PRNewswire/ -- CStone Pharmaceuticals (CStone, HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration ...

2021-04-26 21:14 3272

CStone Announces China NMPA New Drug Approval of Precision Therapy AYVAKIT® (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

SUZHOU, China, March 31, 2021 /PRNewswire/ -- CStone Pharmaceuticals (CStone, HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration ...

2021-03-31 18:20 6253

CStone Pharmaceuticals Reports Financial Results and Business Highlights for Full-year 2020

SUZHOU, China, March 25, 2021 /PRNewswire/ -- CStone Pharmaceuticals (CStone, HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today reported financial results and business highlights for the f...

2021-03-25 22:03 3835

CStone Announces New Drug Approval of GAVRETO(R) (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients

* GAVRETO has been approved for the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer after platinum-based chemotherapy * GAVRETO is the first approved selective RET inhibitor in China and first approved precision therapy for CStone SUZHOU,...

2021-03-24 10:46 4756

CStone Pharmaceuticals Reports Efficacy and Safety Data from the ARROW Trial of Pralsetinib in Chinese Patients with Advanced RET Fusion-positive Non-Small Cell Lung Cancer after Platinum-based Chemotherapy at IASLC WCLC 2020

SUZHOU, China, Jan. 28, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEx: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today announced that results from a cohort of Chinese patien...

2021-01-28 10:15 4123

CStone's Partner Blueprint Medicines Announces U.S. FDA Approval of GAVRETO (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer

SUZHOU, China, Dec. 10, 2020 /PRNewswire/ -- The partner of CStone Pharmaceuticals ("CStone", HKEX: 2616), Blueprint Medicines, announced on December 1st that the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of patients with RET-altered thyroid can...

2020-12-10 08:30 3441

ESMO ASIA Congress 2020 | CStone Pharmaceuticals announces the results of GEMSTONE-302, Sugemalimab has the potential to provide a new treatment option for patients with advanced NSCLC

SUZHOU, China, Nov. 23, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today announced that positive clinical data based on a pre-p...

2020-11-23 09:30 3382

CStone Pharmaceuticals Announces China's NMPA has Accepted its New Drug Application for anti-PD-L1 Monoclonal Antibody Sugemalimab in First-Line Advanced NSCLC

* Currently, there is no anti-PD-L1 monoclonal antibody approved for stage IV NSCLC inChina * An oral presentation of specific clinical trial data of CS1001-302 study will be given at ESMO Asia Congress onNovember 21st SUZHOU, China, Nov. 12, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CSto...

2020-11-12 10:58 3979

CStone and LegoChem Biosciences Enter Global Licensing Agreement for New Antibody Drug Conjugate

* CStone to acquire exclusive rights for development and commercialization outsideSouth Korea for LCB71, an ROR1 antibody drug conjugate * Agreement adds to CStone's pipeline a potential first-in-class/best-in-class drug candidate with monotherapy and combination applications for a range of c...

2020-10-29 07:15 3194

CStone and EQRx Enter Global Strategic Partnership for Two Immune Checkpoint Inhibitors: sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1)

* CStone to out-license to EQRx exclusive rights to two late-stage immuno-oncology assets for development and commercialization outside ofGreater China * Agreement provides a pathway to bring CStone's sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1) to global patient communities by partnering ...

2020-10-27 07:23 2984

CStone Announces Completion of $200 million Share Sale to Pfizer

SUZHOU, China, Oct. 12, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616) announced today the completion of the Share Subscription Agreement through which an affiliate of Pfizer Inc. ("Pfizer", NYSE: PFE) subscribed for newly issued CStone shares at approximatelyUS$200 million (e...

2020-10-12 08:05 5695

CStone Pharmaceuticals Announces Updated Results from Two Studies of Its Anti-PD-L1 Monoclonal Antibody Sugemalimab (CS1001) At 2020 CSCO Annual Meeting

* CS1001-201 study demonstrated an objective response rate (ORR) of 44.7%, a complete response (CR) rate of 31.6%, median overall survival (mOS) of 19.7 months and an one-year overall survival (OS) rate of 55.5% in patients with relapsed or refractory extranodal natural killer /T cell lymphoma ...

2020-09-25 15:28 3672

CStone Announces Preliminary Results from a Bridging Study of Avapritinib in Chinese Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors at the 2020 CSCO Annual Meeting

* Avapritinib has demonstrated strong anti-tumor activity in Chinese patients with PDGFRA D842V mutant GIST * Avapritinib was generally well tolerated in Chinese GIST patients, consistent with the safety profile demonstrated in global studies SUZHOU, China, Sept. 25, 2020 /PRNewswire/ -- CSton...

2020-09-25 14:53 3686

CStone Receives US FDA IND Clearance for CS1001-201 Study to Evaluate Anti-PD-L1 Monoclonal Antibody Sugemalimab Monotherapy in R/R ENKTL

SUZHOU, China, Aug. 31, 2020 /PRNewswire/ -- CStone Pharmaceuticals (SUZHOU) Co., Ltd. ("CStone", HKEX: 2616) today announced that the US Food and Drug Administration (FDA) has completed their review of the Investigational New Drug (IND) application for anti-PD-L1 monoclonal antibody sugemalimab ...

2020-08-31 11:35 3414

CStone Pharmaceuticals Reports Financial Results for the First Half of 2020

SUZHOU, China, Aug. 19, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone"; HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today reported recent business highlights and financial resu...

2020-08-19 09:33 4138

CStone submits new drug application for the targeted therapy avapritinib in Taiwan for the treatment of adults with advanced PDGFRA exon 18 mutant gastrointestinal stromal tumor

SUZHOU, China, March 27, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) today announced that the Company has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for avapritinib, a precision therapy being developed for the t...

2020-03-27 14:02 1451