HongKong:2616

CStone Pharmaceuticals Reports 2022 Annual Results and Business Updates

* The total revenue for 2022 was RMB 481.4 million, with commercial revenue of RMB 394.1 million, which represents a 142% increase compared to the previous year * Healthy financial position with cash reserves of RMB 1.042 billion as of December 31, 2022. The net loss has decreased by 55% from ...

2023-03-15 22:13 3357

CStone announces China's NMPA has accepted the supplementary new drug application of sugemalimab as first-line treatment for patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma

* This supplementary new drug application was filed for the fourth indication for sugemalimab inChina, following applications for stage III and stage IV non-small cell lung cancer and relapsed or refractory extranodal NK/T cell lymphoma. If approved, sugemalimab would be the first PD-L1 monoclo...

2023-02-28 08:05 3236

CStone announces the registrational clinical trial of sugemalimab as first-line treatment in patients with esophageal squamous cell carcinoma met primary endpoints and plans to submit a supplemental NDA to NMPA

* Sugemalimab became the first anti-PD-L1 monoclonal antibody that achieved positive results in the study of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. * Sugemalimab in combination with chemotherapy demonstrated a statistically ...

2023-01-03 08:10 2333

CStone announces China's NMPA has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL)

* This is the third supplemental new drug application (NDA) that CStone has submitted for sugemalimab after the prior two for stage III and IV non-small cell lung cancer. Sugemalimab has the potential to become the world's first immuno-oncology therapy to be approved for patients with relapsed ...

2022-09-13 08:02 2232

CStone Pharmaceuticals Reports 2022 Interim Results and Business Updates

SUZHOU, China, Aug. 25, 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 2022 interim financial results an...

2022-08-25 18:00 3827

CStone presents updated results of a registrational study of sugemalimab in patients with stage III NSCLC via oral presentation at WCLC 2022

* GEMSTONE-301 study result was presented at IASLC 2022 World Conference on Lung Cancer. In addition, the leading Principal Investigator ProfessorYi-Long Wu was invited to highlight key data in a press conference * In the final progression-free survival analysis, sugemalimab showed sustained ...

2022-08-08 08:08 1652

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 ...

2022-07-15 08:02 2737

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 ...

2022-06-07 08:02 2012

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-...

2022-06-06 13:15 1968

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-...

2022-06-06 12:23 1730

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...

2022-06-05 08:02 4059

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...

2022-06-04 08:02 6340

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...

2022-06-01 00:35 4893

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...

2022-05-17 08:02 2268

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...

2022-04-28 08:00 1723

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...

2022-04-22 08:02 2749

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...

2022-04-13 08:02 1496

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 ...

2022-03-31 08:02 2026

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 (...

2022-03-18 10:35 2275

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 ...

2022-03-18 08:37 2557