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. ...
CStone Announces European Commission Approval of Sugemalimab (Cejemly®) as First-Line Treatment for Non-Small Cell Lung Cancer
* Sugemalimab becomes the world's first anti-PD-L1 monoclonal antibody (mAb) approved inEurope for first-line treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC), also marking the first successful international approval of aChina domestic anti-PD-L1 mAb. * The Eur...
CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly® (sugemalimab, anti-PD-L1) as First-Line Treatment for NSCLC
* EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant progression-free survival (PFS) and overall survival (OS) benefits of sugemalimab in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (NSC...
CStone Announces Abstract Release of CS5001 (ROR1 ADC) First-in-Human Clinical Data on ASCO Website
* CS5001 is the first known ROR1 antibody-drug conjugate (ADC) to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas, and among the top two globally in clinical development. * First-in-human study data show that CS5001 is well tolerated with promising anti-tumor activ...
CStone Pharmaceuticals Reports 2023 Annual Results and Business Updates
* Total revenue for 2023 was RMB463.8 million, with commercial revenue of RMB 368.1 million * Healthy financial position with cash reserves of RMB 1,026.7 million as of December 31, 2023 and net loss narrowed by 57% from the past year * CStone established strategic collaborations with multip...
CStone Announces the Fifth Indication Approved for Sugemalimab in China as First-Line Treatment for Gastric Cancer
* Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for the treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. * This marks the 13th NDA approval obtained by CStone and sugemalimab's fifth indication approved inChina, following stage III and IV no...
CStone sells to Servier its exclusive rights to TIBSOVO® in Greater China and Singapore
* The deal enables CStone to prioritize its resources to focus on the development of first-in-class and best-in-class therapies with global rights. * The deal enables Servier to potentially bring additional indications and accessibility of TIBSOVO® to patients in Greater China (including main...
CStone Announces NMPA Approval of Sugemalimab as First-line Treatment for Esophageal Squamous Cell Carcinoma
* Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for use in combination with fluorouracil and platinum-based chemotherapy for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. * This marks the 13th NDA approval obtained by CSt...
CStone Announces Strategic Partnership and Exclusive Licensing Agreement with 3SBio for Nofazinlimab (Anti-PD-1 Antibody) in Mainland China
* CStone to grant 3SBio exclusive rights for the development, registration, manufacturing, and commercialization of nofazinlimab (anti-PD-1 antibody) in mainlandChina. CStone to retain the rights to nofazinlimab outside mainland China. * This partnership will combine the strengths of CStone a...
CStone Announces NMPA Approval of Sugemalimab for Patients with Relapsed or Refractory Extranodal NK/T-cell Lymphoma, the First Anti-PD-1/PD-L1 mAb Approved for this Indication
* Sugemalimab is the world's first anti-PD-1/PD-L1 monoclonal antibody approved for relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL) indication. * This marks sugemalimab's third indication approved in China following Stage III and IV non-small cell lung cancer (NSCLC) and the ...
CStone Pharmaceuticals Reports 2023 Interim Results and Updates
* The total revenue was RMB 261.5 million for the six months ended June 30, 2023. The sales of pharmaceutical products revenue was RMB 246.9 million, representing a growth rate of 53% compared to the same period last year. Commercial gross profit margin improved from 47% to 59%. * Healthy fin...
CStone announces GAVRETO® (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer
* The approval for the first-line treatment of RET fusion-positive non-small cell lung cancer marks the third indication of GAVRETO in Mainland China, and the eleventh new drug application approval that CStone has obtained inGreater China overall. * In the ARROW study, GAVRETO had demonstrate...
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 ...
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...
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 ...
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 ...
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...
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 ...
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 ...
