News for CStone Pharmaceuticals (CSPHF)

Financial Performance: Strong Year-over-Year Improvement

SUZHOU, China, March 24, 2025 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab. The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This marks CStone's second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer.

Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor types. SUZHOU, China, March 6, 2025 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL. CS5001 is also being evaluated as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors in an ongoing global multi-center clinical trial.

SUZHOU, China, March 4, 2025 /PRNewswire/ --CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the first patient has been successfully dosed in the global multicenter Phase I clinical trial of its novel PD-1/VEGF/CTLA-4 trispecific antibody, CS2009, with no infusion reactions or other adverse events observed.

Sugemalimab is the world's first anti-PD-L1 monoclonal antibody approved for the treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The GEMSTONE-303 study results support sugemalimab in combination with chemotherapy as a new standard first-line treatment for patients with PD-L1 combined positive score (CPS) ≥5. Sugemalimab is the first anti-PD-L1 monoclonal antibody demonstrating superior overall survival (OS) and progression free survival (PFS) with a manageable safety profile in combination with chemotherapy compared to placebo plus chemotherapy in patients with locally advanced or metastatic G/GEJ adenocarcinoma who have not received prior systemic treatment for advanced disease and have PD-L1 CPS ≥5. Sugemalimab has received approvals for five indications in China, and for first-line treatment of Stage IV non-small cell lung cancer (NSCLC) in China, Europe and the UK. CStone will continue to engage with health authorities in Europe and other regions for regulatory expansion. SUZHOU, China, Feb. 25, 2025 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced the publication of the GEMSTONE-303 study results for sugemalimab (brand name: Cejemly®) in the prestigious Journal of the American Medical Association (JAMA) .

SUZHOU, China, Feb. 10, 2025 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that its key product, Cejemly® (sugemalimab), has been included in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic Non-Small-Cell Lung Cancer (NSCLC) Living Guideline. Sugemalimab is recommended as a first-line combination therapy for both squamous and non-squamous NSCLC, with substantial clinical benefits. This is a significant milestone in sugemalimab's global journey and provides critical support for our efforts to expand market access, enter the markets, and reach patients.

CStone will receive upfront, regulatory and commercial milestone payments, and book revenue from SteinCares through the supply of sugemalimab in 10 Latin American (LATAM) countries. This marks CStone's third major global commercialization partnership for sugemalimab, with additional deals in Western Europe, Southeast Asia, Canada, and other regions anticipated soon. CStone has received marketing approval for sugemalimab in the EU, EEA countries (Iceland, Liechtenstein, and Norway), and the UK, while actively advancing regulatory submissions for additional indications. SUZHOU, China, Jan. 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced a strategic commercialization partnership with SteinCares, a leading pharmaceutical company with over 40 years of experience and a strong presence in Latin America. Under this agreement, SteinCares will gain the commercialization rights for sugemalimab in 10 LATAM countries, including Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala and Ecuador.

CStone Partners with SteinCares to Market Sugemalimab in Latin America

CStone Announces Submission of Clinical Trial Application in Australia for CS2009, an Innovative PD-1/VEGF/CTLA-4 Trispecific Antibody

CS5001 is so far the first anti-ROR1 ADC known to show clinical anti-tumor activity in both solid tumors and lymphomas. The data presented at ASH highlighted the latest safety and efficacy of CS5001 as a monotherapy for patients with advanced lymphomas. CS5001 is well tolerated in heavily pre-treated patients with advanced B-cell lymphoma. No dose-limiting toxicity (DLT) has been reported up to dose level 10 (DL10). Encouraging anti-tumor activity with high objective response rate (ORR) was observed regardless of ROR1 expression levels, starting from the effective dose, in advanced Hodgkin lymphomas (HLs) (ORR=60.0%) and non-Hodgkin lymphomas (NHLs) (ORR=56.3%). At the preliminary recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), a notably higher ORR of 76.9% was observed in advanced B-cell lymphoma, including 3 evaluable HL cases with complete or partial response, and an ORR of 70% in NHL. The global multicenter Phase 1 trials of CS5001 are currently in progress in the USA, Australia, and China. Dose escalation has been completed with ongoing backfilling of patients for selective DLs. A Phase 1b dose-expansion study across multiple tumor types with registration potential is expected to be initiated soon. SUZHOU, China, Dec. 9, 2024 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced today the presentation of the latest clinical data for CS5001, an anti-ROR1 ADC and one of the leading assets in CStone Pipeline 2.0, at the 66th American Society of Hematology (ASH) Annual Meeting. These data highlight the compound's potential as a treatment for lymphoma.

CStone Reports 2024 Interim Results and Recent Corporate Updates

Adlai Nortye Reports Unaudited First Half 2024 Financial Results and Highlights Recent Operational Progress

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Sugemalimab becomes the world's first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for first-line treatment of both squamous and non-squamous non-small cell lung cancer (NSCLC), also marking the first successful international approval of a China domestic anti-PD-L1 mAb. The European Commission (EC) approval is based on the results of GEMSTONE-302 Phase 3 trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival and overall survival in treatment-naive patients with metastatic NSCLC. CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland. Discussions for commercial partnerships in including Western Europe, Latin America, the Middle East, Southeast Asia, etc., are progressing well and are expected to conclude soon. CStone is actively preparing to submit additional Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) for new indications, including Stage III NSCLC, first-line Gastric Cancer, first-line Esophageal Cancer, and relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL). SUZHOU, China, July 26, 2024 /PRNewswire/ -- CStone Pharmaceuticals ('CStone', HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the European Commission (EC) has approved sugemalimab (Brand name: Cejemly®) in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Sugemalimab has become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe in combination with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC, making CStone the first innovative biopharmaceutical company to successfully bring a China domestic anti-PD-L1 mAb to the international market.

CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly ® (sugemalimab, anti-PD-L1) as First-Line Treatment for NSCLC

Immunome has acquired AL102 and AL101 from Ayala Pharmaceuticals, with AL102's phase 3 study results expected in Q1'25. Check out why I rate IMNM stock a buy.

Key Takeaways: CEO Jason Yang has increased his CStone stake multiple times over the past 18 months to 4.79% of outstanding shares, signaling confidence in the company

CEO Jason Yang has increased his CStone stake multiple times over the past 18 months to 4.79% of outstanding shares, signaling confidence in the company.