Extranodal NK-T-Cell Lymphoma

SUZHOU, China, March 23, 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. The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated: 36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS). 56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit. Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential). Favorable safety profile, no new safety signals identified. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented: "Following sugemalimab's approval in Europe for stage IV NSCLC, we are working closely with EMA to expand its indications in earlier stage lung cancer and other malignancies. With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for stage III NSCLC patients. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide." About Sugemalimab The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications: In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC; For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5. About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . IR contact: [email protected] PR contact: [email protected] Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. 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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. 24, 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) . GEMSTONE-303 is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared to placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma with PD-L1 CPS ≥5. The dual primary endpoints were OS and investigator-assessed PFS. Key secondary endpoints included PFS assessed by the Blinded Independent Central Review Committee (BICR), objective response rate (ORR), and duration of response (DoR). The GEMSTONE-303 article published in JAMA highlights the following key efficacy and safety findings: In patients with PD-L1 CPS ≥5, the sugemalimab group showed statistically significant and clinically meaningful improvements in both OS and PFS compared with the control group. Median OS was 15.6 months in the sugemalimab group compared with 12.6 months in the control group, with a hazard ratio (HR) of 0.75 (95% CI, 0.61-0.92), P=0.006, indicating that sugemalimab plus CAPOX could reduce the risk of death by 25%. Median PFS was 7.6 months in the sugemalimab group versus 6.1 months in the control group, with a HR of 0.66 (95% CI, 0.54-0.81), P<0.001. Grade ≥3 treatment-related adverse events (TRAE) occurred in 53.9% of patients in the sugemalimab group and 50.6% in the control group, indicating that the safety of this combination regimen was manageable. Subgroup analyses demonstrated consistent clinical benefits across all pre-defined subgroups, including patients with varying PD-L1 expression levels: Sugemalimab plus CAPOX significantly prolonged OS in patients with PD-L1 CPS ≥10; median OS was 17.8 months in the sugemalimab group compared with 12.5 months in the control group, with a HR of 0.64 (95% CI, 0.48-0.85), P=0.002. In patients with PD-L1 CPS ≥10, median PFS was 7.8 months in the sugemalimab group compared with 5.5 months in the control group, with a HR of 0.58 (95% CI, 0.43-0.77), P<0.001. In patients with PD-L1 CPS ≥10, ORR was 71.4% in the sugemalimab group compared with 48.6% in the control group. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are honored to see the GEMSTONE-303 study results published in JAMA. This study establishes sugemalimab in combination with chemotherapy as the new standard first-line treatment for patients with PD-L1 CPS ≥5 G/GEJ adenocarcinoma. To date, sugemalimab has been approved for five indications in China. Internationally, we have expanded its regulatory pathways and forged commercialization partnerships in various global markets. The compelling clinical data from GEMSTONE-303 reinforce our confidence in advancing the global registration and commercialization of sugemalimab. We are committed to unlocking its full clinical potential and providing greater survival benefits to patients worldwide." Professor Lin Shen, Peking University Cancer Hospital, the leading principal investigator of the GEMSTONE-303 study, said: "Before the availability of PD-1 monoclonal antibodies, chemotherapy was the standard first-line treatment for unresectable, locally advanced or metastatic G/GEJ adenocarcinoma, with median OS rarely exceeding one year. The combination of anti-PD-1 antibodies and chemotherapy has significantly extended survival for these patients. The GEMSTONE-303 study builds on this progress. As the first anti-PD-L1 antibody approved for this patient population, sugemalimab specifically targeted the PD-L1-expressing population in its pivotal study, achieving significant efficacy with a manageable safety profile. The acceptance and publication of these results in JAMA affirm the innovation of GEMSTONE-303 and the valuable contributions of all researchers and participants involved." *Link to JAMA Network: About Sugemalimab The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications: In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC; For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5. The European Commission (EC) has approved sugemalimab (brand name: Cejemly®) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SUZHOU, China, Feb. 9, 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. According to the ESMO Guideline: For patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumour PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI), sugemalimab-platinum-doublet chemotherapy is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of 4, indicating substantial clinical benefit. Link to guideline: PS 0-1 & any expression of PD-L1 | ESMO For patients with non-squamous NSCLC, PS 0-1, regardless of tumour PD-L1 status and without contraindications for ICI, sugemalimab-platinum-based chemotherapy is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of 4, also indicating substantial clinical benefit. Link to guideline: PS 0-1 & any expression of PD-L1 | ESMO These recommendations are supported by robust clinical data from the Phase III GEMSTONE-302 trial, which demonstrated significant benefits in progression-free survival (PFS) and overall survival (OS) with sugemalimab plus platinum-based chemotherapy, compared to placebo plus platinum-based chemotherapy. Notably, sustained and consistent benefits were observed across various histological subtypes and PD-L1 expression levels. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 ESMO Annual Meeting. Currently, sugemalimab has been approved in China, the EU, and the UK for first-line treatment of advanced NSCLC. After successfully establishing commercial partnerships in dozens of countries in Switzerland, Central and Eastern Europe, the Middle East, Africa, and Latin America, CStone is actively pursuing strategic commercial partnerships in Western Europe, Southeast Asia, and Canada. This effort is in parallel with the overseas registration and launch process for other indications of sugemalimab. About Cejemly® (sugemalimab) The anti-PD-L1 monoclonal antibody Cejemly® (sugemalimab) was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications: In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC; For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5). The European Commission (EC) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 17 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED