Suzhou, China, October 17, 2025—CStone Pharmaceuticals (“CStone,” HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of sugemalimab as monotherapy for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) adults with PD-L1 expression on ≥ 1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, remarked, “We are encouraged that the EMA review for our Stage III NSCLC indication has progressed so rapidly and positively. Coming just one year after sugemalimab's first approval in Europe for first-line metastatic squamous and non-squamous NSCLC in 2024, this marks the second positive opinion and recommendation from CHMP. If approved, sugemalimab’s role as a core immunotherapy for lung cancer will be further solidified, significantly enhancing its market presence and commercial potential. We will work closely with our partners to expedite the full commercialization of sugemalimab across European markets, making this high-quality and accessible treatment option available to more patients.”
Dr. Qingmei Shi, Chief Medical Officer of CStone, added, “CHMP’s recommendation for sugemalimab’s new indication is primarily based on the compelling results from the pivotal Phase III GEMSTONE-301 study, a multicenter, randomized, double-blind clinical trial that demonstrated dual benefits of sugemalimab in progression-free survival and overall survival among patients with stage III NSCLC. If approved, sugemalimab will become the second PD-(L)1 antibody available in Europe for stage III NSCLC, addressing a critical unmet need and bringing new hope to patients. CHMP’s swift positive opinion also serves as strong validation of the capabilities of CStone’s clinical development and regulatory team. We remain dedicated to fulfilling our commitment to meet the urgent medical needs of patients in China and globally.”
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. In October 2025, CHMP issued a positive opinion recommending approval of sugemalimab as monotherapy for the treatment of unresectable stage III NSCLC adults with PD-L1 expression on ≥ 1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas. 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 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: www.cstonepharma.com.
IR contact: ir@cstonepharma.com
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