On October 31, 2024 CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of oncology drugs, reported that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who do not harbor EGFR-sensitizing mutations or genomic tumor alterations in ALK, ROS1, or RET (Press release, CStone Pharmaceauticals, OCT 31, 2024, View Source [SID1234656225]). This is the second marketing authorization application (MAA) approval for sugemalimab in an overseas market, following the approval by the European Commission.
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Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "The approval of Sugemalimab in the UK marks another important milestone in our global expansion. Sugemalimab is the first domestically produced PD-L1 monoclonal antibody to successfully enter the global market. Following its entry into the EU, the world’s second-largest pharmaceutical market, Sugemalimab has secured entry into the UK, a key overseas market. The long-term survival data presented at this year’s ESMO (Free ESMO Whitepaper) further solidified Sugemalimab’s important position in the first-line treatment landscape for metastatic NSCLC."
Dr. Yang added, "In terms of overseas commercialization and registration, we are actively negotiating with partners in Western Europe, Latin America, the Middle East, Southeast Asia, Canada, and other regions, and expect to reach several commercial collaborations in the near future. Concurrently, we are actively communicating with international regulatory agencies, including the European Medicines Agency (EMA), regarding the marketing authorization of sugemalimab for other indications, such as stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma. We look forward to bringing innovative treatment options to more patients worldwide."
This approval is primarily based on results from the multicenter, randomized, double-blind Phase III GEMSTONE-302 clinical study. Sugemalimab combined with chemotherapy significantly prolonged progression-free survival and overall survival compared with placebo combined with chemotherapy in patients with previously untreated metastatic NSCLC. The study data have been published in The Lancet Oncology and Nature Cancer, and have been presented at numerous international conferences as oral presentations and posters.
About Sugemalimab Injection
Sugemalimab is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. Its development is based on the OmniRat transgenic animal platform, licensed from Ligand Corporation in the United States . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab is the closest to the body’s natural G-type immunoglobulin 4 (IgG4) monoclonal antibody, minimizing the potential risk of immunogenicity and related toxicities in patients, offering distinct advantages over similar agents. Sugemalimab’s unique molecular design equips it with a dual mechanism of action: it not only blocks the PD-1/PD-L1 interaction but also mediates the interaction between PD-L1-expressing tumor cells and tumor-associated macrophages (TAMs), inducing antibody-dependent cellular phagocytosis (ADCP) while sparing effector T cells. This differentiated design enables sugemalimab to demonstrate potentially best-in-class efficacy and safety across various tumor types.
Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (trade name: Zegemet) :
First-line treatment in combination with chemotherapy for patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma that expresses PD-L1 (combined positive score [CPS] ≥ 5).
The European Commission (EC) has approved sugemalimab (trade name: Cejemly ) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.