Pharma Focus Asia

CStone's Sugemalimab Granted NMPA Approval for Relapsed or Refractory Extranodal NK/T-cell Lymphoma, Pioneering the Anti-PD-1/PD-L1 mAb Approval in this Indication

Wednesday, November 01, 2023

CStone Pharmaceuticals is a biopharmaceutical company listed on the Hong Kong Stock Exchange under the symbol 2616. They focus on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines. Today, they are thrilled to announce that the National Medical Products Administration (NMPA) of China has granted approval for sugemalimab, an anti-PD-L1 antibody, marketed as Cejemly®, for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). This achievement marks sugemalimab as the world's first anti-PD-1/PD-L1 monoclonal antibody specifically approved for R/R ENKTL.

CStone, expressed his excitement about this milestone, emphasizing the dedication and innovation of CStone's research and development team. He highlighted that sugemalimab's potential extends beyond ENKTL, as it is also being considered for other significant indications, including gastric cancer and esophageal cancer, with biologics license applications currently under review by the NMPA. Furthermore, CStone is actively collaborating with the FDA to expedite sugemalimab's registration in the United States.

Professor Huang Huiqiang, leading the GEMSTONE-201 study at Sun Yat-sen University Cancer Center, expressed gratitude for the NMPA's attention to rare diseases like NK/T-cell lymphoma. He pointed out that patients with R/R ENKTL have faced a severe lack of standard care and limited treatment options, resulting in short survival durations and substantial unmet medical needs. The GEMSTONE-201 study demonstrated that sugemalimab monotherapy exhibits significant anti-tumor activity, durable objective responses, and manageable safety in R/R ENKTL patients. With this approval, there is hope that more R/R ENKTL patients will have access to sugemalimab in the near future.

The approval of sugemalimab for R/R ENKTL is based on the GEMSTONE-201 study, which aimed to assess the efficacy and safety of sugemalimab as a monotherapy for adult R/R ENKTL patients. The results showed that sugemalimab significantly improved the objective response rate (ORR), with a complete response (CR) rate of 35.9% in 78 evaluable patients, as assessed by the Independent Radiology Review Committee (IRRC). Subgroup analyses indicated that sugemalimab is likely to be effective for a broad range of ENKTL patients, even those who had been heavily pretreated. Importantly, sugemalimab demonstrated a well-tolerated safety profile, with no new safety concerns identified. These findings were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO) in March 2023.

Sugemalimab is an anti-PD-L1 monoclonal antibody developed by CStone using the OmniRat® transgenic animal platform, allowing the creation of fully human antibodies in a single step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which offers the advantage of potentially reduced immunogenicity and toxicity for patients compared to similar drugs.

In addition to R/R ENKTL, the NMPA of China has approved sugemalimab for three other indications, including the treatment of unresectable Stage III NSCLC following concurrent or sequential platinum-based chemoradiotherapy, in combination with chemotherapy for the first-line treatment of metastatic squamous and non-squamous NSCLC, and for the treatment of R/R ENKTL. There are ongoing applications for additional indications, including the treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Furthermore, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom are reviewing marketing authorization applications for sugemalimab in combination with chemotherapy as a first-line treatment for metastatic NSCLC.

CStone has a strategic collaboration agreement with Pfizer, encompassing the development and commercialization of sugemalimab in mainland China and the introduction of other oncology medicines to the Greater China market.

The GEMSTONE-201 study is a Phase 2 pivotal study designed to evaluate the efficacy and safety of sugemalimab as a monotherapy for adult R/R ENKTL patients. It has received Orphan Drug Designation and Breakthrough Therapy Designation (BTD) from the U.S. FDA for the treatment of T-cell lymphoma and adults with R/R ENKTL, as well as BTD from the NMPA of China.

Extranodal natural killer/T-cell lymphoma (ENKTL) is a subtype of mature T cell and NK cell lymphoma, comprising a significant portion of mature T-cell and NK-cell lymphomas. Patients with R/R ENKTL have faced limited treatment options and poor survival outcomes, with a one-year survival rate of less than 20%. This rare disease has significant unmet medical needs, making sugemalimab's approval a significant step forward in addressing this challenge. Furthermore, research has shown similarities in the clinical presentation and treatment outcomes of ENKTL in both Western and Asian populations, with ENKTL being more prevalent in East Asia and Latin America.



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