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基石药业-B(02616.HK):舒格利单抗治疗复发或难治性结外NK/T细胞淋巴瘤的新适应症在中国获批,成为首个获批此适应症的PD-1或PD-L1单克隆抗体

Cornerstone Pharmaceutical-B (02616.HK): A new indication of suglizumab for recurrent or refractory extranodal NK/T-cell lymphoma was approved in China, becoming the first PD-1 or PD-L1 monoclonal antibody approved for this indication

Gelonghui Finance ·  10/31/2023 08:04

Gelonghui October 31st 丨Cornerstone Pharmaceutical-B (02616.HK) issued an announcement that the China National Drug Administration (NMPA) has approved the PD-L1 antibody suglimab (choose Jiemei)) It is used to treat patients with recurrent or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). As a result, suglimab became the world's first tumor immunotherapy drug approved for R/R ENKTL indications.

Dr. Yang Jianxin, CEO and Executive Director of Cornerstone Pharmaceutical, said, “We are very pleased that suglimab has been recognized by the NMPA again. The successful approval of the R/R ENKTL indication is not only another important milestone achieved with suglimab following phase III and stage IV NSCLC, but also underpins the foundation of the cornerstone team's exploration and innovation in the field of rare diseases over the years. We have always believed that the unmet clinical needs of cancer patients should not be overlooked because of their small population or rare disease. In addition to lung cancer, suglimab will also cover major indications such as first-line gastric cancer and esophageal cancer. Currently, the new drug marketing application is under review by NMPA. In addition, we will continue to maintain close communication with the FDA to further accelerate the registration and marketing process of suglizumab in the US.”

Professor Huang Huiqiang of the Cancer Hospital Affiliated to Sun Yat-sen University, the main researcher of suglizumab GEMSTONE-201, said, “Thank you to NMPA and relevant departments for their attention to rare diseases such as NK/T cell lymphoma. R/R ENKTL patients have always faced treatment difficulties and lack standard treatment, resulting in a short survival period and a high level of unmet clinical needs. GEMSTONE-201 study data show that suglizumab monoclonal drug can show excellent antitumor activity, long-lasting tumor relief, and good safety in R/R ENKTL patients. With the approval of this indication, we expect more R/R ENKTL patients to use suglimab soon.”

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