中新健康 | 国家药监局批准依沃西单抗注射液上市
中新网5月24日电 据国家药监局网站消息，近日，国家药品监督管理局通过优先审评审批程序批准康方赛诺医药有限公司申报的依沃西单抗注射液(商品名：依达方)上市。本品联合培美曲塞和卡铂，用于经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR突变阳性的非小细胞肺癌(NSCLC)患者的治疗。
依沃西单抗注射液是一种特异性针对肿瘤微环境中的免疫抑制细胞的新一代生物制品，其作用机制是通过激活免疫系统中的效应细胞，增强对肿瘤细胞的识别和杀伤能力。该药物的上市，将为广大患者提供新的治疗选择，有助于提高患者的生活质量和生存率。
国家药监局表示，该产品的上市是基于其在临床试验中展现出的良好安全性和有效性。该药物的批准，也是国家药品监督管理局近年来积极推进药品审评审批制度改革，加快创新药上市进程的重要体现。
康方赛诺医药有限公司表示，公司将严格遵守国家药品监督管理局的要求，确保依沃西单抗注射液的质量和供应，并继续进行市场推广和患者教育工作，让更多患者受益于这一创新治疗方案。
此次依沃西单抗注射液的上市，标志着中国生物医药领域在治疗晚期肺癌方面取得了新的进展，也为全球肺癌治疗领域提供了新的研究方向。
英语如下：
News Title: “Ivosidenib Approved for Market: A New Chapter in EGFR Treatment”
Keywords: Approval, Ivosidenib, Monoclonal Antibody
News Content:
Health China Net | The State Drug Administration has approved the marketing of the ivosidenib monoclonal antibody injection.
Beijing, May 24th, according to the website of the State Drug Administration, the National Medical Products Administration (NMPA) has approved the application for marketing of the ivosidenib monoclonal antibody injection (trade name: Idhifa) from Kangfuxin Pharmaceutical Co., Ltd., through the priority review mechanism. This product is used in combination with pemetrexed and cisplatin for the treatment of patients with non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and have a positive EGFR mutation.
The ivosidenib monoclonal antibody injection is a new generation of biologic product that specifically targets immune suppressive cells in the tumor microenvironment. Its mechanism of action is to activate effector cells in the immune system, enhancing the recognition and killing ability of tumor cells. The approval of this drug provides patients with a new treatment option, which is expected to improve patients’ quality of life and survival rates.
The NMPA stated that the approval of the product is based on its good safety and efficacy demonstrated in clinical trials. This approval is also a significant reflection of the NMPA’s efforts to promote the reform of the drug review and approval process and to accelerate the process of innovative drugs reaching the market in recent years.
Kangfuxin Pharmaceutical Co., Ltd. stated that the company will strictly comply with the requirements of the State Drug Administration to ensure the quality and supply of the ivosidenib monoclonal antibody injection, and will continue to carry out market promotion and patient education work to benefit more patients from this innovative treatment approach.
The approval of the ivosidenib monoclonal antibody injection marks a new progress in the treatment of advanced lung cancer in the field of biopharmaceuticals in China and provides a new research direction for the global lung cancer treatment field.
【来源】http://www.chinanews.com/life/2024/05-24/10222498.shtml
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