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恒瑞医药(600276.SH)收到国家药监局核准签发关于注射用紫杉醇(白蛋白结合型)《药品补充申请批准通知书》

Jiangsu Hengrui Pharmaceuticals (600276.SH) received the National Medical Products Administration's approval to issue the Approval Notice for Supplementary Application of Injection Paclitaxel (Albumin-bound).

Gelonghui Finance ·  Aug 11 03:41

Gelonghui, August 11, 丨 Hengrui Pharmaceutical (600276.SH) announced that recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) received approval from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to issue a “Drug Supplement Application Approval Notice” for injectable paclitaxel (albumin binding type).

Injectable paclitaxel (albumin binding) is an anti-microtubule drug developed by Apolis Life Sciences in the United States. It was first approved for marketing by the US Food and Drug Administration in 2005. The trade name is Abraxane, and it is now marketed in many countries and regions such as the United States, the European Union, and Japan. The company's injectable paclitaxel (albumin binding type) was approved for marketing in August 2018 to treat metastatic breast cancer that failed combination chemotherapy or breast cancer that recurred within 6 months after adjuvant chemotherapy. Currently, major domestic manufacturers of injectable paclitaxel (albumin binding) include Qilu Pharmaceutical (Hainan) Co., Ltd., Zhejiang Haizheng Pharmaceutical Co., Ltd., and Shiyao Group Ouyi Pharmaceutical Co., Ltd. According to inquiries, the total global sales volume of injectable paclitaxel (albumin binding type) in 2023 was about 2.597 billion US dollars. Up to now, projects related to injectable paclitaxel (albumin binding) have invested a total of about 52.91 million yuan in research and development costs.

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