NMPA Approves Five Innovative Drugs for Market Launch
Eli Lilly
Global Pharmaceutical R&D and Production Company
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Recently, the National Medical Products Administration approved the marketing of Pelacanan Spray (brand name: Puyike), a Class 1 innovative drug submitted by Plamed (Jiangsu) Co., Ltd.; Sleverimab Injection (brand name: Jinsuxi), submitted by Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd.; and Elenisgunt Tosylate Tablets (brand name: Zexu/INLURIYO), a Class 1 innovative drug submitted by Eli Lilly Nederland B.V. Additionally, through the priority review and approval procedure, the administration approved the marketing of Shurijiaolunsai Injection (brand name: Kailimei), submitted by Kaixing Life Sciences (Shanghai) Co., Ltd., and granted conditional approval, also via the priority review and approval procedure, for the marketing of Lunkangyilongtuomab for Injection (brand name: Yizekang), submitted by Chengdu Bailidote Biopharmaceutical Co., Ltd.
Peilaijianan Spray is a topical antibacterial agent indicated for the treatment of secondary wound infections in first-degree or superficial second-degree burns and scalds caused by Staphylococcus epidermidis, Staphylococcus haemolyticus, and Acinetobacter baumannii.
Slevecimab Injection is indicated for passive immunization in adults exposed to the rabies virus.
Elacestrant Tosylate Tablets are indicated as monotherapy for adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated locally advanced or metastatic breast cancer who have previously received endocrine therapy; and in combination with abemaciclib for adult patients with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer who have previously received endocrine therapy.
Shu Rui Ji Ao Lun Sai Injection is indicated for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma that is CLDN18.2-positive and human epidermal growth factor receptor 2 (HER2)-negative, in patients who have failed at least two prior lines of therapy.
Lunconyilongtuomab for Injection is indicated for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.
Source: National Medical Products Administration Website
Initial Review: Wang Yao | Secondary Review: Teng Chunyan | Final Review: Liu Bin
