Hengrui Medicine Gains Clinical Trial Approval for Ten New Drugs, Including Weight Loss
核心洞察
Hengrui Medicine (搜索) received NMPA clinical trial approval notifications for ten drugs within two days, spanning oncology, metabolic diseases and chronic kidney disease (搜索).
HRS-1596 (搜索) Tablets, a Class 1 oral candidate from subsidiary Fujian Shengdi Pharmaceutical (搜索), will be studied for weight management and type 2 diabetes (搜索).
HRS-4729 Injection, a GLP-1R/GIPR/GCGR triple agonist peptide, has been cleared for Phase 2 trials in chronic kidney disease (搜索) with no comparable approved drug.
Hengrui Medicine (搜索) and its subsidiaries have received clinical trial approval notifications from China's National Medical Products Administration (搜索) for ten drugs in two days, covering oncology, metabolic diseases and chronic kidney disease (搜索). The list includes HRS-7172 (搜索) Tablets, Adebrelimab Injection, SHR-4610 (搜索) Injection, SHR-8068 Injection, SHR-9839 for Injection (sc), SHR-1826 for Injection, Bevacizumab Injection, HRS-4642 Injection, HRS-6093 (搜索) Tablets and HRS-7058 Capsules. Trials are expected to begin in the near term.
In metabolic disease, subsidiary Fujian Shengdi Pharmaceutical (搜索) won clearance for HRS-1596 (搜索) Tablets, a self-developed Class 1 innovative drug, in weight management and type 2 diabetes (搜索). Animal efficacy models for obesity (搜索) and diabetes showed potential for weight reduction and improvement in blood glucose-related markers; the company states no oral drug targeting the same pathway is approved in China or abroad, with cumulative R&D investment of about CNY 18.4 million ($2.7 million). HRS-4729 Injection, a peptide GLP-1R/GIPR/GCGR triple agonist, has entered Phase 2 for chronic kidney disease (搜索). Hengrui says simultaneous activation of the three receptors suppresses appetite, delays gastric emptying, enhances insulin sensitivity and promotes lipolysis and energy expenditure, with weight loss, improved insulin resistance and reduced renal ectopic fat expected to ease renal metabolic burden. No comparable drug is approved in China or abroad, and cumulative investment totals about CNY 87.6 million ($13.1 million).
HRS-7172 (搜索) Tablets, a novel anti-tumor small molecule inhibitor developed in-house, has no comparable approved drug in China, with cumulative R&D investment of about CNY 61.9 million ($9.2 million). The therapeutic biologic SHR-4595 (搜索) for Injection, which binds tumor cell surface antigens, will be studied in advanced solid tumors (搜索); one drug targeting the same pathway is already approved internationally, so it is not first-in-class. Cumulative investment for that program is about CNY 16.4 million ($2.4 million). Hengrui notes that clinical trial approval is only a starting point, with multiple validation phases still required before market approval applications.
Source: Hengrui Medicine Wins Clinical Trial Approval for Ten New Drugs, Targeting Weight Loss