According to Zhitong Finance APP, Guotai Haitong Securities has released a research report stating that 2025 represents the commercialization year for domestically-produced weight-loss innovative drugs with global competitiveness. On July 3rd, Innovent Biologics' (01801) mazdutide injection received its first national prescription, marking the official implementation of China's innovative weight-loss drug research and development achievements. The firm believes that companies in the weight-loss metabolism field with leading domestic R&D progress, excellent clinical weight-loss data, and overseas business development potential will continue to face multiple catalysts in the future.
Guotai Haitong Securities' main viewpoints are as follows:
Significant progress in domestic weight-loss innovative drug R&D fundamentals includes: (1) Joincare Pharmaceutical completed enrollment of all subjects for the Phase III clinical trial of RAY1225 dual-target injection for obesity indication on July 31st. The first subject was enrolled in June, and the company completed all enrollment work ahead of schedule with rapid and efficient progress. As a bi-weekly formulation administered once every two weeks, it demonstrates significant advantages. Phase II study data showed that the 9mg group achieved an average weight reduction of 15.05% over 24 weeks. (2) United Laboratories' UBT37034 received FDA IND approval. It can reduce weight through selective action on neuropeptide Y2 receptors. Preclinical research results from various animal models show that UBT37034 combined with GLP-1 analogs can significantly reduce weight. For example, when combined with the marketed GLP-1/GIP dual-target drug tirzepatide, it can further reduce animal weight, with weight-loss effects superior to Cagrilintide and Petrelintide currently under development. (3) Leading Biosciences received FDA approval for LAE103's clinical trial IND application on July 31st, comprehensively deploying the ActRIIA+B pathway. (4) Ascletis Pharma expects to obtain 12-week Phase IIa data for ASC30 subcutaneous formulation in Q1 2026. (5) Innovent Biologics' clinical trial application for its small molecule GLP-1 drug IBI3032 was accepted by NMPA on July 16th. (6) Hengrui Medicine achieved an average weight reduction of 19.2% in the 6mg dose group during a 48-week Phase III trial without reaching a plateau, with good safety profile similar to other GLP-1 drugs. Hengrui will submit a new drug marketing application in the near future.
Since the beginning of this year, multiple domestic pharmaceutical companies' related weight-loss drug pipelines have completed numerous authorization and cooperation transactions. On July 30th, CSPC Pharmaceutical authorized Madrigal Pharma the global (excluding China) development, production, and commercialization rights for its oral GLP-1 small molecule SYH2086, with a total authorization transaction value of $2.075 billion, including a $120 million upfront payment. Bory Pharmaceutical reached cooperation with China Resources Sanjiu regarding BGM0504 injection's research and development, registration, production, and commercialization in mainland China (excluding Hong Kong, Macau, and Taiwan).
Risk Warning: Risk of innovative drug R&D failure expectations, risk of innovative drug commercialization progress falling short of expectations, risk of innovative drug overseas authorization falling short of expectations, risk of domestic medical insurance policy cost control.