On January 20, the CDE (Center for Drug Evaluation) announced the implicit approval for clinical trials, showing that TQF3250 capsules, an oral weight-loss product submitted by Chia Tai Tianqing Pharmaceutical Group in November last year, has been approved for clinical trials.
Unlike the more familiar GLP-1 receptor agonists on the market, TQF3250 is an "orally administered small molecule-biased GLP-1 receptor agonist." It preferentially activates cAMP-related pathways, reducing β-arrestin recruitment and receptor endocytosis, aiming to achieve a better balance between duration of action and tolerability. From a mechanistic research perspective, the signal bias of the GLP-1 receptor is indeed considered a potential direction for optimization by the academic community. Rewinding to a month ago, a landmark event occurred in the global narrative of oral weight-loss drugs. Novo Nordisk's oral weight-loss drug received FDA approval in December 2025, seizing a crucial position in the oral weight-loss drug market. Subsequently, Eli Lilly's oral small molecule orforglipron also came under regulatory review. Against this backdrop, Chia Tai Tianqing's decision to push for TQF3250's clinical approval at this time is a typical example of "positioning itself within the window of opportunity." The business logic of oral dosage forms is straightforward: adherence and accessibility are closer to those of medications for chronic diseases, theoretically more conducive to long-term management and population expansion. However, the R&D challenges of oral GLP-1 inhibitors are equally straightforward: absorption exposure, dosing restrictions, gastrointestinal adverse reactions, and discontinuation rates—any one of these could dilute the "capsule advantage." The "biased" label of TQF3250 points precisely to the core challenges of tolerability and sustained action. According to data from PharmNet, in addition to TQF3250 capsules, Chia Tai Tianqing Pharmaceutical Group has already submitted a bid for the market approval of semaglutide under the Class 3.3 biological product category. This means that Chia Tai Tianqing simultaneously covers follower-type products and innovative small molecule reserves in the same market segment. The intention behind this combination is clear: to secure a position with more certain product categories while using innovative assets to strive for future differentiated premiums.
Returning to the actual competitive landscape of oral GLP-1 in China, data from PharmData shows that, in addition to Chia Tai Tianqing Pharmaceutical Group, companies that have entered Phase I clinical trials and are positioned as oral GLP-1 receptor agonists include Innovent Biologics, Wayne Biotech, and Dongbao Zixing. As for multinational pharmaceutical companies, Novo Nordisk's amycretin is also in the early clinical stage in China.
For Chia Tai Tianqing Pharmaceutical Group, TQF3250 is not only an important piece of its metabolic pipeline, but also a key battle to verify its small molecule drug development capabilities.

https://news.yaozh.com/archive/46974.html