Zhengda Tianqing Simeglutide Injection applies for market launch, intensifying competition on the domestic GLP-1 track
On December 11, 2025, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that the injection of semaglutide from Lianyungang Runzhong Pharmaceutical, a subsidiary of Zhengda Tianqing, has officially submitted its application for marketing, with a registration classification of Class 3.3 (biosimilars).
The original research drug Smeglutide was developed by Novo Nordisk, and its trade name includes Ozempic for the treatment of type 2 diabetes ® And Wegovy for weight management ®， With significant hypoglycemic and weight loss effects, it has become one of the best-selling drugs worldwide.
The core compound patent will expire in China in March 2026, sparking a wave of imitation and improvement among local pharmaceutical companies.
Zhengda Tianqing submitted its first clinical trial application in June 2023 and was approved in August of the same year. The first clinical study was launched in October.
Up to now, the company has carried out two key phase III clinical trials: the trial for type 2 diabetes has been completed in June 2024; The trial targeting obesity indications started patient enrollment in December 2024 and completed all recruitment in August of this year, with rapid progress.
According to the Dingxiangyuan Insight database, currently 10 domestic companies have submitted applications for the listing of Simaglutide, including Shiyao Group, Fosun Pharma (Wanbang), Qilu Pharmaceutical, FedEx, Lizhu Group, Huisheng Biotechnology, Zhongmei Huadong, Jiuyuan Gene, Beite Pharmaceutical, etc.
It is worth noting that Qilu Pharmaceutical and Shiyao Group have applied for the path of improved chemical drugs (Class 2.2), while other companies are promoting the path of biosimilars (Class 3.3).
In addition, there are about 10 domestically produced semaglutide products in the Phase III clinical stage, involving companies such as Peptide Biotech, China Resources Shuanghe, and Hanyu Pharmaceutical.
As the patent cliff approaches, the GLP-1 race is shifting from "R&D racing" to "market positioning" and "market competition".
In the next few years, the domestic market for semaglutide may present a pattern of "coexistence of multiple strengths, downward price exploration, and expansion of indications".
Whether or not to establish advantages in quality consistency, production capacity guarantee, commercial channels, and medical insurance access will be the key for each enterprise to break through.
