Brilliant Biologics Submits Semaglutide Injection for Market Approval in China, Targeting Over RMB 4.7 Billion Obesity and Diabetes Market
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
CSPC
Innovative Drug Research and Development, Manufacturer
On April 1, the Center for Drug Evaluation of the National Medical Products Administration（CDE）The official website shows,Chengdu Better BiopharmaceuticalSubmittedSemaglutide InjectionThe marketing application for the Class 3.3 new drug has been accepted. Based on the progress of clinical trials, the indication for this submission is speculated to be for obesity treatment.This submission has resulted in 10 associated acceptance numbers all at once, each accepted as a Category 3.3 new drug, indicating that the domestic production process of this GLP-1 "blockbuster drug" is accelerating once again.
Screenshot source: CDE official website
March 20, 2026SemaglutideInThe formal expiration of China's core compound patent has become a key time node for the entry of domestically produced generic drugs. Original researchSemaglutideYesNovo NordiskThe star GLP-1 product developed has continued to explode in the market since its launch.Global sales reached $34.6 billion in 2025,It is the world's second-largest GLP-1 drug, only after Eli Lilly's tirzepatide.
The growth momentum in the Chinese market is rapid. Data from摩熵医药shows,Semaglutide InjectionBy 2025, the sales revenue of the all-terminal hospital market in China has exceeded 4.7 billion yuan, with a year-on-year increase of 12.59%. However, this vast market is still exclusively monopolized by the original research product, and no domestically produced brands have been approved for marketing.
Screenshot source: All-terminal Hospital Sales Database(Check data. Find Moentropy)
As the patent window opens, companies in China are accelerating their layout. Data from MaxEntropy Pharma shows that, as of now, more than 10 companies in China haveSemaglutideProduct registration for market entry. Among them,Qilu PharmaceuticalAndCSPCOne company applied for a Category 2.2 improved new drug, while most other companies applied under Category 3.3. A full-scale competition for the research and application of "domestically produced semaglutide" has unfolded.
Screenshot source: China Drug Evaluation Database (More clickMini ProgramView)
Chengdu Better BiotechAn important participant in this wave of domestic substitution.。In September 2025, the company had submitted a marketing application for this product to improve blood glucose control in patients with type 2 diabetes. The submission of the obesity indication this time means that its "diabetes + weight loss" dual-track layout strategy has officially landed.
Semaglutide InjectionYesBETTER PharmaceuticalThe first biologic drug to be submitted for marketing approval. According to data from Mosecure Medicine, by 2025, the sales scale of biologic drugs in the full-terminal hospital market in China will exceed 230 billion yuan, with a year-on-year increase of 3.42%, showing significant potential. To date, Betta Pharmaceuticals and its subsidiaries have marketed products involving chemical drugs and traditional Chinese medicine, but no biologic drugs have been approved yet.Semaglutide InjectionIs expected to open the door to the biopharmaceutical market for the company.
Bait BioTwo pivotal Phase III clinical trials have been completed, targeting Type 2 diabetes and obesity indications respectively. Among them, the Phase III trial for obesity aims to evaluate itsSemaglutide InjectionCompared with the original productWEGOVY®Similar efficacy as an adjunct to lifestyle intervention in obese adult patients.
In terms of indication layout, domestically producedSemaglutideThe initial indications for all were Type 2 diabetes, but some companies have begun to seek differentiated competition. In addition to Type 2 diabetes, Jiuyuan Gene, CSPC, and Betta Biologics have also applied for obesity indications, while Livzon Group has applied for secondary prevention of cardiovascular events in diabetes patients, showing that domestic companies are expanding from mere imitation to innovative applications.
Screenshot source: China Drug Evaluation Database (More clicksMini ProgramView)
Earlier, Bet Pharmaceutical has laid out five Class 1 new biologics drugs. Among them,HC010 for InjectionAndBPR-101 CapsuleAlready in Phase II clinical stage,BPR-102 CapsuleReceived clinical approval for the first time in May 2025 for the treatment of postmenopausal atrophic vaginitis.BPR-101 CapsuleIt is a compound preparation containing lactobacilli and their metabolites, aimed at restoring the healthy microecology of the vagina. In May 2025, the Phase II clinical trial of this new drug for bacterial vaginosis has been successfully completed.
As domestically produced semaglutide is successively filed for application and expected to be approved in the future, China’s GLP-1 market will embrace comprehensive competition in terms of price, channels, brand, and service. This is not only a competition of products but also a test of enterprises' overall strength and strategic layout. An industrial revolution that profoundly impacts the treatment landscape of metabolic diseases in China is accelerating.
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