每经记者｜陈俊杰????每经编辑｜黄博文????
On August 7, Hanyu Pharmaceutical (SZ300199, share price 24.38 yuan, market cap 21.533 billion yuan) announced that the company has recently received an acceptance notice for its Tirzepatide injection, issued by the National Medical Products Administration (the “NMPA”); its domestic marketing authorization application for a registered drug production has officially been accepted.
This acceptance marks phased progress for domestic companies in the GLP-1 (glucagon-like peptide-1) drug generic market.
Tirzepatide is a dual-target agonist of GLP-1R/GIPR (glucagon-like peptide-1 receptor/glucose-dependent insulinotropic polypeptide receptor) developed by Eli Lilly and Company.
According to the announcement, the terlipatide injectable dosage form submitted by Hansoh Pharmaceutical for marketing approval is an injection, with a registration category of Chemical Drug Class 4. In terms of indications, the terlipatide injectable formulation filed in this application covers three major therapeutic areas.
The first indication is for type 2 diabetes. This product is indicated for improving blood glucose control in adult patients with type 2 diabetes based on dietary control and an exercise foundation.
The second indication is for long-term weight management. This product is indicated for long-term weight management in adults whose initial body mass index (BMI) meets the requirements, based on controlling their diet and increasing their exercise. Specifically, it includes obese individuals with BMI ≥ 28 kg/m², or overweight individuals with BMI ≥ 24 kg/m² who have at least one weight-related comorbidity. Comorbidities include, for example, hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.
The third indication is for obstructive sleep apnea. This product is indicated, based on controlling the diet and increasing the exercise foundation, for the treatment of moderate to severe obstructive sleep apnea (OSA) in adult patients with obesity.
Tirzepatide holds an important position in the global weight-loss and glucose-lowering drug markets.
The reason the product has been dubbed the “Pharmacy King” by the market mainly stems from its impressive global sales performance. According to Eli Lilly’s financial report data, terlipatide’s total global sales in 2025 were approximately USD 36.507 billion, and global sales in the first half of 2026 were USD 27.693 billion; both ranked first in global drug sales.
In 2025, the glucose-lowering version of Mounjaro generated annual sales of approximately USD 22.965 billion, while the weight-loss version of Zepbound generated annual sales of approximately USD 13.542 billion. Together, these two indication products form the primary drivers of this product’s global revenue.
In terms of the market landscape, as of now there are no generic terlipatide products approved for sale anywhere in the world. The domestic market also has only the imported and localized products from Eli Lilly. Hansoh Pharmaceutical is the first company in China to submit an application for a marketing authorization for terlipatide.
This first generics application has been accepted by the National Medical Products Administration (NMPA), which means that domestic generic drug companies’ plans for this major product have officially entered the official review stage. At the same time, the announcement includes risk warnings: drug marketing approval may be affected by uncertain factors such as patents, and after launch it will also face uncertainties such as changes in the market and environment. Therefore, there is a risk that sales may not meet expectations.
Cover image source: Everyday Net Media Resource Library