HYBIO Pharmaceutical's first domestic marketing application for its tirzepatide injection has been accepted, and the dual filing in China and the US is accelerating its global commercial layout.

Recently, HYBIO Pharmaceutical Co., Ltd. (hereinafter referred to as “HYBIO Pharmaceutical”)’s self-developed application for the registration and marketing authorization of Tirzepatide injection, a domestically produced pharmaceutical product, was officially accepted by the National Medical Products Administration (NMPA). HYBIO Pharmaceutical has become the first company in China to submit an application for Tirzepatide injection, marking an important milestone in the process of localizing and commercializing Tirzepatide and further enhancing its product portfolio in the field of metabolic health.

The application for Tirzepatide Injection covers four main clinical formulations of 2.5 mg, 5 mg, 7.5 mg, and 10 mg, and is classified as Chemical Medicine Class 4. The indications covered include glycemic control in adults with type 2 diabetes, long-term weight management in overweight or obese adults, and moderate to severe obstructive sleep apnea associated with obesity. As the scale of people with diabetes, overweight, and obesity continues to expand in China, the demand for metabolic disease treatment and weight management is growing. The simultaneous application of multiple formulations and indications is expected to further enhance the product’s clinical coverage capabilities and lay the foundation for subsequent market entry and commercialization.

By filing applications in both China and the United States, Jianyu Pharmaceutical has established a leading position in the global market for Tirzepatide. The acceptance of its domestic application marks an important milestone in the company’s efforts to expand its global presence for GLP-1 products. In June 2026, the US FDA accepted the company’s ANDA application for Tirzepatide injection for the dual indications of blood sugar reduction and weight loss. With the NMPA’s formal acceptance of the application, Jianyu Pharmaceutical has now established a global strategy of concurrently filing applications and advancing its Tirzepatide products in both China and the United States.

From taking the lead in overseas markets to accelerating in the domestic market, it is backed by years of research and development, industrialization, and quality system support of peptide drugs by HYBIO Pharmaceutical. Relying on the mature peptide research and development technology platform, large-scale production capacity, and international quality management system, the company is continuously promoting the accelerated transformation of GLP-1 series products from research and registration to commercialization. The global single product continues to expand, and the GLP-1 market remains in a high growth period.

Tirzepatide is a GLP-1R/GIPR dual-target receptor agonist, which has demonstrated significant clinical value in areas such as glycemic control and weight management, and has become an important variety in the global metabolic disease treatment field. According to financial data disclosed by Eli Lilly, global sales of the Tirzepatide product series reached USD 36.507 billion in 2025, of which the hypoglycemic product Mounjaro achieved sales revenue of USD 22.965 billion, and the weight-loss product Zepbound achieved sales revenue of USD 13.542 billion. In the first half of 2026, global sales of Tirzepatide further reached USD 27.693 billion, a year-on-year increase of 88%, continuing its strong growth momentum. The Chinese market has also maintained rapid growth. Eli Lilly disclosed that its revenue from Tirzepatide in the Chinese market in the first half of 2026 was USD 1.635 billion, a year-on-year increase of 73%. Behind the sustained growth in market performance is the continuous release of treatment demand for diabetes, obesity, and related metabolic diseases worldwide. As the indications for GLP-1 drugs continue to expand and patient accessibility continues to improve, their market space and clinical value are still being further unlocked. Deepen efforts in high-end peptides, accelerate domestic substitution and globalization process.

At present, the global GLP-1 drug industry is in a phase of rapid expansion, and R&D innovation, large-scale production, cost control, and global registration capabilities have become key to corporate competition. Leveraging its first-mover advantage of being the first to file for market approval domestically and simultaneously filing in both China and the US, HYBIO Pharmaceutical Co., Ltd. is further strengthening its strategic positioning in the Tirzepatide field. In the future, HYBIO Pharmaceutical Co., Ltd. will continue to leverage its comprehensive advantages accumulated over the long term in the R&D, production, and international registration of peptide drugs, continue to deeply cultivate high-end peptide innovative drugs and high-end complex generic drugs, accelerate the review, registration, and commercialization of key products, and meet the treatment needs of patients at home and abroad in the fields of diabetes, obesity, and related metabolic diseases with high-quality, highly accessible products. From domestic filing to global layout, HYBIO Pharmaceutical Co., Ltd. is using Tirzepatide as an important fulcrum to further improve its GLP-1 product matrix and promote the Chinese peptide drug industry to move towards higher quality, higher efficiency, and a broader global market.

About HYBIO

HYBIO Pharmaceutical Co., Ltd. (stock code: 300199) is a national high-tech enterprise that has been deeply engaged in the field of peptide innovation for over two decades, focusing on the R&D, production, and global sales of innovative peptide drugs. The company has built a complete pipeline covering major global metabolic targets, encompassing GLP-1 single-target and multi-target innovative drugs as well as several globally significant peptide varieties, and has formed a full-industry-chain layout from APIs to formulations, from R&D to commercialization, and from the Chinese market to the global market, including, but not limited to, original innovative drugs of GLP-1R/GIPR/GCGR triple receptor agonists, retatrutide, tirzepatide, semaglutide, liraglutide, etc.