Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") recently received the Pharmaceutical Product Registration Certificate for liraglutide injection issued by National Medical Products Administration (approval number: GYZZS20230066, trade name: Tongboli). With the approval, the Company has become the second Chinese company with market approval for liraglutide injection and ranks among the few companies that sell Chinese GLP-1 receptor agonist ("GLP-1 RA") products.

As the Company's first GLP-1 RA product approved for marketing, liraglutide injection marks a milestone. With its approval, the Company now boasts a comprehensive diabetes treatment portfolio that covers all human insulins and insulin analogs, DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 RAs, offering patients a wide range of treatment options.

With the approval, liraglutide injection will be marketed in China along with existing products to fortify the Company's leadership in diabetes treatment. For the overseas market, the Company will partner with Kexing Biopharm to accelerate the registration and subsequent commercialization of liraglutide injection. The Company will leverage its first mover advantage to increase its market share as soon as possible and open up room for growth, laying a solid foundation for the launch of ensuing GLP-1 products.

Keeping up with the global trend in R&D of peptide-based weight-loss and antidiabetic drugs, Tonghua Dongbao is betting on a variety of GLP-1 RA products. In addition to liraglutide injection, it also has several programs under development, including semaglutide injection, dual GLP-1/GIP receptor agonists, and oral GLP-1 RAs. The goal is to put in place a diversified GLP-1 portfolio and tap into the market potential in weight loss, NASH, and other indications. The market approval and upcoming sales of liraglutide injection will lay a good market foundation for the Company's subsequent launch of GLP-1 products.

About liraglutide injection

Liraglutide is a glucagon-like peptide (GLP-1) analog that activates the human GLP-1 receptor and promotes insulin secretion from the pancreas. Developed by Novo Nordisk, it was introduced into the Chinese market in 2011, and approved for blood glucose control in adults with type 2 diabetes. The liraglutide injection (trade name: "Tongboli") developed by the Company is a biosimilar of the brand-name drug Victoza (liraglutide injection).

The market potential for GLP-1 drugs is huge. According to available statistics, the global market for GLP-1 RAs is growing rapidly, exceeding USD 20 billion in 2022. In China, the demand for GLP-1 RA drugs is also surging. According to data from Menet.com, in Q1 and Q2 2023, the sales of GLP-1 RA drugs in Chinese public medical institutions and urban brick-and-mortar pharmacies reached nearly RMB 4 billion, recording a YoY increase of more than 50%, of which liraglutide injection sales accounted for nearly RMB 1 billion.