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Breakthrough in GLP-1 Global Expansion | Tonghua Dongbao's Liraglutide Injection Approved for Marketing in Peru

Date:2025-11-29
Author:東寶
Views:0

Recently, a liraglutide injection, developed by Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or "the Company") and its partner, Kexing Biopharm Co., Ltd. ("Kexing Biopharm"), has been approved for marketing by the Peruvian General Directorate of Medicines, Supplies and Drugs (DIGEMID). This marks the Company's first overseas approval for its liraglutide injection. The milestone expands the Company's global product portfolio beyond insulin into the fast-growing GLP-1 segment, demonstrating its enhanced global presence and overall capabilities.

Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog that activates the GLP-1 receptor and stimulates insulin secretion from the pancreas. It can be used alone or in combination with other glucose-lowering medicines to improve glycemic control. It also provides cardiovascular protection and promotes weight loss. The product is recognized worldwide for its proven efficacy and high safety.

The number of people with diabetes continues to increase worldwide. According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition (2024), 589 million adults aged 20–79 had diabetes in 2024, representing 11.1% of the world's population in this age group. The total number of people with diabetes is projected to rise to 853 million by 2050. Given the high and rapidly growing prevalence of diabetes in emerging markets, the Company is working with Kexing Biopharm to expand into global emerging markets, covering 17 countries across Latin America, the Middle East and North Africa, Southeast Asia, and Southern Africa.

Since the beginning of their global expansion partnership, the two parties have leveraged their respective strengths and worked efficiently together to advance overseas registration and GMP audits for the liraglutide injection. In February this year, the Company underwent an on-site GMP audit by the Egyptian Ministry of Health and Population. In April, the Company received a GMP certificate issued by Colombia's National Food and Drug Surveillance Institute (INVIMA). This month, it also passed an on-site GMP audit by the Brazilian Health Regulatory Agency (ANVISA), a PIC/S participating authority. The marketing approval in Peru is another milestone for the liraglutide injection in global expansion.

Since the beginning of this year, the Company has maintained rapid growth in overseas revenue, and multiple products have achieved important progress in international registrations. Its insulin portfolio has been approved for marketing in five emerging markets, including Indonesia and Uzbekistan. The U.S. Biologics License Application (BLA) for insulin aspart has been accepted for review by the U.S. Food and Drug Administration (FDA). Looking ahead, the Company will continue to accelerate its internationalization strategy, further expand overseas sales opportunities, and enable more patients worldwide to benefit from high-quality and accessible diabetes treatment products.


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