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GLP-1 Global Expansion | Tonghua Dongbao's Liraglutide Injection Undergoes GMP Inspection by the Egyptian Ministry of Health and Population
Date：2025-03-03
Author：東寶
Views：2
Recently, the liraglutide injection, developed by Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or "the Company") and its partner, Kexing Biopharm Co., Ltd. ("Kexing Biopharm"), received an on-site Good Manufacturing Practice (GMP) inspection by the Egyptian Ministry of Health and Population. The inspection was conducted at Tonghua Dongbao's manufacturing site, with the Company and Kexing Biopharm working closely together to support the process. The inspection is progressing smoothly.
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog that activates the GLP-1 receptor and stimulates insulin secretion from the pancreas. In addition to effectively controlling blood glucose levels, liraglutide provides cardiovascular protection and promotes weight loss. The product is recognized worldwide for its proven efficacy and high safety.
In December 2022, Tonghua Dongbao and Kexing Biopharm signed an exclusive licensing agreement, granting Kexing Biopharm the exclusive rights to sell its liraglutide injections in 17 emerging markets. Tonghua Dongbao's liraglutide injection received marketing approval from the National Medical Products Administration (NMPA) in November 2023, making the Company the second Chinese manufacturer to launch a liraglutide product in China. Sales of the product began in 2024. Meanwhile, the two companies are advancing the registration of liraglutide in licensed overseas markets to meet the treatment needs of more patients.
A study published in The Lancet reported that the number of adults with diabetes worldwide reached 828 million in 2022, an increase of 630 million compared to 1990. In the Middle East and North Africa (MENA) region, influenced by local lifestyles and dietary patterns, the prevalence of non-communicable chronic diseases such as cardiovascular disease, diabetes, and cancer continues to rise. Due to strong purchasing power in the region, there is significant market potential for branded drugs and high-end generic drugs. According to the International Diabetes Federation (IDF), the prevalence of diabetes in the MENA region stands at 16.2%. Among the 50 countries with the highest obesity rates globally, 18 are in the MENA region, indicating significant growth opportunities for liraglutide. Egypt is the second-largest pharmaceutical market in the MENA region. A research report cited by MASRAWY identified Egypt as one of the top 10 countries worldwide with the highest number of people with diabetes, with a prevalence rate of 20.90%.
If the liraglutide injection is approved in Egypt, it will speed up its launch in the Egyptian market and help the Company expand into neighboring markets. The product will serve as a key gateway for the Company's entry into the endocrine and metabolic disease treatment sector in the MENA region. Furthermore, Egypt is one of Kexing Biopharm's key overseas markets and a strategic hub for deepening its presence in the MENA pharmaceutical sector.
Global expansion is a long-term and complex process that requires sustained effort. The Company is committed to advancing its global strategy with firm belief, clear planning, and pragmatic action. As more products, such as the liraglutide and insulin series, pass factory inspections and receive approvals in more countries and regions, the Company will speed up its global expansion. In the future, more high-value products will enter international markets, providing safe, effective, and affordable treatments, giving patients more choices, and driving the Company's long-term growth.
