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Recently, Kexing Biopharm's liraglutide biosimilar, a product exported in cooperation with Tonghua Dongbao Pharmaceutical, officially obtained the Good Manufacturing Practice (GMP) certificate issued by the Brazilian National Health Surveillance Agency (ANVISA), a member country of PIC/S (International Pharmaceutical Certification Cooperation Organization). This marks a new stage in the compliance process of the product in the core Latin American market.

As a globally recognized high-standard pharmaceutical quality management system, GMP certification in PIC/S member countries is renowned for its stringent, standardized, and highly mutually recognized nature. Brazil, as the largest economy in Latin America, a core pharmaceutical market, and a key PIC/S member country, has an ANVISA regulatory system aligned with international standards, with review processes covering the entire process of drug production and quality management. Since partnering with Tonghua Dongbao to expand overseas, both parties have fully leveraged their respective strengths, ensuring product quality while accelerating registration and channel development in target overseas markets, jointly promoting market access and implementation in multiple countries.

Liraglutide, a GLP-1 receptor agonist, is a benchmark drug in the global treatment of metabolic diseases. It is mainly used for glycemic control in type 2 diabetes and has the advantages of clear efficacy, good safety and wide clinical application.

According to data from the International Diabetes Federation (IDF) Global Diabetes Atlas, there were 589 million adults aged 20-79 with diabetes worldwide in 2024; this number is projected to rise to 853 million by 2050. With the continued rise in diabetes incidence, emerging markets such as Latin America are experiencing increased demand for high-quality, readily accessible biologics. Liraglutide biosimilars, with their cost-effectiveness, have become one of the mainstream choices for many patients.

Previously, the product had obtained GMP certification in Colombia and been approved for marketing in Peru. With the addition of the GMP certification in Brazil, it has achieved multiple breakthroughs in the Latin American market. This is a significant achievement since the establishment of Kexing Biopharm's Brazilian subsidiary. As more products are launched in Latin America, the company's international competitiveness will be further strengthened.

In the future, Kexing Biopharm will continue to accelerate its globalization process, leveraging its increasingly mature overseas operating system and rich product pipeline to drive more high-quality biopharmaceuticals to the international market and contribute to improving global health accessibility.

https://www.kexingbiopharm.com/
Kexing Biopharm

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