Zhong Guo Zheng Quan Bao·2025-11-26 03:12Core Viewpoint - The successful completion of the GMP audit for the liraglutide injection by Tonghua Dongbao and its partner Sinovac Biotech marks a significant step in the company's internationalization strategy and paves the way for market entry in Brazil and expansion in South America [1][2]. Group 1: Company Developments - Tonghua Dongbao and Sinovac Biotech have collaborated to obtain exclusive commercialization rights for liraglutide injection in 17 emerging markets [1]. - The GMP audit conducted by Brazil's ANVISA was based on PIC/S guidelines, covering the entire production and quality management chain, and resulted in a "zero defect" outcome [1][2]. - The successful audit is seen as a key breakthrough for the company's international strategy, facilitating rapid entry into the Brazilian market [2]. Group 2: Market Context - Brazil has seen an increase in diabetes prevalence, with 16.62 million patients aged 20-79 and a prevalence rate of 10.7% [2]. - The country has established itself as a benchmark in the emerging pharmaceutical market since joining PIC/S in 2021, known for its stringent GMP standards [2]. - The company plans to accelerate the commercialization of more high-value products globally, enhancing treatment options for patients and driving long-term growth [2].