Tonghua Dongbao Pharmaceutical Co., Ltd. ( "the Company" or "Tonghua Dongbao") underwent an on-site inspection by the European Medicines Agency (EMA) in April 2024. Recently, the Company received a notice that its human insulin drug substance (DS) production facilities comply with the European Union (EU) GMP regulations and are ready for commercial manufacturing in the EU.

In 2013, the Company received EU GMP certification for human insulin DS, making it the first company in China to obtain EU GMP certification for a biological DS. To expand its international market presence, the Company began the registration process for a human insulin injection in the EU. In January 2013, the Company's marketing authorization application (MAA) for the human insulin injection was accepted by the EMA.

From April 15 to 18, 2024, EMA-commissioned inspectors from the national competent authorities of two EU countries conducted a four-day on-site inspection of Tonghua Dongbao's multi-product human insulin DS production facilities. In July 2024, the Company received notification of passing the EMA pre-approval GMP inspection, demonstrating that Tonghua Dongbao has rigorously adhered to EU GMP standards for over a decade, with its human insulin DS meeting EMA quality requirements.

The Company's journey in insulin production began in 1998 with the successful development of China's first recombinant human insulin, Gansulin. Commercialization was achieved in 2008, making China the third country in the world, after the United States and Denmark, to industrialize recombinant human insulin. By 2023, the Company has captured over 40% of China's human insulin market share, firmly establishing its leadership in the sector (according to Pharmcube data).

The Company boasts the largest fermentation system among human insulin manufacturers in China, with world-leading capabilities in fermentation, expression, yield, purity, and testing. Leveraging its superior product quality and large-scale production capacity, the Company has exported insulin products globally for years.

In recent years, the Company has been pursuing opportunities across the world, accelerating its global strategy. Besides the recent EMA pre-approval GMP certification for human insulin, the Company has been expanding its product portfolio in international markets. For insulin products, the Company has established a strategic partnership with Kingfriend to jointly enter the U.S. insulin market with three insulin variants: Aspart, Glargine, and Lispro. Furthermore, the Company expanded the registration and application of Insulin Glargine and Insulin Aspart in developing countries. For GLP-1 products, the Company has partnered with Kexing Biopharm to market liraglutide injection in 17 emerging markets.

With the expansion and diversification of its product portfolio, the Company is bringing more high-quality products, including human insulin and insulin analogs, GLP-1RA, and first-in-class drugs, to the international market. This is part of its strategy to accelerate internationalization through various channels and means.