Mabwell (688062.SH), an innovative biopharmaceutical company with an integrated industry chain, announced that it has completed the first commercial shipment of its Denosumab Injection to the overseas market. This delivery marks the official entry of the product into clinical application overseas and represents a major step in the company's globalization strategy.

Mabwell's two Denosumab Injection products (marketed in China as MAILISHU and MAIWEIJIAN) have previously received the marketing authorization from the Drug Regulatory Authority of Pakistan (DRAP). Furthermore, the company has submitted the marketing authorization application in several other key markets, including Jordan, Egypt, and Brazil.

Demonstrating strong manufacturing compliance standards, T-mab, a wholly-owned subsidiary of Mabwell, has successfully passed Good Manufacturing Practice (GMP) on-site inspections conducted by multiple overseas regulatory authorities earlier this year, achieving "zero deficiency" results for its Denosumab production lines.

"This marks a significant milestone in Mabwell's global commercialization layout," said Mr. Hu Huiguo, Director, Senior Vice President, and Secretary of the Board at Mabwell. " The company has already signed formal agreements covering dozens of countries across overseas markets. We are actively advancing the registration to launch our products in more countries to further enhance the global accessibility of Denosumab Injection and meet the unmet needs of patients worldwide."