On September 26, 2023, our company received the “Notice of Pharmaceutical GMP Compliance Inspection Results” issued by the Beijing Municipal Administration for Drug Supervision. Our 0.1% (5ml:5mg) Sodium Hyaluronate Eye Drops have successfully passed the pharmaceutical GMP compliance inspection. This product is the first one our company has brought to market under the MAH (Marketing Authorization Holder) system—having obtained marketing authorization as the MAH—and has undergone on-site verification. This milestone marks the official launch of our company’s commercialization efforts.

Since the company obtained the Drug Registration Certificate for this product in May 2023, the company’s Quality Management Department has been actively communicating with the Beijing Municipal Administration for Drug Supervision and organizing relevant departments to meticulously prepare for the inspection. Led by the Quality Management Department, a comprehensive review and梳理 of the MAH’s core elements was conducted in accordance with the requirements set forth by the National Medical Products Administration for marketing authorization holders. During the three-day inspection in July, the inspection team focused on key areas including organizational structure, key personnel, document management, material and supplier management, contract manufacturing management, product release and shipment management, as well as change and deviation management. Relevant departments cooperated closely to provide detailed responses to all questions raised by the inspection team. The inspection team recognized our company’s quality management system and also offered professional recommendations for further optimizing our system’s structure.

This GMP compliance inspection of our sodium hyaluronate eye drops represents a comprehensive assessment of our company’s MAH quality system. The successful completion of this inspection demonstrates that our company possesses a robust quality management system and excellent operational management capabilities. It also marks the official launch of our commercialization journey in the ophthalmic products market. Sodium hyaluronate eye drops are the best-selling product in the dry-eye disease drug market, accounting for over 25% of the entire dry-eye disease market share. Among these, the multi-dose eye drops in the 0.1% concentration continue to hold the largest share of the sodium hyaluronate market. In accordance with the requirements of the MAH system, our company will integrate resources across the group, organize contract manufacturing arrangements effectively, and, taking the entry of ophthalmic drugs into the market as an opportunity, establish dedicated marketing and sales teams and build a robust distribution network—thus laying a solid foundation for the commercialization of our biopharmaceutical products.