On May 17, 2024, information regarding Shenyang DASAN Pharmaceutical Technology Co., Ltd.'s acquisition of an MAH B-Certificate scope addition was reported by the Korean media outlet The Yakup (Pharmaceutical News).

The report noted that the product for which the manufacturing license was obtained was transferred from the Central R&D Center of Dasan Pharmaceutical in Korea, marking the first project for Dasan Pharmaceutical to file for registration in the Chinese market.

The advancement of this project successfully broke away from the existing model where Korean companies only entered the Chinese pharmaceutical market through exports, creating a precedent for obtaining manufacturing licenses using China's local MAH system. This represents a new business model of significant strategic importance for Korean pharmaceutical companies seeking to enter the Chinese market.

Through the MAH system, Shenyang DASAN Pharmaceutical Technology Co., Ltd. has obtained manufacturing licenses twice. This will serve as a crucial hub for Korean companies targeting the Chinese market. Furthermore, leveraging Dasan Pharmaceutical Korea's excellent bilayer tablet technology and formulation capabilities, it is believed that more Korea-China collaborative projects will be pursued in the future.

The MAH (Marketing Authorization Holder) system is a regulatory model that separates the marketing authorization of a drug from its manufacturing license. Under this mechanism, the authorization to market a drug and the permission to manufacture it are independent, allowing pharmaceutical manufacturers, research institutions, or scientific researchers to become independent marketing authorization holders.

With the implementation of the MAH system, Shenyang DASAN Pharmaceutical Technology Co., Ltd., adhering to the principle that the marketing authorization holder is responsible for the entire lifecycle of a drug, has actively recruited production and quality management talents on the foundation of its pure R&D team. The company has established an MAH quality management system, integrated and enhanced it with the quality management requirements of R&D projects. Currently, the MAH management system at Shenyang DASAN includes a team of 15 members, covering roles such as corporate responsible person, production responsible person, quality responsible person, qualified person for batch release, pharmacovigilance responsible person, production administrators, quality administrators, on-site QA for manufacturing, pharmacovigilance and adverse reaction specialists, and regulatory affairs specialists.

Through the joint efforts of all employees, Shenyang DASAN Pharmaceutical Technology Co., Ltd. obtained its first pharmaceutical manufacturing license in 2023. With the continuous issuance of various policies and regulations by the National Medical Products Administration regarding marketing authorization holders and contract manufacturing, and with increasingly stringent regulatory oversight of manufacturing enterprises operating under contract manufacturing models, the company has organized internal quality system audits and rectifications in accordance with policy and regulatory requirements. It has adjusted its organizational structure, integrated functional personnel, and improved its MAH quality management system. In 2024, it successfully obtained a scope addition for a second manufacturing license project. This transformation has positioned the company as a high-quality B-Certificate enterprise covering both R&D and manufacturing, making it a diversified enterprise capable of developing and holding its own products internally while also undertaking generic drug R&D projects externally.