DASAN Pharmaceutical recently successfully held a "Strategy Briefing on Entering the Chinese Pharmaceutical Market" in Seoul targeting pharmaceutical industry professionals. The briefing attracted approximately 60 participants from 20 domestic pharmaceutical companies, demonstrating the high level of interest in the Chinese market.

The briefing provided an in-depth discussion of China's drug registration system and recent regulatory changes, with a primary focus on the strategy for entering the Chinese market centered around the "MAH (Marketing Authorization Holder) system."

Liu Zhenhao, Head of DASAN Pharmaceutical's China Business Division, who served as the main speaker, stated: "China adopts a registration system different from Korea's, making it more pragmatic to obtain licensing rights through the MAH system. The strategy of submitting stability study reports followed by product licensing is particularly realistic and feasible for Korean pharmaceutical companies."

(Liu Zhenhao, Head of DASAN Pharmaceutical's China Business Division)

The briefing also shared practical application cases of the MAH system and commercialization processes. DASAN Pharmaceutical emphasized that its Chinese subsidiary, Shenyang DASAN Pharmaceutical Technology Co., Ltd. (Shenyang DASAN), serves as the actual executing partner for MAH business. It has a system in place to commercialize Korean pharmaceutical companies' technologies in China, and to act as an agent for licensing and production processes. Shenyang DASAN has successfully operated licensing projects such as cetirizine hydrochloride injection and telmisartan amlodipine combination products, and has established an MAH system covering the entire drug lifecycle management.

A dedicated Q&A session focused on the MAH system was held during the briefing. Participants actively raised questions on topics such as licensing procedures, clinical trial requirements, quality management systems, and experience cooperating with the Chinese government. The practical support services provided by Shenyang DASAN, including GMP site audit agency, bilingual (Korean-Chinese) quality systems, and MAH insurance design, also garnered significant interest.

DASAN Pharmaceutical emphasized: "By utilizing the MAH system, companies can move away from the traditional model of relying solely on exports. Through technology transfer and establishing localized production bases, they can build a competitive foothold in the Chinese market."

Furthermore, DASAN Pharmaceutical plans to conduct surveys among briefing participants and continue to offer support activities that can effectively assist Korean pharmaceutical companies in their globalization strategies.