MAH System Stimulates the Vitality of Innovation - Hillgene Empowers the Cellular Therapy Products with CQDMO Services

On July 22-23, 2022, the first International MAH (Marketing Authorization Holder) Cooperation and Innovation Summit was held in Hangzhou.

This conference focused on the MAH system, and centered around hot topics such as MAH supervision, difficulties and solutions for innovative drug MAHs, shared my country's latest pharmaceutical industry policies and regulatory directions, and discussed how companies can seize opportunities under the MAH system and lead the global pharmaceutical innovation development trend. Mr. Richard Li, COO of Spectrum Biotech, was invited to participate in the forum report and roundtable meeting.

Roundtable Dialogue--Mr. Richard Li, COO of Spectrum Biotech

Mr. Li Cha, COO of Spectrum Biopharmaceuticals, participated in the roundtable discussion on the theme of [Macromolecular Drug Production, Self-built or Outsourced] at the first International MAH Cooperation and Innovation Summit.

Mr. Li Cha said: On the issue of production capacity, the entire cell therapy management system has not yet reached a consensus, including supervision, which is also a process of crossing the river by feeling the stones. My personal understanding of production capacity requires additional hardware, management, and supervision, and the most important thing is to have a considerable amount of competitive products as a prerequisite. Effective production capacity can produce each batch of drugs and reduce the overall cost, so that the entire Chinese production capacity, whether innovative drugs or generic drugs, can reflect certain advantages in terms of efficacy or cost. I think this is the real production capacity.

The implementation of the MAH system has greatly encouraged R&D innovation, avoided repeated investment by R&D companies, optimized resource allocation, and strengthened corporate responsibility entities. It is also an innovative way of supervision. However, there will still be some problems in the specific implementation. At the convening of the first International MAH Cooperation and Innovation Summit Forum, each expert started from his own expertise, fully discussed, expressed his own opinions, and discussed MAH practices from multiple aspects and angles such as supervision, innovative drugs, traditional Chinese medicine, and MAH cooperation, to solve doubts for everyone present and provide new ideas and new directions.

At present, the only CAR-T cell drug order in China that is commercially produced by a third party authorized by MAH is placed with Spectrum Biopharmaceuticals. Spectrum Biopharmaceuticals will also work with the industry to contribute to the MAH system and the entire cell therapy field with its unique CQDMO technology service platform.