Boehringer Ingelheim Biopharmaceuticals China Receives Approval Under Under China’s New MAH Model

January 3, 2020

Boehringer Ingelheim Biopharmaceuticals China is the first company to apply the adopted Marketing Authorization Holder system within the revised Chinese Drug Administration Law through its partnership with BeiGene for its monoclonal antibody, tislelizumab.

Boehringer Ingelheim Biopharmaceuticals China, the Shanghai-based contract manufacturing business of Germany’s Boehringer Ingelheim, announced on Dec. 30, 2019 that it is the first company to apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law through its partnership with BeiGene, a Beijing, China-based biopharmaceutical company, for its monoclonal antibody, tislelizumab.

According to a Boehringer Ingelheim press release, tislelizumab was recently approved by the National Medical Products Administration of China (NMPA) as the first biopharmaceutical manufactured by a multinational contract manufacture service provider in China. It will also be the first biopharmaceutical commissioned under the new MAH model in China.

“This is an important milestone, not only to ensure the supply of medicines for patients in China, but also for the rapidly emerging Chinese biopharmaceutical R&D landscape,” said John Oyler, chairman and CEO of BeiGene, in the press release. “The collaboration between BeiGene and Boehringer Ingelheim Biopharmaceuticals China demonstrates that the country’s MAH trial project can be successfully applied in order to advance the life sciences industry in China.”

The process of reforming the MAH system in China began in 2014 when a new regulatory pathway that let third parties manufacture biopharmaceutical products for drug authorization holders was established, according to the press release. A year later, tislelizumab was introduced as the pilot project for the new concept.

“We are very proud to become the first company starting commercial biopharmaceutical manufacturing under the MAH model in China,” said Dr. Jiali Luo, general manager and site head of Boehringer Ingelheim Biopharmaceuticals China, in the press release. “The trial project was smoothly conducted and now proven successful. The newly established model can be of great benefit for the Chinese health care system and provide Chinese patients broader access to more innovative medicine.”

“We congratulate BeiGene for reaching this very important milestone with the approval of their antibody in China. We are excited and set up to reliably supply this important innovative product according to international quality standards,” added Dr. Uwe Buecheler, head of the Biopharmaceuticals Business Unit at Boehringer Ingelheim, in the press release. “This is the first commercial biopharmaceutical manufactured in our facilities in China. By reaching this milestone, we are adding another important biopharmaceutical to our outstanding product track record of now 36 licensed biopharmaceuticals for patients worldwide.”

Source: Boehringer Ingelheim