Through its collaboration with Beigene, Ltd. and the provision of manufacturing services for their monoclonal antibody tislelizumab, Boehringer Ingelheim Biopharmaceuticals China is the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL). The National Medical Products Administration of China (NMPA) recently approved the new monoclonal antibody tislelizumab as the first biopharmaceutical manufactured by a multinational contract manufacture service provider in China. It is also the first innovative 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 Research & Development landscape,” states John Oyler, Chairman and CEO of Beigene, Ltd. 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. In 2014, the process of reforming the local MAH/Contract Manufacturing model in order to enable a new regulatory pathway for authorizing third parties to manufacture biopharmaceutical products for drug authorization holders was initiated. In 2015, tislelizumab, where Boehringer Ingelheim Biopharmaceuticals China is the manufacturer, became the pilot project for the new regulatory approach and is now the first biologic approved under this new setup.
“We are very proud to become the first company starting commercial biopharmaceutical manufacturing under the MAH model in China.” says Dr. Jiali Luo, General Manager and Site Head of Boehringer Ingelheim Biopharmaceuticals China. “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.” Beigene, a global commercial-stage biopharmaceutical company focused on developing and commercializing innovative drugs for the treatment of cancer, and Boehringer Ingelheim Biopharmaceuticals China started their collaboration in 2013. Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim Bioxcellence, has been providing the chemistry, manufacturing, and control (CMC) services for tislelizumab.
“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,” stated Dr. Uwe Buecheler, Head of the Biopharmaceuticals Business Unit at Boehringer Ingelheim. “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.”