Milestone for Biopharmaceuticals in China
December 30, 2019
- Boehringer Ingelheim manufactures first biopharmaceutical approved in China under new MAH contract manufacturing regulatory system
- Boehringer Ingelheim’s contract manufacturing business partners with BeiGene, Ltd.
- Contribution to China’s healthcare system by strengthening the domestic biopharmaceutical R&D of Boehringer Ingelheim’s partners
Shanghai, China, December 30, 2019 – 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 biologic 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 very 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.”
About Boehringer Ingelheim
Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.
Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros corresponded to 18.1 per cent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
About BeiGene Ltd.
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA™ (zanubrutinib) and in China, the Company has received approval to market its anti-PD-1 therapy tislelizumab and markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb companyi.
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
i ABRAXANE® is registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.