17. February 2016

Boehringer Ingelheim to launch China's first biopharma CMO pilot project

  • The first project provides biopharma CMO manufacturing for BeiGene’s self-developed immuno-cancer therapies
  • Biopharma manufacturing site is expected to be put into operation in the 1st quarter of 2017
  • Boehringer Ingelheim will team up with more medicine research enterprises and institutions to promote clinical research and market debut of innovative products


Shanghai, China, February 4, 2016 - German pharmaceutical giant Boehringer Ingelheim announced today that Boehringer Ingelheim China Biopharmaceuticals Site has been selected to launch the country’s first biopharma CMO pilot project. The biopharma manufacturing base is jointly developed by Boehringer Ingelheim and Shanghai Zhangjiang Biotech & Pharmaceutical Base Development Company. The first client under the pilot project will be BeiGene. The new site will provide biopharma CMO manufacturing for BeiGene’s self-development immuno-cancer therapies.

“The launch of the CMO pilot project marks a key milestone for our biopharma business in China,” said Dr. Luo Jiali, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Co Ltd. “We will accelerate the development of the biopharma site, break the original ‘bottleneck of manufacturing’ in the biopharma industry chain, and provide our clients with the world’s leading contracted manufacturing management system, quality assurance system as well as supply chain management for the products. We will also team up with more medicine research enterprises and institutions to promote clinical research and market debut of innovative products. We will leverage our advanced manufacturing platform and management expertise to help Chinese enterprises bring their products into the global markets. We are very glad that we are playing an important and active role in fostering China’s biopharma CMO pilot project.”

As a global leader in biopharma CMO manufacturing, Boehringer Ingelheim has advanced technology and abundant experience in the field. Selecting Boehringer Ingelheim to undertake the first CMO pilot project will help Shanghai’s regulatory authorities better monitor the quality of biopharma manufacturing, significantly facilitate commercialization of the biopharma sector in Shanghai and even in China, and contribute to Shanghai’s efforts to develop a technology innovation center with global influence. Boehringer Ingelheim is also an important player to drive China’s biopharma CMO pilot project.

In August 2015, the State Food and Drug Administration submitted a request to the State Council to launch a pilot Marketing Authorization Holder program in 10 provinces and municipalities. By the end of 2015, the Standing Committee of the National People's Congress had issued a decision to authorize the State Council to carry out the pilot program, providing policy breakthrough and legal basis for biopharma CMO. Contract manufacturing of biopharmaceuticals is just a good example to demonstrate how the Marketing Authorization Holder system works.

Under the Marketing Authorization Holder system, a holder of the drug approval number could be a drug production enterprise, a research institute or a researcher, who are required to market the drugs on their own and take the responsibility for the drugs during their entire life cycles. After receiving the approval numbers, holders are allowed to manufacture the drugs on their own or choose contract manufacturers instead. Contract manufacturing will therefore help separate drug marketing authorization holders from drug production enterprises and significantly contribute to the industry’s growth. Prior to the trial of the Marketing Authorization Holder program, drug research companies had to develop their own production lines and were not allowed to resort to contract manufacturers.

Biopharma is one of the major industries highlighted in the 12th Five-Year-Plan both in Shanghai and nationwide. For a long time, it has been difficult for pharma research companies to put new drugs into commercial use due to high technology thresholds in biopharma manufacturing. The launch of the biopharma CMO pilot project will help break the “bottleneck” of manufacturing in the original biopharma industry chain to turn it into a “service platform”. Pharma research enterprises can now focus only on developing innovative drugs while pharma manufacturers will focus on commercial production and quality control to help research-oriented companies commercialize the products and maximize their value.

As a new model for the pharma industry, biopharma contract manufacturing has been included in the “22 Measures to Promote Shanghai’s Development of a Technology Innovation Center” and also listed as one of the 10 key innovative trial projects under the a coordinated development program between China (Shanghai) Pilot Free Trade Zone and Shanghai Zhangjiang National Innovation Demonstration Zone. It is expected to facilitate the implementation of the innovative strategy for the biopharma industry in Shanghai.

David Preston, President and CEO of Boehringer Ingelheim China,Hong Kong and Tai Wan, commented: “The launch of the biopharma CMO pilot project is thanks to strong support of all levels of government units in Shanghai. Biopharma is one of our core businesses in China. We believe that the innovative CMO model will help more biopharma enterprises manufacture and market innovative biopharma products and provide Chinese patients with more high-quality innovative bio-medicines.”

 

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 146 affiliates and more than 47,700 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. Prescription Medicines, the company’s largest business segment, invested 19.9% of its sales in R&D.

Boehringer Ingelheim’s biopharmaceutical business is supported by three pillars: contract manufacturing, biosimilars and new biological entity. As one of the largest biopharmaceutical contract manufacturers, BI has successfully marketed 23 biopharmaceuticals. BI operates three development and production sites worldwide: Biberach/Riss (Germany), Vienna (Austria) and Fremont (USA) and has initiated the establishment of a new site in Shanghai (China). The company has already established a Biosimilar Business for the development of its own biosimilars. Meanwhile, BI develops manufacturing processes and analytical methods for its New Biological Entities.

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