Press Releases Archive Boehringer Ingelheim BioXcellence™

Boehringer Ingelheim Biopharmaceuticals China supports BeiGene in its China NDA submission of anti-PD-1 antibody, tislelizumab

September 3rd 2018

  • First biologic manufactured by Boehringer Ingelheim BioChina accepted for New Drug Application review
  • Important milestone for Boehringer Ingelheims’ collaboration partner BeiGene in immuno-oncology
  • Boehringer Ingelheim BioChina is proud to support BeiGene in serving patients worldwide with this important medicine

Shanghai, China, September 3rd, 2018 – BeiGene Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the National Medical Products Administration of China (NMPA, formerly known as CFDA) has accepted its new drug application (NDA) for its anti-PD-1 antibody, tislelizumab, for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL).

Since BeiGene and Boehringer Ingelheim 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 support of the tislelizumab. Boehringer Ingelheim assisted BeiGene with tislelizumab’s development through process and analytical method development, supply of GMP clinical material, and CMC filing support with the NMPA.

Tislelizumab is an investigational anti- PD-1 antibody being studied in a number of malignancies, such as relapsed/refractory classical Hodgkin’s Lymphoma, non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, mature T-and NK-cell lymphomas, and urothelial cancer. Boehringer Ingelheim Biopharmaceuticals (China) Ltd. is committed to providing BeiGene with full contract manufacturing support and supply of tislelizumab at the highest global quality standards to serve patients with this important medicine, if approved.

About Boehringer Ingelheim Biopharmaceuticals China

As one of the world’s largest biopharmaceutical producers, Boehringer Ingelheim is China’s first international provider of biopharmaceutical contract manufacturing solutions with all-round services, including process development, clinical trials and product supply, to its clients in China and all over the world. Boehringer Ingelheim Biopharmaceuticals (China) Ltd.’s facility was officially put into operation in May 2017. As the first and only biopharmaceuticals facility in line with global standards set by a multinational pharma company in China, the facility has become a major milestone in Boehringer Ingelheim’s strategic blueprint for its biopharmaceuticals business globally.

About Boehringer Ingelheim

Improving the health and quality of life of patients 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 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 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.

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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.