echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > China's first innovative biopharmaceutical product commissioned by a professional contract manufacturer to be put on the market has been approved, and will be put into commercial production in the bio pharmaceutical base of Ingram, bringer

    China's first innovative biopharmaceutical product commissioned by a professional contract manufacturer to be put on the market has been approved, and will be put into commercial production in the bio pharmaceutical base of Ingram, bringer

    • Last Update: 2019-12-31
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Shanghai, December 30, 2019 / Meitong news agency / -- on December 28, a tumor antibody drug baizean (general name: tirelizumab injection) manufactured by bringer Ingelheim biopharmaceutical (China) Co., Ltd through the mode of entrusted production was approved by China National Drug Administration (nmpa) for listing to treat the relapse of at least second-line system chemotherapy or Patients with refractory classical Hodgkin's lymphoma (R / rchl) Baize'an ® is independently developed by Baiji Shenzhou, a global innovative biopharmaceutical enterprise It is the first innovative biopharmaceutical approved by the domestic listing license holder through entrusted production mode after the new drug administration law of the people's Republic of China (hereinafter referred to as the new drug administration law) comes into force The new tumor immune drug is not only "developed in China", but also "made in China": it will be put into commercial production at the bringer Ingelheim biomedical base in Zhangjiang, Shanghai, and will soon benefit patients The approval of baizean ® is a major milestone of the drug listing license system in the drug administration law implemented on December 1: Based on the previous cooperation agreement between Baiji Shenzhou and bolingyingehan biopharmaceutical (China) Co., Ltd., bolingyingehan will provide long-term commercial contract production services for the product As a result, the approval of this new drug has created two "China first": after the implementation of the new drug administration law, this drug has become the first innovative biological drug commissioned by a professional contract manufacturer to be put on the market; Boehringer Ingelheim biopharmaceutical (China) Co., Ltd became the first company to successfully provide entrusted production services for biopharmaceutical production after the implementation of the new drug management law According to reports, in the past, two major links of drug registration and production in China were "tied up" According to the new version of Drug Administration Law implemented on December 1 this year, the MAH system in China has been clarified, the separation of drug production license and marketing license has been realized, and drug research and development institutions and scientific research personnel are allowed to act as drug registration applicants, while a third party is authorized to act as the holder of drug marketing license for the commercial production of drugs "The approval of baizean ® is the successful application of the new drug management law just promulgated: on the one hand, the new drug is expected to benefit cancer patients in China and around the world At the same time, the cooperation between Baiji Shenzhou and bringer Ingelheim biopharmaceutical (China) Co., Ltd will not only ensure the high-quality production and stable supply of this bio innovative drug, but also support the clinical trials of the drug in more cancer indications fields We can be sure that the new drug administration law will further promote the rapid rise of China's biopharmaceutical industry, and is expected to promote the development of life science research in China "Dr Wu Xiaobin, President of Baiji Shenzhou, pointed out Dr Luo Jiali, general manager of Boehringer Ingelheim biopharmaceutical (China) Co., Ltd., said: "congratulations to Baiji, China At the same time, we are also proud to be the first company in China to commercialize biopharmaceutical production based on the new drug management law In 2016, as the only biopharmaceutical contract manufacturer, bringer Ingelheim biopharmaceutical (China) Co., Ltd actively participated in the reform of China's drug listing license holders and contract production mode The pilot project went smoothly and successfully Now, with the approval of new drugs, we will devote ourselves to the commercial production of products We believe that this new model will help the development of Chinese medicine industry and provide more innovative drugs for Chinese patients " Baiji Shenzhou is a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotumor therapy Cooperation between the two sides began in 2013 Bioxcellence, contract manufacturing division of biopharma (E) We have been providing chemical, production and control (CMC) management for bazaar ® Next, according to the international quality standards, Boehringer ingelham will supply this important innovative product to Baiji for a long time Globally, bringer Ingelheim has provided a total of 35 listed biological products to patients all over the world, which is a unique achievement in the field of biopharmaceutics "As the first innovative biopharmaceutical produced under a contract after the new version of Drug Administration Law of the people's Republic of China comes into force, the commercial production of baizean ® is just the beginning I foresee that in the future, more innovative biopharmaceutical products will be continuously supplied to patients all over the world from bringer Ingelheim's Chinese biopharmaceutical production base "Biopharmaceutical contract production is one of our core businesses in China," said Mr Gao Qifei, President and CEO of Greater China at bringer Ingelheim Through this innovative mode of biopharmaceutical contract production, we can help more Biopharmaceutical Enterprises in China to produce and market innovative biopharmaceutical products, so that more patients can benefit "He stressed that adhering to the concept of" taking root in China and serving China ", Boehringer Ingelheim has always been committed to the sustainable development in China, vigorously supporting Shanghai to build into a first-class biomedical industry base, and more willing to contribute to the development of China's biomedical industry! Adorable adorable
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.