echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Big move! The domestic pharmaceutical company has invested nearly 100 million yuan in generics

    Big move! The domestic pharmaceutical company has invested nearly 100 million yuan in generics

    • Last Update: 2018-12-26
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    [China Pharmaceutical network industry trends] on December 22, Shandong step pharmaceutical released a notice on signing a technical service contract According to the announcement, recently, Shandong Danhong, a wholly-owned subsidiary of Shandong step pharmaceutical, signed two technical service (entrustment) contracts with Beijing shenlanhai biomedical According to the public information, there is no relationship between Shenzhen blue sea pharmaceutical and the company and the holding subsidiary of step pharmaceutical The business scope of deep blue sea biomedicine mainly includes technology development, technology promotion, technology transfer, technology consultation, technical service, medical research and experimental development, etc As of September 30, 2018, the total assets of Shenzhen Blue Sea Pharmaceutical Co., Ltd is about 11.43 million yuan, with a net asset of about 6.51 million yuan From January to September, 2018, the company realized an operating revenue of about 9.26 million yuan and a net profit of - 6.61 million yuan (the above data are not audited) According to the announcement, Shandong Danhong entrusted shenlanhai pharmaceutical to carry out phase I (hereinafter referred to as "project 1") and phase III clinical trials (hereinafter referred to as "project 2") of the project of recombinant anti-tumor necrosis factor - α all human monoclonal antibody injection (hereinafter referred to as "bc002"), in accordance with the current "drug clinical trial quality management specification (GCP)" and "drug registration management measures" And the clinical trial scheme of the project to carry out clinical research work together As early as October 26 of this year, Shandong bubo released a notice that the company's holding subsidiary Shandong Danhong Pharmaceutical Co., Ltd "recombinant anti-tumor necrosis factor - α (TNF - α) all human monoclonal antibody injection" was approved by the State Drug Administration and issued the drug clinical trial approval The application indications are rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis As of September 30, 2018, the R & D cost invested by the company in bc002 project is about 19 million RMB According to the announcement, the content of item 1 is the phase I tolerance and pharmacokinetics clinical study of healthy subjects by single subcutaneous injection of bc002 compared with the original drug sumerial Item 2 phase III clinical trial is a phase III clinical trial to compare the efficacy and safety of bc002 and the original research drug sumerial subcutaneous injection in the treatment of active ankylosing spondylitis, as well as the pharmacokinetic study of phase III clinical patients combined According to the announcement, the cost of phase I clinical trial of project 1bc002 is RMB 14.98 million Project 2 bc002 phase III (PK with patients) clinical trial cost is 59.47 million yuan In conclusion, step pharmaceutical has invested nearly 100 million yuan in the project of "recombinant anti-tumor necrosis factor - α (TNF - α) all human monoclonal antibody injection" to make sumil's generic drugs, which is a huge number! It can also be seen that the blood has been shed According to the agreement between Shandong Danhong and deep sea blue medicine, the economic benefits of the intellectual property rights of the recombinant anti TNF - α all human monoclonal antibody injection of Shandong Danhong belong to its own According to the public information, sumerial, the original research drug, is an anti TNF - α all human monoclonal antibody drug developed by Aberdeen, which is suitable for the treatment of rheumatoid arthritis, ankylosing spondylitis and other autoimmune diseases Xiumei was approved by FDA in 2002 and listed in China in 2010 It was approved for rheumatoid arthritis indication, ankylosing spondylitis indication in 2013 and treatment of adult moderate and severe chronic plaque psoriasis in May 2018 However, due to its high price, the price of a single unit is more than 7000, which is difficult for domestic patients to bear the high cost With the release of favorable policies for generic drugs and the continuous growth of patients' demand, many domestic pharmaceutical companies are also stimulated to carry out generic drug research and development in this context At present, there is no generic medicine for this product in China, but there are more than 20 pharmaceutical companies under research, including Qilu pharmaceutical, Zhengda Tianqing, Haizheng, and Xinda biology, including this time's steplength pharmaceutical It can be seen that the market competition will be very fierce in the future.
    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.