Clinical approval of recombinant human anti-human IL-6R monoclonal antibody injection of Lizhu medicine

Today, Lizhu Pharmaceutical Group announced that its holding subsidiary, Zhuhai Lizhu mAb Biotechnology Co., Ltd (hereinafter referred to as "Lizhu mAb"), has received the approval document for clinical trial of drugs (approval document No.: 2018l03177) of recombinant humanized anti-human IL-6R monoclonal antibody injection approved and issued by the State Drug Administration The following is the full text of the announcement: Recently, Zhuhai lizumab Biotechnology Co., Ltd (hereinafter referred to as "lizumab"), a holding subsidiary of Lizhu Pharmaceutical Group Co., Ltd (hereinafter referred to as "the company"), received the approval document for clinical trial of drugs (approval document No.: 2018l03177) approved and issued by the State Drug Administration The details are hereby announced as follows: 1 Main contents of drug approval document: drug name: recombinant humanized anti-human IL-6R monoclonal antibody injection English name / Latin name: recombinant humanized anti-human IL-6R monoclonal antibody solution for injection dosage form: injection specification: 80mg / 4ml application matters: domestic drug registration classification: biological products for treatment Applicant: Zhuhai lizumab Biotechnology Co., Ltd approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and is approved for clinical trial 2、 Drug R & D and related information "recombinant humanized anti-human IL-6R monoclonal antibody injection" has been developed for nearly three years The clinical trial application was accepted on November 28, 2017 (acceptance No.: cxsl1700170 Yue), and was officially approved by the State Drug Administration on October 11, 2018 "Recombinant humanized anti-human IL-6R monoclonal antibody injection" is a biological similar drug of tocilizumab It has the same mechanism of action as the original drug, and can specifically combine with IL-6R The company and all members of the board of directors guarantee that the content of information disclosure is true, accurate and complete without false records, misleading statements or major omissions It can inhibit the signal transduction mediated by IL-6 and IL-6R, and reduce the inflammatory response It is suitable for adult patients with moderate to severe active rheumatoid arthritis who have insufficient response to DMARDs As of the date of disclosure of this announcement, "recombinant humanized anti-human IL-6R monoclonal antibody injection" has invested about 48.1086 million yuan in R & D of the drug 3、 At present, there is an anti-il-6r monoclonal antibody product in foreign countries, tocilizumab (trade name: actemra ®) According to Roche's 2017 annual report data, the sales volume of tocilizumab in 2017 is about 1.926 billion Swiss francs According to the qvia database, the sales volume of topuzumab in China in 2017 was about 37 million yuan There is no domestic product on the market Up to now, there are 6 domestic approved clinical monoclonal antibody manufacturers targeting at "IL-6R / IL-6" (including lizumab) 4、 Approval procedures to be performed for product listing: after obtaining the clinical approval document of "recombinant humanized anti-human IL-6R monoclonal antibody injection", the company shall carry out clinical research according to the content of the approval document and be approved by the State Drug Administration before listing It is preliminarily estimated that it will take 2 years to complete phase I and phase III clinical trials.