Haizheng Yinglixi single anti-listing application accepted has invested 110 million yuan

On the 11th, Haizheng Pharmaceuticals announced thatthis product is Janssen Biologics B.VCompany Class-like drug (generic name: Injection with Invlisie monoantigen) biosimilar seeking, is a specific blocking tumor necrosis factor (TNF-alpha) Human mouse chimeric monoclonal antibody, with TNF-alpha soluble form (sTNF-alpha) and transmembrane form (tmTNF-alpha) in high affinity, inhibitted TNF-alpha binding to the receptor, thus causing TNF to lose biological activityThe dosage form is an injection and is 100 mg in sizeThis product was developed in strict accordance with the guidelines of biosimilar drugs, and the results of pharmacological, non-clinical, and clinical trials (pharmacokinetics, efficacy, safety, and immunogenicity) were highly similar to those of the original drug classwas approved by the FDA and the European Medicines Review Authority (EMEA) in 1998 and 1999, respectively, and entered the Chinese market in 2007, where more than one million patients have been treated in 85 countries and regions and have more than 20 years of safe use experienceThe indications approved in China are rheumatoid arthritis, crohn's disease in adults and children over 6 years of age, fistula Crohn's disease, hyperthyroidism, psoriasis and adult ulcerative colitisGlobal sales in 2019 were $4.38 billionThere are currently no domestic markets for injectable inversimono anti-biosimilarsso far, the inversi-single research and development project for injection has invested about 110 million yuanaccording to the "Zhejiang Haizheng Borui Biopharmaceutical Co., Ltd." signed by Haizheng Pharmaceuticals, Haizheng Pharmaceuticals (Hangzhou) Co., Ltdand Taileague, such as Haizheng Borui or its wholly-owned subsidiary was issued in accordance with the law in the name of the Invrisi single anti-drug registration certificate, the completion of the equity transfer contract milestone compensation and special transfer compensation in the Invrisi single anti-specific event, will not trigger in-the-inverliation anti-specific eventSource: Haizheng Pharmaceuticals Announcement