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

Medical Network May 13 hearing on the 11th, Hisun be published, he said recently the sea is a wholly owned subsidiary of vPro is the biological received State Food and Drug Administration issued "injectable infliximab" listing applications "accepted notice"product JanssenBiologicsB.V corporate g (common name: infliximab injection)Similarly a biological agent, a specific blocking necrosis factor a (TNF- [alpha]) of human-mouse chimeric monoclonal antibody, can bind with high affinity to the soluble form of TNF-α (sTNF-α) and transmembrane forms (tmTNF-α), inhibition of TNF-α binding to the receptor, thereby the loss of biological activity of TNFAn injection formulation, size of 100mgThis product is strictly in accordance with the guidelines developed bio-similar drugs, pharmacy, non-clinical and clinical trials (pharmacokinetics, efficacy, safety and immunogenicity study of geometric immunity) than the study results are highly similar to the original drug RemicadeRemicade are US FDA and the EuropeanReview Authority (EMEA) in 1998 and 1999 approved for marketing in 2007 to enter the Chinese market, currently in 85 countries and regions worldwide More than a million patients received infliximab treatment, with 20 years of security experienceRemicade approved indications in Chinese rheumatoid arthritis, more than 6 years and adultsCrohn's disease, fistula of Crohn's disease, ankylosing spondylitis, psoriasis, ulcerative colitis and adult2019 global sales of $ 4.38 billionThere are not yet injectable infliximab bio-similar drugs in the domestic marketUp to now, injectable infliximab R & D projects have been put around 110 million yuanaccording to Hisun, Hisun Pharmaceutical (Hangzhou) Co., Ltdsigned with PAG "Zhejiang Hisun Pharmaceutical Co., Ltdbiological vPro equity transfer contract", the sea is as vPro or its wholly owned its subsidiary, according to the law issued under the name of infliximabregistration certificate, completed the share transfer contract infliximab particular event milestones compensation and special compensation in the transfer will not trigger infliximab cash compensation obligations too specific events of the AU.