Five New Oral Antiviral Drugs Will Be Approved In China！

2024-05-11

临床结果抗体药物偶联物临床2期临床3期

Joincare Pharma announced that it would soon communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration(NMPA) regarding the New Drug Application(NDA) for its antiviral drug TG-1000 in April. It means that at least five new oral antiviral drugs will be approved in the fure years in China, perhaps.Joincare licensed in TG-1000 from TaiGen Biotechnology and obtained the novel pan-influenza antiviral drug, which interrupts viral replication and transmission via a cap-snatching mechanism to demonstrate broad-spectrum activity against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses, early in 2023.Before the deal announced, top-line results from a Phase II study suggest TG-1000 effectively alleviate flu symptoms and clear flu viruses.Joincare initiated a Phase III study for TG-1000 in September of last year, and announced that it had completed the unblinding of influenza antiviral TG-1000 phase III study in April of this year.Preliminary datas suggest that the median time to alleviation of all influenza symptoms after TG-1000 treatment was shorter than that of the placebo group, with a statistically significant difference. TG-1000 also possesses great safety profile, and there was no clinically significant safety concerns observed.The phase III study of TG-1000 is a multi-center, randomized and double-blinded study. The purpose is to evaluate the efficacy and safety of TG-1000 compared with placebo in adult and adolescent patients with uncomplicated acute influenza infection. 752 participants are randomly allocated to TG-1000 treatment group and placebo control group. Consistent with China influenza surveillance data, the majority of patients admitted to the Phase III study are influenza virus A infected.The primary endpoint of the study, the median time to alleviation of all influence symptoms of TG-1000 group (60.9 hours), was shorter than that of the placebo group (87.9 hours). It shows that TG-1000 effectively shortens the time for influenza symptom alleviation, which is statistically significant (P<0.0001).The secondary endpoints of the study include antiviral efficacy, clinical symptom alleviation, and influenza related complications. Those indicators are still undergoing testing and statistical analysis.The incidence rate of adverse effect (AE) of TG-1000 group is similar to that of placebo group. TG-1000 treatment group possesses favorable safety profile with no death or serious adverse reaction occurred.It is expected that Joincare will file a NDA for TG-1000 in the second half of the year in China. Furthermore, TaiGen will advance cooperation and development negotiation in Europe, the U.S., and other Asian countries.In China, beside TG-1000 and Roche’s Xofluza(baloxavir marboxil) which was approved in 2021, there are at least three influenza virus polymerase acidic (PA) endonuclease inhibitors in advanced stages.The CDE has accepted the NDAs for Qingfeng Pharma’s GP681 and Zenshine Pharma’s Seloxavir Marboxil (ZX-7101A) for the treatment of uncomplicated influenza in Novemer, 2023 and February, 2024 separately. Meanwhile, AnDiConBio announced that its ADC189 for influenza A and B in adults and adolescents in a Phase III study met its primary and secondary end points in April 29 of this year.Moreover, a NDA for Raynovent Biotech’s ZSP1273 for influenza A was accepted by CDE in December, 2023. Unlike the aboves, ZSP1273 is a potent antiviral polymerase basic 2 (PB2) inhibitor of cap binding to the PB2 subunit of influenza A polymerase. In vitro testing showed ZSP1273’s more excellent antiviral activity against influenza A strains than Tamiflu and Xofluza, as well as against strains resistant to both.It seems that we haven’t see so many new oral antiviral drugs waiting for a regulatory agency to review or approve almost at the same time in the U.S., EU and Japan before.Source: Joincare, TaiGen, Qingfeng, Zenshine, AnDiConBio, Raynovent.本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！