CSPC PHARMA (01093) Announces Clinical Trial Approval for Emicizumab Injection (SYS6053)

Bulletin Express

Mar 04

CSPC Pharmaceutical Group Limited announced that its Emicizumab Injection (SYS6053) received approval from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials. The product is a modified bispecific humanized IgG4 monoclonal antibody designed to bridge coagulation factor IXa and factor X, and it is being developed as a biosimilar to Hemlibra® for the treatment of Hemophilia A.

According to the announcement, the product is categorized as a Class 3.3 therapeutic biological product, with pharmaceutical and non-clinical results showing high similarity to the reference drug in terms of quality, safety, and efficacy. This similarity supports further clinical studies for treating patients with Hemophilia A.

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The product is a modified bispecific humanized IgG4 monoclonal antibody designed to bridge coagulation factor IXa and factor X, and it is being developed as a biosimilar to Hemlibra® for the treatment of Hemophilia A.</p>\n<p>According to the announcement, the product is categorized as a Class 3.3 therapeutic biological product, with pharmaceutical and non-clinical results showing high similarity to the reference drug in terms of quality, safety, and efficacy. This similarity supports further clinical studies for treating patients with Hemophilia A.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"01093","symbol_name":"石药集团","start_time":0,"source_url":"","article_id":"1176182883","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1176182883","pubTimestamp":1772624450,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Bulletin Express","introduction":"Full Coverage of HK & US Stock Announcements","home_visible":1,"id":"1053168898","head_image":"https://community-static.tradeup.com/news/ed558ed0402cbe7d1ef4d150458f2b2e"},"summary":"CSPC Pharmaceutical Group Limited announced that its Emicizumab Injection (SYS6053) received approval from the National Medical Products Administration of the People’s Republic of China to conduct...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"01093":"石药集团"},"translate_title":"石药集团(01093)公布依米珠单抗注射液(SYS6053)临床试验批件","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":1},"content_text":"CSPC Pharmaceutical Group Limited announced that its Emicizumab Injection (SYS6053) received approval from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials. 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