HENGRUI PHARMA (600276.SH) Subsidiary's HRS-5965 Capsule Proposed for Priority Review

Stock News

Nov 03

HENGRUI PHARMA (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsule has been proposed for inclusion in the priority review list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The public notice period is seven days.

The intended indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

The priority review was granted as the application meets the requirements under the "Drug Registration Management Measures" and the NMPA's 2020 Announcement No. 82 regarding breakthrough therapy drug evaluation procedures. It qualifies under the priority review category for "innovative or improved drugs addressing clinical shortages, major infectious diseases, or rare diseases."

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The public notice period is seven days.</p>\n<p>The intended indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.</p>\n<p>The priority review was granted as the application meets the requirements under the \"Drug Registration Management Measures\" and the NMPA's 2020 Announcement No. 82 regarding breakthrough therapy drug evaluation procedures. It qualifies under the priority review category for \"innovative or improved drugs addressing clinical shortages, major infectious diseases, or rare diseases.\"</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2580892862.HKD","symbol_name":"FRANKLIN SEALAND CHINA A-SHARES \"A\" (HKD) ACC","start_time":0,"source_url":"","article_id":"1163031186","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1163031186","pubTimestamp":1762160438,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Stock News","introduction":"Global Stock News First-Time Broadcast","home_visible":1,"id":"1036600163","head_image":"https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a"},"summary":"HENGRUI PHARMA (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsule has been proposed for inclusion in the priority review list by the Center for Drug...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"600276":"恒瑞医药","LU2580892862.HKD":"FRANKLIN SEALAND CHINA A-SHARES \"A\" (HKD) ACC","LU2097828805.USD":"AZ EQUITY CHINA \"A-AZ\" (USD) ACC","LU2495084118.USD":"ALLIANZ CHINA A-SHARES \"ATH\" (USDHDG) ACC","LU1064131003.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"A\" (USD) ACC","LU1969619763.USD":"EASTSPRING INV CHINA A SHARES GROWTH \"A\" (USD) ACC","LU1146622755.USD":"安本中国A股股票基金A Acc","LU0359201885.HKD":"BGF CHINA \"A2\" (HKD) ACC","LU1997244956.HKD":"ALLIANZ CHINA A-SHARES \"AT\" (HKD) ACC A","BK0196":"行业龙头","01276":"恒瑞医药","LU0405327494.USD":"ALLSPRING CHINA A FOCUS \"I\" (USD) ACC","LU2097828474.EUR":"AZ EQUITY CHINA \"A\" (EUR) ACC A","BK0239":"医药制造","LU2148510915.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"R\" (USD) ACC","LU1820825898.SGD":"Aberdeen Standard SICAV I - China A Share Equity A Acc SGD-H","LU1655091616.SGD":"JPMorgan Funds - China A-Share Opportunities A (acc) SGD","LU1580142542.USD":"Blackrock Systematic China A-Share Opportunities A2 USD","LU2289578879.USD":"ALLIANZ CHINA A OPPORTUNITIES \"AT\" (USD) ACC","LU0359201612.USD":"贝莱德中国基金A2","LU1328615791.USD":"FULLERTON LUX FUNDS - ALL CHINA EQUITIES \"I\" (USD) ACC","LU1064130708.USD":"FULLERTON LUX FUNDS - CHINA A EQUITIES \"I\" (USD) ACC","LU0359202008.SGD":"Blackrock China Fund A2 SGD-H","BK0183":"MSCI概念","LU2328871848.SGD":"Eastspring Investments - China A Shares Growth AS SGD","LU1997245177.USD":"安联神洲A股基金","LU1023057109.AUD":"BGF CHINA \"A2\" (AUDHDG) ACC","BK0188":"融资融券","LU2580892789.USD":"FRANKLIN SEALAND CHINA A-SHARES \"A\" (USD) ACC","BK0012":"证金概念","LU0405327148.USD":"ALLSPRING CHINA A FOCUS \"A\" (USD) ACC","LU1781817850.SGD":"Blackrock Systematic China A-Share Opportunities A2 SGD-H","LU1255011170.USD":"JPM CHINA A-SHARE OPPORTUNITIES \"A\" (USD) ACC","LU2543165471.USD":"E FUND (HK) GLOBAL QUALITY GROWTH \"A\" (USD) ACC","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","BK0028":"国家队","LU2097828557.USD":"AZ EQUITY CHINA \"A\" (USD) ACC","BK1191":"制药","LU2097828631.EUR":"AZ EQUITY CHINA \"A\" (EUR) ACC","LU1997245094.SGD":"安联神州A股基金AT Acc SGD","BK0060":"抗癌","LU2097828714.EUR":"AZ EQUITY CHINA \"BAZ\" (EUR) ACC"},"translate_title":"恒瑞医药（600276.SH）子公司HRS-5965胶囊拟优先审评","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600276":1,"01276":1},"content_text":"HENGRUI PHARMA (600276.SH) announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsule has been proposed for inclusion in the priority review list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The public notice period is seven days.\nThe intended indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.\nThe priority review was granted as the application meets the requirements under the \"Drug Registration Management Measures\" and the NMPA's 2020 Announcement No. 82 regarding breakthrough therapy drug evaluation procedures. It qualifies under the priority review category for \"innovative or improved drugs addressing clinical shortages, major infectious diseases, or rare diseases.\"","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}