CSPC Pharmaceutical Group Pertuzumab Injection Marketing Application Accepted by NMPA

Reuters

11/12

CSPC Pharmaceutical Group Pertuzumab Injection Marketing Application Accepted by NMPA

CSPC Pharmaceutical Group Ltd. has announced that its marketing authorisation application for Pertuzumab Injection has been accepted by the National Medical Products Administration (NMPA) of China. Developed by its subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., the biosimilar product is intended for the treatment of HER2-positive breast cancer. The application is primarily supported by results from a Phase III equivalence clinical trial, which demonstrated that the product is highly similar to the reference drug in terms of efficacy, safety, and tolerability. The application is currently under regulatory review. No grant or funding from multiple organizations was mentioned in the announcement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CSPC Pharmaceutical Group Ltd. published the original content used to generate this news brief on November 12, 2025, and is solely responsible for the information contained therein.

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Developed by its subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., the biosimilar product is intended for the treatment of HER2-positive breast cancer. The application is primarily supported by results from a Phase III equivalence clinical trial, which demonstrated that the product is highly similar to the reference drug in terms of efficacy, safety, and tolerability. The application is currently under regulatory review. No grant or funding from multiple organizations was mentioned in the announcement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CSPC Pharmaceutical Group Ltd. published the original content used to generate this news brief on November 12, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1807302812.USD","symbol_name":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251112:nNDL78WD56:1","article_id":"2582324700","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2582324700","pubTimestamp":1762941950,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"CSPC Pharmaceutical Group Ltd. has announced that its marketing authorisation application for Pertuzumab Injection has been accepted by the National Medical Products Administration  of China. 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Developed by its subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., the biosimilar product is intended for the treatment of HER2-positive breast cancer. The application is primarily supported by results from a Phase III equivalence clinical trial, which demonstrated that the product is highly similar to the reference drug in terms of efficacy, safety, and tolerability. The application is currently under regulatory review. No grant or funding from multiple organizations was mentioned in the announcement.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CSPC Pharmaceutical Group Ltd. published the original content used to generate this news brief on November 12, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}