Hansoh Pharmaceutical Secures NMPA Approval for New Indication of XINYUE (Inebilizumab) for IgG4-Related Disease

Reuters

09/06

Hansoh Pharmaceutical Secures NMPA Approval for New Indication of XINYUE (Inebilizumab) for IgG4-Related Disease

Hansoh Pharmaceutical Group Co., Ltd. announced on September 1, 2025, that their innovative drug XINYUE (Inebilizumab Injection) has received drug registration approval from China's National Medical Products Administration (NMPA) for a second indication. The approval allows the drug to be used for treating immunoglobulin G4-related disease (IgG4-RD) in adult patients. This decision follows the inclusion of the indication in the NMPA's Priority Review and Approval Procedure earlier this year. The approval is backed by positive results from the MITIGATE trial, which demonstrated inebilizumab's effectiveness in reducing disease flares and maintaining a strong safety profile. Hansoh Pharma's collaborator, Amgen, had previously received approval from the U.S. FDA for the same indication in April 2025.

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. Hansoh Pharmaceutical Group Co. Ltd. published the original content used to generate this news brief on September 06, 2025, and is solely responsible for the information contained therein.

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The approval allows the drug to be used for treating immunoglobulin G4-related disease (IgG4-RD) in adult patients. This decision follows the inclusion of the indication in the NMPA's Priority Review and Approval Procedure earlier this year. The approval is backed by positive results from the MITIGATE trial, which demonstrated inebilizumab's effectiveness in reducing disease flares and maintaining a strong safety profile. Hansoh Pharma's collaborator, Amgen, had previously received approval from the U.S. FDA for the same indication in April 2025.\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. Hansoh Pharmaceutical Group Co. Ltd. published the original content used to generate this news brief on September 06, 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":"IE00BJT1NW94.SGD","symbol_name":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250906:nNDLbHMGlj:1","article_id":"2565513246","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2565513246","pubTimestamp":1757140594,"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":"Hansoh Pharmaceutical Group Co., Ltd. announced on September 1, 2025, that their innovative drug XINYUE  has received drug registration approval from China's National Medical Products Administration  for a second indication. 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The approval allows the drug to be used for treating immunoglobulin G4-related disease (IgG4-RD) in adult patients. This decision follows the inclusion of the indication in the NMPA's Priority Review and Approval Procedure earlier this year. The approval is backed by positive results from the MITIGATE trial, which demonstrated inebilizumab's effectiveness in reducing disease flares and maintaining a strong safety profile. Hansoh Pharma's collaborator, Amgen, had previously received approval from the U.S. FDA for the same indication in April 2025.\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. Hansoh Pharmaceutical Group Co. 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