Shanghai Henlius Biotech Inc. Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines

Reuters

2025/07/02

<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> Inc. Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines

Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. This certification applies to the drug substance and drug product lines for HLX11 and HLX14, indicating that these production lines meet the European Union's Good Manufacturing Practice standards. The approval facilitates the commercial production and distribution of HLX11 and HLX14 within the EU, bolstering the company's global pharmaceutical market presence. This development follows a previous exclusive licensing agreement with Organon LLC for the global commercialization of these products, excluding mainland China, Hong Kong, Macau, and Taiwan.

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. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief on July 02, 2025, and is solely responsible for the information contained therein.

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Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/SGBCF\">Shanghai Henlius Biotech</a> Inc. Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. This certification applies to the drug substance and drug product lines for HLX11 and HLX14, indicating that these production lines meet the European Union's Good Manufacturing Practice standards. The approval facilitates the commercial production and distribution of HLX11 and HLX14 within the EU, bolstering the company's global pharmaceutical market presence. This development follows a previous exclusive licensing agreement with Organon LLC for the global commercialization of these products, excluding mainland China, <a href=\"https://laohu8.com/S/HKRHF\">Hong Kong</a>, Macau, and Taiwan.\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. 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Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-07-02 18:13</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/SGBCF\">Shanghai Henlius Biotech</a> Inc. Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. This certification applies to the drug substance and drug product lines for HLX11 and HLX14, indicating that these production lines meet the European Union's Good Manufacturing Practice standards. The approval facilitates the commercial production and distribution of HLX11 and HLX14 within the EU, bolstering the company's global pharmaceutical market presence. This development follows a previous exclusive licensing agreement with Organon LLC for the global commercialization of these products, excluding mainland China, <a href=\"https://laohu8.com/S/HKRHF\">Hong Kong</a>, Macau, and Taiwan.\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. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief on July 02, 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":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250702:nNDL3dvSdz:1","article_id":"2548936358","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2548936358","pubTimestamp":1751451224,"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":"Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. 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Obtains EU GMP Certificates for HLX11 and HLX14 Production Lines\n    \n\n        Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. This certification applies to the drug substance and drug product lines for HLX11 and HLX14, indicating that these production lines meet the European Union's Good Manufacturing Practice standards. The approval facilitates the commercial production and distribution of HLX11 and HLX14 within the EU, bolstering the company's global pharmaceutical market presence. This development follows a previous exclusive licensing agreement with Organon LLC for the global commercialization of these products, excluding mainland China, Hong Kong, Macau, and Taiwan.\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. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief on July 02, 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":"corporation","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}