{"id":41559,"date":"2025-09-16T16:58:58","date_gmt":"2025-09-16T08:58:58","guid":{"rendered":"https:\/\/flcube.com\/?p=41559"},"modified":"2025-09-16T16:58:59","modified_gmt":"2025-09-16T08:58:59","slug":"sino-biopharmaceutical-secures-nmpa-approval-for-degarelix-generic-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41559","title":{"rendered":"Sino\u202fBiopharmaceutical Secures NMPA Approval for Degarelix Generic in China"},"content":{"rendered":"\n

Sino Biopharmaceutical Limited (HKG: 1177<\/a>)<\/strong> announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ)<\/strong> has received approval from the China National Medical Products Administration (NMPA)<\/strong> for the first\u2011in\u2011world generic of Degarelix Injection<\/strong>, a highly complex androgen\u2011deprivation therapy used in prostate cancer.<\/p>\n\n\n\n

Product & Regulatory Milestones<\/h4>\n\n\n\n
Milestone<\/th>Detail<\/th><\/tr><\/thead>
Original Development<\/strong><\/td>Degarelix (brand name Firmagon<\/em>) \u2013 first approved in the U.S. in 2008, entered the Chinese market in 2018.<\/td><\/tr>
CTTQ Generic<\/strong><\/td>First generic version worldwide: approved in the EU (Sept\u202f2023), provisional U.S. approval (Aug\u202f2025).<\/td><\/tr>
NMPA Approval<\/strong><\/td>Granted in September\u202f2025 for use in prostate cancer patients requiring androgen\u2011deprivation therapy.<\/td><\/tr>
Patent Challenge<\/strong><\/td>CTTQ successfully defended its generic claim, earning a 12\u2011month exclusivity period in China.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market & Commercial Impact<\/h4>\n\n\n\n