{"id":71967,"date":"2026-08-07T20:59:57","date_gmt":"2026-08-07T12:59:57","guid":{"rendered":"https:\/\/flcube.com\/?p=71967"},"modified":"2026-08-07T20:59:59","modified_gmt":"2026-08-07T12:59:59","slug":"takeda-expands-revestive-approval-in-china-with-new-1-25-mg-specification-for-pediatric-short-bowel-syndrome-patients-as-young-as-4-months","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=71967","title":{"rendered":"Takeda Expands Revestive Approval in China with New 1.25 mg Specification for Pediatric Short Bowel Syndrome Patients as Young as 4 Months"},"content":{"rendered":"\n

Takeda Pharmaceutical Company Limited<\/strong> (TYO: 4502<\/a>; NYSE: TAK<\/a>) announced that China’s National Medical Products Administration (NMPA)<\/strong> has approved the 1.25 mg specification of Revestive (teduglutide for injection)<\/strong>, expanding the indication to treat short bowel syndrome (SBS)<\/strong> in pediatric patients with a corrected gestational age of 4 months and older<\/strong> who have undergone intestinal adaptation and remain dependent on parenteral nutrition support.<\/p>\n\n\n\n

Regulatory Milestone & Product Expansion<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Revestive (teduglutide for injection) \u2013 1.25 mg specification<\/td><\/tr>
New Indication<\/strong><\/td>Short bowel syndrome in pediatric patients \u22654 months corrected gestational age<\/td><\/tr>
Approval Date<\/strong><\/td>August 6, 2026<\/td><\/tr>
Previous Approval<\/strong><\/td>5 mg specification approved February 2024 (patients \u22651 year)<\/td><\/tr>
Patient Criteria<\/strong><\/td>Clinically stable, post-intestinal adaptation, parenteral nutrition dependent<\/td><\/tr>
Therapeutic Class<\/strong><\/td>Rare digestive disease treatment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Clinical Innovation<\/h2>\n\n\n\n