{"id":53258,"date":"2026-01-08T00:25:59","date_gmt":"2026-01-07T16:25:59","guid":{"rendered":"https:\/\/flcube.com\/?p=53258"},"modified":"2026-01-08T00:26:00","modified_gmt":"2026-01-07T16:26:00","slug":"xtalpis-rtx-117-wins-nmpa-ind-for-cmt-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53258","title":{"rendered":"XtalPi’s RTX-117 Wins NMPA IND for CMT Therapy"},"content":{"rendered":"\n

ReviR Therapeutics<\/strong>, an incubated company of XtalPi<\/strong> (HKG: 2228<\/a>), announced that RTX-117<\/strong> has received Investigational New Drug (IND) approval<\/strong> from China’s National Medical Products Administration (NMPA)<\/strong> to treat Charcot-Marie-Tooth disease (CMT)<\/strong>, with Phase\u202fI trials scheduled to commence in Q1\u202f2026<\/strong>. The drug, which has also obtained U.S. FDA IND approval and Orphan Drug Designation<\/strong>, is the first Class\u202f1 innovative drug<\/strong> in China targeting CMT and the first rare disease program from the ReviR-XtalPi AI and robotics-assisted R&D collaboration to reach the clinic.<\/p>\n\n\n\n

Regulatory & Program Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>RTX-117<\/td><\/tr>
Developer<\/strong><\/td>ReviR Therapeutics (incubated by XtalPi)<\/td><\/tr>
Regulatory Status<\/strong><\/td>NMPA IND approved (China); FDA IND approved (U.S.)<\/td><\/tr>
Indication<\/strong><\/td>Charcot-Marie-Tooth disease (CMT)<\/td><\/tr>
Orphan Designation<\/strong><\/td>U.S. FDA Orphan Drug Designation (qualifies for priority review and extended market exclusivity)<\/td><\/tr>
Clinical Timeline<\/strong><\/td>Phase\u202fI initiation Q1\u202f2026<\/td><\/tr>
Significance<\/strong><\/td>First-in-class CMT drug in China; first AI\/robotics co-developed rare disease pipeline to enter clinic<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Background: Charcot-Marie-Tooth Disease<\/h2>\n\n\n\n

Epidemiology<\/strong>:<\/p>\n\n\n\n