{"id":78148,"date":"2026-09-02T14:57:56","date_gmt":"2026-09-02T06:57:56","guid":{"rendered":"https:\/\/flcube.com\/?p=78148"},"modified":"2026-09-02T14:57:57","modified_gmt":"2026-09-02T06:57:57","slug":"gensci161-wins-nmpa-clinical-trial-acceptance-for-ctd-ild-expanding-bispecific-antibody-pipeline-of-changchun-high-new-technology","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78148","title":{"rendered":"GenSci161 Wins NMPA Clinical Trial Acceptance for CTD-ILD, Expanding Bispecific Antibody Pipeline of Changchun High & New Technology"},"content":{"rendered":"\n

Changchun High & New Technology Industries (Group) Inc.<\/strong> (SHE: 000661<\/a>) announced that its novel bispecific antibody GenSci161<\/strong> has received clinical trial application (CTA) acceptance from the National Medical Products Administration (NMPA)<\/strong> for a new indication: connective tissue disease-associated interstitial lung disease (CTD-ILD<\/strong>).<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Agency<\/th>Approval Type<\/th>Product<\/th>Indication<\/th>Date<\/th>Next Steps<\/th><\/tr><\/thead>
NMPA<\/strong> (China)<\/td>CTA Acceptance<\/td>GenSci161<\/strong><\/td>Connective tissue disease-associated interstitial lung disease (CTD-ILD<\/strong>)<\/td>02 Sep 2026<\/td>Initiation of clinical trials in CTD-ILD<\/strong> patients in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This marks another indication expansion for GenSci161<\/strong> in China. The antibody had previously received NMPA<\/strong> clearance for clinical trials in endometriosis, moderate-to-severe hidradenitis suppurativa, and non-infectious uveitis (NIU).<\/p>\n\n\n\n

Drug Profile & Mechanism of Action<\/h2>\n\n\n\n