{"id":64874,"date":"2026-05-09T21:11:46","date_gmt":"2026-05-09T13:11:46","guid":{"rendered":"https:\/\/flcube.com\/?p=64874"},"modified":"2026-05-09T21:11:47","modified_gmt":"2026-05-09T13:11:47","slug":"innovent-biologics-secures-third-breakthrough-therapy-designation-for-ibi363-in-mss-pmmr-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64874","title":{"rendered":"Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS\/pMMR Colorectal Cancer"},"content":{"rendered":"\n

Innovent Biologics, Inc.<\/strong> (HKG: 1801<\/a>) announced that its first-in-class PD-1\/IL-2\u03b1-bias bispecific antibody (BsAb) fusion protein<\/strong>, IBI363<\/strong>, has received Breakthrough Therapy Designation (BTD)<\/strong> from China’s Center for Drug Evaluation (CDE)<\/strong>. The designation covers the treatment of advanced microsatellite stable or mismatch repair proficient (MSS\/pMMR) colorectal cancer<\/strong> in patients who have failed at least two prior lines of standard systemic therapy, when administered in combination with bevacizumab<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone Details<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Compound<\/strong><\/td>IBI363<\/td><\/tr>
Mechanism<\/strong><\/td>First-in-class PD-1\/IL-2\u03b1-bias bispecific antibody fusion protein<\/td><\/tr>
New BTD Indication<\/strong><\/td>Advanced MSS\/pMMR colorectal cancer + bevacizumab<\/td><\/tr>
Patient Population<\/strong><\/td>\u22652 prior lines of standard systemic therapy failed<\/td><\/tr>
Clinical Stage<\/strong><\/td>Phase III study initiated in China<\/td><\/tr>
Regulatory Authority<\/strong><\/td>Center for Drug Evaluation (CDE), China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This marks the third Breakthrough Therapy Designation<\/strong> for IBI363 from Chinese regulators, complementing its existing regulatory momentum.<\/p>\n\n\n\n

Comprehensive Regulatory Portfolio<\/h2>\n\n\n\n