{"id":64879,"date":"2026-05-09T21:16:02","date_gmt":"2026-05-09T13:16:02","guid":{"rendered":"https:\/\/flcube.com\/?p=64879"},"modified":"2026-05-09T21:16:03","modified_gmt":"2026-05-09T13:16:03","slug":"keymed-biosciences-secures-nmpa-breakthrough-therapy-designation-for-cm336-in-al-amyloidosis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64879","title":{"rendered":"Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis"},"content":{"rendered":"\n

Keymed Biosciences Inc.<\/strong> (HKG: 2162<\/a>) announced that its BCMA\u00d7CD3 T cell engager (TCE)<\/strong>, CM336<\/strong> (OM336), has received Breakthrough Therapy Designation (BTD)<\/strong> from China’s Center for Drug Evaluation (CDE)<\/strong> under the National Medical Products Administration (NMPA)<\/strong>. The designation covers treatment of relapsed or refractory light chain (AL) amyloidosis<\/strong> in patients who have previously received bortezomib and CD38 monoclonal antibody therapy<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone Details<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Compound<\/strong><\/td>CM336 (OM336)<\/td><\/tr>
Mechanism<\/strong><\/td>BCMA\u00d7CD3 T cell engager (TCE)<\/td><\/tr>
Indication<\/strong><\/td>Relapsed\/refractory AL amyloidosis<\/td><\/tr>
Patient Population<\/strong><\/td>Previously treated with bortezomib and CD38 monoclonal antibody<\/td><\/tr>
Regulatory Authority<\/strong><\/td>CDE\/NMPA, China<\/td><\/tr>
Designation Type<\/strong><\/td>Breakthrough Therapy Designation (BTD)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This BTD represents a significant advancement for AL amyloidosis treatment, a rare and often fatal condition with limited therapeutic options for relapsed\/refractory patients.<\/p>\n\n\n\n

Global Development & Partnership Timeline<\/h2>\n\n\n\n