{"id":68904,"date":"2026-06-25T23:12:09","date_gmt":"2026-06-25T15:12:09","guid":{"rendered":"https:\/\/flcube.com\/?p=68904"},"modified":"2026-06-25T23:12:10","modified_gmt":"2026-06-25T15:12:10","slug":"takeda-secures-nmpa-approval-for-adzynma-chinas-first-recombinant-adamts13-therapy-for-congenital-ttp","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68904","title":{"rendered":"Takeda Secures NMPA Approval for Adzynma \u2013 China’s First Recombinant ADAMTS13 Therapy for Congenital TTP"},"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 granted marketing approval<\/strong> for Adzynma (apadamtase alfa\/cinaxadamtase alfa)<\/strong>, a recombinant ADAMTS13 protein drug<\/strong> indicated for on-demand or prophylactic enzyme replacement therapy (ERT)<\/strong> in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP)<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Approval Type<\/strong><\/td>Full marketing approval<\/td><\/tr>
Product<\/strong><\/td>Adzynma (apadamtase alfa\/cinaxadamtase alfa)<\/td><\/tr>
Indication<\/strong><\/td>On-demand or prophylactic ERT for cTTP in pediatric and adult patients<\/td><\/tr>
Approval Date<\/strong><\/td>25 Jun 2026<\/td><\/tr>
Significance<\/strong><\/td>First and only recombinant ADAMTS13 therapy approved in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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