{"id":64624,"date":"2026-05-07T14:09:44","date_gmt":"2026-05-07T06:09:44","guid":{"rendered":"https:\/\/flcube.com\/?p=64624"},"modified":"2026-05-07T14:09:45","modified_gmt":"2026-05-07T06:09:45","slug":"sino-biopharmaceuticals-subsidiary-tianqing-secures-expanded-nmpa-approval-for-saitanxin-first-in-class-cdk2-4-6-inhibitor-moves-to-first-line-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64624","title":{"rendered":"Sino Biopharmaceutical’s Subsidiary Tianqing Secures Expanded NMPA Approval for Saitanxin \u2013 First-in-Class CDK2\/4\/6 Inhibitor Moves to First-Line Breast Cancer"},"content":{"rendered":"\n

Chia Tai Tianqing Pharmaceutical Group<\/strong>, a wholly owned subsidiary of Sino Biopharmaceutical Ltd.<\/strong> (HKG: 1177<\/a>), announced that China’s National Medical Products Administration (NMPA)<\/strong> has granted an additional indication approval<\/strong> for Saitanxin (culmerciclib)<\/strong>, the first-in-class CDK2\/4\/6 inhibitor<\/strong>. The drug can now be used in combination with fulvestrant as initial endocrine therapy<\/strong> for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer<\/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>Expanded indication approval<\/td><\/tr>
Product<\/strong><\/td>Saitanxin (culmerciclib) \u2013 first-in-class CDK2\/4\/6 inhibitor<\/td><\/tr>
New Indication<\/strong><\/td>First-line treatment: HR+\/HER2- locally advanced or metastatic breast cancer + fulvestrant<\/td><\/tr>
Previous Indication<\/strong><\/td>Second-line treatment following prior endocrine therapy (approved December 2025)<\/td><\/tr>
Approval Date<\/strong><\/td>7 May 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 CULMINATE-2 Phase III Study<\/h2>\n\n\n\n
Endpoint<\/th>Culmerciclib + Fulvestrant<\/th>Placebo + Fulvestrant<\/th>Benefit<\/th><\/tr><\/thead>
Median Progression-Free Survival (mPFS)<\/strong><\/td>Not reached<\/td>20.2 months<\/td>Statistically significant improvement<\/td><\/tr>
Risk Reduction (Progression or Death)<\/strong><\/td>\u2013<\/td>\u2013<\/td>44% reduction<\/strong><\/td><\/tr>
Patient Population<\/strong><\/td>HR+\/HER2- advanced breast cancer, first-line setting<\/td>Same<\/td>Demonstrated superior efficacy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The CULMINATE-2 Phase III study<\/strong> provided the pivotal evidence supporting this regulatory decision, establishing culmerciclib’s substantial clinical benefit in the first-line advanced breast cancer setting<\/strong>.<\/p>\n\n\n\n

Product Profile & Therapeutic Innovation<\/h2>\n\n\n\n