{"id":56652,"date":"2026-02-09T20:16:04","date_gmt":"2026-02-09T12:16:04","guid":{"rendered":"https:\/\/flcube.com\/?p=56652"},"modified":"2026-02-09T20:16:05","modified_gmt":"2026-02-09T12:16:05","slug":"kelun-biotechs-jiatailai-secures-fourth-nmpa-approval-for-hr-her2-breast-cancer-indication","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56652","title":{"rendered":"Kelun-Biotech\u2019s Jiatailai Secures Fourth NMPA Approval for HR+\/HER2- Breast Cancer Indication"},"content":{"rendered":"\n

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.<\/strong> (HKG: 6990<\/a><\/strong>) announced that the National Medical Products Administration (NMPA)<\/strong> has granted approval for a fourth indication<\/strong> for Jiatailai (sacituzumab tirumotecan)<\/strong>, its TROP2-targeted antibody-drug conjugate (ADC)<\/strong>. The new authorization covers adult patients with unresectable or metastatic HR+\/HER2- breast cancer<\/strong> who have progressed after prior endocrine therapy and chemotherapy, significantly expanding the drug\u2019s addressable oncology market.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Sichuan Kelun-Biotech (6990.HK)<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Asset<\/strong><\/td>Jiatailai (sacituzumab tirumotecan) \u2013 TROP2 ADC<\/td><\/tr>
New Indication<\/strong><\/td>HR+\/HER2- breast cancer (post-endocrine, post-chemo)<\/td><\/tr>
Approval Basis<\/strong><\/td>Phase III OptiTROP-Breast02 study<\/td><\/tr>
Total Indications<\/strong><\/td>Four (2 NSCLC + 1 TNBC + 1 HR+\/HER2- BC)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 OptiTROP-Breast02 Study<\/h2>\n\n\n\n
Endpoint<\/th>Jiatailai<\/th>Investigator’s Choice Chemotherapy<\/th>Clinical Benefit<\/th><\/tr><\/thead>
Median PFS (BICR-assessed)<\/strong><\/td>8.3 months<\/td>4.1 months<\/td>102% improvement<\/strong><\/td><\/tr>
Subgroup Consistency<\/strong><\/td>PFS benefit across all pre-specified subgroups<\/td>\u2013<\/td>Broad applicability<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Study Design:<\/em> Phase III, randomized, Jiatailai monotherapy vs. investigator’s choice chemotherapy in unresectable\/metastatic HR+\/HER2- breast cancer<\/p>\n\n\n\n

Approved Indication Portfolio<\/h2>\n\n\n\n
Indication<\/th>Patient Population<\/th>Approval Status<\/th><\/tr><\/thead>
Non-small cell lung cancer (NSCLC)<\/strong><\/td>Specific subpopulations<\/td>Approved (2 indications)<\/td><\/tr>
Triple-negative breast cancer (TNBC)<\/strong><\/td>Advanced\/metastatic<\/td>Approved<\/td><\/tr>
HR+\/HER2- breast cancer<\/strong><\/td>Post-endocrine, post-chemo<\/td>Newly approved (4th indication)<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Global Partnership & Commercial Positioning<\/h2>\n\n\n\n