{"id":64848,"date":"2026-05-09T15:13:56","date_gmt":"2026-05-09T07:13:56","guid":{"rendered":"https:\/\/flcube.com\/?p=64848"},"modified":"2026-05-09T15:13:56","modified_gmt":"2026-05-09T07:13:56","slug":"kelun-biotech-submits-new-nmpa-filing-for-jaitailai-in-first-line-nsclc-combination-therapy-with-keytruda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64848","title":{"rendered":"Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda"},"content":{"rendered":"\n

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.<\/strong> (HKG: 6990<\/a>) announced it has submitted a new indication approval filing with China’s National Medical Products Administration (NMPA)<\/strong> for Jaitailai<\/strong> (sacituzumab tirumotecan), its TROP2-targeted antibody drug conjugate (ADC)<\/strong>. The company is seeking approval for the drug’s use in first-line patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)<\/strong> in combination with Merck & Co.’s pembrolizumab<\/strong> (Keytruda).<\/p>\n\n\n\n

Proposed Indication Details<\/h2>\n\n\n\n
Parameter<\/th>Specification<\/th><\/tr><\/thead>
Patient Population<\/strong><\/td>First-line locally advanced or metastatic NSCLC<\/td><\/tr>
Biomarker Requirements<\/strong><\/td>PD-L1 TPS \u2265 1%, EGFR mutation-negative, ALK-negative<\/td><\/tr>
Treatment Regimen<\/strong><\/td>Jaitailai + pembrolizumab (anti-PD-1 monoclonal antibody)<\/td><\/tr>
Regulatory Status<\/strong><\/td>NMPA filing submitted<\/td><\/tr>
Drug Class<\/strong><\/td>TROP2-targeted antibody drug conjugate (ADC)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This proposed indication would expand Jaitailai’s utility into the first-line NSCLC setting, representing a significant commercial opportunity given the large patient population and established role of PD-1\/PD-L1 inhibitors in this treatment paradigm.<\/p>\n\n\n\n

Commercial & Development Context<\/h2>\n\n\n\n