25/09/2026 In Phase 3 EXCALIBER-RRMM trial, ZENBEXUS™-based therapy significantly improved response depth and MRD-negative CR versus DVd in RRMM In Phase 2 CARTITUDE-2 study, single CARVYKTI infusion delivered 5-year treatment-free remission in 50% of early-line RRMM patients US FDA granted priority review for imfinzi + enfortumab vedotin in cisplatin-ineligible MIBC MSD and Daiichi Sankyo have voluntarily withdrawn the US BLA for I-DXd in previously treated ES-SCLC In Phase

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref) China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC To note, in Ma