科伦博泰生物 (6990.HK): Kelun / Merck's sac-TMT scores the first global Ph3 win in endometrial cancer

Bernstein Quick Take on Sichuan Kelun-Biotech (6990.HK): Kelun/Merck's TROP2 ADC sac-TMT reported results from the global Phase III TROFUSE-005 study in previously treated advanced/recurrent endometrial cancer, with data simultaneously published in The Lancet. As the first readout from the global TroFuse series, the data validate translation of prior China-only data to global settings. At a median follow-up of 14 months, sac-TMT achieved median PFS of 7.2m vs 3.9m for treatment of physician's choice (HR 0.59, p<0.0001) and median OS of 19.0m vs 12.1m (HR 0.68, p=0.0001), best-in-class versus ADC peers. Safety was generally manageable with Grade ≥3 TRAEs of 54.4%, though stomatitis (55% any grade, ~10% Grade ≥3) and a 44.5% dose interruption rate remain noteworthy; prophylactic steroid mouthwash significantly reduced stomatitis. The FDA has accepted the BLA under Priority Review with a PDUFA date of 15 June 2027. Rating Outperform, price target HK$526 (close HK$480.20, 10% upside).