Kelun secures China approval for first homegrown HER2 breast cancer ADC

Chinese biotech Kelun-Biotech (HKEX: 6990) has gained approval from the National Medical Products Administration for trastuzumab botidotin (A166), its HER2-targeted antibody-drug conjugate for patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior therapy.

The authorization is based on a Phase III trial showing the drug improved progression-free survival against Roche’s (ROG: SIX) T-DM1, with a favorable overall survival trend. Detailed results will be presented at the ESMO Congress in Berlin. Kelun plans to roll out trastuzumab botidotin in China during the second half of 2025.

Chief executive Michael Ge said the approval marked a “significant advancement” for Chinese patients, noting it is the country’s first domestically developed HER2 ADC capable of broadly addressing second-line and later settings. HER2-positive disease represents around 15–20% of all breast cancer cases and often carries a poor prognosis.