CMBI: DUALITYBIO-B (09606) Elfe-D combination data reinforce ADC + IO 2.0 thesis; rating "Buy"

CMBI issued a research report stating that it believes DUALITYBIO-B (09606)'s valuation remains primarily driven by the B7-H3 ADC asset Elfe-D, and the bank maintains its "Buy" rating with a target price of HK$284.5. The bank noted that Elfe-D is expected to become a blockbuster product, supported by emerging efficacy, differentiated safety, and a potential first-mover advantage in ADC + IO 2.0 combinations; the latest ESMO update, together with last month's WCLC data, further reinforces this investment thesis, showing encouraging early efficacy in lung cancer and non-lung solid tumors (including SCLC, PROC, HCC and CC), with manageable tolerability. The bank noted that ESMO presented global Phase 2 data for Elfe-D combined with pumitamig, covering 142 patients with HCC, CC, PROC, HNSCC and melanoma, approximately 60% of whom had received at least two prior lines of therapy, with encouraging responses observed across all five tumor types; uORR for PROC, CC and HCC was 80.6%, 50% and 42.9%, respectively. Last month's WCLC lung cancer data also support the ADC + IO 2.0 thesis, with uORR in efficacy-evaluable SCLC patients reaching 92.3% in first-line and 76.2% in second-line. Regarding safety, Grade 3 TRAEs occurred in only 38.7% of patients with non-lung solid tumors and 26.5% of lung cancer patients, with a limited incidence of ILD/pneumonitis. The bank believes that the global Phase 3 monotherapy study in chemotherapy-naive mCRPC continues to provide the primary support for valuation, while the expanding combination data offer considerable upside optionality. Looking ahead, the first pivotal study of Elfe-D combined with pumitamig may be initiated in late 2026 or early 2027, which is expected to become the next major catalyst, with key projects potentially following in 2027.