GTHT has released a research report stating that, based on the exceptionally smooth progress of DUALITYBIO-B's (09606) pipeline in 2025, it has raised the potential global peak sales expectations for HER2 ADC DB1303, B7H3 ADC DB1311, and HER3 ADC DB1310. Using a DCF valuation method, the firm has increased DUALITYBIO's target price to HK$455.56, maintaining an Add rating.
Key points from GTHT are as follows: According to the firm's summary, DUALITYBIO has a rich catalyst schedule for 2026, with anticipation for the readout of the following data: 1) Final results from the global registrational trials of HER2 ADC for EC and BC indications; 2) Clinical results from the combination of B7H3 ADC, HER2 ADC, and TROP2 ADC with the PDL1*VEGF bispecific antibody BNT327; 3) Updates on early clinical data for the already partnered pipelines B7H4 ADC and EGFR*HER3 ADC, as well as progress updates on the CDH17 ADC clinical trial; 4) Disclosure of FIH data for the early-stage pipeline PDL1*B7H3 ADC.
Based on the smooth progress of HER2 ADC DB1303 in two registrational trials during 2025, and the optimistic tone from BNTX's latest R&D Day, the firm is confident about the readout of global registrational results for 2L+ EC and 2L HR+/HER2- BC in 2026, leading to an NDA filing.
Given the potential of B7H3 ADC DB1311 demonstrated in 2025 against a broad spectrum of solid tumors and its outstanding efficacy in CRPC, the firm anticipates the company will initiate the first global registrational Phase III trial for the 2L CRPC indication (chemo naïve) in 2026.
Following the initiation of a global registrational trial for MSD's HER3 ADC in 2L+ HR+/HER2- BC, and DB1310's superior clinical performance head-to-head in the same indication, the firm expects the company to continue advancing the global clinical development of DB1310 for this indication in 2026.
Based on the updated data for TROP2 ADC DB1305 in solid tumors and TNBC disclosed in 2025, the firm believes DB1305's efficacy is comparable to DATO. Furthermore, based on the demonstrated efficacy improvements in 2025 of PD(L)1 mAb + ADC, PD(L)1*VEGF bispecific + chemotherapy, and PD(L)1*VEGF bispecific + ADC over PD(L)1 mAb + chemotherapy across multiple indications, and the Best-in-Class potential of DUALITYBIO's ADCs, the firm is optimistic about the data performance of BNTX's PDL1*VEGF bispecific BNT327 in combination with DB1311, DB1303, and DB1305.
Considering that BNTX & DUALITYBIO have the fastest global clinical progress and the most extensive data, the firm is positive about their potential in the competition to define the next generation of standard oncology treatments.
Risk warnings include: 1) Risks of R&D progress falling short of expectations; 2) Risks of drug sales underperforming expectations; 3) Policy risks; 4) Industry risks; 5) Other risks.
Comments