For 1H25, DualityBio reported revenue of RMB1.23bn (+23% YoY), primarily driven by licensing and collaboration payments. While the Company has no commercialized products, its extensive partnerships with BioNTech, BeOne, GSK, Avenzo, and Adcendo-totaling over US$6.0bn in potential deal value- along with potential additional collaborations, are expected to provide sustained funding as clinical programs progress. R&D spending declined 7% YoY to RMB349mn in 1H25, while administrative expenses rose 71% YoY to RMB126mn, mainly due to IPO-related costs. Excluding the fair value impact of preferred shares from the IPO, adjusted net profit reached RMB146mn (+14.2% YoY). As of Jun 2025, the Company maintained a solid cash balance of RMB3.75bn, sufficient to support continued R&D and pipeline expansion.
De-risked ADC pipeline progressing toward commercialization.
BioNtech and DualityBio plan to file the NDAs for DB-1303/BNT323 (HER2 ADC) targeting HER2-expressing 2L+ EC in the US and 2L+ HER2+ BC in China by end-2025, marking a major step towards commercialization. A global Ph3 trial in HR+/HER2-low breast cancer is also ongoing. DB- 1311/BNT324 (B7-H3 ADC) has shown encouraging efficacy in heavily pre- treated CRPC patients, achieving a rPFS of 8.3 months. In 3L+ SCLC, DB- 1311 (9mg/kg) delivered a 70.4% ORR, positioning it competitively among B7-H3 ADC candidates. Meanwhile, DB-1310 (HER3 ADC) demonstrated a PFS of 8.3 months at 5mg/kg in 4L+ EGFR-TKI-resistant NSCLC, which was superior than competing therapies in this setting.
Front-runner in ADC and next-generation IO combination. As an early mover in ADC and next-generation IO combinations, DualityBio and BioNTech are advancing multiple Ph1/2 trials evaluating BNT327 (PD- L1/VEGF bsAb) in combination with their HER2, B7-H3, and TROP2 ADCs across various tumor types. Initial data from the TROP2 ADC + BNT327 combo, presented at AACR in April, demonstrated superior tumor growth inhibition versus each monotherapy alone. In 67 solid tumor patients, the TRAE discontinuation rate was low at 4.5%, and among 13 heavily pretreated PROC patients, the ORR was high at 54%. We believe that by leveraging BioNTech’s global clinical development capabilities, the full global value of DualityBio’s ADC assets can be effectively unlocked.
Advancing next-generation ADCs. DualityBio is advancing its next- generation bispecific ADC pipeline, including DB-1419 (PD-L1/B7H3 ADC) and DB-1418/AVZO-1418 (EGFR/HER3 ADC), both in Ph1/2 development. The EGFR/HER3 ADC has been out-licensed to Avenzo. In light of promising results from Henlius’ PD-L1 ADC in both sq- and nsq- IO-resistant NSCLC, DualityBio’s PD-L1/B7H3 ADC has demonstrated dual functions of cytotoxic and immune activity in preclinical models (link). Beyond oncology, the Company is also developing DB-2304 (BDCA2 ADC) for autoimmune diseases, targeting SLE/CLE in Ph1 trial.
Maintain BUY. Given the Company’s unique positioning in ADC and next- generation IO combination, we raise our TP from HK$270.34 to HK$367.06 based on a DCF valuation (WACC: 9.87%, terminal growth rate: 3.5%).