Differentiated ADC product pipeline. DualityBio has a robust pipeline of in-house discovered antibody-drug conjugate (ADC) candidates which is a testament to the Company's prowess in ADC innovation. DB-1303/BNT323 (HER2 ADC)’s first indication (HER2-expressing EC) is projected to file FDA accelerated approval as early as 2025 as per the management. DB- 1311/BNT324 (B7-H3 ADC) is under development both as monotherapy and in combination with immunotherapy for SCLC, CRPC, among others.
　　Early results showed that for 3L+ SCLC patients, DB-1311 (9mg/kg) achieved 70.4%, quite competitive compared to other B7-H3 ADC peers.
　　For heavily pre-treated CRPC patients, DB-1311 showed a rPFS of 8.3 months, supporting further investigations. DB-1310 (HER3 ADC) has adopted a differentiated development strategy focused on EGFRm NSCLC in combination with osimertinib, and KRASm NSCLC. Meanwhile, DB-1310 monotherapy demonstrated promising mPFS results of 8.3 months for heavily pre-treated 4L+ EGFR-TKI resistant NSCLC, highlighting the potential of the drug candidate as a monotherapy. DB-1305/BNT325 (TROP2 ADC) targets indications currently under-explored by other TROP2 ADC candidates, such as OC. Moreover, to harness the potent anti-tumor activity of ADCs along with the sustained benefit of next-generation IO, DualityBio/BioNtech are conducting Ph1/2 trials of DB-1311/DB-1305 + BNT327 (PD-L1/VEGF bsAb) across tumor types as an early mover in this promising ADC + next-gen IO space.
　　Eye on global markets with a replicable partnership model. In line with
　　its global strategy, DualityBio has established a number of strategic partnerships to accelerate the development of its pipeline across key global markets. Incorporated in 2019, with a relatively short operating history, DualityBio's innovative ADC assets have attracted global biopharmaceutical companies, resulting in multiple strategic partnerships with BioNTech (collaborations on B7-H3 ADC, HER2 ADC, and TROP2 ADC), BeiGene (collaboration on B7-H4 ADC), Adcendo (collaboration on the DITAC platform), GSK (collaboration on DB-1324 and certain ADCs), and Avenzo (collaboration on EGFRxHER3 BsADC). These partnerships have generated a total deal value exceeding US$6.0bn. DualityBio strives to be the partner-of-choice for global biopharma companies seeking innovative ADC programs. DualityBio's high-profile partnerships serve as industry validation of its platform and pipeline assets. The replicability of DualityBio's partnership model creates a sustainable path for future innovation.
　　Initiate at BUY: We expect DualityBio’s total revenue to reach RMB2.0bn/ 1.5bn/ 1.5bn in FY25E/ 26E/ 27E, mainly from license and collaborations revenue. We expect the Company to book product sales revenue in 2027E.
　　We derive our target price of HK$270.34 based on a DCF valuation (WACC: 11.04%, terminal growth rate: 2.5%).