CICC has reiterated its Outperform rating on DUALITYBIO-B (09606) with an unchanged target price of HK$430, implying a 63.4% upside potential from the current share price, based on a DCF valuation model. The company reported 2025 revenue of RMB 1.85 billion, exceeding the institution's expectations, primarily driven by higher-than-anticipated R&D collaboration reimbursement income. Key points from CICC are as follows.
The advancement of the first-tier pipeline is progressing at full speed globally. According to the company's announcement, as of 2025, DUALITYBIO-B had enrolled approximately 3,200 patients in global clinical trials cumulatively, with about 1,200 new enrolments in 2025 alone. Notably, around 50% of these new enrolments came from regions outside China, demonstrating highly efficient execution. The company has submitted a marketing application in China for DB-1303 targeting HER2+ breast cancer. Furthermore, patient enrollment for the global Phase 3 registrational trial in HR+ HER2- breast cancer was completed in February 2026, with data readout expected in 2026. A marketing application for DB-1303 targeting HER2-expressing endometrial cancer is anticipated to be submitted in the U.S. in 2026. For DB-1311, data readout in February 2026 showed best-in-class potential in metastatic castration-resistant prostate cancer, and a global Phase 3 registrational trial for this indication is set to commence shortly. DB-1310 has demonstrated promising preliminary efficacy data in both EGFR-mutant non-small cell lung cancer and HR+ HER2- breast cancer, and has received FDA Fast Track designation, laying a solid foundation for subsequent development.
Potential catalysts in 2026 are abundant, including combination therapy explorations and progress in the second-tier pipeline. In collaboration with BioNTech, DUALITYBIO-B is conducting multiple combination trials for DB-1303, DB-1311, DB-1305, and pumitamig, with data readouts expected throughout 2026. The company has dosed the first patient in the Phase 2a trial for DB-2304, drawing attention to the proof-of-concept for this innovative autoimmune ADC approach. Additionally, DB-1317, DB-1324, DB-1418, and DB-1419 are all advancing in global clinical studies. Preclinical data for the company's dual-payload DUPAC platform was presented at the 2025 AACR annual meeting.
Risk factors include potential R&D failures, a worsening competitive landscape, delays in external collaborations, and slower-than-expected commercialization.
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