DUALITYBIO-B Surges Over 5% on Global Phase III Trial Milestone for B7-H3 ADC with BioNTech

Stock News05-27

DUALITYBIO-B (09606) rose more than 5%. At the time of writing, the stock was up 3.14% to HK$222.6, with a turnover of HK$152 million. The catalyst for the move is recent news from the company's official channels. DUALITYBIO-B announced that the global Phase III pivotal registration clinical study for DB-1311/BNT324, a B7-H3-targeting antibody-drug conjugate (ADC) developed in collaboration with BioNTech SE (BNTX.US), has successfully administered the first dose to a patient globally. The study is for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not previously received taxane-based chemotherapy. This Phase III trial is supported by data from an ongoing Phase I/II clinical trial. Results from 129 heavily pre-treated advanced mCRPC patients in that trial showed that DB-1311/BNT324 has encouraging anti-tumor activity and a manageable safety profile. The related data was presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). On May 12, 2026, DUALITYBIO-B exercised its exclusive option to participate in sharing the research and development costs for DB-1311/BNT324 in the United States and to share in the profits and losses from the commercial operation of the drug.

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