DUALITYBIO-B (09606) opened up over 4%. As of press time, the stock rose 4.63% to HK$380, with a turnover of HK$7.506 million.
On the news front, DUALITYBIO-B announced that starting from September 8, 2025, the company's shares will be included as constituent stocks of the Hang Seng Composite Index by Hang Seng Indices Limited and added to the list of eligible securities under the Shanghai-Hong Kong Stock Connect southbound trading.
The inclusion in the Hang Seng Composite Index and qualification as Stock Connect eligible securities represents high recognition from the capital market regarding the company's performance and value. This enables eligible investors from mainland China to directly invest in shares listed on The Stock Exchange of Hong Kong Limited through the Shanghai Stock Exchange. The inclusion is expected to further expand the company's investor base and potentially increase share trading liquidity.
Additionally, it's noteworthy that on September 5, DUALITYBIO-B announced that following evaluation by the Independent Data Monitoring Committee (IDMC), the Phase III clinical trial of DB-1303/BNT323 for HER2-positive unresectable or metastatic breast cancer patients who previously received trastuzumab and taxane treatment has achieved the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared to the control group.
The company plans to communicate with the Center for Drug Evaluation of the National Medical Products Administration regarding the submission of a Biologics License Application (BLA) for DB-1303/BNT323. DB-1303/BNT323 is a clinical-stage HER2 ADC candidate currently being evaluated in two ongoing registrational clinical trials and another potential global registration study. The company's partner BioNTech SE is preparing to submit a marketing authorization application for DB-1303/BNT323 in 2025.