BeBetter's World-First Dual-Target HDAC/PI3K Inhibitor Gains Approval in China

BeBetter Med's ifupinostat has received approval from China's National Medical Products Administration (NMPA) as the world’s first HDAC/PI3K dual-target inhibitor for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). The drug simultaneously blocks PI3K signalling and epigenetic regulator HDAC, showing synergistic antitumour effects and broader activity than single-target inhibitors.

In Phase IIa trials, ifupinostat achieved a 50% objective response rate (ORR) and 66.7% disease control rate (DCR) in heavily pretreated r/r DLBCL patients, including two CAR-T non-responders. BeBetter is exploring its potential in other blood cancers such as r/r Peripheral T-cell lymphoma (PTCL) and r/r follicular lymphoma (FL) as well as in solid tumours through ongoing Phase II trials. The drug, supported by China's Major New Drug Innovation program, previously earned Breakthrough Therapy Designation (BTD) in 2021.

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