By Fineline Cube 
Guangzhou BeBetter Medicine Technology Co., Ltd’s first-in-class HDAC/PI3Kα dual-targeted inhibitor BEBT-908 has received conditional approval from China’s National Medical Products Administration (NMPA). The drug is indicated for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) in patients who have failed at least two prior lines of systemic therapy.
Clinical Performance
BEBT-908, the world’s first dual HDAC/PI3Kα inhibitor with a synergistic mechanism, is the first home-grown drug in China for r/r DLBCL. In the pivotal Phase IIb clinical trial, the drug demonstrated an overall response rate (ORR) of 33.8% and achieved an enhanced ORR of 54.6% after excluding COVID-19-related patient dropouts or treatment deviations. Additionally, the drug extended median overall survival (OS) to 8.8 months, significantly surpassing current chemotherapy regimens (4.0-4.7 months), and reached 18.0 months median OS in responsive patients. Notably, the drug produced ≥67% ORR in both CAR-T therapy-resistant and bispecific antibody treatment-failed populations.-Fineline Info & Tech