On October 8, 2023, the New Drug Application (NDA) of BEBT-908, a class I new drug independently developed by BeBetter Med Inc. has been officially accepted by the China National Medical Products Administration's Center for Drug Evaluation (CDE). This drug is intended for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in adult patients who have previously received at least two systemic therapies. Currently, this application has received CDE priority review qualification, and represents the world's first and only small molecule dual-target inhibitor designed for PI3K/HDAC in the marketing registration application stage.
According to analysis by Frost & Sullivan, diffuse large B-cell lymphoma (DLBCL) accounts for approximately 41.0% of non-Hodgkin lymphoma (NHL) cases, making it the most prevalent subtype of NHL. In 2021, there were an estimated 222,000 DLBCL patients in China, and it is expected to reach 299,000 by 2030. DLBCL's treatment pathway primarily revolves around R-CHOP as first-line therapy. However, DLBCL exhibits high heterogeneity and invasiveness, with approximately 30-40% of patients progressing to relapsed or refractory (r/r DLBCL) status, often developing drug resistance after a period of treatment. Currently, there is no standard third-line or above treatment regimen for r/r DLBCL, and there is an unmet clinical need for small-molecule targeted therapies in this field.
The NDA for BEBT-908 is based on its key Phase IIb clinical trial data, which enrolled 93 r/r DLBCL patients. The primary endpoints, including objective response rate (ORR) assessed by independent review committee (IRC) and investigator assessment, exceeded the conditional approval requirements of the regulatory agency, significantly extending overall survival (OS) in patients. In terms of safety, treatment-related adverse events (TRAEs) were predominantly hematologic adverse events, which were either self-resolved during the treatment period or manageable with drug intervention, demonstrating good safety and tolerability. Related research findings will be published in academic journals and presented at scientific conferences.
BEBT-908 is the world's first PI3K/HDAC dual-target inhibitor to reach the NDA filing stage. It simultaneously targets the core signaling pathways of PI3K and epigenetic modification target HDAC, resulting in synergistic anti-tumor effects. Compared to single-target PI3K inhibitors or HDAC inhibitors, BEBT-908 has significantly increased activity across various hematologic malignancies and solid tumors, showcasing broad-spectrum anti-tumor activity. Based on its outstanding clinical data, it has been selected for China's "13th Five-Year" National Major New Drug Creation Project, passed the acceptance evaluation and received CDE’s designation of "Breakthrough Therapy." Phase IIa clinical data for BEBT-908 show that an objective response rate (ORR) of r/r DLBCL treated with third-line or higher therapy was 50% in subjects who completed a post-treatment tumor evaluation at the recommended Phase II dose (22.5 mg/m2) , with a disease control rate (DCR) of 66.7%. Notably, two patients who had previously undergone CAR-T therapy achieved complete and partial responses after BEBT-908 treatment. With its promising anti-tumor efficacy and safety profile, BEBT-908 is poised to become the first domestically approved small molecule targeted innovative drug for third-line and above treatment of r/r DLBCL in China.
In addition to r/r DLBCL, BEBT-908 also shows promising therapeutic potential in other hematologic malignancies. The company is conducting Phase II clinical trials in indications such as relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), relapsed or refractory follicular lymphoma (r/r FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), and marginal zone lymphoma (r/r MZL).
Furthermore, BEBT-908 has demonstrated broad and robust anti-tumor activity against solid tumors in preclinical studies. The company continues to explore its potential for late-stage solid tumor treatment and is conducting Phase Ib/II clinical trials combining BEBT-908 with fulvestrant/BEBT-109/BEBT-209 for late-stage solid tumor treatment.
About BeBetter Med:
BeBetter Med Inc. is a biopharmaceutical company focused on the research and development of breakthrough medications in vital therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. Established in 2012 in Guangzhou by Professor Changgeng Qian alongside a cadre of global returnees, BeBetter Med utilizes its proprietary technology platform to formulate groundbreaking pharmaceutical solutions that balance clinical effectiveness with practical utility. Adhering to the ethos of "Committed to Innovation, Striving for Excellence," the company is unwavering in its commitment to independent research and development of globally patented, safe, and effective medications.
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