Necessaire Biotech (688759.SH): Received Clinical Trial Approval Notice for Irinotecan Hydrochloride for Injection (BEBT-908) Combined with CHOP for Treatment of Previously Untreated Peripheral T-Cell Lymphoma

Gelonghui, March 13 — Beibeite (688759.SH) announced that the company recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA), approving the clinical trial of Iprinomestat hydrochloride injection (BEBT-908) combined with the CHOP regimen in treatment-naive peripheral T-cell lymphoma patients.

Iprinomestat hydrochloride injection (BEBT-908) is the company’s independently developed, the world’s first approved HDAC/PI3Kα dual-target inhibitor. It selectively inhibits the tumor cell signaling core protein kinase PI3Kα and the epigenetic regulator HDAC, producing a synergistic anti-tumor effect through dual blockade. This strongly disrupts the tumor cell signaling network, inhibits tumor cell proliferation, and induces apoptosis. The product received conditional approval for market launch from the NMPA in June 2025. It is currently used as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL) who have previously received at least two lines of systemic therapy. The company is also advancing a confirmatory Phase III clinical trial of its combination with rituximab for second-line and above treatment of r/rDLBCL.

Peripheral T-cell lymphoma is a highly heterogeneous and aggressive subset of non-Hodgkin lymphoma, with a significantly higher incidence in the Chinese population compared to Western populations, and most subtypes have very poor prognosis. Currently, first-line treatment mainly relies on traditional chemotherapy with the CHOP regimen. While it can achieve short-term tumor control, it has limitations such as insufficient depth of remission and limited long-term survival benefits. Over 40% of patients experience relapse or refractory disease within one year after first-line therapy. Existing targeted therapies are limited, and there remains a significant unmet clinical need.

The approval for this clinical trial is mainly based on the results of an open-label, multicenter Phase II study of Iprinomestat as a second-line or above treatment for relapsed or refractory peripheral T-cell lymphoma, along with various non-clinical data. These findings demonstrate the product’s good anti-tumor activity and manageable safety profile in the treatment of peripheral T-cell lymphoma, laying a solid foundation for advancing its combination with chemotherapy into first-line clinical studies. The planned clinical trial is an open-label, multicenter Phase II study designed to systematically evaluate the efficacy, safety, and pharmacokinetics of Iprinomestat combined with the CHOP regimen in newly diagnosed peripheral T-cell lymphoma patients, while exploring the correlation between tumor biomarkers and treatment outcomes. This could potentially break through the efficacy bottleneck of traditional chemotherapy and provide a new first-line treatment option for newly diagnosed patients.

Due to the high-tech, high-risk, and high-value nature of pharmaceutical products, the early research and development, as well as the entire process from drug development, clinical trial approval, to production, involve long cycles and many steps, with considerable uncertainties. Investors are advised to exercise caution and be aware of investment risks.