Ifupinostat Hydrochloride for Injection Receives Conditional Approval in China, Marking a Breakthrough in r/r DLBCL Treatment
The National Medical Products Administration (NMPA) of China has granted conditional approval for Ifupinostat Hydrochloride for Injection (brand name: Beitelin), developed by Guangzhou BeBetter Medicine Co., Ltd.
This Class 1 innovative drug is approved as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who have received at least two prior lines of systemic therapy.
✨ The approval was granted under the priority review pathway, providing a new treatment option for patients with limited choices.
A First-in-Class Dual PI3K/HDAC Inhibitor
Ifupinostat (formerly known as BEBT-908 or Shuanglisita) is the world’s first approved dual PI3K/HDAC inhibitor.
It simultaneously inhibits phosphatidylinositol 3-kinase (PI3K), a key node in tumor signaling pathways, and histone deacetylase (HDAC), a central target in epigenetic modification.
🔬 This dual-target synergy enhances its broad-spectrum antitumor efficacy, far surpassing that of single-target PI3K or HDAC inhibitors.
Promising Clinical Results with Strong Efficacy and Safety
The approval is based on results from a pivotal Phase IIb clinical study, in which the ✅ objective response rate (ORR), assessed by both the Independent Review Committee (IRC) and investigators, exceeded the threshold for conditional approval.
✅ Ifupinostat also demonstrated significant improvement in overall survival (OS).
✅ Treatment-related adverse events (TRAEs) were primarily hematologic and manageable, typically resolving spontaneously or with medical support, confirming good safety and tolerability.
In an earlier Phase IIa study, ifupinostat achieved an ORR of 50% and a DCR of 66.7% at a dose of 22.5 mg/m² among patients who had undergone three or more prior therapies for r/r DLBCL.
Notably, two patients previously treated with CAR-T therapy achieved complete (CR) and partial (PR) responses following ifupinostat treatment.
Expanding Clinical Potential Across Hematologic and Solid Tumors
Beyond relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
🧬 Ifupinostat is currently under Phase II clinical evaluation for additional hematologic malignancies, including:
- 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)
- Relapsed or refractory marginal zone lymphoma (r/r MZL)
Preclinical data demonstrate broad and potent antitumor activity against multiple solid tumor types.
Bebetter Pharmaceuticals is actively advancing Phase Ib/II combination trials of Ifupinostat with fulvestrant, BEBT-109, and BEBT-209, aiming to expand its application in advanced solid tumor therapy.
Ifupinostat Hydrochloride Recognized in China’s Major Drug Innovation Program
Owing to its innovative dual-target mechanism and outstanding clinical outcomes, Ifupinostat was selected for China’s “13th Five-Year Major New Drug Innovation Program” and received Breakthrough Therapy Designation from the CDE in October 2021.
🌟 This approval represents a significant milestone in China’s homegrown oncology innovation.
About Beitelin and Guangzhou BeBetter Medicine
Beitelin (Ifupinostat Hydrochloride for Injection) is developed by Guangzhou BeBetter Medicine, a biopharmaceutical company dedicated to innovative cancer drug development.
The company continues to explore the full potential of ifupinostat as a broad-spectrum anticancer agent and a cornerstone of precision oncology.
✨ As innovative oncology drugs such as Beitelin enter the market, DengYueMed plays a vital role in ensuring the efficient distribution, accessibility, and international availability of cutting-edge therapies in China and beyond.
Dengyue will still ensure that innovative therapies reach patients in need efficiently and safely.
