Kangpu Biopharma Receives FDA IND Clearance for Class 1 Innovative Drug KPG-818 in Multiple Hematologic Malignancies

Kangpu Biomedical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Kangpu Biomedical”) recently received a letter of approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States for KPG-818 in the treatment of various hematologic malignancies, including mantle cell lymphoma, adult T-cell leukemia/lymphoma, indolent lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, multiple myeloma, and chronic lymphocytic leukemia (IND No.: 142686).

KPG-818 is a next-generation oral small-molecule immunomodulatory drug with independent global intellectual property rights, designed and developed by Kangpu Biomedical. It belongs to the class of CRBN E3 ubiquitin ligase complex (Cullin-RING E3 ubiquitin ligase complex, CRL4-CRBN) modulators. Preclinical study data indicate that KPG-818 can effectively downregulate the expression levels of cytokines such as IL-6 and TNF-α, and efficiently degrade the zinc finger transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). In preclinical trials, KPG-818 demonstrated favorable GLP toxicological tolerance and drug-like pharmacokinetic properties, and showed superior therapeutic efficacy in various animal models of hematologic malignancies.

KPG-818 has demonstrated favorable oral absorption, pharmacokinetic parameters, and toxicological tolerability in the ongoing Phase I clinical trial in healthy volunteers for the treatment of systemic lupus erythematosus (SLE) in the United States, which is nearing completion.

Dr. Ge Chuansheng, Chairman and CEO of Kangpu Biomedical

“The discovery of protein ubiquitination and its degradation was awarded the Nobel Prize in 2004, and it is playing an increasingly important role in the field of innovative drug development, with enormous potential. After years of diligent exploration, Kangpu Biomedical has achieved a series of significant results in the modulation of signaling pathways related to protein ubiquitination and degradation. The approval by the U.S. FDA for clinical trials of KPG-818 for the treatment of various hematologic malignancies marks another major and exciting milestone in Kangpu Biomedical’s development journey. We are collaborating with world-class clinical development organizations, looking forward to providing a superior treatment option for patients worldwide as soon as possible,” said Dr. Ge Chuansheng, Founder, Chairman, and CEO of Kangpu Biomedical.

Founded in 2011 and headquartered in the Zhangjiang Hi-Tech Park in Shanghai, Kangpu Biomedical is a clinical-stage innovative biopharmaceutical company. The company boasts a seasoned team of experts and operational professionals with robust capabilities, international vision, and extensive industry experience in innovative drug development. Driven by innovation and focused on therapeutic areas such as cancer, autoimmune diseases, and inflammation, Kangpu Biomedical leverages its proprietary technologies—including internationally leading next-generation protein ubiquitination and degradation platforms and the X-Synergy® novel drug combination technology platform—to develop global, first-in-class small-molecule targeted immunomodulatory innovative drugs with independent global intellectual property rights. Kangpu Biomedical’s overarching strategic goal is to establish a modern biopharmaceutical enterprise integrating research and development, manufacturing, and sales, committed to providing patients with first-in-class or best-in-class treatment solutions, addressing urgent and unmet clinical needs, and contributing to the conquest of disease and the enhancement of human health and well-being.