Kangpu Biopharma's KPG-818 Receives NMPA IND Approval for Multiple Myeloma Treatment

HEFEI, China, February 25, 2025 — Kangpu Biopharmaceuticals, Ltd. has announced a significant milestone in its development of innovative cancer treatments. The company received approval for its investigational new drug (IND) application from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) for KPG-818. This approval marks a crucial step in the quest to treat relapsed or refractory multiple myeloma (RRMM).

KPG-818 is an innovative oral treatment designed as a molecular glue modulator targeting the E3 ubiquitin ligase complex known as CRL4-CRBN. Its mechanism demonstrates a strong affinity for cereblon (CRBN), a protein crucial in the degradation pathways of certain transcription factors. KPG-818 effectively degrades the Aiolos (IKZF3) and Ikaros (IKZF1) proteins, which belong to the Ikaros family of zinc-finger transcription factors involved in B-cell development. This drug exhibits multifaceted therapeutic properties, including immunomodulatory, anti-angiogenic, and anti-tumor activities.

The progress of KPG-818 has been underscored by the completion of its Phase I clinical trial in the United States. This trial focused on patients with various hematological cancers, providing promising preliminary data. For individuals with RRMM who have undergone extensive prior treatments — including two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (such as bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (like daratumumab or isatuximab) — KPG-818 showed favorable safety and tolerability profiles. The trial also revealed positive pharmacokinetic properties and encouraging therapeutic outcomes, suggesting potential efficacy in this challenging patient population.

Kangpu Biopharmaceuticals is a company at the forefront of clinical-stage biopharmaceutical innovation, dedicated to discovering and developing novel therapies for a range of conditions. These include solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders. The company is renowned for employing cutting-edge approaches such as targeted protein degradation to create its diverse pipeline of promising drug candidates. Among its technological platforms are NeoMIDES®, gDACs®, and X-SYNERGY®, each contributing to the development of potentially groundbreaking first-in-class and best-in-class therapeutics.

Kangpu's commitment to advancing healthcare solutions is evident through its strategic pipeline and the continuous development of novel therapeutic approaches. The company's focus remains on addressing unmet medical needs and providing effective treatments for complex diseases, thereby improving patient outcomes and quality of life.

As KPG-818 progresses through further stages of clinical development, Kangpu Biopharmaceuticals continues to build on its momentum, striving to make substantial contributions in the field of oncology and beyond. With this recent IND approval, the company is poised to expand its impact and further its mission of pioneering transformative therapies for patients worldwide.