Kangpu Biopharmaceuticals Received CDE Approval for Phase IIb Clinical Trial of KPG-818 in Moderate to Severe Cutaneous Manifestations of SLE

HEFEI, China, April 28, 2025 /PRNewswire/ -- Kangpu Biopharmaceuticals, Ltd. announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved Phase IIb clinical trial of KPG-818 capsule for the treatment of moderate to severe cutaneous manifestations of systemic lupus erythematosus (SLE).

About Cutaneous Manifestations of SLE

SLE is a complex, heterogeneous, inflammatory, chronic autoimmune disease in which the body's immune system attacks its own tissues, including skin, joints, and kidneys. Skin is the second most frequently affected organ system of SLE. The majority of SLE patients experience cutaneous manifestations over the course of the disease. Cutaneous manifestations of SLE carries a significant burden with regard to psychosocial well-being and medical costs.

Treatment options for cutaneous manifestations of SLE are limited, and current therapies (e.g., glucocorticoids, antimalarials, immunosuppressants) often lack efficacy or carry systemic side effects. There are tremendous unmet medical needs for novel therapeutics, especially an oral agent.

About KPG-818

KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high binding affinity to CRBN and potent degradation of zinc-finger transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-818 effectively regulates immune cells (B cells, T cells, and pDC cells) and the release of multiple cytokines, possessing immunomodulatory, anti-angiogenic and anti-tumor effects. In the Phase IIa clinical study in SLE patients completed in the US, KPG-818 was well tolerated and demonstrated promising preliminary efficacy in SLE patients with cutaneous manifestations. KPG-818 was well tolerated in healthy subjects in a Phase I clinical study completed in China.

About Kangpu Biopharmaceuticals, Ltd.

Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®.

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