SUZHOU, China, Dec. 20, 2024 -- CD Biopharma, a rapidly advancing clinical-stage biotech company that develops innovative therapies across a broad spectrum of immunotherapy areas, today announced that its IND application for CD-001, the company's leading clinical candidate, has been approved by the National Medical Products Administration (NMPA) for clinical trials.
Dr. Jian Xu, CEO of CD Biopharma, stated: "Following the FDA's clearance for clinical trials in September this year, making our product the world's second PD-1/IL-21 bi-targeting fusion protein to enter clinical phase, we are delighted to announce another significant milestone - our IND application has received formal clearance from NMPA. This IND approval demonstrates our team's exceptional capabilities from drug discovery to clinical development. CD-001 has become the first domestically developed product of its kind to receive concurrent clinical trial approvals in both China and the United States, bringing new therapeutic hope to cancer patients globally. CD Biopharma will continue to advance the development of next-generation immunotherapy drugs, delivering more and superior treatment options to cancer patients worldwide, helping them achieve a better quality of life."
About CD-001
CD-001, the company's leading clinical candidate, is built on its proprietary Bispecific Fusion Protein (BsFP) platform. This potential therapy, designed to target PD-1 positive CD8+ T cells using an anti-PD-1 antibody and engineered IL-21 mutant, aims to address unmet medical needs in oncology and viral infections.
About CD (Suzhou) Biopharma
Founded in 2021, CD Biopharma is a rapidly advancing clinical-stage biotech company focused on developing innovative therapies across a broad spectrum of immunotherapy areas, including oncology, viral infections, and autoimmune diseases. The company's proprietary Bispecific Fusion Protein (BsFP) platform and IMmune-Enhanced (IME) cell technology, which enable advanced cell modification, continue to drive breakthrough research and clinical outcomes that transform patient care. CD Biopharma is headquartered in Suzhou, China, with additional research operations in Beijing, China.