Suzhou, China, March 11, 2025 – CD (Suzhou) Biopharma today announced that its lead investigational candidate, CD-001, has received implicit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate clinical trials for hematologic malignancies. This approval, under IND Registration No. CXSL2400919, follows the commencement of the First-in-Human (FIH) Phase I trial for solid tumors earlier this year in January.
"We are pleased to reach this significant milestone with CD-001’s approval to enter clinical trials in hematologic malignancies," said Dr. Jian Xu, CEO of CD (Suzhou) Biopharma. "This expansion into hematologic malignancies aligns with our strategic clinical development plan. These malignancies present unique biological characteristics, particularly within their immune microenvironment, offering both challenges and opportunities for targeted therapies. Our preclinical data has shown CD-001’s promising efficacy and favorable safety profile across a range of hematologic cancer models. This approval not only validates our scientific approach but also broadens the potential therapeutic application of our platform. We are now moving forward with activating clinical sites and advancing this program, with the aim of providing meaningful therapeutic benefits to patients with these challenging malignancies."
CD (Suzhou) Biopharma remains dedicated to its science-driven, patient-centered approach as it continues to develop next-generation immunotherapies to address significant unmet medical needs in oncology.
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.
Preclinical studies have demonstrated potent anti-tumor activity across multiple tumor models in mice, with a favorable safety and pharmacokinetic profile observed in non-human primate toxicology studies. The program has received IND clearance from both the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) for advanced solid tumors, with first-in-human (FIH) solid tumor trials currently underway. The IND application for hematological malignancies has also received implicit approval from NMPA.
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.
