Huadong Medicine unit gets trial approval for HDM3019

Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd., has received approval from China's National Medical Products Administration (NMPA) for clinical trials of HDM3019, a Class 1 therapeutic biological product. The drug, also known as IMB-101, is a bispecific antibody targeting OX40L and TNFα. It has shown promise in preclinical studies for its ability to regulate inflammatory cytokines and inhibit T-cell and plasma cell differentiation. Huadong Medicine acquired exclusive rights to HDM3019 in 37 Asian countries through a licensing agreement with South Korean company IMBiologics. A previous Phase Ia trial in the United States demonstrated a good safety and tolerance profile. While this approval marks a significant step, the company cautions that the drug's development is subject to risks, including uncertainties related to clinical trial outcomes and regulatory approvals.