Dezhan Healthcare Company Limited (000813.SZ) has announced that its wholly-owned subsidiary, Beijing Honghui Xin Pharmaceutical Technology Co., Ltd., recently received notification from the U.S. Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for WYY026B Injection has been approved, allowing the commencement of related clinical research.
WYY026B Injection is a Class 1 chemical innovative drug independently developed by Honghui Xin, with proprietary intellectual property rights. Preclinical pharmacodynamic studies have demonstrated significant therapeutic effects, including improvement in neurological function scores and reduction in cerebral infarction area.
Mechanistic studies indicate that WYY026B can enhance oxygen utilization in brain tissue, thereby improving cerebral hypoxia, while also possessing antioxidant and anti-inflammatory properties.
The clinical trial application for this drug was recently approved by the U.S. FDA, permitting clinical research to proceed according to the submitted protocol.
The approval of the IND application for WYY026B Injection in the United States marks an important milestone in the drug's development process and will further enhance the company's core competitiveness in the field of cardiovascular and cerebrovascular drug research and development.