Gelonghui, December 16, Zhejiang Wolwo Bio-Pharmaceutical (300357.SZ) announced that the company recently downloaded the "Clinical Trial Approval Notice" from the National Medical Products Administration's online service hall, and the clinical trial application for the "Dust Mite Membrane Agent" submitted by the company has been approved. The registration category is Class 1 Therapeutic Biological Product. The indication is for specific immunotherapy used in adult patients with allergic rhinitis related to dust mite sensitization (with or without allergic conjunctivitis or allergic asthma).
After obtaining the "Clinical Trial Approval Notice," this product will undergo Phase I, Phase II, and Phase III clinical trials, as well as the application for marketing authorization, before it can be marketed, and the results carry significant uncertainty. Currently, the company is actively preparing for the Phase I clinical trial of this product and will timely fulfill its information disclosure obligations based on the progress.