regulation
Harbour BioMed and Kelun-Biotech Receive NMPA Approval for HBM7575/SKB575 for Asthma Treatment
Harbour BioMed and Kelun-Biotech announced that the NMPA has approved their IND application for HBM7575/SKB575, a drug candidate for asthma treatment. This approval allows the companies to proceed with clinical development.
AS1 NewsSource: prnewswire.com
Harbour BioMed (HKEX: 02142), a biopharmaceutical company specializing in antibody therapeutics, and Kelun-Biotech have received approval from the National Medical Products Administration (NMPA) in China for their Investigational New Drug (IND) application for HBM7575/SKB575. This approval marks a key step in the development of their novel therapy aimed at treating asthma. The companies announced this milestone on July 15, 2026, signaling progress in their pipeline of immunology-focused drugs.
The IND approval enables Harbour BioMed and Kelun-Biotech to initiate clinical trials in China, which is a critical phase for assessing the safety and efficacy of HBM7575/SKB575. The drug candidate is part of their broader strategy to develop innovative antibody-based treatments for respiratory conditions.
This development is expected to positively influence the companies' prospects, potentially expanding their portfolio in respiratory therapeutics and strengthening their market position. The approval also reflects regulatory confidence in their research and development capabilities.
While the immediate market impact depends on subsequent trial results, this milestone underscores the companies' commitment to advancing novel therapies in immunology and respiratory medicine. Investors may view this as a step toward future commercialization and revenue generation.
The approval facilitates clinical development of HBM7575/SKB575, potentially advancing the companies' pipeline and future revenue streams.