China Clears HBM7575 Trial for Asthma Treatment

Harbour BioMed and Kelun-Biotech have announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HBM7575/SKB575, allowing the experimental therapy to enter clinical development for the treatment of asthma.

The approval marks another important milestone for the two companies, which are jointly developing the long-acting bispecific antibody as a potential treatment for chronic immune-related diseases. The therapy had already entered Phase 1 clinical testing for atopic dermatitis, with the first participant recently receiving the investigational treatment.

HBM7575/SKB575 is a long-acting bispecific antibody designed to target thymic stromal lymphopoietin (TSLP), a protein that plays a key role in triggering inflammation linked to several allergic and immune-mediated diseases. The therapy also targets a second undisclosed biological pathway, which the companies believe could improve treatment outcomes by addressing multiple disease mechanisms at the same time.

The latest regulatory approval allows researchers to begin clinical studies evaluating the medicine in patients with asthma, a chronic respiratory disease that affects an estimated 300 million people worldwide.

Asthma causes inflammation and narrowing of the airways, making it difficult for people to breathe. Common symptoms include wheezing, coughing, chest tightness and shortness of breath. Although many patients are able to manage their condition with existing medicines, a significant number continue to experience frequent asthma attacks and ongoing symptoms that reduce their quality of life.

Current standard treatments for asthma mainly include inhaled corticosteroids (ICS) to reduce airway inflammation and bronchodilators to relax the muscles around the airways. While these therapies are effective for many people, they do not work well for every patient, especially those with severe or difficult-to-control asthma.

As a result, there is growing interest in developing new medicines that target the underlying biological causes of the disease rather than simply controlling symptoms. Researchers believe long-acting biologic therapies could provide longer-lasting disease control while reducing the need for frequent medication use.

HBM7575/SKB575 is being developed with that goal in mind. By targeting TSLP and another undisclosed pathway, the investigational therapy aims to reduce inflammation more effectively and potentially provide longer-lasting benefits for patients living with chronic immune-mediated diseases.

The asthma approval comes shortly after the first patient was dosed in a Phase 1 clinical trial evaluating HBM7575/SKB575 for atopic dermatitis, a chronic inflammatory skin disease commonly known as eczema. The rapid expansion of the clinical program reflects the companies’ plans to evaluate the therapy across multiple immune-related conditions.

Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed, welcomed the latest regulatory approval and said the company is encouraged by the rapid progress of the program.

He noted that after recently dosing the first participant in the atopic dermatitis study, the company is pleased to see HBM7575/SKB575 move quickly into clinical development for asthma. According to Wang, having clinical programs underway in two major disease areas provides an opportunity to explore the full potential of the therapy in treating chronic immune-mediated conditions.

Harbour BioMed said it plans to continue advancing its clinical development strategy and evaluate the medicine’s ability to improve treatment options for patients whose diseases are not adequately controlled by existing therapies.

If future clinical trials demonstrate the therapy is safe and effective, HBM7575/SKB575 could become a new long-acting treatment option for asthma and other immune-related diseases. However, the medicine is still in the early stages of clinical development, and additional studies will be needed before it can be considered for regulatory approval and routine patient use.