#China #Chengdu #Kelun-Biotech #Harbour BioMed #SKB575

NMPA Grants Approval for SKB575/HBM7575

In a groundbreaking announcement on March 9, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., alongside Harbour BioMed, confirmed that China's National Medical Products Administration (NMPA) has approved their Investigational New Drug (IND) application for SKB575/HBM7575. This marks a significant milestone in developing innovative therapies for atopic dermatitis, a chronic inflammatory skin condition affecting millions globally.

Atopic dermatitis, characterized by persistent itching, redness, and irritation, impacts around 20% of children and nearly 10% of adults. Despite the availability of current treatments, including topical corticosteroids and biologics, many patients fail to achieve sustained relief, underscoring the urgent need for new therapeutic options.

Dr. Michael Ge, CEO of Kelun-Biotech, expressed excitement about the approval, highlighting it as a pivotal moment in tackling autoimmune diseases. He noted that SKB575/HBM7575 represents a novel treatment option, emphasizing its long-acting profile that may significantly enhance patient experience by reducing dosing frequency.

The uniqueness of SKB575/HBM7575 lies in its design as a bispecific antibody, targeting thymic stromal lymphopoietin (TSLP) and an undisclosed antigen. This dual mechanism aims to inhibit pathways associated with TSLP—and, simultaneously, counteract resistance often seen with standard single-target therapies. Preliminary data suggests that the extended half-life of this antibody allows for subcutaneous administration every three months, positioning it as a promising candidate for long-term management of atopic dermatitis patients.

Dr. Jingsong Wang, founder and CEO of Harbour BioMed, reiterated the importance of the IND approval, stating it addresses significant unmet medical needs linked to autoimmune diseases. By efficiently targeting key inflammatory pathways, this innovative bispecific antibody could set a new precedent in treating atopic dermatitis effectively.

This collaboration between Kelun-Biotech and Harbour BioMed showcases their commitment to advancing research and development in the challenging landscape of autoimmune diseases. As per their agreement, Kelun-Biotech leads the global development and commercialization of SKB575/HBM7575, while Harbour BioMed supports the initiative through investment and shared benefits.

About the Collaboration

The synergy between Kelun-Biotech and Harbour BioMed symbolizes a promising collaboration in biopharmaceutical development. Both companies are dedicated to utilizing their respective strengths in research to pave the way for innovative solutions targeting various diseases, particularly those that are complex and multifaceted in nature.

Kelun-Biotech aims to establish itself as a leading player in the global market of innovative drugs, demonstrated by its extensive portfolio of ongoing projects and successful drug approvals. In tandem, Harbour BioMed’s proprietary antibody technology platforms are instrumental in creating a diverse pipeline that promises to address modern healthcare challenges in immunology and oncology.

The future of SKB575/HBM7575 looks promising as both companies prepare to move forward with clinical trials, bringing hope to many patients awaiting improved treatment options for atopic dermatitis. This approval not only reflects the innovation in therapeutic approaches but also the relentless pursuit of enhanced patient outcomes in the realm of biopharmaceuticals.

For those seeking more information about this groundbreaking development or the companies involved, the respective company websites offer detailed insights into their ongoing projects and future prospects.