China's New Asthma Drug Gambit: Kelun-Biotech Aims for Market Disruption

CHENGDU, China – July 15, 2026 – In a move signaling both clinical progress and strategic ambition, China’s Kelun-Biotech, along with partner Harbour BioMed, announced today it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) to begin clinical trials for its novel asthma therapy, SKB575/HBM7575. While IND approvals are routine milestones, this one warrants a closer look. The asset is not just another entrant into a crowded field; it’s a long-acting, dual-target antibody designed to challenge the very definition of best-in-class treatment in a global biologics market projected to exceed $17 billion by 2031.

The approval allows the partners to test the therapy in asthma patients, adding a second major indication to its development program, which already includes a Phase I study for atopic dermatitis. For Kelun-Biotech, a subsidiary of the massive Kelun Pharmaceutical, this isn't just about developing a drug. It's about leading the charge in global innovation, a clear signal that Chinese biopharma is no longer content to simply manufacture or license Western innovations.

A Market Ripe for Disruption

Asthma is a relentless global health crisis, affecting over 300 million people. While inhaled corticosteroids and bronchodilators form the bedrock of treatment, a stubborn 5-10% of patients suffer from severe, uncontrolled forms of the disease. This segment, though small, accounts for a disproportionate share of healthcare costs and patient suffering. It’s here, in the high-stakes arena of severe asthma, that biologic therapies have become game-changers and blockbuster assets.

The market is dominated by titans. Sanofi and Regeneron's Dupixent (dupilumab), an anti-IL-4Rα antibody, is the reigning sales champion. Close behind are anti-IL-5 therapies like GSK's Nucala (mepolizumab) and AstraZeneca's Fasenra (benralizumab). More recently, the arrival of Tezspire (tezepelumab) from AstraZeneca and Amgen, a first-in-class TSLP inhibitor, has reshaped the landscape by offering a solution for a broader range of patients, including those with low levels of inflammatory cells known as eosinophils (Type 2-low asthma).

Despite these multi-billion-dollar therapies, significant unmet needs persist. Industry data reveals that even among patients on biologics, roughly half still experience exacerbations and suboptimal disease control. The burden of frequent oral corticosteroid use—with its severe side effects ranging from osteoporosis to diabetes—remains a grim reality for many. This persistent gap between available treatments and patient needs creates a clear opportunity for a therapy that can offer broader, more durable control with enhanced convenience.

The Bispecific Gambit: Engineering a Superior Weapon

This is precisely the opportunity Kelun-Biotech and Harbour BioMed are targeting with SKB575/HBM7575. The therapy is a bispecific antibody, meaning it’s engineered to engage two different targets simultaneously. One target is TSLP (thymic stromal lymphopoietin), the same upstream inflammatory mediator blocked by Tezspire. By inhibiting TSLP, the drug aims to shut down a wide cascade of inflammatory pathways, providing the broad efficacy that has made Tezspire a formidable competitor.

But it’s the second, undisclosed target that represents Kelun-Biotech’s strategic gambit. The company claims that blocking this second antigen creates a "synergistic effect," potentially delivering more potent and comprehensive inflammation control than a single-target approach ever could. While the identity of this second target remains a closely guarded secret, the dual-mechanism approach is designed to tackle the complex, heterogeneous nature of asthma head-on.

Dr. Michael Ge, CEO of Kelun-Biotech, stated, "As a differentially designed and engineered bispecific antibody, SKB575/HBM7575 is expected to achieve potent inflammation control and broad patient coverage through its dual-target synergistic mechanism, whilst offering convenient administration." The key phrase here is "convenient administration." The antibody has been engineered for an exceptionally long half-life. Based on preclinical data, the companies anticipate a human dosing interval of more than three months. This would represent a monumental leap in convenience over Tezspire (every four weeks) and Dupixent (every two weeks), potentially driving patient and physician preference and improving long-term adherence.

From 'Made in China' to 'Innovated in China'

The development of SKB575/HBM7575 is emblematic of a powerful secular shift in the global pharmaceutical landscape. For decades, the model was clear: Western firms innovated, and Chinese companies either licensed those drugs for the local market or served as manufacturing partners. Kelun-Biotech is flipping that script. According to the collaboration agreement, Kelun-Biotech is leading the asset's design, global development, and eventual commercialization, with Harbour BioMed participating as an investment and development partner.

This is not an isolated case. It reflects a broader industrial strategy, supported by Chinese regulators like the NMPA, to build a world-class, innovation-driven biopharma ecosystem. With over 30 innovative projects in its pipeline and a world-leading proprietary platform for antibody-drug conjugates (ADCs), Kelun-Biotech is positioning itself not as a regional player, but as a global contender. The NMPA's swift IND approval for a second major indication underscores the domestic support for such globally competitive assets.

The road ahead remains challenging. An IND approval is merely the ticket to the starting line of a long and costly clinical development marathon. SKB575/HBM7575 must now prove its safety and efficacy in human trials, first for atopic dermatitis and now for asthma. The competition will not stand still; established players are continually working to expand labels and develop next-generation therapies. However, by pursuing two major chronic inflammatory diseases simultaneously, Kelun-Biotech is executing a savvy strategy to maximize the value of its innovative platform. For now, all eyes are on the clinic, where SKB575/HBM7575 must prove that its elegant design translates into a decisive victory for patients and a major windfall for its developers.