Asthma and Allergy Drug Development Is Failing Too Often--A Translational Reset Is Needed: HKEY-AIRx™1.0

BOSTON and SUZHOU, China, Jan. 27, 2026 /PRNewswire/ -- HKeyBio, a preclinical CRO focused on autoimmune and allergic disease drug development, announced HKEY-AIRx™1.0, a translational preclinical strategy designed to address why many asthma and allergy programs with strong preclinical data fail clinically.

Despite substantial investment and advanced biologics, asthma and allergy pipelines face high attrition and late-stage disappointment. Often, the issue lies not in target selection, but in how preclinical evidence is generated and interpreted.

"Too many programs enter the clinic with data that answer academic questions rather than development questions," said HKeyBio's scientific leadership. "The real risk is basing early decisions on models that don't reflect disease endotypes, clinical positioning, or patient heterogeneity."

HKEY-AIRx™1.0 is built to support executive-level decision-making by aligning:

• Disease endotypes and patient heterogeneity
• Drug mechanism and modality differentiation
• Preclinical model choice and translational endpoints

This enables leadership teams to assess a program's potential for clinically meaningful benefit before committing to costly IND and clinical milestones.

The strategy uses a portfolio-based approach reflecting the complexity of asthma and allergic airway diseases, including T2-high, non-T2, and innate immune mechanisms, as well as acute inflammation versus chronic remodeling.

For biotech leaders, asthma/allergy programs often represent disproportionate capital allocation relative to success probability. HKEY-AIRx™1.0 helps de-risk pipelines by generating data that inform go/no-go decisions, asset differentiation, IND-enabling strategies, and portfolio prioritization.

HKeyBio emphasizes translational endpoints and biomarkers to determine whether a compound is investable, defensible, and clinically actionable.

Positioning as a strategic partner rather than just a service provider, HKeyBio supports small molecules, biologics, and combination therapies, aligning preclinical evidence with regulatory and clinical realities.

"Our clients seek clarity, not just more data," added the team. "We help leadership make earlier, better-informed decisions to protect patients and capital."

About HKeyBio
HKeyBio is a global preclinical CRO specializing in autoimmune and allergic diseases. With over 20 years of core team experience, it has supported 500+ IND submissions worldwide. Operating on a foundation built on ISO 9001 certification, adherence to GLP principles, and AAALAC accreditation, HKeyBio provides efficient, compliant solutions to accelerate drugs to clinic.

For more information, visit www.hkeybio.com or contact tech@hkeybio.com.