Taipei, Taiwan – HCmed Innovations Inc., a leading CDMO specializing in inhalation drug-device combination products, announced that its adaptive breath-actuated mesh nebulizer, AdheResp®, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). AdheResp® is the world’s first breath-actuated mesh nebulizer equipped with built-in connectivity, and uniquely ready for large-scale manufacturing to support pharmaceutical partners in clinical trials—accelerating new drug development.

  AdheResp® features adaptive breath-actuation technology, generating aerosol exclusively during inhalation. This optimizes drug delivery efficiency while reducing medication waste and minimizing fugitive emissions into the environment. Crucially, AdheResp® operates without heat accumulation during nebulization, offering significant advantages for temperature-sensitive, high-value biologics such as mRNA or antibody-based therapies by preserving drug activity and enhancing treatment outcomes.

  Through its mesh nebulizer platform, HCmed delivers comprehensive, high-quality aerosolization solutions essential for inhalation drug development, from clinical stages to commercial launch. FDA 510(k) clearance will help partner pharma companies substantially reduce development costs, strengthen intellectual property protection through customized drug-device solutions, and create differentiated market value to deliver safer and more effective therapies for patients.

  "Achieving this regulatory milestone underscores HCmed’s commitment to pioneering innovative solutions for drug development and reinforces our leadership in the CDMO field," said Jason Cheng, CEO of HCmed Innovations. "We will continue expanding regulatory approvals and strategic collaborations to advance our global presence."