TranspireBio CEO Presents Industry Perspective on FDA’s Updated Bioequivalence Framework at FDA/CRCG Workshop

TranspireBio CEO Presents Industry Perspective on FDA’s Updated Bioequivalence Framework at FDA/CRCG Workshop

PR Newswire

SUNRISE, Fla., Oct. 15, 2026 /PRNewswire/ — TranspireBio Holdings Inc. (TranspireBio, or the Company), an integrated clinical-stage biopharmaceutical company advancing inhaled therapeutics for respiratory and systemic diseases, today announced that Xian-Ming Zeng, Ph.D., Chief Executive Officer at TranspireBio, delivered a presentation at the FDA/Center for Research on Complex Generics (CRCG) workshop titled “Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods.” Other members of TranspireBio’s team, Abhishek Gupta, Ph.D., Chief Scientific Officer; Mark Lepore, M.D., Chief Medical Officer; and Chirag Shah, M.Pharm., Director, R&D, Formulation Development, were also invited to serve as panelists in the workshop, which convened regulatory, academic, and industry experts at the Universities at Shady Grove in Maryland on October 14–15, 2026 to discuss advances in the development and evaluation of complex generic inhalation therapies. 

Transpire Bio

At the workshop, Dr. Zeng delivered a presentation titled “An Industry Perspective on FDA’s Updated Bioequivalence Framework for Generic Inhalation Drugs.” The presentation provided an industry perspective on the FDA’s evolving bioequivalence framework for complex generic inhalation products, including opportunities, challenges, and practical considerations for implementing innovative approaches that may support more efficient development of high-quality therapies.  

“We appreciated the opportunity to engage with regulators, industry colleagues, and academic researchers on advancing improvements in clinical development for inhalation products,” said Dr. Xian-Ming Zeng. “The workshop’s focus on innovative approaches to establish bioequivalence has the potential to help translate rigorous science into more efficient development pathways and ultimately broaden patient access to high-quality inhaled medicines.” 

About TranspireBio Holdings Inc.  

TranspireBio Holdings Inc. is an integrated, U.S.-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. TranspireBio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. The company has developed multiple proprietary inhalation technology platforms, including dry-powder inhalers and soft mist inhalers, which support its advancing pipeline of innovative inhalation medicines. TranspireBio’s pipeline includes potential therapies for idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF), pulmonary arterial hypertension (PAH), diabetes, obesity, and central nervous system (CNS) indications. For more information, please visit www.transpirebio.com.  

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SOURCE Transpire Bio