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- The U.S. Patent and Trademark Office issued patent number 12,514,854 B2 for REZENOPY, an Orange Book-listable patent providing intellectual property protection until February 5, 2041. - REZENOPY is the highest-strength naloxone HCl nasal spray approved by the FDA at 10 mg, designed to address overdoses involving multiple or potent opioids that may require higher doses. - Scienture expects to begin commercial availability in early Q2 2026, targeting the $154 million annual U.S. naloxone market with 9.3 million units sold annually. - The patent strengthens Scienture's exclusive U.S. commercialization rights obtained through a March 2025 agreement with Summit Biosciences Inc., a Kindeva subsidiary.
- Kindeva has opened a new 150,000 square foot UK headquarters at Charnwood Campus Science Innovation and Technology Park in Loughborough to expand its MDI services and develop next-generation propellants. - The facility will focus on developing and testing environmentally friendly propellants as the industry transitions away from current propellants used in pressurized metered-dose inhalers due to environmental legislation. - Research estimates that inhalers contribute to 0.03% of total global greenhouse gas emissions and represent 3% of the UK National Health Service carbon footprint. - The site offers comprehensive drug development services from early-stage viability through commercial analysis, including Chemistry, Manufacturing and Controls strategy and regulatory support.
- Kindeva and Rocket Science Health have formed a non-exclusive partnership to develop the RSH Olfactory Delivery Device, a dual nostril intranasal platform that precisely targets the olfactory clefts for direct CNS drug delivery. - The innovative device overcomes complex nasal anatomy challenges by ejecting a laminar stream rather than conventional plume sprays, with proprietary dispensing tips extending past the nasal valve for optimal drug deposition. - The technology is designed with human factors considerations for accessibility and accurate dosing, particularly benefiting cognitively and physically impaired patients requiring self-administration. - Kindeva's CDMO expertise and regulatory pathway knowledge will support RSH's journey toward FDA approval and eventual commercial distribution of this breakthrough intranasal delivery innovation.
