Ensifentrine

A dual phosphodiesterase inhibitor delivered by dry powder inhaler met its primary endpoint in a Phase IIb randomized trial in chronic obstructive pulmonary disease (COPD), providing the first controlled efficacy data for AN01. Redwood City, California-based AirNexis Therapeutics presented results from study HSK39004-T1-202 at the 2026 European Respiratory Society Congress in Barcelona. The trial, conducted in China by AirNexis' partner Haisco Pharmaceutical Group, randomized 195 symptomatic COPD patients — 90 on single bronchodilator background therapy and 105 on dual bronchodilator therapy — in a 1:1:1 ratio to AN01 0.75 mg, AN01 1.5 mg, or placebo for four weeks. Both doses met the primary endpoint of change from baseline in FEV₁ area under the curve from 0 to 12 hours post-dose (ΔFEV₁ AUC₀₋₁₂h) at Week 4, with treatment differences of 116 mL for the 0.75 mg dose and 127 mL for the 1.5 mg dose versus placebo. In patients already receiving dual bronchodilator therapy — a population with limited remaining pharmacological options — both doses still produced improvements of 74 mL and 75 mL, respectively. Among patients on single bronchodilator therapy, the improvements were larger at 164 mL and 189 mL. No treatment-related adverse events were reported in the 0.75 mg group, the dose under investigation in the Phase III program; the 1.5 mg group recorded a treatment-related adverse event rate of 6.1%, compared with 7.9% in the placebo group. AN01 inhibits both PDE3, driving bronchodilation through smooth muscle relaxation, and PDE4, reducing inflammatory mediator release — a dual mechanism designed to provide additive benefit on top of existing bronchodilator regimens. The most direct comparator is ensifentrine (Ohtuvayre), a nebulized dual PDE3/4 inhibitor developed by Verona Pharma and approved by the US FDA in June 2024. In the Phase III ENHANCE-1 and ENHANCE-2 trials, ensifentrine produced FEV₁ AUC₀₋₁₂h improvements of 87 mL and 94 mL versus placebo, respectively. AN01's reported 116–127 mL improvements are numerically larger, though cross-trial comparisons are limited by differences in study design, duration, and patient populations. AirNexis completed a Phase I multiple ascending dose study in healthy volunteers in Australia and said it is preparing to initiate its own Phase II program in 2027. Haisco's Phase III DPI study in China is already underway (NCT07583849). AN01 has now been administered to more than 600 subjects across both companies' programs, the company said. Spot something wrong? Report an issue with this article

Specialized CDMOs combine precision, agility and scale to meet the evolving needs of complex pharmaceutical manufacturing. This is production on purpose. The drugs that define the future of pharmaceutical manufacturing are not the ones that serve the largest populations. They are the ones that are hardest to get right. Getting them right requires a manufacturer that combines the precision of specialized production with the scale to serve millions of patients reliably. Enter a new type of manufacturing. According to DrugPatentWatch, 85 percent of the Contract Development and Manufacturing Organization (CDMO) market is in specialized, precision mid-market companies. This sector of the market depends on specialized, targeted CDMOs for clinical supply chain resilience, reliable manufacturing, and regulatory compliance. For either smaller developers or those in the earlier stages of drug manufacturing, specialized CDMOs are generally more accessible. These types of CDMOs are usually more flexible, can help with troubleshooting, and can make changes much more quickly than very large manufacturers who have set processes and procedures. Specialized manufacturers usually specialize in complex, lower-volume drug development and production. Drugs include sterile injectables, ophthalmic solutions, or any product that must follow specific manufacturing methods. These are often biologicals but also include small molecule drugs that require sterile fill-finish or aseptic processing, such as preservative-free ophthalmic treatments. Targeted CDMOs are providing more agile, focused approaches to manufacturing as the entire pharmaceutical and biotech industries move away from the “one size fits all” model of drug development While Ritedose is the largest U.S.-based CDMO using sterile, precision-driven Blow-Fill-Seal (BFS) technology to manufacture drugs, we are prioritizing our ability to retain agility and adapt to new clients and drug classes, as well as economic and geopolitical conditions. These agile processes enable the development of valuable specialized drugs and aseptic processing of these more targeted products. For example, earlier this year Ritedose announced we entered a partnership with TenPoint Therapeutics Ltd., to manufacture its new drug Yuvezzi™, the first (and only) dual-agent FDA-approved eye drop to treat presbyopia, an eye condition (impaired closeup vision) affecting 128 million Americans. Ophthalmic drugs must be manufactured under strict aseptic conditions because of the unique environment of the eye. Meanwhile, we are continuing with our innovative, agile and reliable manufacturing of respiratory drugs for various diseases, including Ohtuvayre®, a first-in-class, steroid-free maintenance treatment for COPD in adults, and generic Tobramycin, which treats infections of Pseudomonas aeruginosa, a common bacterial infection among cystic fibrosis patients. It’s a common misconception that targeted, specialized manufacturing addresses only rare diseases or small subsets of more common ones. As noted, presbyopia affects more than one hundred million Americans, and COPD affects 11 million in the United States alone. These are significant products that could potentially yield billions in revenues for their makers. And their manufacturing needs to be commercially viable. There’s no room for bloat. Processes must be efficient and intensified, with greater continuity. Precision-driven processes also plays a strong role, speeding up processing while reducing errors and the risk of contamination. It’s also necessary to optimize the production of starting ingredients, reliably sourcing every part of the supply chain, and using these ingredients and processes in the most cost-effective (yet safe and dependable) way possible. CDMOs can achieve viability in several ways, using their agility to create a process that works for the manufacturer, drug sponsor, providers and patients. Firms have looked at making manufacturing more product-agnostic so that processes can be used over a wider range of products. They have also looked at repurposing certain materials to manage costs. Still others, including Ritedose, have invested in digital innovations and advanced technologies, including artificial intelligence/large language models, to increase efficiency. One important fact that the move away from mass-market drug development has revealed is that historically, the drug-manufacturing industry is not very standardized. Suppliers have been used to working in silos, and manufacturers have services, technologies and products from a wide range of vendors. There is now clearly a need to make product transfers seamless, by integrating equipment, data and software. The future of pharmaceutical manufacturing will need to be flexible, adaptable, efficient and above all have quality built into every step. Building relationships and trust is key to how we operate at Ritedose. We have a 25-year history of reliable, safe and on-time manufacturing with our customers. To achieve this level of trust, it’s important to make sure a CDMO’s strengths sync with what you need for your current stages of drug development. Here, we work with our drug-manufacturing customers to ensure we make the right mix together. Specialized CDMOs combine precision, agility and scale to meet the evolving needs of complex pharmaceutical manufacturing. This is production on purpose.