At the shareholders’ meeting on the 27th, Pharmosa Biopharm Chairman Chien-Chih Wang stated that drug-device combination has become a prevailing trend. The company’s two flagship products, L606 and L608, are undergoing accelerated clinical development, with efforts underway to evaluate the potential of new indications. In 2025, Pharmosa plans to deepen its global licensing efforts and advance both clinical development and production capacity, driving growth through the dual engines of operations and corporate value.
General Manager Pei Kan noted that the inhaled drug L608 is scheduled for formal submission to the U.S. FDA in the second half of this year for a Phase II clinical trial targeting Raynaud’s phenomenon and digital ulcers associated with systemic sclerosis (SSc-RP/DU). Patient enrollment for the trial will be launched simultaneously. The product has completed a Phase I human trial in Australia, confirming its sustained-release absorption profile. It has also received orphan drug designation from both the U.S. FDA and the European Medicines Agency (EMA), highlighting its clinical potential and addressing global unmet medical needs. These recognitions are expected to significantly accelerate the pace and flexibility of subsequent clinical development and licensing negotiations.
In addition to ongoing global development for the SSc-RP/DU indication, L608 is also being actively evaluated for potential licensing partnerships outside North America for the treatment of pulmonary arterial hypertension (PAH), a move aimed at expanding its commercial value and international footprint. The proprietary breath-actuated nebulizer designed specifically for L608 has completed optimization and is ready for mass production. The next-generation design emphasizes user convenience for at-home administration, providing strong clinical support for the combination product. A second Phase I clinical trial is already underway in New Zealand and is expected to complete enrollment this year. The results will serve as a critical reference for expanding indications and shaping future clinical strategies.
L606 continues to demonstrate strong global licensing momentum, with partnerships already established in North America, Europe, Japan, the Middle East, North Africa, and Turkey, steadily completing its global market presence. Partner company Liquidia is advancing L606 in a Phase III clinical trial in North America for PAH, and is also initiating a global Phase III trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Kan emphasized that Pharmosa has completed both the development and production readiness of its breath-actuated nebulizer, strengthening the market competitiveness and technological leadership of its drug-device combinations. As clinical trials progress, the company will gradually recognize milestone payments in accordance with licensing agreements. Combined with revenue from clinical drug use and the nebulizer device, this will inject new momentum into operational growth and cash flow.
In parallel, Pharmosa is actively building an aseptic filling facility to enhance the manufacturing capacity and quality stability of its clinical and commercial-stage products. This initiative will provide strong support for ongoing clinical trials and global market expansion.
Wang underscored that 2025 marks a critical turning point for Pharmosa’s product pipeline as it advances toward global clinical development. The company will continue to leverage its core strength as a drug-device integration platform, deepening global licensing and collaborations while pushing forward with clinical development and production planning, driving growth through the dual engines of operations and corporate value.
Resource: 國邑藥品搶藥械整合商機 董座：兩產品臨床加速
