Pharmosa announced on the 18th that it has completed the development and testing of a new generation of advanced nebulizers, which can be mass-produced and used in clinical trials at any time. This marks another milestone after the L608 new drug, which adopted a novel mesh vibrating nebulizer, entered the clinical stage, demonstrating Pharmosa's gradual establishment of a unique nebulizer technology and product platform. In the future, this will expand the development of "drug-device combination" new drugs, ensuring the quality and stability of the supply chain.
According to Pharmosa, this new generation product is developed in collaboration with a medical device manufacturer with mesh nebulization technology. It is suitable for the inhalation administration of nano-liposomal drugs, featuring respiratory entrainment, ultra-low residual volume, and utilizing a mesh module that is unclogged, highly efficient in delivery, and does not compromise sustained-release effects. It incorporates various unique designs to achieve stable drug delivery doses and includes technological features such as Bluetooth connectivity and personalized smart learning. It will serve as the delivery device for its new inhaled drug formulations, providing patients with a more convenient treatment mode.
Considering the global commercialization needs of its new drugs and the flexibility of regulations on drug-device combinations, Pharmosa has collaborated with a partner with international medical device technology capabilities in the planning of clinical development programs for L606/L608. They have invested in the development of a new type of mesh vibrating nebulizer and introduced the first proprietary product specifically for Pharmosa into Phase I clinical trials of L608 in Australia. Now, with the completion of the development of a new generation of mesh vibrating nebulizers of different specifications, optimization of functionality and convenience, and preparation by the partners for mass production, they are ready to participate in clinical trials at any time.
Pharmosa pointed out that the drug-device combination new drug L606, currently undergoing Phase III clinical trials for type 1 pulmonary arterial hypertension (PAH) in the United States, uses the second-generation I-neb Advance nebulizer. Unlike the first-generation product I-neb, it is an inhalation nebulizer product that is easier to operate and has been further optimized, with smooth progress in the trials. With the completion of testing of its proprietary new type of mesh vibrating nebulizer platform, Pharmosa will in the future introduce this comprehensive "drug + device" combination product line into subsequent clinical trials in a timely manner to provide partners and patients with more options and ensure the quality and stability of the supply chain.
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