Pharmosa Biopharm's Inhaled Drug L606 Wins China Approval to Launch Global Phase 3
核心洞察
Pharmosa Biopharm (搜索) said partner Liquidia (搜索) received NMPA approval to activate China clinical trial sites for the global Phase 3 Re-Spire trial of inhaled L606.
Liquidia (搜索) funds and runs the global Re-Spire trial, while Pharmosa manufactures and sells clinical drug supply under their licensing agreement.
China market rights for L606 remain with Pharmosa and are not yet out-licensed, with no approved PH-ILD therapy currently available in China.
Pharmosa Biopharm (搜索) announced that its long-acting inhaled drug L606 has received notification from partner Liquidia (搜索) that China's National Medical Products Administration (搜索) has approved activation of clinical trial sites in China. Those sites will join the global Phase 3 pivotal Re-Spire trial in pulmonary hypertension associated with interstitial lung disease (搜索) (PH-ILD), bringing China into the program's global development network.
Under the licensing and collaboration agreement between the two companies, Liquidia (搜索) is responsible for the costs and execution of the global Re-Spire trial, while Pharmosa manufactures the clinical trial drug supply and sells it to Liquidia. Pharmosa said the added sites should expand patient enrollment and shorten the overall development timeline. Commercialization rights for L606 in China remain with Pharmosa and have not been out-licensed.
Pharmosa noted that China has no approved drug specifically indicated for PH-ILD, leaving demand unmet. L606 is a long-acting inhaled prostacyclin analog (搜索) designed for a more convenient dosing regimen. Beyond PH-ILD and pulmonary arterial hypertension (搜索), the company said the approved submission data can support expansion into additional indications including idiopathic pulmonary fibrosis (搜索).
Source: Pharmosa Biopharm's Inhaled Drug L606 Wins China Approval to Launch Global Phase 3