Companies Initiated Phase I trial in December 2020
TAIPEI, May 3, 2021 /PRNewswire/ -- HCmed today announces the start of a strategic partnership with global biotherapeutics leader CSL Behring to collaboratively develop CSL Behring's plasma derived immunoglobulin administered via HCmed's new generation vibrating-mesh nebulizing device (CSL787). Under the terms of the agreement, CSL Behring will have sole responsibility for the development and commercialization of the combination product, with HCmed leading the development of the customized nebulizing device specifically optimized for CSL Behring's formulation. HCmed will receive an upfront payment and device and development milestones. Upon the parties' execution of a subsequent agreement for commercial supply of the customized nebulizing device, HCmed will also receive royalties from global net sales of CSL Behring's formulation for use with the combination product.
The CSL787 Phase I clinical trial has commenced, with the first subject dosed in December 2020. This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of nebulized CSL787 after administration of single and multiple ascending doses in healthy subjects and subjects with non-cystic fibrosis bronchiectasis.
"We are excited to announce this collaboration with global biotherapeutics leader CSL Behring. It further validates our proprietary nebulizer platform AdheResp, which transforms the delivery of biologics from an intravenous (IV) to an inhalation route, thereby better reaching the respiratory tract. This breakthrough application is capable of delivering inhaled antibodies, peptides, and proteins. Our platform can be customized to enhance drug delivery for a range of formulations and adjusted to meet specific performance requirements. The vision is to provide a new highly-efficient treatment device for patients who suffer from chronic respiratory diseases and to improve their treatment adherence and quality of life," said Jason Cheng, the Chief Executive Officer of HCmed.
"CSL Behring is driven by its promise to help patients lead full lives by discovering, developing, delivering and partnering on innovations that address unmet needs in our areas of scientific expertise," said Douglas Lee, SVP Plasma Product Development at CSL Behring. "We look forward to working with HCmed to demonstrate the potential promise of nebulizing immunoglobulins for those patients who experience debilitating respiratory conditions."
Founded in 2014, HCmed Innovations Co., Ltd. focuses on the development of drug-device combination products based on its vibrating mesh nebulizer technology. The company is venture-backed with funding from Vivo Capital and other major investors from the US, Taiwan, and Japan. With the completion of the development of its first-generation nebulizers in less than 5 years, its medical devices have successfully received several regulatory approvals, such as European CE, Taiwan TFDA, Brazilian Anvisa, Indonesian Badan POM and China NMPA. HCmed's mesh nebulizers have been launched in Brazil and China. The vision is to bring significant value to global pharma partners through a cost efficient and risk minimized pathway, designing combination products that can provide great contributions in the respiratory field. For additional information about HCmed, please visit www.hcmed-inno.com.
SOURCE HCmed Innovations Co., Ltd.