04 May 2021 | News
HCmed Signs a Global Development Agreement with Global Biotechnology Leader CSL Behring
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Taiwanese firm HCmed has announced the start of a strategic partnership with global biotherapeutics leader CSL Behring, based in US, to collaboratively develop CSL Behring's plasma derived immunoglobulin (Ig) 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.
Douglas Lee, SVP Plasma Product Development at CSL Behring said, "We look forward to working with HCmed to demonstrate the potential promise of nebulizing immunoglobulins for those patients who experience debilitating respiratory conditions."