AffaMed Therapeutics to commercialize Galcanezumab for Migraine Prevention in Mainland China

17 January 2023 | Tuesday | News

Affamed to obtain sole commercialization rights upon regulatory approval in Mainland China to Galcanezumab, a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). Target to address unmet medical needs for millions of Chinese migraine patients.
Image Source : Public Domain

Image Source : Public Domain

AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to address critical unmet medical needs in neurological, psychiatric and ophthalmic disorders today announced that it has entered into an agreement with Eli Lilly and Company ("Eli Lilly") to obtain sole commercialization rights to import, market, promote, distribute and detail Galcanezumab once approved in Mainland China. A new drug application for Galcanezumab as a preventative treatment for episodic migraine in adults was submitted by Eli Lilly to China's National Medical Products Administration ("NMPA") in June 2022.

Migraine is a disabling, neurologic disease affecting almost one in every ten Chinese with an estimated 130 million prevalent cases, of which approximately two-thirds are women[1]. Despite its high prevalence, migraine remains under-recognized and under-treated in China. Building on its deep and long-standing scientific and commercial experience and insight in the Chinese migraine market, AffaMed views this collaboration with Eli Lilly as a critical opportunity to address the significant unmet need and to improve the quality of life for migraine patients in China.

"We are excited to reach this agreement with Eli Lilly to bring this innovative product to Chinese patients who are suffering from migraine with symptoms that dramatically impair their quality of life." Dr. Dayao Zhao, CEO of AffaMed commented: "This agreement further demonstrates AffaMed's aspiration to provide innovative treatments to Chinese patients and represents an important milestone in strengthening AffaMed's neurology pipeline."

In the Phase 3 PERSIST[2]Study, a randomized, double-blind, placebo-controlled pivotal trial designed to assess the efficacy and safety of Galcanezumab in patients with episodic migraine from ChinaIndia, and Russia, the least squares (LS) mean reduction from baseline in monthly MHDs over 3 months was significantly greater with Galcanezumab compared with placebo (-3.81 days vs. -1.99 days; p < 0.0001). Significantly greater mean proportions of patients with galcanezumab versus placebo had ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs (all p < 0.0001).

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