affirm get sole commercialization Rights Under Regulatory Approvals Mainland China to Galcanezumab, a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). It aims to address the unmet medical needs of millions of migraine sufferers in China.
Shanghai, January 17, 2023 /PRNewswire/ — AffaMed Therapeutics (“AffaMed”) today announced that it is a global clinical-stage biopharmaceutical company dedicated to addressing critical unmet medical needs in neurological, psychiatric and ocular diseases. and Eli Lilly and Company (“Eli Lilly”) intends to acquire the exclusive commercialization rights to import, market, promote, distribute and refine galcanezumab after approval in mainland China. increase. Lilly has submitted a new drug application for galcanezumab for the prophylaxis and treatment of episodic migraines in adults in the United States. Chinese National Medical Products Administration (“NMPA”) June 2022.
Migraine is a disabling neurological disease that affects nearly 1 in 10 Chinese and an estimated 130 million patients, approximately two-thirds of whom are women.Despite its high prevalence, migraine remains underrecognized and undertreated. ChinaBased on years of scientific and commercial experience and insights in the Chinese migraine market, AffaMed has established this partnership with Eli Lilly to address a critical unmet need and improve quality of life for migraine sufferers. view it as an important opportunity to improve. China.
“We are thrilled to have reached an agreement with Eli Lilly to bring this innovative product to Chinese patients suffering from migraine headaches, a condition that dramatically impairs their quality of life.” Zhao TaoyoAffaMed’s CEO commented:
In Phase 3 PERSISTA study, randomized, double-blind, placebo-controlled pivotal trial was designed to evaluate the efficacy and safety of galcanezumab in patients with episodic migraine from . China, IndiaWhen Russia, the least-squares (LS) mean reduction from baseline in monthly MHD over 3 months was significantly greater with galcanezumab compared with placebo (-3.81 days vs. -1.99 days; p < 0.0001). A significantly higher mean proportion of patients in the galcanezumab and placebo groups decreased MHD from baseline by ≥50%, ≥75% and 100% (all p < 0.0001).
Migraine is a severe, disabling neurological disorder characterized by recurrent episodes of moderate to severe headache accompanied by other symptoms such as nausea, sensitivity to light and sensitivity to sound., The prevalence in Chinese is 9.3%, while the prevalence in women is 12.8%, more than double the prevalence in men of 5.8%. It is reported to be the second most disabling disease affecting daily life of all diseases.
Galcanezumab is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). Developed by Eli Lilly and approved by the FDA. September 2018 Prophylactic treatment of migraine in adults, and June 2019 For the treatment of episodic cluster headaches in adults. Galcanezumab (under the brand name Emgality® usa) is an innovative therapeutic approach to this neurological disorder and is also the first and only drug approved by the US FDA to reduce the number of attacks for the treatment of episodic cluster headache. It is currently used by migraine sufferers in 20 countries around the world.
About AffaMed Therapeutics
AffaMed Therapeutics is a clinical-stage biopharmaceutical company with innovative pharmaceutical, digital and surgical products that address significant unmet medical needs in ophthalmic, neurological and psychiatric disorders in ophthalmic, neurological and psychiatric patients focused on the development and commercialization of Greater China and around the world. AffaMed Therapeutics’ management team has acquired deep industry expertise and extensive experience in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations with leading multinational biopharmaceutical companies. I’m here. China and globally.
The product mentioned is currently an investigational drug for the indicated indication and is not yet approved in mainland China. Affamed and Lilly do not endorse the use of unapproved medicines or indications.
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Hu et al. Phase 3, Randomized, Double-Blind, Placebo-Controlled PERSIST Study, The Journal of Headache and Pain. 2022
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Source AffaMed Therapeutics Ltd.