AffaMed Therapeutics to Commercialize Galcanezumab Injection in Mainland China for Migraine Prevention

AffaMed Therapeutics Obtains Exclusive Commercialization Rights for Galcanezumab Injection in China to Meet the Significant Unmet Medical Needs in the Field of Migraine Prevention and Treatment. Galcanezumab Injection is a selective binding calcitonin gene-related peptide. (CGRP) Monoclonal antibody.

ShanghaiJanuary 17, 2023PR Newswire -- AffaMed Therapeutics, a clinical-stage innovative biopharmaceutical company dedicated to addressing unmet medical needs in the fields of neurology, psychiatry, and ophthalmology worldwide, today announced that it has reached an agreement with Eli Lilly and Company ("Lilly") to be responsible for the commercialization of galcanezumab injection in China -- a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). In June 2022, Lilly submitted a new drug application for galcanezumab injection to the National Medical Products Administration (NMPA) of China. This product will be indicated for the preventive treatment of episodic migraine in adults.

Migraine is a disabling neurological disease. In China, nearly one in ten people is affected, with a total patient population of approximately 130 million, about two-thirds of whom are women.^[1]. Nevertheless, awareness and treatment of migraine in the Chinese market still have room for improvement. Thanks to its leadership team's long-term experience in China’s migraine market, AffaMed Therapeutics has already built a core commercial team with deep scientific expertise and commercial insight. AffaMed Therapeutics believes that the collaboration with Eli Lilly will address unmet needs in migraine prevention and treatment in China, improving the quality of life for Chinese migraine patients.

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, said: "We are very pleased to have reached an agreement with Eli Lilly to bring the innovative drug galcanezumab injection to Chinese patients with migraine. The quality of life for these patients is often severely affected by the symptoms of migraine. This agreement with Eli Lilly further demonstrates AffaMed Therapeutics' commitment to bringing innovative treatment options to patients in China. It also represents an important milestone in strengthening the company's product portfolio in the field of neurology."

According to PERSIST^[2]A Study, a Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial, Aimed to Evaluate the Efficacy and Safety of Galcanezumab Injection in Patients with Episodic Migraine in China, India, and Russia: At the primary endpoint of monthly headache days, the average reduction in monthly migraine days over more than three months of treatment was significantly greater in the galcanezumab injection group compared to the placebo group (-3.81 days vs. -1.99 days; p-value < 0.0001). Additionally, compared to placebo, the average proportion of patients treated with galcanezumab injection who experienced a reduction of ≥50%, ≥75%, and 100% in monthly headache days from baseline was significantly higher (all p-values < 0.0001).

About Migraine

Migraine is a serious disabling neurological disease, characterized by recurrent moderate to severe headaches, accompanied by symptoms such as nausea, sensitivity to light, and sensitivity to sound.^[3,4]The prevalence of adult migraine in the Chinese population is as high as 9.3%, with a prevalence rate of 12.8% in women, more than twice the rate of 5.8% in men.^[1]According to reports, migraine is the second leading disabling disease, seriously affecting patients' daily life and activities.^[5]。

About Galcanezumab Injection

Galcanezumab Injection is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). Galcanezumab Injection was developed by Eli Lilly and Company and was approved by the U.S. FDA in September 2018 for the preventive treatment of migraine in adults. In June 2019, it was approved for the treatment of episodic cluster headaches in adults. As an innovative treatment for neurological disorders, Galcanezumab Injection is also the first and only drug approved by the U.S. FDA for episodic cluster headaches (U.S. market brand name: Emgality).^®), and has now been approved in 20 countries worldwide for the treatment of migraine. The New Drug Application (NDA) for galcanezumab injection was officially accepted by China's National Medical Products Administration (NMPA) in July 2022.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical-stage innovative pharmaceutical company dedicated to developing and commercializing transformative drugs, digital therapies, and medical device products to address unmet critical healthcare needs in the treatment of ophthalmic, neurological, and psychiatric disorders for patients in Greater China and globally. The management team at AffaMed Therapeutics possesses comprehensive expertise and industry experience, having held senior management positions in leading multinational biopharmaceutical companies in China and globally, successfully advancing and leading innovation in drug discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations.

Note:

The product described in the text is an investigational drug for the mentioned indications and has not been approved in mainland China. AffaMed Therapeutics and Eli Lilly and Company do not recommend any unapproved drugs./Indications for Use.

References

1.  Yu S, Liu R, Zhao G, et al . The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012, 52:582 ~ 591.

2.  Hu et al, Galcanezumab in episodic migraine the phase 3, randomized, double–blind placebo–controlled PERSIST study, The Journal of Headache and Pain. 2022

3.  Katsarava Z, Buse D, Manack A, et al. Defining the differences between episodic migraine and chronic migraine. Current Pain Headache Reports. 2012;16:86.

4.  Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL, and resource use amongst chronic and episodic migraineurs. Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301.

5.  GBD 2016 Headache Collaborators (2018) Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 17(11):954–76.