Qilu Pharmaceutical's Dimethyl Fumarate Enteric-Coated Capsules (Shenfuning®) Approved for Multiple Sclerosis Treatment in China and Europe

Multiple Sclerosis(MS) is an immune-mediated chronic inflammatory disease of the central nervous system.DemyelinationSexual diseases, patients will gradually become disabled or even die.Multiple sclerosis is a rare disease, with about 40,000 people currently affected in China, primarily young adults aged 20-40.As multiple sclerosis progresses, it can severely impact the patient's quality of life and impose a heavy financial burden on the patient's family.

Dimethyl FumarateIndicated for the treatment of adult patients with relapsing multiple sclerosis, including clinically isolated syndrome, relapsing-remitting, and active secondary progressive forms. This product is a first-line initial treatment drug recommended by multiple guidelines both in China and internationally, effectively reducing the annual relapse rate, lesion count, and slowing disability progression caused by the disease. Studies show that treatment with dimethyl fumarate can result in 45% of patients experiencing no disease relapse over 10 years, 77% of patients remaining able to walk without assistance (EDSS <3.5) after 10 years of treatment, and 81% of patients showing no disease progression over 10 years.^[1]Clinical study results show that dimethyl fumarate has good efficacy, safety and compliance, and can effectively improve the quality of life of patients.

In 2020, Qilu Pharmaceutical initiated the development of this product and innovatively adopted a product development format involving enteric-coated capsules containing microtablets. As a new type of multi-unit dosage form, microtablets offer advantages such as easy swallowing, accurate dosing, and flexible dose adjustments. The research team established strict internal control standards, conducting systematic research and quality comparisons between their self-produced product and the reference formulation. They simultaneously carried out bioequivalence studies, the results of which demonstrated that the product’s quality and efficacy met the market requirements in China and the EU. This ultimately led to the synchronized approval and market launch of dimethyl fumarate enteric-coated capsules in China and the EU, improving the availability of clinical medications for rare neurological diseases.

Qilu Pharmaceutical will continue to uphold the core values of "Great Medicine, Sincerity and Dedication, Family and Country, All Under Heaven," focusing on unmet medication needs, bringing more high-quality Qilu medicines to patients, and contributing to the building of a Healthy China.

References:

[1] Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association, Fu-Dong Shi,Huang Dehuiet al. Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis (2023 Edition)[Z]. Chinese Journal of Neurology, 2024, 57(1):10-23.