Our Dimethyl Fumarate Enteric Capsules (Dimethyl Fumarate for short) was approved on August 1, 2023, with the trade name of Bactrim®, Bactrim® is the first generic drug of Dimethyl Fumarate in China, and the listing of Bactrim® realizes the localization of DMT therapeutic field, and it also confirms once again that Sichuan Hongming Bosi has always been practicing the corporate responsibility of making good medicines, solving the people's problems, and benefiting the society.

Multiple sclerosis is the leading cause of non-traumatic disability in young people.

     Multiple sclerosis is a rare disease with a low incidence in China, with about 40,000 people suffering from the disease, mainly in the 20-40 year old population.1,2 The disease is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system, with an irreversible progression of the disease, leading to disability and even death. It has been reported that 54.2% of patients are unemployed due to multiple sclerosis, 43.91% of patients are unable to take care of themselves due to the disease, and more than half of them are disabled, with physical disability accounting for more than 86% of all disabled persons, which is the main cause of non-traumatic disability among young people.1,3,4 Multiple sclerosis seriously affects the quality of life of patients and aggravates the socio-economic burden.

Dimethyl fumarate belongs to the first-line drugs for multiple sclerosis DMT treatment and significantly improves patients' quality of life

      Multiple sclerosis (MS) is a lifelong disease, and the treatment is divided into acute phase treatment and remission phase treatment, and its remission phase treatment takes controlling the disease progression as the main goal, and DMT treatment is recommended. Dimethyl fumarate is the first-line starting therapeutic agent for DMT recommended by multiple guidelines at home and abroad.5-10 It can effectively reduce the annual relapse rate, the number of MRI lesions, and disability progression in patients. Studies have confirmed that treatment with dimethyl fumarate resulted in 45% of patients having no disease recurrence over a 10-year period, 77% of patients walking without disability (EDSS<3.5) after 10 years of treatment, and 81% of patients having no disease progression over a 10-year period.11 Dimethyl fumarate significantly improves the quality of life of patients. As of 2019, dimethyl fumarate is approved in 69 countries/territories and 415,000 patients have been treated in clinical trials or prescribed.

Bactrim® Overcomes Technical Difficulties to Be a Good Drug for Chinese People

     Prior to 2018, there was a serious lack of MS therapeutic drugs in China, and MS patients were faced with the situation of having no drugs available during the remission period of the disease, and could only allow the disease to aggravate step by step, and ultimately progress to become disabled or even die. In order to solve the urgent clinical needs of domestic MS patients, our company set up a project to develop this variety in 2015; and in 2019, we were successfully awarded the "13th Five-Year" National Science and Technology Major Special Project of Major New Drug Creation and Manufacturing Project. After 8 years of precipitation, we are pleased to be the first domestic generic of dimethyl fumarate, realizing the localization of DMT treatment and improving the accessibility of clinical drugs for rare diseases in the field of neurology.

    In line with the corporate responsibility of making good drugs, solving people's problems and benefiting the society, Bactrim® has high quality standards and has completed bioequivalence experiments. The production process of Bactrim® is strict, using imported excipients, applying a number of patented processes, establishing higher standards of internal control and making some of the major impurities lower, and adopting the world's top enteric microchip capsule filling instruments to make the drug content more stable, which effectively reduces the blood concentration of the drug in the patients taking different capsules at different times. The use of the world's top enteric microtitle capsule filling instrument makes the drug content more stable, effectively reducing the fluctuation of blood concentration of patients at different times of taking different capsules, guaranteeing the stability of the product's therapeutic efficacy, and the safety of a more controlled. Chinese people can also choose their own production of drugs.

References:

[1] China Multiple Sclerosis Patient Health Insight Blue Book and 2021Edition of China Multiple Sclerosis Patient Survival Quality Report

[2] Tian DC, et al. Lancet Reg Heazlth West Pac. 2020 Aug 6;1:100010

[3] Ren Changhong, et al. Chinese Journal of Practical Pediatrics, 2013, 28(12): 942-946.

[4] Berkovich R, et al. J Med Econ. 2021 Jan-Dec;24(1):46-53.

[5]Torkldse⊘, et al. Eur JNeurol 2016 Jan;23 Suppl 1(Suppl 1)-18-27.

[6]Comi G et al. Lacet. 2017Apr 1;389(10076)1347-1356;

[7]2019 UK NHS TreatmentAlgorithm for Multiple Sclerosis Disease-Modifying Therapies.

[8]Yamout B,et al Mult SclerRelat Disord,2020 Jan;37:101459;.

[9] Chen Juan J, et al. Chinese Neuroimmunology and Neurology Miscellaneous.2020;27(3):222-230;

[10]Freedman MS.et al.Can J Neurol Sci.2020,47:437-455；

[11]Ralf Gold,et al. Mult Scler.2022 Apr;28(5):801-816.230;