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Jul 01,2026
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524 Reminton® (Infliximab for Injection), introduced by Kexing Biopharm from Mabpharm, has recently received approval from the National Medical Products Administration (NMPA) for a new indication: the treatment of ulcerative colitis (UC) in children aged 6 years and older. This marks the seventh approved indication for Reminton® in China and represents an important milestone in expanding the product’s application in pediatric autoimmune diseases.
As the first approved infliximab biosimilar in China, Reminton®®has benefited numerous patients with autoimmune diseases since its launch, providing clinicians with a reliable and effective treatment option.
Ulcerative colitis is a chronic, relapsing inflammatory bowel disease. In children, UC not only causes symptoms such as diarrhea, rectal bleeding, and weight loss, but can also significantly impair nutrient absorption and physical development, potentially leading to delayed puberty, psychological disorders, and other long-term complications.
In recent years, the incidence of pediatric UC has shown an upward trend in China. Conventional therapies often face limitations, including slow onset of action, steroid dependency, and potential impacts on growth and development. For children with moderate-to-severe active UC, early initiation of biologic therapy has been recommended by both domestic and international clinical guidelines as an effective treatment strategy.
Currently, biologic treatment options for UC in children aged 6 years and older remain limited in China, and some available therapies do not adequately cover younger pediatric populations. The newly approved indication for Reminton® covers children and adolescents aged 6 to under 18 years, addressing an important unmet clinical need and providing a well-supported, evidence-based treatment option for pediatric gastroenterology.
Prior to this approval, Reminton® had already been approved for the treatment of:
Crohn’s Disease (CD) in adults and children (NLT 6 years old).
Fistula Crohn’s disease
Ulcerative Colitis (UC) in adults.
Rheumatoid arthritis(RA)
Ankylosing spondylitis (AS)
Plaque Psoriasis (Ps)
With the addition of the new indication for ulcerative colitis in children aged 6 years and older, Reminton® now possesses two independent pediatric indications, covering the two major forms of inflammatory bowel disease (IBD).
As an infliximab product included in China’s National Reimbursement Drug List (NRDL), Reminton® offers both strong cost-effectiveness and broad reimbursement accessibility. The expansion into pediatric UC is expected to reduce the economic burden on affected families and enable more patients to benefit from standardized biologic therapy.
In recent years, Kexing Biopharm has focused on therapeutic areas including autoimmune diseases and oncology, striving to provide patients of different age groups with safe, high-quality, and affordable treatment options.
Infliximab for Injection (Reminton®) is one of the company’s core products in the field of autoimmune disease treatment. While strengthening its position in the domestic market, Kexing Biopharm has also continued to advance the global expansion of Reminton®. The product has already received marketing approvals in more than ten countries, including Peru, Indonesia, Pakistan, and Bangladesh, with its international commercialization network continuing to expand.
Looking ahead, Kexing Biopharm will remain committed to addressing unmet clinical needs, advancing the development and market penetration of innovative therapies in China while accelerating efficient expansion into overseas markets, ultimately contributing to better health outcomes for patients worldwide.
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Jul 13,2023
