On 23 April 2026, China Medical System Holdings Limited (CMS) announced that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for MG-K10 (Comekibart Injection) to treat moderate-to-severe seasonal allergic rhinitis (SAR) in adults inadequately controlled by intranasal corticosteroids. The filing covers Mainland China and represents a pivotal regulatory milestone for the Group’s pipeline of type 2 inflammation therapies.
MG-K10 is a Class 1 innovative, long-acting anti-IL-4Rα humanised monoclonal antibody designed to block IL-4 and IL-13 signalling pathways. With a longer half-life than existing anti-IL-4Rα agents, MG-K10 is administered once every four weeks—twice the current industry dosing interval—positioning it as a potential first-in-class, long-acting biologic in this category.
Efficacy data from a multicentre, randomised, double-blind Phase III trial in adult SAR patients met its primary endpoint, demonstrating statistically significant symptom improvement versus placebo alongside a favourable safety profile.
The commercial opportunity is sizeable: allergic rhinitis prevalence in China has risen to 17.6%, affecting about 250 million people, of whom approximately 52.2% suffer persistent moderate-to-severe disease. Current standards—intranasal corticosteroids and antihistamines—leave around 62% of this cohort inadequately controlled and can cause undesirable side effects, underscoring demand for new therapeutic options.
CMS holds co-development rights (excluding atopic dermatitis) and exclusive commercialisation rights for MG-K10 across Mainland China, Hong Kong, Macao, Taiwan and Singapore, obtained through a January 2025 collaboration with Hunan Mabgeek Biotech. Successful approval would allow CMS to deploy its academic promotion infrastructure and sales network, expanding its CMS Vision franchise from ophthalmology into otolaryngology and bolstering its presence in type 2 inflammatory diseases.
Shareholders and investors are advised to exercise caution when dealing in CMS securities pending further updates on the regulatory review process.