China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that its subsidiary, Dermavon Holdings Limited (“Dermavon”, an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement of the Group on 22 April 2025 for details) together with its subsidiaries holding the co-development rights (except for atopic dermatitis (AD)) and the exclusive commercialization rights of Class 1 innovative drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection (“MG-K10” or the “Product”) received the drug clinical trial approval notice issued by National Medical Products Administration (“NMPA”) on 28 September 2025. The NMPA has agreed to conduct a Phase III clinical trial of MG-K10 for chronic spontaneous urticaria (CSU).
About MG-K10
MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling of key type 2 inflammatory cytokines IL-4 and IL-13, for the treatment of type 2 inflammatory diseases. Currently marketed anti-IL-4Rα drugs require biweekly dosing, while MG-K10 has a longer half-life, enabling a four-week dosing frequency. It is expected to become the world’s first long-acting anti-IL-4Rα monoclonal antibody to be launched on the market, and has the potential to become the Best-in-Class (BIC).
The group and Hunan Mabgeek Biotechnology Co., Ltd. (“Mabgeek Biotechnology”) are actively preparing to initiate the relevant clinical trials. MG-K10 has also achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study in adults with moderate-to-severe AD, meeting the primary research endpoint as designed. Asthma, prurigo nodularis, and seasonal allergic rhinitis have all entered the Phase III clinical trial stage in China. In the previously completed Phase II clinical trial for adult patients with moderate-to-severe asthma, MG-K10 also demonstrated good efficacy and safety[1]. MG-K10 has also obtained IND approval for eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps in China.
About Chronic Spontaneous Urticaria（CSU）
CSU is a common chronic inflammatory skin disease characterized by recurrent episodes of urticaria (wheals) and/or angioedema (swelling) lasting 6 weeks or longer, without identifiable external triggers. According to a report by China Insights Consultancy, the number of CSU patients in China reached approximately 10.2 million in 2023[2]. The characteristics of CSU can significantly impact patients’ quality of life, and its treatment remains challenging due to its unknown etiology. Antihistamines are the standard treatment for CSU. However, many patients still experience ineffective disease control despite antihistamines, and alternative treatment options are limited. Anti-IL-4Rα monoclonal antibodies have demonstrated efficacy in the treatment of CSU and a favorable overall safety profile[3], offering a new treatment option, particularly for patients who have had an inadequate response to or intolerance to traditional treatments. However, as of now, there are no IL-4Rα monoclonal antibodies have been approved for the treatment of CSU in China.
MG-K10 has the potential to become Best-in-Class. The addition of new indication for CSU will further enhance the product’s competitiveness. With a long-acting formulation administered once every four weeks, it will provide CSU patients with a new effective and safe treatment option. If approved for marketing, MG-K10 will further enrich the Group’s product portfolio, offer differentiated medication choices for patients in China, meet the clinical demand for drugs with good efficacy, safety and patient compliance, and ultimately benefit patients. In the field of dermatological treatment, the Product will synergy with Dermavon’s commercialized innovative drug ILUMETRI (tildrakizumab injection), exclusive drug Hirudoid (mucopolysaccharide polysulfate cream) and a series of innovative drugs under development and dermatological skincare products in terms of expert networks and market resources.
On 24 January 2025, the Group through its subsidiaries entered into a Collaboration Agreement with Mabgeek Biotechnology for MG-K10. In accordance with the agreement and supplementary agreements, the Group has obtained the co-development right as stipulated in the agreement and exclusive commercialization right to the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore; its subsidiary Dermavon has obtained, through its subsidiary, the co-development rights (excluding AD) and exclusive commercialization rights for the Product in the field of dermatological indications in Mainland China.
Reference:
- The data of the product’s Phase II clinical trial for asthmaindication as disclosed by Mabgeek: https://www.mabge.com/index.php?c=show&id=18
- China Insights Consultancy. Industry report on global and China Dermatology Treatment and Care Industry
- Guidelines for the diagnosis and treatment of refractory chronic spontaneous urticaria in China (2025 edition) [J]. Chinese Journal of Dermatology, 2025, 58(6): 485-496.doi:10.35541/cjd.20240674
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.