SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement with Hunan Mabgeek Biotechnology Co., Ltd. (“Mabgeek Biotechnology”) and its subsidiary for Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection MG-K10 (“MG-K10” or the “Product”). The Group has obtained the co-development right as specifically agreed upon 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 (the “Territory”); Mabgeek Biotechnology will support the commercialization activities and is responsible for the sale and supply of the Product. The collaboration term is perpetual.

IL-4Rα is considered a key target for the treatment of type 2 inflammatory diseases, such as atopic dermatitis (AD), asthma, prurigo nodularis, etc. Anti-IL-4Rα monoclonal antibodies are among the best-selling biologics in this field. 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. Following Fc mutation, MG-K10 allows long dosing interval owing to its prolonged half-life, and it is expected to be the first long-acting anti-IL-4Rα monoclonal antibody marketed in China. Currently marketed anti-IL-4Rα drugs require dosing every two weeks, whereas MG-K10 only requires dosing every four weeks, demonstrating good efficacy and safety. MG-K10 has the potential to be the Best-in-Class (BIC).

This collaboration marks another significant milestone for Dermavon (formerly known as CMS Skinhealth)’s layout in the dermatology field. MG-K10 will enrich the global differentiated innovative pipeline of Dermavon, and will strongly synergize with the existing product portfolio, such as marketed innovative drug ILUMETRI (tildrakizumab injection), marketed exclusive drug Hirudoid (mucopolysaccharide polysulfate cream) and dermatology-grade skincare products of Heling soothing product series (developed for AD patients), and innovative pipeline drugs ruxolitinib cream (for the topical treatment of mild to moderate AD and non–segmental vitiligo) and povorcitinib (for the treatment of non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis and chronic spontaneous urticaria), etc. Leveraging its proven clinical development and commercialization capabilities, the Group will fully cooperate with Mabgeek Biotechnology to promote the approval of MG-K10 in China, bringing a new treatment option with lower dosing frequency, good efficacy and safety to patients with type 2 inflammatory diseases in China.

More information about MG-K10

MG-K10 is a Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection that used for the treatment of type 2 inflammatory diseases, including AD, asthma, prurigo nodularis, allergic rhinitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, chronic obstructive pulmonary disease and so on. It holds substance patents in specific countries/regions within the Territory.

MG-K10 has entered Phase III clinical trials in China for AD, asthma, and prurigo nodularis. In the completed Phase II clinical trials for adult moderate-to-severe AD and moderate-to-severe asthma, MG-K10 has demonstrated good efficacy and safety^[1-2]. Additionally, MG-K10 has obtained IND approval for eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, and seasonal allergic rhinitis in China.

According to Frost & Sullivan, the global market for treatments targeting IL-4Rα is expected to reach US$28.7 billion by 2030, with a compound annual growth rate (CAGR) of 21.8% from 2020 to 2030. In China, the market is projected to reach US$4.08 billion by 2030, with a CAGR of 76.8% from 2020 to 2030.

About AD indication

MG-K10’s first indication, AD, is a chronic inflammatory skin condition characterized by severe itching. It is the most burdensome non-fatal skin disease globally, with at least 230 million people affected worldwide^[3]. AD is also a prevalent and high-burden chronic disease in China, with the prevalence showing an upward trend^[3]. According to the Global Burden of Disease Study 2019, the number of AD patients in China increased by 25.65% from 1990 to 2019^[3]. It is estimated that there are approximately 36.09 million AD patients in China^[3], with approximately 9.625 million suffering from moderate-to-severe AD^[4].

Current treatment options for AD primarily include topical and systemic treatments. For moderate-to-severe AD, topical medications are often insufficient to achieve disease control, necessitating the initiation of systemic treatments. However, due to the limitations in efficacy and safety of traditional systemic therapies for AD, moderate-to-severe AD patients often experience delays in systemic treatment initiation, poor compliance, and suboptimal disease control, leaving a significant unmet need in clinical practice^[3]. MG-K10, with its extended dosing interval of once every four weeks, is expected to improve patient adherence and provide a new, effective, and safe systemic treatment option for patients with moderate-to-severe AD.

About Mabgeek Biotechnology

Mabgeek Biotechnology was founded in 2016 and has always adhered to the research and development concept of “innovation, efficiency and safety”, focusing on the fields of allergic inflammatory diseases and autoimmune diseases. Mabgeek Biotechnology is equipped with a research and development team composed of top industry experts. With excellent research capabilities and deep industry experience, Mabgeek Biotechnology uses its unique TEADA high-throughput antibody screening platform to develop innovative antibody drugs with high biological activity, excellent druggability, and differentiation. Mabgeek Biotechnology is committed to providing safer, more effective and more convenient treatment solutions for patients worldwide. For more information about Mabgeek Biotechnology and its products, please visit: https://www.mabge.com/.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference:

1. The data of the product’s Phase II clinical trial for AD indication as disclosed by Mabgeek: https://www.mabge.com/en/index.php?c=show&id=23
2. The interim data of the product’s Phase II clinical trial for asthma indication as disclosed by Mabgeek: https://www.mabge.com/index.php?c=show&id=18
3. Chinese Society of Dermatology, China Dermatologist Association. Clinical pathway for the diagnosis and treatment of moderate to severe atopic dermatitis in China (2023): an expert consensus[J]. Chinese Journal of Dermatology, 2023, 56(11): 1000-1007. DOI: 10.35541/cjd.20230247.
4. Mao, Dandan et al. Prevalence and risk factors of atopic dermatitis in Chinese adults: a nationwide population-based cross-sectional study. Chinese medical journal vol. 136,5 604-606. 5 Mar. 2023, DOI:10.1097/CM9.0000000000002560

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.

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