SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 2 December 2024, the Group through a wholly-owned subsidiary of the Company entered into an Exclusive Commercialization Agreement (the “Agreement”) with Atom Therapeutics Co., Ltd (hereinafter referred to as “Atom Therapeutics”, formerly named as “Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.”) of class 1 innovative drug ABP-671 for the treatment of gout and hyperuricemia (the “Product”). In accordance with the Agreement, the Group is entitled to an exclusive commercialization right of the Product in Mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. The term of cooperation commences on the effective date of the Agreement and extends for ten years from the date the Product is first approved for market launch in Mainland China (the “Authorization Term”). Upon the expiration of the Authorization Term, it may be automatically renewed for an additional ten years, subject to specific conditions stipulated in the Agreement.

ABP-671 is a class 1 innovative chemotherapeutic drug for the treatment of gout and hyperuricemia, currently in Phase 2b/3 clinical trials for gout in China and overseas. The Product reduces renal re-absorption of uric acid by inhibiting Urate Anion Transporter 1 (URAT1). The results of two completed phase 2 clinical trials demonstrated favorable efficacy and safety profiles across multiple dose groups (ranging from 1 mg to 12 mg) of ABP-671. The 2 mg once-daily dosage of the Product was proved to be as effective as, or even better than, benzbromarone or febuxostat (maximum dosage of 80mg). The reduction in uric acid levels was sustained throughout the 24-hour period, with no significant safety concerns identified. This product is anticipated to offer more effective and safer treatment alternatives for patients suffering from gout and hyperuricemia^[1]. Multiple patents in regard to substance and use of the ABP-671 have been granted in China.

Hyperuricemia is defined as a fasting blood uric acid level exceeding 420μmol/L (7.0 mg/dL) in adults on a normal purine diet on two separate days. The deposition of urate crystals in hyperuricemia patient results in arthritis, medically termed gout. Hyperuricemia and gout can cause acute and chronic inflammatory injury in articular cartilage, bone, kidney and vascular wall, which can lead to multiple organ damage of the heart, brain and kidney, etc. The data presented in the White Paper on Hyperuric Acid and Gout Trends in China (2021) indicates that, the incidence rate of hyperuricemia is 13.3%, with approximately 177 million hyperuricemia patients and the incidence rate of gout is 1.1% in general, with about 14.66 million gout patients in China. Frost & Sullivan indicates that, the number of people with hyperuricemia and gout in China will continue to increase in the future, reaching 240 million and 52.2 million respectively by 2030. Currently, the commonly used uric acid-lowering drugs in clinical practice in China are those which inhibit uric acid synthesis or promote uric acid excretion. Due to certain limitations in the efficacy and safety of the marketed uric acid-lowering drugs, such as causing renal failure, sudden cardiac death or severe liver toxicity. There is still an urgent need for effective and safe uric acid-lowering drugs among gout and hyperuricemia patients in China.

ABP-671 is currently with the potential to be the promising and safe product for the treatment of gout and hyperuricemia. Through this collaboration, it fills the blank in the CMS’s product portfolio of the treatment of gout. Gout and hyperuricemia are both rheumatic diseases and chronic metabolic diseases, which are highly consistent with the Group’s strategic layout in the cardio-cerebrovascular/ gastroenterology business and the network resources of marketed products. If approved for marketing in the future, the Product will synergize with the Group’s marketed product Metoject (methotrexate injection) in rheumatology and with Elcitonin (elcatonin injection) in endocrinology and orthopedics, in terms of expert network and market resources. Based on the unmet clinical needs and the expected solid clinical data of the Product, the Group is looking forward to the smooth advancement of the clinical development of ABP-671, allowing patients with relevant indications to benefit from this innovative treatment sooner.

About ATOM THERAPEUTICS

Atom Therapeutics was founded in March 2012, focused on the research and development of innovative drugs with global commercial value and competitiveness in the metabolic and inflammatory area. Atom Therapeutics’s main core team members come from the United States, with extensive experience in the research and development of innovative drugs. Atom Therapeutics has achieved remarkable development in the past few years. Atom Therapeutics’s core product ABP-671 is under pivotal clinical stage for the treatment of chronic gout. Atom Therapeutics’s another small molecule innovative drug named as ABP-745, used for indications in the field of anti-inflammatory immune indications. The Phase 1 clinical of ABP-745 exhibited outstanding pharmacokinetics and safety. The clinical trial is on the verge of entering Phase 2. For more information about Atom Therapeutics and its pipeline, please visit https://www.atombp.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 results of Phase 2 clinical trials was published and can be found at: https://www.atombp.com/2023/03/01/atom-bioscience-announces-positive-results-of-phase-2a-china-clinical-trial-of-its-urat1-inhibitor-for-chronic-gout/

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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Source: China Medical System Holdings Ltd.