SHENZHEN, CHINA – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on  27 October 2025, the Group through its subsidiary CMS VISION INTERNATIONAL MANAGEMENT LIMITED entered into a Distribution Agreement (the “Agreement”) with Novartis Pharma Services AG (“Novartis”) for Ranibizumab Injection (“Lucentis^®”) and Brolucizumab Injection (“Beovu^®”). In accordance with the Agreement, the Group has obtained the exclusive right to import, distribute, sell and promote as specifically agreed upon in the Agreement in the People’s Republic of China (for the purpose of the Agreement, excluding the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan) ; Novartis will continue to be responsible for the production and supply of the products. The term of cooperation comes into effect on the effective date of the Agreement and remains valid for a period of five years.

Both collaborative products have been approved for marketing in China. Among them, Lucentis® is the first anti-vascular endothelial growth factor (VEGF) drug approved for ophthalmic use in China, and has accumulated mature clinical application experience, providing reliable support for numerous patients with ocular fundus diseases. Lucentis® has been approved for the treatment of multiple ocular neovascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), etc. Another product, Beovu^®, is a next-generation anti-VEGF drug approved in China in May 2025 for the treatment of DME. Leveraging its innovative advantages of ultra-small molecular weight (only 26 kDa) and high concentration, Beovu^® significantly improves retinal anatomical structure, helps more DME patients gain visual improvement, and alleviates treatment burden.

The Group’s ophthalmology business company, “CMS Vision”, focuses on deploying and developing innovative ophthalmic pharmaceuticals and medical devices with urgent clinical needs on a global scale, striving to become a “leading ophthalmology pharmaceutical company in China”. This collaboration will enhance the overall competitiveness of CMS Vision in the field of ophthalmology. CMS Vision already covers ophthalmic disease areas such as fundus diseases, asthenopia and glaucoma. With the addition of Lucentis^® and Beovu^®, the portfolio will generate strong synergies with the marketed exclusive drug Augentropfen Stulln Mono Eye Drops (Esculin and Digitalisglycosides Eye Drops) and the marketed exclusive medical device EyeOP1 Glaucoma Treatment Device in terms of customer base, expert resources, and channel networks. This will further strengthen CMS Vision’s academic brand competitiveness in ophthalmology, provide positive momentum for sustained collaboration and the development of clinically needed innovative ophthalmic products, and offer patients more diverse treatment options. At the same time, CMS Vision’s professional ophthalmology team will integrate marketing channels and academic resources to improve the overall team efficiency. The collaboration is expected to have a positive impact on the Group’s financial results.

More Information about LUCENTIS^® and Ocular Neovascular Diseases

Lucentis^® is a recombinant humanized monoclonal antibody Fab fragment targeting VEGF. It targets and inhibits human vascular endothelial growth factor A (VEGF-A), thereby suppressing vascular endothelial cell proliferation, neovascularization, and vascular leakage. As the first anti-VEGF drug approved for ophthalmic use in China^[3], Lucentis^® has been approved for the treatment of multiple ocular neovascular diseases since its launch in China in 2011, including nAMD, DME, macular edema following RVO, choroidal neovascularization (CNV), diabetic retinopathy (DR), and retinopathy of prematurity (ROP). In 2017, Lucentis^® was included in the National Reimbursement Drug List (NRDL) for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance. It has accumulated mature clinical application experience, providing reliable support for numerous patients with ocular fundus diseases.

Ocular neovascular diseases are a group of severe blinding ophthalmic conditions characterized by increased vascular permeability, vascular leakage, and loss of vascular integrity, mainly including nAMD, DR, DME, RVO, CNV, ROP, etc. Anti-VEGF drugs are recommended as first-line therapy for ocular neovascular diseases in multiple authoritative guidelines^{[3, 4]}. According to a Frost & Sullivan report, the number of patients with ocular neovascular diseases in China is projected to increase from 47.8 million in 2019 to 61.2 million in 2030. The Chinese ophthalmic anti-VEGF drug market is expected to grow from RMB 2.4 billion in 2019 to RMB 18.6 billion in 2030. As stated in Anti-VEGF Drugs for Fundus Neovascular Diseases, Lucentis^®—the first anti-VEGF drug approved for the treatment of ocular neovascular diseases in China—has demonstrated favorable safety and efficacy in multiple clinical trials. It has been widely used in the treatment of ocular neovascular diseases, and its launch represents a major advancement in clinical ophthalmic treatment^[5].

More Information about BEOVU^® and the DME Indication

Beovu^® is a novel VEGF-A-targeted humanized single-chain antibody fragment. It received approval from the National Medical Products Administration of China (NMPA) in May 2025 for the treatment of DME. As the current anti-VEGF drug with the smallest molecular weight (only 26 kDa), Beovu^® is administered once every 6 weeks during the loading phase of the DME treatment (compared to once every 4 weeks for other anti-VEGF drugs) and once every two to three months during the maintenance phase. In the global Phase 3 KESTREL and KITE Studies for treatment-naive DME patients, Beovu^® met all primary efficacy endpoints and the visual benefit persisted until Week 100. Additionally, patients in the Beovu^® 6mg group had less intraretinal fluid (IRF) and/or subretinal fluid (SRF). The median number of injections of Beovu^® in the first year (7 times) was lower than that of aflibercept (9 times), while its overall safety profile was comparable to the latter^[6]. Data from the Chinese real-world study (BEST Study) showed that for previously treated and inadequately controlled DME patients, BCVA improved by 6.1 letters from baseline 1 week after the first injection of Beovu^®, and by 10 letters after the third injection (Week 12). Beovu^® provides a more optimized treatment option for previously treated DME patients^[7].

DME is a retinal thickening caused by capillary leakage in the macular area, which is the result of the breakdown of the blood retinal barrier and mainly affects central vision.^[8]. According to a Frost & Sullivan report, there are approximately 7.89 million DME patients in China in 2025. However, even with the current standard anti-VEGF regimens, approximately 30%-50% of DME patients still exhibit suboptimal fluid control^[9-11]. A survey in the 2022 White Paper on the Current Status of Chronic Disease Management for Common Ocular Fundus Diseases in China showed that treatment adherence among Chinese patients is relatively poor, with over 30% of DME patients failing to complete the loading phase treatment. There is an urgent clinical need for more potent, longer-lasting, and more adherence-friendly treatment options to improve the diagnosis and treatment of DME patients. As a next-generation anti-VEGF drug, Beovu^® offers a potential solution to this challenge. Leveraging its innovative advantages of ultra-small molecular weight and high concentration, Beovu^® significantly improves retinal anatomical structure, helps more DME patients gain visual improvement, and alleviates treatment burden.

About NOVARTIS

Novartis is a globally renowned pharmaceutical company headquartered in Basel, Switzerland. The company focuses on four core therapeutic areas with urgent patient needs—Cardiovascular, Renal and Metabolic Disease, Oncology, Immunology, and Neuroscience—as well as five key technology platforms: Chemotherapy, Biotherapy, xRNA, Radioligand Therapy, and Gene and Cell Therapy.

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 in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development  of the Group. 

Reference:

1. Product-related information can be found on the Novartis website at:

https://www.novartis.com.cn/news/big-news-noxtex-welcomes-the-approval-o…

2. Lim, Jennifer I et al. “Diabetic Retinopathy Preferred Practice Pattern^®.” Ophthalmology vol. 132,4 (2025): P75-P162. doi:10.1016/j.ophtha.2024.12.020
3. Chinese Vitreo-Retina Society of Chinese Medical Association, Fundus Disease Group of Chinese Ophthalmologist Association. Evidence-based guidelines for diagnosis and treatment of age-related macular degeneration in China(2023)[J]. Chinese Journal of Ophthalmology,2023,59(5):347-366. 
4. Xu Xun, Wang Jianying. Changes in Disease Spectrum Drive the Evolution of Clinical Medications [N]. Health News, 2023-07-05(005).
5. Hou Huimin, et al. Anti-VEGF drugs for fundus neovascular diseases[J].International Review of Ophthalmology,2024,48(6):464-470.
6. Wykoff CC, Garweg JG, Regillo C, et al. KESTREL and KITE Phase 3 Studies: 100-Week Results With Brolucizumab in Patients With Diabetic Macular Edema. Am J Ophthalmol. 2024;260:70-83.
7. Honghua Yu, 2025 China Forum on Fundus Diseases & International Retina Symposium, June 4-7, Wuxi, China.
8. Chinese Vitreo-Retina Society of Chinese Medical Association, Fundus Disease Group of Chinese Ophthalmologist Association. Evidence-based guidelines for diagnosis and treatment of diabetic retinopathy in China (2022)[J]. Chinese Journal of Ocular Fundus Diseases,2023,39(2):99-124.
9. Dai Hong, et al. Advances in the treatment strategies of diabetic macular edema and the problems[J]. Chinese Journal of Ocular Fundus Diseases,2022, 38(1): 6-9.
10. Bressler, Neil M et al. “Persistent Macular Thickening Following Intravitreous Aflibercept, Bevacizumab, or Ranibizumab for Central-Involved Diabetic Macular Edema With Vision Impairment: A Secondary Analysis of a Randomized Clinical Trial.” JAMA ophthalmology vol. 136,3 (2018): 257-269.
11. Chatziralli, I et al. “Identification of time point to best define ‘sub-optimal response’ following intravitreal ranibizumab therapy for diabetic macular edema based on real-life data.” Eye (London, England) vol. 31,11 (2017): 1594-1599.

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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