The board (the “Board”) of directors (the “Directors”) of China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on 7 October 2022, the Group through a subsidiary of the Company – a dermatology medical aesthetic company (“CMS Skinhealth”) entered into a License, Collaboration and Distribution Agreement (the “License Agreement”) with BMI KOREA CO., LTD. (“BMI”), a South Korean company, for the type A botulinum toxin 100 units vacuum dried powder for solution for injection (the “BMI Botulinum Toxin Product” or the “Product”).
In accordance with the License Agreement, the Group through CMS Skinhealth gained an exclusive license to develop, register, import and commercialize the BMI Botulinum Toxin Product in Mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. The License Agreement will commence on its effective date and continue to be valid until the tenth anniversary of the first marketing authorization approval date of the Product in Mainland China. Upon the expiration of the aforementioned term, the License Agreement may automatically be renewed for every single period of five years thereafter unless otherwise agreed.
THE BMI BOTULINUM TOXIN PRODUCT
The BMI Botulinum Toxin Product is developed to temporarily improve moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults aged 19 to 65. The Phase III clinical trial conducted in South Korea demonstrated that the BMI Botulinum Toxin Product has comparable efficacy and safety to Botox®. The Biologics License Application (BLA) for the Marketing Approval of the Product has been submitted to the Ministry of Food and Drug Safety (MFDS) of South Korea in July 2022. Botulinum toxin is a safe and effective medical aesthetic material which is widely used in integrative anti-aging solutions. Type A botulinum toxin products are manufactured with mature technology and enjoy a good market acceptance.
The market of botulinum toxin products in China is promising. According to Frost & Sullivan statistics, the market size of botulinum toxin products in Mainland China reached approximately RMB3.9 billion in 2020 with a compound annual growth rate (CAGR) of 26.9% from 2016 to 2020. The market size of botulinum toxin products in Mainland China is expected to reach RMB11.4 billion and RMB29.6 billion in 2025 and 2030 respectively with a CAGR of 21.1% from year 2025 to 2030.
BMI
BMI, based in Jeju Island, South Korea, was founded in 2005. It engages in the development and production of pharmaceuticals, medical devices and medical aesthetic products. BMI started exporting its products to the United States, several European countries and Asian countries since 2007. Its Jeju plant and Osong plant have acquired GMP certification. For further information about BMI and its products, please visit its official website: https://bmikr.co.kr.
REASONS FOR AND BENEFITS OF ENTERING INTO THE LICENSE AGREEMENT
This collaboration consists with the Group’s strategy to continuously expand into the medical aesthetic field. The botulinum toxin product is a mainstream and core product in light medical aesthetic (non-surgery medical aesthetic) field and has become one of the most popular light medical aesthetics products among consumers in China. The introduction of the BMI Botulinum Toxin Product fills the blank of botulinum toxin product in the Group, compacts the Group’s business foundation in the light medical aesthetic field and makes the Group’s medical aesthetic product matrix more diversified. The BMI Botulinum Toxin Product will synergize with the Group’s other medical aesthetic products such as Vmonalisa hyaluronic acid, providing comprehensive solutions to satisfy the needs of youth and beauty of the Chinese customers who love and seek for beauty.
The market of the botulinum toxin products in Mainland China is still in the rapid growth stage with fast product introduction. Relying on the increasingly mature medical aesthetic sales and promotion system, the Group will build a continuous first-class competitiveness for the BMI Botulinum Toxin Product and achieve its selling and rapid growth in Mainland China.
The Group will continue to leverage global resources and introduce the advanced international medical aesthetic products into China, aiming to build CMS Skinhealth into a leading dermatology, medical aesthetic and health management company in China.