On March 5, 2025, Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary Viora Ltd. (hereinafter referred to as "Viora") received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA), and its application for registration of the Class III medical device optical radiofrequency therapy device V30 was accepted.

It is reported that Viora, an energy source medical beauty device company, was acquired 100% of its equity by Sinclair, a wholly-owned subsidiary of Huadong Medicine in the UK, in February 2022. This time, the acceptance of Sinclair's Xinkeli Aesthetics all-round skin medical beauty product V30 registration application is another major progress in the field of medical beauty energy source equipment. Huadong Medicine continues to expand its minimally invasive + non-invasive medical beauty map, realizes the layout of the entire industry chain on a global scale, continuously enhances its comprehensive strength in the medical beauty sector, and gradually advances to the strongest king of domestic medical beauty.

All-round medical beauty equipment will usher in benchmark products to fill the gap in the high-end compliance market

The announcement shows that V30 is a medical beauty multifunctional operation platform developed by Viora, a wholly-owned subsidiary of Sinclair, which integrates radio frequency (RF), intense pulsed light (IPL), and Nd:YAG laser energy source. It has CORE™ bipolar radio frequency and PCR™ intense pulsed light proprietary technologies, and can be equipped with V-IPL intense pulsed light handle, V-ST radio frequency handle, and V-Nd:YAG laser operation handle. It can flexibly match exclusive treatment plans according to different populations and different skin problems, and provide comprehensive solutions for the face and body. It is intended to be used for skin tightening, hair removal, vascular and pigmented lesions, acne, etc. The V series products are highly compatible and can be adapted to new technologies developed by Viora in the future. At present, V30 has obtained US FDA and EU CE registration certification.

According to the data, the energy source medical beauty device treatment course has the advantages of short recovery time, low single price, and high user frequency. It can be used as an auxiliary treatment for daily skin care and is currently receiving great attention in various treatments. In recent years, the market for medical beauty energy source devices has grown rapidly. According to Medical Insight data, the scale of China's medical beauty optoelectronics market has reached 35.674 billion yuan in 2022. According to the calculation of Huayi Research Institute, the total market size of China's medical beauty optoelectronics industry in 2023 is about 13.503 billion yuan, of which the scale of equipment is 10.929 billion yuan and the scale of consumables is 2.414 billion yuan. It is estimated that the market size will

reach 19.289 billion yuan in 2028. It is worth mentioning that the willingness of high-spending people to use medical beauty has increased significantly, and young users have become a new force in the high-end market. The "2024 Insight Report on China's Medical Beauty Industry" by Deloitte and Allergan stated that among the surveyed population in 2023, high-end people with annual medical beauty consumption of more than 50,000 yuan accounted for 26%, and the willingness to consume medical beauty has increased significantly compared with 10.30% in 2022. Young users already have the habit of medical beauty consumption. The 2023 Deloitte Allergan survey showed that among the high-end medical beauty population with an annual consumption of more than 50,000 yuan, customers under 30 years old accounted for 44%. In contrast, China's high-end optoelectronic equipment manufacturers are still in the development stage, and the mid-to-high-end market is still occupied by leading overseas companies. The domestic medical beauty market urgently needs more diversified and higher-quality high-end compliant medical beauty energy source equipment products.

Sinclair, a wholly-owned subsidiary of Huadong Medicine, has continued to deepen its EBD business and has achieved a full layout of energy source medical beauty equipment products, basically achieved mainstream technology coverage of energy source equipment, and provided high-quality, cost-effective non-invasive and minimally invasive solutions. The product application range covers anti-aging, body and facial shaping and other fields. At the same time, Huadong Medicine is constantly accelerating the pace of high-end and high-quality energy source products landing in China. At present, it has three energy source equipment products that have been launched in China, including the frozen whitening product Cool Snow, the radio frequency anti-aging product Rui Ai'an, and the intense pulsed light radio frequency therapy device V20 (trade name: Rui Yan'an®). The acceptance of the V30 Class III medical device registration application is expected to further enrich Huadong Medicine's domestic medical beauty product matrix, so as to continue to provide excellent experience and services for beauty seekers in all aspects.

Accelerate the internationalization of products and continue to expand the high-end medical beauty market

Medical beauty is one of Huadong Medicine's core areas. At present, the company has created a comprehensive and differentiated product matrix through forward-looking layout, and the number of products and coverage areas are at the forefront of the industry: it has 40 high-end products in the field of "non-invasive + minimally invasive" medical beauty, of which more than 20 products have been launched at home and abroad, and more than 10 global innovative products are under development. The product portfolio covers non-surgical mainstream medical beauty fields such as facial filling, facial cleaning, thread embedding, skin management, body shaping, hair removal, and private repair. It has formed a comprehensive product cluster, and the number of products and coverage areas are at the forefront of the industry, and its international influence continues to increase. In addition, the company's medical beauty business has a professional marketing team of nearly 300 people, and has built a global medical beauty marketing network. At present, product sales have covered more than 80 countries and regions in the world.

Among non-surgical medical beauty injection products and energy source devices, Huadong Medicine has achieved full coverage of the high-end market, and has global rights and interests in many patented products in the fields of facial and body filling, facial cleaning, body shaping, thread embedding, energy source devices, etc., and has an international medical beauty operation and BD team. In the field of medical aesthetic injections, Huadong Medicine already has a number of important products, including Ellansé®, MaiLi series hyaluronic acid, Lanluma® regenerative injection, botulinum toxin product YY001, etc. In this field, Huadong Medicine has achieved full coverage of the three major categories of regenerative, hyaluronic acid, and botulinum toxin. Each category has formed more than two differentiated product pipelines, building a comprehensive multi-dimensional aesthetic product system, and providing more professional, safe, efficient and comprehensive solutions for the majority of beauty seekers.

In recent years, Huadong Medicine has been continuously accelerating the pace of global high-end medical aesthetic products landing in China. In January 2025, another blockbuster medical beauty product of the company - MaiLi Extreme, a cross-linked sodium hyaluronate gel for injection containing lidocaine (trade name: MaiLi® Shuoying®) was approved for marketing by NMPA. In addition, the marketing authorization applications for injectable recombinant botulinum toxin type A YY001 and polycaprolactone microsphere facial filler Ellansé® M were accepted by NMPA in December 2024 and January 2025, respectively.

At the same time, the clinical progress of Huadong Medicine's multiple medical beauty injectable products is constantly advancing. MaiLi Precise completed the follow-up of the primary endpoint of the clinical trial in September 2024, and is currently conducting a safety follow-up; the clinical trial of the poly-L-lactic acid collagen stimulator Lanluma® V completed the enrollment of all subjects in November 2024, and is currently conducting a safety follow-up; the clinical trial of the injectable polycaprolactone microsphere facial filler Ellansé® Yi Yanshi® S type with the newly added indication of forehead filling and improving forehead contour completed the enrollment of all subjects in November 2024, and is currently conducting a safety follow-up; the dermal injection filler KIO021 obtained the ethics approval of the group leader in December 2024, and all pre-trial work is progressing in an orderly manner.

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