Medical Device Registration Certificate Obtained for Ten Products Including Recombinant Type III Collagen Gel Dressing

Strong R&D Capability and Fast Registration Capability Further Implement the Self-developed Pipelines

Medical device registration certificate has been issued by the National Medical Products Administration (the “NMPA”) of the People’s Republic of China (the “China”) in relation to ten products, including three skin repair products (the recombinant type III collagen gel dressing, skin repair dressing and medical skin repair dressing sheet), four medical skin care dressing patch products ( medical skin care dressing, medical skin care dressing patch, medical repair wet dressing and medical repair wet dressing patch) and three medical scar repair products (the medical scar repair solution, medical scar repair sheet and medical silicone scar gel) .

The approved skin repair products and medical scar repair products from MeiYan KongJian mainly focus on the two pain points of wound healing and scar repair after medical aesthetics treatment. It not only accelerates the repair and regeneration of damaged tissues and effectively prevents the forming of scar, but also repairs and lightens new skin scars for better post-treatment results. The approved products are Class II medical devices, have good synergy with many medical aesthetics products of the Group, and are able to form an effective and complementary product portfolio after they are launched during the year.

The three approved skin repair products are all containing type III collagen. The main component of the product, collagen, not only protects the skin, promotes skin tissue anabolism and cell regeneration, maintains the moisture of the stratum corneum and the integrity of the fibrous structure, improves the living environment of skin cells, accelerates blood circulation and metabolism of local skin tissue, accelerates tissue regeneration and repair, and directly improves the barrier function of the skin. In addition to forming moisture on the skin surface and repairing the skin barrier, these three types of products also help improve the symptoms of dermatitis, eczema, dry flaking and redness caused by sensitive skin. In addition, recombinant type III collagen gel dressing can also be used for post-laser repair and post-surgical wound repair, etc. It not only accelerates the repair and regeneration of damaged tissues and effectively prevents the forming of scar, but also repairs and lightens new skin scars for better post-treatment results.

According to Frost & Sullivan data, the market size of China’s medical skin repair dressings grew from approximately RMB230 million in 2016 to approximately RMB4.18 billion in 2020, at a compound annual growth rate (CAGR) of approximately 105.7%. It is expected that by 2025, the market size of medical skin repair dressing products will reach approximately RMB20.14 billion, with a CAGR of approximately 37% from 2020 to 2025. Among, market size of the mainstream products, patch-type skin repair dressing, is in rapid growth, with consumption reached 340 million pieces and sales reached more than RMB5 billion in 2019. The consumption is expected to reach 900 million pieces in 2024. In China’s patch-type medical skin repair dressing market, domestic brands or companies dominate the market, with close to 70% market share (measured by sales). Collagen, sodium hyaluronate and others each account for about one-third of the patch-type medical skin repair dressing market in China.

For the three medical scar repair products, medical scar repair solution and medical scar repair sheet can be used to assist in improving skin pathological scars and assisting in preventing the formation of skin pathological scars; medical silicone scar gel is used to assist in preventing and assisting in improving hyperplastic scars caused by burns, cuts, injuries and surgery.

According to the QY Research report, scar treatment modalities mainly used for local topical treatment include gels, creams and scar dressing, etc. The local topical scar treatment market in China is expected to be US$75.24 million in 2020 and will reach US$110 million by 2026.

Besides, the four approved Class II medical skin care dressing patch products follow the “wet healing theory” of post-medical aesthetics treatment wound repair, which can effectively help skin wounds to produce collagen fibers and epithelial cells rapidly in a moist and low-oxygen environment, while stimulating cytokine secretion, reducing pollution and accelerating wound healing. With its high safety, weak irritation, low allergy rate and ease of use, the application of medical skin care dressing products in the medical aesthetics industry has been widely welcomed by beauty seekers and professional doctors, becoming a common posttreatment skin care product after non-surgical medical aesthetics projects such as laser surgery, skin resurfacing through Alpha Hydroxy Acid, Thermage, HydraFacial, micro-needling and other treatments, in order to achieve hydration and repair, soothe the skin and other medical skin care efficacy. Besides, these products have a wide range of sales channels, not only for sales in beauty salons, supermarkets, stores, but also in pharmacies and hospitals.

Mr. Julia Miao, Deputy Chief Executive Officer of Sihuan Pharmaceutical Holding Group, said: “The approved ten products of the recombinant type III collagen gel dressing, etc., are another ten new self-developed products from MeiYan KongJian being approved after PLLA gel Karlian®, medical skin care/repair gel and medical scar repair products. The ten approved products have good synergy with many medical aesthetics products of the Group, and are able to form an effective and complementary product portfolio after it is launched during the year. The approval of several self-developed products not only reflects the strong R&D capability and the fast registration capability of MeiYan KongJian, but also marks the further implementation of the self-developed pipelines of the Group’s medical aesthetics products, and enriches and expands the product portfolio of MeiYan KongJian, the medical aesthetics platform of the Group.”

MeiYan KongJian
MeiYan KongJian is a medical aesthetics subsidiary of Sihuan Pharmaceutical, a large pharmaceutical and medical aesthetics group company in China. Focusing on the high-growth and low-penetration PRC medical aesthetics market experiencing explosive growth, MeiYan KongJian has successfully established a “one-stop” new medical aesthetics platform in China and is dedicated to building a leading company featuring full medical aesthetics product matrix in China by leveraging the rigour and innovation of pharmaceutical companies through globalized layout and localized production, comprehensive and professional medical aesthetics product matrix, strong product R&D and registration capabilities as well as diversified marketing channel ability.

Sihuan Pharmaceutical has a forward-looking layout in the medical aesthetics field, and enteredinto an exclusive distribution agreement in China with Hugel, Inc., a leading biomedical company in South Korea, in relation to botulinum toxin Letybo® and hyaluronic acid in 2014. Letybo® has been successfully approved for marketing in China as the first botulinum toxin product imported from South Korea in October 2020. After years of development, MeiYan KongJian has built a complete product matrix across medical aesthetics value chain with “self-development + BD” dual engine drivers. Taking the coverage of the whole life cycle of beauty enthusiasts as the starting point, its product layout covers a variety of high-quality medical aesthetics products, including the filling, shaping, supporting, supplementing, optoelectronic device, body sculpturing, skin care and others. MeiYan KongJian is equipped with strong in-house R&D and technology transformation capabilities, and its current R&D pipelines have more than ten self-developed class III medical aesthetics products and tens of class II medical aesthetics products. Besides, MeiYan KongJian has established the Meiyen Laboratory in Los Angeles, the United States, to conduct innovative technology introduction, independent research and development of new generation medical aesthetics products and biomaterial, and the technology transformation and manufacture in China. Leveraging the global resources of Sihuan Pharmaceutical, the parent company, MeiYan KongJian has strong product registration, manufacture and sales capabilities and is able to accelerate the launch of new products. At present, MeiYan KongJian has completed the construction of three domestic manufacture bases with a gross floor area of 16,000 square meters. It has currently planned for 9 production lines equipped with optimized quality management system and is able to implement effective risk management in the whole life cycle of products. Most members in the sales team of MeiYan KongJian come from multinational medical aesthetics and pharmaceutical enterprises with rich sales experience for medical aesthetics products. They work closely with tens of agents with the sales network covering more than 200 cities and 2,200 medical aesthetics institutions nationwide.