Haisco Biotech's Amino Acid Cross-linked Sodium Hyaluronate Gel Receives NMPA Approval for Market Launch

Source: Smart Medical Device, reproduction without authorization is prohibited.

Not long ago, according to an announcement by Haohai Biological Technology, its wholly-owned subsidiary, Shanghai Qisheng Biological Preparation Co., Ltd., recently received the "Medical Device Registration Certificate of the People's Republic of China" issued by the National Medical Products Administration for the product Sodium Hyaluronate Gel Injectable Cross-linked with Amino Acids.

It is reported that this product is suitable for injection into the middle to deep layers of the dermis and subcutaneous tissue, correcting moderate to severe nasolabial fold wrinkles.

The announcement states that this product is based on the company's self-developed, world-first organic cross-linking technology and is the only hyaluronic acid product in China that uses the natural product lysine as a cross-linking agent. This cross-linking agent is an essential amino acid for the human body, offering better long-term safety compared to traditional chemical cross-linking agents. Additionally, this product is the first in China to block the active site of hyaluronidase, providing a longer-lasting characteristic.

After implantation, this product can directly increase the volume of skin and soft tissue, stimulate local collagen proliferation, repair sunken deformities and promote growth on the face and body surface, reduce or eliminate static wrinkles, adjust the contour of certain facial features, and achieve minimally invasive cosmetic beauty effects for facial enhancement.

It is reported that the injectable cross-linked sodium hyaluronate gel, also known as hyaluronic acid filler, is a common filler that can be used for cosmetic surgery and skin damage repair. It belongs to Class III medical devices. The injectable cross-linked sodium hyaluronate gel product usually consists of a syringe and the filling material preloaded in the syringe, which is injected into the dermis or subcutaneous tissue to fill and increase tissue volume.

The company stated that in the field of medical aesthetics hyaluronic acid, it has independently developed and mastered cross-linking technologies such as monophasic cross-linking, low-temperature secondary cross-linking, linear particle-free cross-linking, and organic cross-linking. The approval this time marks that the company's fourth-generation hyaluronic acid product, which uses organic cross-linking technology, is qualified for sales in the Chinese market, further enriching the company’s portfolio of medical aesthetics hyaluronic acid products.

Haohai Biological Technology pointed out that the development of the hyaluronic acid industry needs to integrate marketing strategies and efficacy, rather than focusing solely on product prices and market share. The company aims to shift from single-product marketing to function-based marketing and comprehensive treatment for specific areas. In line with this, new regenerative materials have been introduced, including regenerative materials, botulinum toxin, and synthetic biology materials.

At the same time, during this process, energy devices play an important supplementary role. By combining the use of energy devices and biomaterials to improve skin texture, the company has launched a comprehensive solution for skin rejuvenation, implementing three-dimensional treatment and integrated treatment.

Currently, EndyMed, a wholly-owned subsidiary of the company's subsidiary Ouhua Meike, focuses on radiofrequency skin care devices; Raik Photoelectric, another subsidiary under Ouhua Meike, specializes in laser skin care devices. Together with the company’s full range of hyaluronic acid, epidermal growth factor, chitosan, and collagen products, they create a combined therapeutic effect for skin treatment.

In terms of talent team collaboration, the company acquired 100% equity of Ophthalmic Medical last year, integrating its advantageous resources to leverage the high synergy between Haohai Biological Technology and Ophthalmic Medical in technology research and development, product layout, as well as marketing.

According to Haohai Biological Technology during an institutional research reception, Haimagic Moon White uses essential amino acids as cross-linking agents, significantly different from traditional chemical cross-linkers, thus offering higher biosafety, especially long-term safety after implantation. The modification site of Haimagic Moon White is the carboxyl group on the molecule, which differs from the traditional hydroxyl modification site. Moreover, the carboxyl group is the recognition site for specific hyaluronidase in the body, thereby slowing down the enzyme recognition process and providing a longer-lasting effect.

▲Fourth-Generation Organic Cross-Linked Hyaluronic Acid Product

In addition, the introduction of amino acid cross-linking agents improves the current situation where traditional product systems are mostly electronegative, adding an appropriate amount of electropositivity, which is more conducive to cell adhesion and proliferation. Therefore, this product can promote the migration and proliferation of fibroblasts and keratinocytes, stimulate local collagen production, and exhibit stronger regenerative activity compared to traditional products.

In summary, this product achieves functional improvement and the organic unity of structure and function by introducing a natural cross-linking agent to enhance the microstructure of the gel system.

Haohai Biological Technology emphasized that the company will utilize the differentiated functions and price positioning of this product with the first three generations of hyaluronic acid products: "Haiwei," which focuses on "shaping"; "Jiaolan," which emphasizes "filling"; and "Haimei," which highlights "precise sculpting." The aim is to explore and build a new product portfolio model to meet the increasingly diversified demands of the medical aesthetics market. Through an extensive sales network, precise and flexible sales strategies, and a professional sales team, the company seeks to increase the overall market share of its hyaluronic acid product series and strengthen the leadership position of its domestically produced hyaluronic acid brand in China.

Regarding the company's R&D strategy, it stated that the overall strategic thinking for the company’s R&D is as follows: The first is "Me too," the second is "Me better," and the third is "Me only." This approach remains unchanged.

Haohai Biological Technology introduced that the company's medical beauty products are based on comprehensive research and development from the skin surface to the bone. From the perspective of skin rejuvenation, the company will deeply develop the EndyMed device to form a series of products. At the same time, the company extensively conducts research on laser products, including photorejuvenation, picosecond, ultra-picosecond, and ice-point lasers, and also pays attention to opportunities in cryolipolysis and corresponding liposuction procedures.

In addition to energy devices, the company will also invest in the development of a series of hyaluronic acid injections for skin rejuvenation. Currently, the company's ongoing projects include enhanced hyaluronic acid injectables, medical cross-linked chitosan gel, intelligent cross-linked collagen fillers, etc., aiming to expand the field of skin hydration through multiple products, substances, raw materials, and indications.

In the field of fillers, the company will actively develop comprehensive products with the technical feature of "Haimai Moon White," focusing on safe, green combination products without chemical adhesives. On this basis, the company is also developing painless cross-linked injectable sodium hyaluronate gel to diversify its product offerings. Additionally, the company is actively expanding into the botulinum toxin sector.

——【END】——

Conference Theme: MCC2024 International Medical Aesthetics Equipment Conference

Conference Date: September 11, 2024

Conference Venue: Bao Cube Center, Shenzhen, China

Organizers: Smart Medical Device Network, Medical Beauty Online

Organizer: Shenzhen Zhongzhi Exhibition Co., Ltd.

Booth Reservation