The technological development and prosperity of any industry have gone through the transition from extensive growth to standardized maturity.
In December of last year, the Guangzhou Administration for Market Regulation issued the “FAQs on General Cosmetics Filing (51st Edition)” which provided a definition for whether microcrystal or microneedle products belong to the category of cosmetics. This signifies that sponge microneedle products may be excluded from the cosmetics catalog, causing significant shock within the industry.
However, according to Yang Guozhong, the Deputy General Manager of Beijing CAS Microneedle Technology Ltd. (CASMN), this development brings more benefits than drawbacks. He states, “This marks the attention of regulatory authorities towards microcrystal and microneedle products, which is beneficial for the long-term healthy development of microcrystal cosmetics.”
In recent years, microcrystal cosmetics companies, represented by Beijing CAS Microneedle, have continuously strengthened their research and development capabilities, production capacities, promoted the drafting of relevant industry standards, and built their own brands. These efforts have contributed to the ongoing market education of microcrystal cosmetics and facilitated the development of standardized practices in the market.
CHAILEEDO has noticed that microcrystal cosmetics, which have emerged during the era of efficacy skincare, are gradually maturing with the continuous improvement of regulations. They are quietly approaching the eve of large-scale application.
Established by a Doctoral Supervisor at the Chinese Academy of Sciences: Microcrystal Cosmetics Development Seizes Opportunities
Looking back at the rise of microcrystal cosmetics, it is closely intertwined with the development of microneedle drug delivery technology.
As early as 1958, Alan Richard Wagner, an American, proposed the concept of intradermal injection using microneedles and filed a patent. However, there were no breakthrough advancements until the patent expired in 1979.
On the other side of the ocean, scientists led by Gao Yunhua, a doctoral supervisor at the Institute of Chemistry, Chinese Academy of Sciences (CAS), embarked on intensive technological research in 2003.
At that time, Gao Yunhua took on the national “863” Program’s MEMS major project, and after the approval of the project on transdermal drug delivery technology using single-crystal silicon microneedles, he devoted himself to the research and development of microneedle transdermal drug delivery technology. Beijing CAS Microneedle served as the technology transfer base for the Chinese Academy of Sciences, ultimately realizing the research and development of polymer microneedle transdermal technology, pilot production, and the construction of a large-scale production service platform.
In recent years, with the rise of ingredient-conscious consumers and an increase in consumer awareness, the Chinese beauty market has entered an era where skincare without efficacy is no longer favored. Transdermal drug delivery technology using microneedles has also found its application in the cosmetics field.
In fact, to provide consumers with tangible effects, in addition to choosing highly active and powerful raw ingredients, the effective absorption of these ingredients by the consumer’s skin is equally crucial.
CHAILEEDO’s analysis reveals that there are mainly two methods to promote the skin’s absorption of active ingredients. One approach involves technical processing of the active ingredients themselves, improving their efficacy and absorption efficiency. For example, supramolecular technology has received significant attention in recent years. The other approach involves using tools to enhance skin absorption. The latest achievement of microneedle transdermal drug delivery technology in the cosmetics field is the soluble microcrystal patch, which is an important representative.
According to Yang Guozhong, the soluble microcrystal patch, as a transformed result of microneedle drug delivery technology in the cosmetics field, utilizes active ingredients arranged in a micrometer-scale lattice pattern. It physically and non-invasively reduces the density of the stratum corneum and creates microchannels on the skin’s surface, significantly improving skincare efficiency.
As a relatively new and rapidly developing technological achievement, the soluble microcrystal patch has received enthusiastic response from the beauty market, demonstrating strong demand. Currently, according to a cosmetics regulatory app, there are 4,191 data entries related to “microneedles” and 633 data entries related to “microcrystal patches.”
However, due to the lack of an official definition for microneedle and microcrystal products and the rapid market development, there have been instances of exaggerated claims, which have subsequently drawn the attention of regulatory authorities.
In December of last year, the Guangzhou Market Supervision Administration explicitly stated that products claiming to be microcrystal or microneedle products, such as those using hydrolyzed sponges or similar needle-like materials and corresponding production techniques, and achieving effects or product penetration by piercing the skin, are beyond the scope of cosmetics.
CHAILEEDO has noticed that this is the first conceptual regulation by local regulatory authorities for microcrystal or microneedle products. Regarding this, Yang Guozhong believes, “This notice mainly targets sponge microneedle products. Soluble microcrystal patches, due to their limited needle height, can only reach the depth of the stratum corneum treatment and do not involve breaking the skin.”
“The industry is developing rapidly, mainly to prompt companies to examine whether they engage in exaggerated advertising and further regulate industry development,” added Yang Guozhong.
Clearly, looking ahead, it is imperative for regulatory authorities to standardize microcrystal or microneedle products. With the sound establishment of regulations, the soluble microcrystal patch will also usher in enormous development opportunities.
Leading the Drafting of the Group Standard for “Soluble Microcrystal Patch”: Pioneering the Mass Production Process of Flexible Soluble Microcrystal Patches
The standardized development of the industry requires not only the involvement of regulatory authorities but also the active responsibility of enterprises as market participants.
CHAILEEDO has noticed that since its establishment, Beijing CAS Microneedle has been actively promoting the standardization and unification of soluble microcrystal patches in terms of conceptual standards, aiming to eliminate obstacles for the long-term development of the industry.
In March 2022, under the guidance of the China Anti-Aging Promotion Association, the group standard for “Soluble Microcrystal Patch” was officially implemented, with Beijing CAS Microneedle serving as the head of the drafting working group. CHAILEEDO has noticed that the drafting units also include well-known industry enterprises such as Huaxi Biotechnology Co., Ltd., Youwei (Zhuhai) Biotechnology Co., Ltd., and Suzhou Yuefuda Biotechnology Co., Ltd.
Yang Guozhong expressed to CHAILEEDO, “The group standard for ‘Soluble Microcrystal Patch’ is the first group standard developed around microcrystal products in China, highlighting the leading position of Beijing CAS Microneedle in the industry.”
While promoting the industry’s positive development, with its profound research background, Beijing CAS Microneedle has been continuously strengthening its research and development and production capabilities, highlighting its competitive advantages and rapidly growing into a leading enterprise in the industry.
For example, in terms of research and development, Beijing CAS Microneedle has always focused on technological innovation and product development. It currently has the most comprehensive reserve of microneedle technology, covering three major categories and six types of microneedle technology, as well as various processes. It can meet the needs of microneedle formulations with different ingredients and holds more than 50 domestic and international patents.
It is worth mentioning that Beijing CAS Microneedle has also made bold innovations in the mass production process of soluble microcrystals. It is reported that the main challenge in mass production of soluble microcrystals lies in achieving a uniform and stable manufacturing process. The commonly used methods internationally are mold shaping and stretch molding.
However, the mold shaping method is prone to problems such as incomplete filling of the needles, incomplete needle body shape, or needle breakage during the filling process. The stretch molding process can achieve needle body solidification at room temperature, which can better maintain the activity of the product. However, it also faces difficulties in formula development and the inability to customize the needle body shape.
Therefore, Beijing CAS Microneedle has pioneered a flexible, soluble microcrystal patch rapid forming process, which achieves one-step molding of the macro shape and microstructure of the microneedle patch at room temperature. It also meets the requirements for uniform loading of active substances and high production rates in batch production.
In addition to its strong research and development capabilities, the production capacity of Beijing CAS Microneedle should not be underestimated. Currently, Beijing CAS Microneedle has two major R&D and production bases in Beijing and Chongqing. The comprehensive R&D base in Beijing’s biopharmaceutical base covers an area of over 4,000 square meters and has the world’s largest pilot-scale production line with an annual capacity of 20 million patches. It has transformed the independently innovated soluble microneedle technology from the laboratory level to industrial-scale production, solving the industrialization problem of soluble microneedles.
It is worth mentioning that Beijing CAS Microneedle’s subsidiary registered in Chongqing, Beijing CAS Microneedle (Chongqing) Technology Co., Ltd., covers an area of over 8,000 square meters and has a GMP automated production line with an annual capacity of 150 million patches. It is one of the world’s largest production bases for microcrystal patches.
With its deep accumulation in the field of microneedles, in March 2022, Beijing CAS Microneedle received a 100 million yuan Series A financing led by Alibaba, which will support its further development and innovation.
With its strong research and development capabilities and impressive production capacity, Beijing CAS Microneedle is able to maintain its industry leadership and help customers seize market opportunities.
Providing One-Stop Services for Research and Development, Filing, and Production
Three Proprietary Brands Debut at China International Beauty Expo (CIBE)
Looking ahead, with the gradual standardization of regulations, soluble microcrystal patches are bound to see more brand attempts and layouts. As a research and development-oriented company with contract manufacturing as its core business, Beijing CAS Microneedle always prioritizes customer needs and is committed to providing competitive products and services.
CHAILEEDO has learned that unlike most domestic microneedle technology companies in China, Beijing CAS Microneedle established a comprehensive CRO (Contract Research Organization) and CDMO (Contract Development and Manufacturing Organization) development model, which includes cosmetics. It can provide a one-stop solution for the cosmetics industry, from product and formula development to filing registration and production.
It is worth mentioning that in order to further expand the market for microcrystal cosmetics and promote market education, Beijing CAS Microneedle has also created three proprietary brands: Kesimei, Microacu, and Zhongkemojing, which will debut at the 63rd CIBE.
According to the introduction, the Microacu brand focuses on anti-aging effects and provides effective solutions for skin problems for the 30-60 age group. It is positioned in offline channels, including cosmetics stores. Kesimei focuses on fashion and luxury and is an online brand that provides technological and fashionable skincare experiences for young people aged 14-30. It is mainly sold on e-commerce platforms such as Douyin (TikTok).
Different from the Microacu and Kesimei brands, which require 6-8 hours of application, the Zhongkemojing brand highlights a 30-minute application and focuses on firming and reducing fine lines. It is sold both online and offline.
To bring more competitive products to customers, Beijing CAS Microneedle is actively working on the filing of microneedle and microcrystal products. Recently, Beijing CAS Microneedle successfully obtained the Class II Medical Device Registration Certificate and Class II Medical Device Production License for “Microneedle Transdermal Patch.” Meanwhile, it is also intensifying efforts in drug research and development to further expand its product line and market share.
Looking back at the development history of various niche markets, from the initial sprouts to flourishing growth, in the tidal wave of development, there are always companies that stand out, leading the industry forward. With a sense of responsibility for industry development and strong research and production capabilities, Beijing CAS Microneedle has become the “hidden champion” in the microcrystal cosmetics field.
