China's NMPA Unveils Policy Boosting Eight Innovative Cosmetic Ingredients, Benefiting Major Biotech Firms

11Month17On [date], the National Medical Products Administration released the "Opinions on Deepening Cosmetic Supervision Reform to Promote High-Quality Industry Development" (hereinafter referred to as the "Opinions"), closely aligning with the main theme of deepening regulatory reform and promoting high-quality industry development, and proposing24Opinions on Reform,48Specific reform measures.

A relevant official from the Department of Cosmetics Supervision of the National Medical Products Administration stated that the issuance of the "Opinions" is a measure to deepen the reform of cosmetics supervision and promote the high-quality development of the cosmetics industry in China.

It is worth noting that the current "Opinions" particularly emphasizeEstablish a specialized review channel for cosmetics with new efficacy claims and encourage enterprises to strengthen research and development of cosmetics for the "silver-haired" demographic.

“The Opinion” proposes that the National Medical Products AdministrationA dedicated review channel will be established for cosmetics with new efficacy claims, implementing immediate review upon submission, and a pre-submission consultation mechanism for the registration of such cosmetics will be instituted., while strengthening guidance and services for enterprises, optimize the review and approval procedures to better adapt to new consumer demands and emerging trends in industry development. On this basis, support industrial innovation and development by adjusting cosmetic classification rules and catalogs, and simplifying management requirements for certain products.

In addition, the “Opinions” also explicitly propose thatPromote the development of the silver economy in the cosmetics sector, encourage enterprises to strengthen R&D of cosmetics for the elderly population, and conduct frontier basic research on mechanisms such as skin aging.Support the development, application, registration, and filing of cosmetics tailored to the characteristics and needs of the elderly population, thereby meeting their diverse consumer demands.

According to an analysis by the China Fragrance and Flavor Cosmetics Industry Association, public consumer demand for cosmetics continues to rise, with growing expectations for new efficacies and novel products. Meanwhile, enterprises demonstrate a strong willingness to innovate, aiming to achieve differentiated operations and enhance product appeal by developing cosmetics with new efficacies.The pursuit of enhanced efficacy and a broader product portfolio has become a new driving force for the development of the cosmetics industry.

As the potential of the “silver economy” continues to be unleashed, cosmetics specifically developed for the elderly population will become a key track for industrial innovation and development. This trend is expected to foster a cohort of silver-haired cosmetic brands with Chinese characteristics, achieving a win-win outcome in both social and economic benefits.

The “Opinions” support for cosmetics with new efficacies and anti-aging benefits may benefit hyaluronic acid,SqualaneEight major cosmetic ingredients based on innovative biomanufacturing technologies, involving Bloomage Biotech,Freda, Jinbo Bio, Yili Chuannig Biotechnology, and Jinsan Bio, among other well-known enterprises.

The traditional production of hyaluronic acid once relied on extraction from animal tissues, a process that was complex and costly. However, hyaluronic acid produced via biotechnology not only allows for the customization of molecular weight according to application requirements but also enables multi-level moisturizing effects by combining hyaluronic acid molecules of different weights.

Low-molecular-weight hyaluronic acid can better penetrate the skin, providing deep hydration and repair functions, while high-molecular-weight hyaluronic acid helps lock in moisture, enhance the skin barrier function, and significantly improve overall skincare efficacy. Currently, the global annual production of hyaluronic acid reaches500tons, of which80%The above is produced through microbial fermentation, and the number of related technical patents has exceeded500items, demonstrating the extensive application of this technology in the market.

Domestic companies with hyaluronic acid operations include Bloomage Biotech, Freda, Dr. Ling, Shuiyang Shares, and Hunan Weichu.Among them, Bloomage Biotech has become a major global supplier of hyaluronic acid, securing a leading position in the global market.Estée LauderandNeutrogenaMany brands utilize hyaluronic acid to provide moisturizing benefits to their products, while also offering a certain thickening effect.

Compared with animal-derived collagen, recombinant collagen:

High safety profile: Collagen extracted from animal tissues may carry pathogens such as those causing bovine spongiform encephalopathy (BSE), whereas recombinant collagen is produced via genetic engineering technology, eliminating the risk of viral contamination at the source.

Low allergenicity and enhanced biocompatibility: Due to its homology with human collagen, recombinant collagen exhibits superior biocompatibility and a lower risk of allergic reactions compared to heterologous animal-derived collagen.

Excellent processability; genetic recombination technology can modify the characteristic sequences of collagen, thereby obtaining collagen for specific applications;

High reproducibility in manufacturing; recombinant collagen can be produced at scale using microbial expression systems through high-density fermentation while ensuring quality.

Domestic companies with a presence in recombinant collagen include Giant Biogene, Jinbo Bio, Marubi Bio, Bloomage Biotech, and Trautec Medical,Juyuan Biotechetc.,Among them, Jinbo successfully created the world's first100%Human homologous, capable of self-assembling into a triple-helix structureAType RecombinationIVType humanized collagen, in2022Year and2023Has been granted two Chinese invention patents in successive years.

Ceramides were discovered by German scientistsJohannes Thudichum Yu19It was first isolated from brain tissue in the 21st century, and significantly improves skin hydration and resistance to external stimuli by maintaining the moisture content and barrier function of the stratum corneum.

In traditional industry, ceramides are primarily extracted from neural tissues such as bovine brain or spinal cord. This approach not only requires substantial amounts of animal-derived raw materials but also raises ethical concerns and incurs high production costs. Ceramides produced via yeast fermentation, in addition to offering improved purity and production efficiency, feature molecules that more effectively maintain skin moisture balance by enhancing the lipid structure of the stratum corneum, playing a significant role in repairing the damaged skin barrier.

According to incomplete statistics,Domestic companies involved in the production of ceramide raw materials include Chongqing Zhihe Biology, Yili Chuannig Biotechnology Co., Ltd., Weibolai, and Shenzhen Dickman Biotechnology.Among them, Zhihe Biotech has achieved large-scale, low-cost production of ceramides through microbial fermentation technology, breaking the two-decade-long monopoly by international giants in this field and becoming the third company globally to master this core technology.

Squalane is a high-quality oil extracted from the livers of deep-sea sharks. It is highly stable and offers an excellent user experience, making it widely used in skincare products. However, traditional squalane was sourced from the livers of blue whales and sharks.1Tons of squalane required3000sharks, posing a threat to shark populations and incurring high costs. Therefore, the European Union has banned the use of animal-derived squalane as a cosmetic ingredient.

Leveraging synthetic biology technologies, laboratories can produce products identical to natural squalene, thereby protecting the ecological environment and achieving sustainable production. This enables the continued use of squalene, a high-quality ingredient, in cosmetics, while reducing production costs and promoting the sustainable development of the industry.

According to incomplete statistics,Domestic companies with squalane operations include Senrui Biotech, Chuannig Biotech, Yichun Dahaihai, and Taichuang Biotech., among which Yichun Dahai Turtle has deeply cultivated squalene (squalane is produced by hydrogenating squalene) and is the largest and only enterprise in China dedicated to the research of plant-based squalene extraction.

Ergothioneine is a natural antioxidant that has been continuously used in anti-aging health supplements and skincare products in recent years. As early as1909In that year, scientists discovered ergothioneine in a fungus, within human physiologypHIt does not undergo auto-oxidation in solution. As a natural antioxidant, ergothioneine can scavenge free radicals, promote normal cell growth, and is characterized by its safety and non-toxicity.

Generally, ergothioneine can be produced through three methods: biosynthetic fermentation, extraction, and chemical synthesis. Currently, biosynthetic fermentation has become the primary method for producing low-cost ergothioneine, utilizing fungal mycelium fermentation technology for its biosynthesis.

It is understood that the global90%of ergothioneine produced via microbial fermentation or enzymatic catalysis,Domestic companies such as Yili Chuannig Biotechnology, Bloomage Biotech, Jinsan Biotech, Zhongke Xinyang, and Shanghai Ergothioneine Group have already broken through technical barriers, with some enterprises achieving purity levels reaching99%the above production.

Resveratrol is a natural polyphenolic compound primarily derived from plants such as grapes, Polygonum cuspidatum, peanuts, and mulberries. It has garnered significant attention due to its diverse biological activities. Studies have demonstrated that resveratrol exhibits various physiological effects, including anticancer, antioxidant, anti-inflammatory, cardiovascular protective, immunomodulatory, and anti-aging properties. Consequently, it has been widely applied in numerous fields, including pharmaceuticals, cosmetics, and food products.

Furthermore, multiple studies have confirmed that resveratrol plays a significant role in improving skin conditions and delaying skin aging, demonstrating its substantial development potential and application prospects in the fields of cosmetology and dermatology.

Companies with domestic resveratrol operations include Heyi Pharmaceutical, Hunan Luman Biotech, Five Female Doctors, Hunan Hongjian Biotech, and Hebei Weidakang Biotech.Among them, Hebei Weidakang Bio achieved a global first by constructing microbial cell factories,5-Large-Scale Biomanufacturing of Natural Products Such as 5-Hydroxytryptophan, Melatonin, and Resveratrol.

Ginsenosides, as the primary active constituents of the rare medicinal plant ginseng, are renowned for their significant pharmacological activities, including antioxidant and anti-inflammatory effects.1957In [year], scientists first isolated this bioactive saponin component. Traditional extraction methods, such as water decoction, ethanol maceration, and steam distillation, require large quantities of ginseng roots, resulting in substantial resource consumption and low production efficiency.

By optimizing fermentation conditions and metabolic pathways, synthetic biology technology enables the efficient production of high-purity ginsenosides, reducing the use of chemical solvents and waste generation while significantly lowering costs, thereby allowing ginsenosides—once a rare medicinal ingredient—to be applied in daily skincare consumer products.

Domestic companies leveraging synthetic biology for the production of ginsenosides include Synbioverse (Suzhou), Giant Biogene, and Jilin Dongzhou Bio.Among them, Giant Biogene, leveraging its proprietary synthetic biology technology and conversion processes, became the first company in China to achieve the production of five types of high-purity rare ginsenosides—Rk3、Rh4、Rk1、Rg5andCKcompanies capable of mass production at the scale of hundreds of kilograms; Synbio Tech is a biotechnology enterprise dedicated to producing natural compounds using synthetic biology technology. Its founding team originates from the Chinese Academy of Sciences and was co-established by two academicians: Academician Zhao Guoping, a molecular microbiologist, and Academician Yue Jianmin, an organic chemist.

10-Hydroxy-2-decenoic acid (10-HDA) known as “liquid gold” and the “longevity factor,” is an unsaturated fatty acid found exclusively in royal jelly, with a content of only1.4-2.4%, is considered a core indicator for assessing the quality of royal jelly. Years of scientific research both domestically and internationally have demonstrated that 10-hydroxy-2-decenoic acid (10-HDA) possesses unique efficacy in human medical treatment, health care, and cosmetic skincare. Renowned for its significant anti-aging, anti-inflammatory, antioxidant, and skin-whitening properties, it is hailed as the “golden ingredient” in high-end skincare products, being exceptionally precious and available in extremely limited quantities.

For cosmetics companies, the high cost of naturally extracted 10-hydroxy-2-decenoic acid (10-HDA) has limited its widespread application. However, once this “golden ingredient,” 10-HDA, achieves mass production, it will unlock significant potential for corporate growth and even drive transformation across the entire industry. Synthetic biology offers hope for stable, large-scale manufacturing.

Domestic companies leveraging synthetic biology technology for the production of 10-hydroxy-2-decenoic acid include Freda Biotech, among others.It is reported that Freda Biotech is the first company in China to achieve the preparation of 10-hydroxy-2-decenoic acid (royal jelly acid) using synthetic biology methods and to launch it on both domestic and international markets, thereby filling a gap in the industry. Currently, the synthetically produced royal jelly acid has successfully completed the filing for new ingredients with the National Medical Products Administration, under the filed name “10-Hydroxyl-2-Decenoic Acid,” with the filing number “National Cosmetic Raw Material Filing No.”20240052”。

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