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Zhongshan Biotech completed the registration of the master file of chondroitin sulfate, the first raw material for medical devices in China

author:Mountain creatures

Today, the medical aesthetic industry is still a sunrise industry. According to the data of Qichacha, as of March 1, 2024, the number of existing medical cosmetology-related enterprises in mainland China is 124,100, and the number of domestic medical cosmetology-related enterprises registered has shown a positive growth trend for ten years. In 2023 alone, the number of registered medical cosmetology-related enterprises in mainland China will reach 46,600, a year-on-year increase of 38.61%!

Zhongshan Biotech completed the registration of the master file of chondroitin sulfate, the first raw material for medical devices in China

Bucking the trend, CITIC Securities predicts that the overall size of China's medical aesthetic market will reach 1.3 trillion yuan in 2030.

Behind the digital growth, every link in the industrial chain is superimposed. Returning to the essence of industry development, technological innovation and iteration are the underlying logic to promote growth. Looking back at the past few decades of Chinese medical cosmetology, the development of the industry is basically at the same frequency as the development of sodium hyaluronate technology.

Nowadays, with the continuous emergence of new materials and technologies, the industry has also opened round after round of upgrades and iterations, but the path of "creating wealth" of sodium hyaluronate is still worthy of our reference and learning; At the same time, we can also use the growth path of sodium hyaluronate to examine whether the current new materials are "promising in the future".

It is understood that Zhongshan Biotech, which has been maintaining technological innovation and leadership in the field of sodium hyaluronate, has recently completed the registration of the master file of sodium chondroitin sulfate (CS), a raw material for medical devices, at the Medical Device Technology Evaluation Center of the State Drug Administration.

Zhongshan Biotech completed the registration of the master file of chondroitin sulfate, the first raw material for medical devices in China

Overview of the domestic and foreign markets of sodium chondroitin sulfate industry

In terms of the global sodium chondroitin sulfate industry, the mainland accounts for 80% of the global market and is the world's largest producer and exporter, but the relevant research lags far behind other countries. Looking around the international market, the application of chondroitin sulfate sodium has become increasingly mature, including drugs, functional foods and cosmetics, and in the field of medical devices, although the product has extensive research, but there are few terminal application products, especially in China, this field is still in the blank stage.

First of all, in terms of raw materials, the raw materials of sodium chondroitin sulfate extracted from animal cartilage have been included in the latest versions of the pharmacopoeia of the United States (USP43), Europe (EP.10.0), Japan (Japanese Pharmacy Prescription Drugs Specifications), China (Chinese Pharmacopoeia 2020 Edition) and other countries.

Secondly, in the application of pharmaceutical products, there are injections, eye drops, capsules and tablets that have been approved for marketing in China, and there are more than 100 products that have been approved for marketing. It is mainly used for neuropathic headache, neuralgia, arthralgia, arteriosclerosis, treatment of atherosclerotic diseases, angina pectoris and hyperlipidemia.

In addition, sodium chondroitin sulfate is widely used in the field of health food, and its raw material sources are also diverse. From the perspective of the development of supply and demand, the demand for sodium chondroitin sulfate is strong at this stage, but the quality of supply is uneven, which is also an important reason for the slow development of the industry.

The production cycle of raw materials is long, the distribution is scattered, and it is difficult to collect, store and transport, so it is difficult to achieve centralized large-scale acquisition. Continental chondroitin sulfate sodium is in the extensive stage of development, but based on the extensive market demand for crude extracts and semi-finished products, the current development trend is still upward, and first-line big-name enterprises will still choose high-purity, high-quality chondroitin sulfate sodium raw materials.

However, whether it is the overseas market or the domestic market, there are few medical device terminal products related to chondroitin sulfate sodium. According to public literature, there are only single digits of medical devices that have been landed, including the viscoelastic agent for ophthalmic surgery launched by Alcon Company in the United States, IBSA in Switzerland for the treatment of cystitis, and the German INSTILLAMEDFARCO-PHARMA GmBH launched a sterile solution based on sodium hyaluronate.

Therefore, on the whole, the overall development space of the sodium chondroitin sulfate industry is huge, first of all, the brand owner starts from the needs of consumers, and has very high requirements for product quality, which also requires a high degree of professionalism from raw material supply to process production, and quality control in place.

Focusing on the field of medical cosmetology, if the sodium chondroitin sulfate industry wants to achieve long-term and rapid development, it needs to establish a sound system in supervision; Strictly control the quality from the raw material end; make breakthroughs and innovations in process technology; Constantly broaden the scenarios in the application.

The prospect of sodium soft sulfate is promising, and Zhongshan Biotech continues to empower the industry as a "leader".

As a representative of the high quality of upstream raw materials of sodium hyaluronate in China, Zhongshan Biotech has been at the forefront of development, continuously cultivating the quality of sodium hyaluronate, and laying a solid foundation for the high-quality development of the industry.

Similarly, with insight into the application prospect of chondroitin sulfate sodium in the field of medical devices, Zhongshan Biotech has carried out in-depth research. And on April 11, 2024, the registration of the master file of the first domestic raw material chondroitin sulfate sodium for medical devices will be completed, and the matrix of the company's raw material large single products is gradually improving.

First of all, starting from the characteristics of sodium chondroitin sulfate, a raw material for medical devices launched by Zhongshan Biology, it is extracted from shark bone, which has good compatibility with the human body, low adverse reactions, and easy human absorption, and is a natural biological scaffold material for tissue engineered articular cartilage; From a technical point of view, Zhongshan Biotech uses ultrafiltration technology and precipitation technology in the process of extracting sodium chondroitin sulfate, which has obvious removal effect on enzymatically hydrolyzed proteins, impurities and heavy metals, and the product has high purity, ≥ 98.0%, which is higher than the pharmacopoeia standard. From the perspective of applications in the medical field, the product can be used for Class II and Class III medical devices, such as: dressings, tissue adhesives, hydrogels, ophthalmic surgery, etc., and can also be used as biomedical materials directly for skin filling.

As an enterprise that has grown up with sodium hyaluronate, Zhongshan Biotech has been very mature in concept and technology. The completion of the registration of the master file of chondroitin sulfate, the first raw material for medical devices in China, not only has a first-mover advantage in the market, but also lays a high-quality foundation for the sodium chondroitin sulfate industry in advance.

As more and more players enter the chondroitin sulfate sodium industry, this track is bound to move towards a process of high standards and strict requirements. As the first "certified" manufacturer, Zhongshan Biotech will sit as a "leader" to lead the rapid development of chondroitin sulfate sodium in the field of medical devices, and continue to empower partners with forward-looking layout thinking.

At present, the application of sodium hyaluronate is gradually popularized, and the market size of sodium chondroitin sulfate will continue to grow upward. It is believed that in the future, driven by the economic outlet of the biotechnology industry, Zhongshan Biotech will continue to promote the innovation and development of the medical aesthetic industry and the biotechnology industry with down-to-earth perseverance. From May 15th to May 17th, Zhongshan Biotech will also bring chondroitin sulfate sodium to the 90th China International Pharmaceutical API/Intermediates/Packaging/Equipment Fair (APi China), and sincerely invite everyone to visit booth 1.2G40 to learn and exchange!

Zhongshan Biotech completed the registration of the master file of chondroitin sulfate, the first raw material for medical devices in China

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