What are active vitamin D3 derivatives?
To get this straight, first we need to understand what vitamin D is. Vitamin D is a fat-soluble vitamin and the fourth vitamin humans discovered — it ranked fourth, hence the name vitamin D. By the definition of vitamins, a vitamin is a biologically active component found in food that the body cannot synthesize. But vitamin D3, an important type of vitamin D, can be synthesized in the human body; since the name carried over, it's still called a vitamin. That's the relationship between vitamins, vitamin D, and vitamin D3.
Vitamin D3 derivatives are the relatively complex products formed when hydrogen atoms or atomic groups in the vitamin D3 molecular formula are replaced by other atoms or atomic groups.
As research into vitamin D3's functions deepened, it was found that it not only promotes calcium and phosphorus absorption in the intestines but can also induce normal cell differentiation and inhibit excessive cell proliferation. Given this effect, scientists considered using vitamin D3 to treat diseases of excessive cell proliferation such as tumors and psoriasis, but found that vitamin D3 often brings serious adverse reactions like hypercalcemia and hyperkalemia.
Some media say the WHO's Joint Expert Committee on Food Additives will start evaluating aspartame at the end of June and is expected to announce results on July 14 — the same day the IARC formally declares aspartame a 'possibly carcinogenic' substance. In this gathering aspartame crisis, some companies have already rushed to distance themselves. Genki Forest says none of its products contain aspartame; its sweetener formula is mainly erythritol, which solves the taste problems of sweeteners like aspartame. A Nayuki Tea official also said that in November 2022 Nayuki announced all products use an upgraded natural sweetener, monk fruit sugar. Monk fruit is a medicinal-and-edible plant native to China, and its extract, mogroside, is a natural sweet substance. So am I about to say goodbye to sugar-free cola? Life suddenly looks a lot dimmer. Cola dodged the 'kills sperm' rumor but can't dodge 'possibly carcinogenic.' Cola really has it rough — first the rumor it kills sperm, now sugar-free cola is said to possibly cause cancer. The 'cola kills sperm' joke is said to come from 1960s South America, where local women liked to wash their private parts with cola after sex to kill sperm and prevent pregnancy. People believed the carbonation in cola could kill sperm, the sugar could 'detonate' sperm, and after shaking, cola could be sprayed deep into the vagina — basically used as a condom. That's why the American rock band The Fugs has a song called 'Coca-Cola Douches.' As the joke spread, it evolved into 'drinking cola kills sperm.' Probably the most influential urban legend ever? So this time, aspartame is about to be classified as a possible carcinogen — is that reliable? The topic hit the top of the trending list. Some netizens took it well, saying if you've got a cola in hand, 'drink it fast, it's not carcinogenic this month yet.' According to a Washington Post report on the 22nd, aspartame is one of the most common artificial sweeteners in the world. A French study last year suggested that consuming large amounts of aspartame may increase adults' cancer risk, and the US has begun re-reviewing the sweetener. The American Beverage Association, representing drink makers, rebutted the conclusion. Some media asked the WHO for confirmation, and the WHO responded that it will publish relevant content on this topic on July 14. Currently, the IARC classifies carcinogenic factors into five groups based on the likelihood of causing cancer: Group 1: confirmed carcinogenic to humans.
China, with its advanced industrial preparation capacity and low-cost advantages in hyaluronic acid, has become the main global exporter of hyaluronic acid raw materials. Based on calculations (summing market shares of sample companies in China), China's hyaluronic acid share reached 73% in 2018 and rose 3 percentage points to 76% in 2021.
Among them, Bloomage Biotech's market share has continued to increase, from 36% globally in 2018 to 44%. The company has a stronger edge in pharmaceutical-grade hyaluronic acid and is one of the few globally to obtain pharmaceutical-grade product qualifications in China, Europe, and North America.
Below we break down the company's core competitiveness in hyaluronic acid raw materials from three dimensions: technology, production capacity, and qualifications. Technology: leveraging two major technological advantages—microbial fermentation and biological enzyme cutting—to establish production efficiency and product quality.
Microbial fermentation: Currently, the industry's main process for producing hyaluronic acid raw materials is microbial fermentation, using the natural property of strains to metabolize and produce hyaluronic acid, through wild strain mutagenesis and high-throughput screening to achieve large-scale fermentation production.
The company's fermentation yield reaches 12-14 g/L, while the industry average is 6-7 g/L, higher than the industry level.
Biological enzyme cutting: Molecular weight is an important parameter of hyaluronic acid. High molecular weight hyaluronic acid (e.g., over 2,000 kDa) is suitable for medical products like ophthalmic viscoelastic agents, while oligo-hyaluronic acid (molecular weight below 10 kDa) has high absorption characteristics and easily penetrates the dermis.
It promotes damage repair and provides cell protection. Generally, commercial hyaluronic acid raw material products have molecular weights between 500 kDa and 2,000 kDa; producing ultra-high, low, and oligo molecular weights beyond this range is difficult.
Through comprehensive enzyme cutting and separation/purification technology, the company achieved industrial breakthroughs in different molecular weights, with raw material molecular weight ranging from 2 kDa to ultra-large 4,000 kDa. The company has a strong leading advantage in large-molecular-weight hyaluronic acid.
By mutagenesis screening, the company obtained high-quality strains capable of producing high-molecular-weight hyaluronic acid, and using segmented temperature-controlled fermentation and purification technology, achieved industrial production of hyaluronic acid up to 4,000 kDa.
Terminal sterilization technology: The company was the first in China to adopt terminal sterilization technology for hyaluronic acid injections, replacing aseptic filling for similar products, achieving a technological breakthrough. This technology raised the sterility assurance level from one in a thousand to one in a million, significantly improving product safety.
The company thoroughly solved the technical challenge of terminal moist heat sterilization for such products through technological innovation, and was cited by the CFDA as the standard sterilization method for these products.
Through process control, key quality parameters such as nucleic acids and endotoxins are 1/50 and 1/20 of the limits set by the European Pharmacopoeia international standards, reaching international leading levels. High R&D spending drives the company to the forefront of technological innovation.
In H1 2022, the company's R&D expense ratio was 6.11%. Compared with peer chemical raw material companies, this 6% is relatively high, and the R&D spending amount is above the industry level, demonstrating the company's important determination to invest in technological R&D.
