Botanicals Development
This project has hundreds of thousands of active saponin drugs, which solves the supply of pure monomer saponin in fine chemicals and provides a new way out for the pharmaceutical industry. During the past 10 years, our research projects have achieved great success. The establishment of extraction, transformation, and synthesis We have obtained a large number of new active saponin compounds on the testing platform and filled the gap in the scientific community for synthetic saponins. Our team will keep a variety of natural and optimized saponin compound libraries, and provide preliminary compound characteristics for the industry and research teams in various countries. More effective for drug screening. We have a large number of saponins compounds, which have been patented in the United States, Europe, China, Japan, Australia, South Korea and Canada, and many more are in the process of application. Chinese traditional medicine has a history of thousands of years. The traditional Chinese medicine industry is also our country’s traditional advantageous industry. As an important part of China's medical and health industry chain, the traditional Chinese medicine industry has been continuously developing and growing under the drive of a series of national support policies. It has a strategic position. Gradually highlight.
Our team is engaged in discovering active ingredients for the treatment of cancer from plants. The purpose is to use our new active compounds in the field of anti-cancer drugs to develop therapeutic drugs with new therapeutic mechanisms and low toxicity, and to develop drug resistance to cancer cells. First-line drugs. We have more than 20 years of experience in new drug development. Our strengths are the discovery, identification, isolation, improvement and synthesis of anticancer saponin compounds. We have identified 100,000 new compounds and established an effective platform for further synthesis and identification of drug candidates. We have 30 patents, and more new patents will continue to be produced in the process of developing hundreds of new compounds.
Three all-natural botanicals in the FDA application
We already have three all-natural botanicals in preparation for IND application to the US FDA:
(1) Anticancer drugs for ovarian cancer (this project is protected by invention patents)
Ovarian cancer is the cancer with the highest morbidity and mortality rate in women, and is called the "silent killer". Ovarian cancer hides in the pelvic cavity. There is no sign. 80% of ovarian cancer patients are at an advanced stage when they are discovered, which makes the patient lose the opportunity for surgery. The recurrence rate after first-line drug treatment is also the highest. Our Texas team screened effective molecules from tens of thousands of natural saponins for cancer treatment, and finally discovered a natural anti-cancer saponins (5962) extracted from a shrub plant, which has a significant anti-cancer effect on ovarian cancer. This natural saponin extract (5962) can inhibit the growth of ovarian cancer cells and prevent tumor angiogenesis to kill cancer cells. Our experimental results show that the use of natural saponin extract (5962) can reduce the aggressiveness of ovarian cancer cells by more than 80%. Ten days after the mice were inoculated with the tumor, their tumors shrank significantly by 45%. Its mechanism of action is to increase the synthesis of angiopoietin-2 (ANGPT2) to inhibit tumor angiogenesis. Experiments have shown that natural saponin extract (5962) increases ANGPT2 by 300% and inhibits tumor angiogenesis.
(2) Inhibitor of adhesion protein (this project is protected by invention patent)
Cancer cell metastasis is the main feature of malignant tumors and the primary cause of death that cannot be prevented in cancer patients. The occurrence of cancer cell metastasis involves complex pathways in the microenvironment where cancer cells are located. It is important that cancer cells produce a favorable environment for the expression of adhesion proteins to strengthen self-metastasis. Therefore, restraining the expression of cancer cell adhesion proteins to treat cancer cell metastasis is The latest targeting method. The internationally renowned pharmaceutical companies Glaxo (GSK) and Roche Pharmaceuticals (Roche) have invested heavily in an attempt to overcome this problem. GSK GlaxoSmithKline has a clinical drug [adhesion protein (FAK protein) inhibitor in development , The Shanghai InxMed company is working on a phase 1 clinical drug [adhesion protein (FAK protein) inhibitor] in China and the United States, which is a project to inhibit adhesion protein to treat gastric cancer metastasis and spread. Its A round raised tens of millions of dollars. Investors Including Roche's world's largest pharmaceutical companies. The important thing is that we are more sure that we are in the right direction from the development trends of major pharmaceutical companies. The adhesion protein inhibitors we developed can effectively inhibit (FAK protein) and more effectively (fibronectin), with a wider range of efficacy, and a foundation for mixed therapy. GSK GlaxoSmithKline and Roche Pharmaceuticals (Roche) develop chemical medicines. Our saponin medicines are natural products and can be used in many types of products. This adhesion protein inhibitor is a huge market because it is not limited to the type of cancer and has a wide range of applicable diseases. Furthermore, the drugs currently used to treat cancer cell metastasis (Cisplatin/ Docettaxel/ Doxorubicin/ Hydroxyurea) are very toxic and can cause irreversible trauma to patients. Therefore, it is more urgent to develop our natural saponin drugs.
Three) MH-1341-OD is aimed at women with postmenopausal uterine atrophy and withering (this project is protected by invention patents)
(I) Technical characteristics of MH-1341-OD:
Our confidence in MH-1341-OD is based on several key findings.
One of them is that the absorption rate is too low. Therefore, the blood concentration of the patient after taking the medicine is not only low but also uneven, with different effects and low treatment efficiency.
Another example is our successful prediction of the concentration of active ingredients in the patient's blood (Figure 1).
Therefore, we can accurately predict the dose of the active ingredient. This data is very important for clinical testing.
The ratio of natural active ingredients is not the same as the ratio of each other. Data shows that a group of active ingredients of MH-1341-OD is much more effective than the natural ratio.
Therefore, to develop MH-1341-OD well, new dosage forms and delivery channels must be redesigned.
Figure 1: The pharmacokinetic model of PPT predicts the concentration of effective components in the blood after the patient has taken it (red line). O is the blood concentration of the patient's active ingredient.
After preliminary research, MH-1341-OD not only has no carcinogenic side effects, it also has cancer treatment effects (Figure 2). This feature is the advantage of MH-1341-OD.
Figure 2: The active ingredients bind differently to female hormone receptors. So the downstream role is different.
The drug MH-1341-OD project is aimed at the indications of uterine atrophy, dryness, and cancer prevention. Academician Keith of the United States has led the work of an expert group to strive for the IND approval of the US FDA in the first half of 2022. If MH-1341-OD can be successfully developed, it can be used to develop other related medicines for women after receiving the approval from the US FDA for herbal prescription drugs.
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The global market for drugs to treat menopausal women is approximately $22 billion.
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We decided to develop a product to treat vaginal atrophy first. The market is about $1.6 billion. Although the market is small, there are almost no products on the market that are safe (non-toxic) (Figure 3). The side effects of existing competitors' products are breast cancer and uterine cancer.
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If the first MH-1341-OD variety is successful, then four prescription drugs related to menopausal and menstruating women can be continuously developed, with higher economic benefits, and all products show that there will be a world market of $22.5 billion.
(II) Market situation of similar products
(A) Survey of similar products in the domestic market
With reference to the CMH monitoring data of Zhongkang in 2015, the market share of menopausal chemicals has remained at more than 50%, but it has been declining year by year, and the proportion of proprietary Chinese medicines has increased accordingly. Chinese patent medicines are mostly composed of natural estrogen or phytoestrogens, which can avoid some of the side effects of synthetic estrogen and are more safe. With the popularization of the concept of phytoestrogens, it is expected that the share of Chinese patent medicines will further increase.
With the improvement of women's health awareness, menopausal medication has also become a major force in the women's medication market. According to population sampling data from the National Bureau of Statistics, it is forward-looking that the number of women aged 45-54 (high menopause) in China in 2017 will be 125 million. According to the Union
The United Nations World Health Organization estimates that by 2030 there will be more than 1.2 billion menopausal women in the world, and China's menopausal women will exceed 210 million, accounting for about 1/7 of the total population.
Female menopause has become a topic of widespread public concern. In China, due to the relatively large proportion of menopausal women and the high incidence of menopausal syndromes, the market for menopausal drugs has steadily expanded and has great development potential. According to data from the Prospective Industry Research Institute, my country's female menopausal medication retail market has steadily expanded. In 2017, sales reached 270 million yuan, a year-on-year increase of 28.6%. In the retail market, the share of Chinese patent medicines for women's menopause remained above 50%, and showed a small increase. In 2017, it was 51.9%, while the proportion of Western medicines decreased accordingly. With the implementation of the "Traditional Chinese Medicine Law of the People's Republic of China" and the advancement of the "Thirteenth Five-Year Plan for the Development of Chinese Medicine", Chinese medicine and Chinese medicine have received more attention and attention, which has promoted the development of the Chinese medicine market to a certain extent. The market share of proprietary Chinese medicines may increase further.
Percentage of Chinese and Western medicines in the retail market of female menopausal medicines from 2015 to 2017 (%)
2015-2017 Changes in Top 5 Brand Shares of Chemical Drugs in Female Menopause Drugs Retail Market (%)
(B) Investigation of similar products in the international market
The main competitive product for the treatment of vulvovaginal atrophy in the U.S. market
(C) Advantages of MH-1341-OD product
(I) The biological activity of oral isoflavones absorbed through the gastrointestinal system will be affected by first-pass metabolism, which will reduce the bioavailability, leading to undeniable differences in the efficacy of individual users, and even serious treatment failures;
(Ii) Optimize the key isoflavone ratios and interactions in MH-1341-OD through advanced pharmacy platform technology,
The overall activity of MH-1341-OD has been significantly enhanced;
(Iii) Choosing the intravaginal suppository form can avoid the first-pass metabolic effect, make the dose significantly lower than the dose previously studied, reduce all possible adverse reactions related to the dose size, and significantly increase the safety of the product;
(Iv) Topical application can greatly reduce the difference in clinical utility between individuals, and at the same time avoid side effects related to systemic application;
(V) The principle of MH-1341-OD preferentially activates the ER-β receptor, which may avoid the carcinogenic effects associated with the activation of the ER-α receptor, reduce the probability of adverse reactions, improve the safety of the product, and help MH -1341-OD competes with the market share of products that focus on the structure of animal hormones in the current market;
(Vi) The ingredients of MH-1341-OD have successfully applied for patents, laying a solid foundation for exploring the huge North American market.
(D) MH-1341-OD product target
(I) Obtain the IND from the FDA and proceed with phase I and II clinical trials (US, China)
(Ii) Owning a series of independent intellectual property rights, the current status of existing or applying technology patents:
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US 10,114,931 B2 (USA)
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10307451 (Canada)
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CN 101790682 B (China)
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5491377 (Japan)
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10-1459805 (Korea)
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179546 (Singapore)
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2008234619 (Australia)
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2135074 (European Union)
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Pending (Brazil)
(E) Project implementation steps
(I) GACP planting; the GACP standard planting MH-1341-OD drug base was established in Canada, and Ron will be responsible for it.
(Ii) Follow standard procedures to phase II clinical medicine.
(F) Project progress (to be confirmed internally)
