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The target group
Our project comes from the elderly calcium problem. China already has a population of 1.4 billion, and the economy develops rapidly. People are asking for a better life now. Among them, the bone and calcium problem is a problem we can not ignore.
China is an ancient civilization, and Chinese food culture is of great antiquity and well-known globally. However, China's dietary structure also has brought trouble for people's calcium problems. In the traditional diet of East Asians, including Chinese people, vegetarians are the leading food, supplemented by meat, and rarely consume animal dairy products, leading to a low calcium intake. Some plants also contain many oxalates, phosphate, and other elements, which complex calcium ions and reduced calcium ions' absorption rate.
Statistics show that the average Chinese consumes less calcium than the recommended daily intake and many Chinese face serious bone problems. It is estimated that in 2006, there were nearly 70 million osteoporosis patients in China, and the number of bone loss has exceeded 200 million. Despite the lack of recent epidemiological data, estimates of osteoporosis and bone loss in China far exceed these figures. The problem of osteoporosis is more severe in the elderly, and there are deaths due to falls and fractures every year. Therefore, we limited our target population to the elderly.
Product form
Our project aims to design a genetically engineered probiotic that colonizes and secretes a short peptide in the gut. This short peptide binds to calcium ions to increase soluble calcium and increases the absorption rate of calcium in the intestine, thus achieving calcium supplementation.
Our products are basically positioned as probiotics health products. The relatively mature probiotics products in the market include probiotics lozenges, drops, powders, and capsules. And we chose to make our program available to the target population in the form of probiotic capsules. Compared with other forms of probiotics, the capsule has unique advantages, such as high bioactivity and mature technology. Besides, the commonly used capsule shell is plant fiber shell, which is less than the traditional gelatin capsule additive and more suitable for the elderly.
Commonly used probiotic lozenges can add more additives and adhesives, sweeteners, and molding needs heating, which will damage the probiotics' activity. Due to many additives, although easily accepted by children, older people won't care about whether the drug will taste good. A lot of additives can add the burden on the health of the elderly, instead of other forms such as drops, dry powder each have advantages, but there are not easy to save, the shortcomings of high cost, it is not a good choice for the elderly.
business plan
We have a long-term plan for the realization of our project, and we have won the investors' approval.
The first milestone is two months later. We plan to obtain all plasmids by Cai Lab and prove that all components can function normally. But we still need to contact medical laboratories for the future's clinical trial. If we want our project to apply, it is a necessary step. We also need to contact investment institutions for financial support.
After six months, we are supposed to successfully import all components into the recipient bacteria and make sure that all imported parts function as expected. We also want to consult experts and doctors and pay attention to relevant laws and regulations that enable our project to process smoothly.
Ten months later, we may start our experiment on the mouse, and confirm that the successful preclinical trial has passed the review of FDA in the same period, obtain the approval of clinical trial, and apply for clinical trial.
One year later, we may start our phase I, II, and III clinical trials. And then, we're continually tweaking our programs based on the results of the clinical trials.
Five years later, some pharmaceutical companies may prepare our test data for new drug applications to the FDA following the application procedures. At that time, our products may be used by the public.