Seize the opportunity and seize the blank spot in the market
Allergy is a disease with abnormal immune system. When people eat, touch or inhale a substance, the body will overreact, and the substance that causes this reaction is the so-called "allergen". There are thousands of allergens, including dust mites, pollen, food, drugs, and even temperature changes and mental stress, among which dust mites and pollen are the direct allergens of more than 95% allergic people. Under normal circumstances, the human body will produce antibodies to protect the body from diseases, but allergic people will mistake normal and harmless substances for harmful things, produce antibodies and have allergic symptoms. Common allergic diseases include rhinitis, food allergy, asthma and bronchitis. Desensitization therapy is a therapeutic concept that has been used for 100 years. However, due to serious technical difficulties, 1986 invented sublingual desensitization therapy, and it was not until 1998 that the World Health Organization published a position document that sublingual desensitization was safe and effective. When Wuwu Bio was founded in 2002, Dr. Hu Yunxi, the founder of the company, saw that the research and development of sublingual desensitization drugs was a great business opportunity, which was of great help to hundreds of millions of allergic patients in China. At the same time, as an early returnee who joined the domestic biotechnology industry, he thought it could supplement some major technical deficiencies of sublingual desensitization drugs at that time, so he began to invest in this pharmaceutical industry with great potential. "There is no future in making generic drugs. If you want to do it, do what others don't. " Hu Yunxi's goal is clear, and he must make contributions to the field of medical innovation in the motherland.
At the beginning of our army's establishment, it faced many challenges such as capital, talents and business environment. In the case of extremely limited funds, the Fifth Five-Year Plan decided that "it is better to break a finger than to hurt ten fingers", that is, to increase funding for key projects and concentrate all resources to promote dermatophagoides farinae allergy projects, and finally successfully realized the standardized extraction of dermatophagoides farinae allergen active protein.
In June 2006, our company's biological products production workshop passed the GMP certification organized by CFDA, and realized the industrial production of Chang Di, a drop for treating dust allergy, which was listed in June 2006. So far, this drug is the first and only standardized hypoglossal desensitization drug in China. The emergence of "Chang Di" enables domestic patients to use the most advanced sublingual desensitization therapy in the world to treat allergic diseases.
"Chang Di" is an upgraded version of China's sublingual desensitizer. Our company has the most advanced biopharmaceutical research and development technology in the field of allergen drugs and independent innovation of related product patents. One of the core technologies is the definition of allergen protein activity. In 1998, the World Health Organization clearly pointed out that sublingual desensitization therapy is effective in treating allergic diseases caused by allergens, but standardized preparations must be used. The most important indicator of drug standardization in protein is protein activity, not quality or volume, because some "inactivated" protein actually has no therapeutic effect. Wuwu Bio invented the definition of allergen protein activity with completely independent intellectual property rights, which ensured the stability and repeatability of allergen protein biological activity, which is unmatched by any other products in the world so far.
Another core technology of the "Five-Year Plan" is protein stabilization technology at room temperature. Because the main component of desensitizing drugs is protein, it is easily affected by temperature and loses its activity, reducing its efficacy. Generally, it cannot be stored at room temperature for a long time, and its transportation must also be carried out in a low temperature environment. Our company has developed a brand-new protein stabilization technology, which enables the company's protein drugs to be stored and carried at room temperature, and still keep the activity of protein stable for a long time.
In addition, there are high-standard quality control of protein drugs: the quality control of our allergen protein products adopts the highest standards in the global industry, exceeding the quality standards recommended by the World Health Organization and similar products abroad. Artificial aseptic purification and population culture of dust mites: the standard three-level seed bank management technology is used to manage mite species, and the species of individual dust mites are screened through molecular identification, thus ensuring the purity and safety of pharmaceutical raw materials.
At the same time, we attach great importance to the intellectual property protection of core patents and have applied for more than ten domestic and foreign patents. It is precisely because of these core technologies that in the past 10 years, two new biological products ("Chang Di" and "Changdian") independently developed by our army were approved for listing, and each new drug is the best in this kind of products-with good curative effect and safe and convenient use. Many patients with severe allergic asthma and allergic rhinitis have been separated from the first-aid drugs that they could not leave before because of sublingual desensitization treatment.
Besides Chang Di and Changdian, Wuwu Bio has also developed a number of products for the diagnosis and treatment of allergic diseases, such as house dust mite skin puncture diagnostic kit, dust mite mixture, Artemisia annua powder drops and dermatitis diagnostic patch.
Raise funds for technical transformation
As an enterprise dedicated to original drugs, the research and development cycle of new drugs is long and the cost is high, but our company has completed the product research and development at the fastest speed. This is not only due to the high-level research ability and hard work of its R&D personnel, but also inseparable from the capital strength of society. 20 14, 14 In June, Wuwu Bio was listed on the Growth Enterprise Market and gained strong capital support.
According to the previous disclosure of Wuwu Bio, the listed fund-raising projects mainly include the technical transformation project with an annual output of 3 million dermatophagoides farinae drops, the technical transformation project of allergen research and development center, the marketing network expansion and information construction project and other liquidity related to the main business. Among them, the technical transformation project with an annual output of 3 million dermatophagoides farinae drops will use an investment of 65,438+140,000 yuan.
With the rising incidence of allergic brucellosis, patients' increasing concern for their own health, the further promotion of the company's academic knowledge, the improvement of doctors' and patients' awareness of sublingual desensitization therapy, the approval of new indications for dermatophagoides farinae drops in the future and the gradual entry into overseas markets, the demand for dermatophagoides farinae drops will maintain a rapid growth trend in a certain period of time.
The data showed that from 20 10 to 20 12, the sales volume of biological dermatophagoides farinae decreased, with the compound annual growth rate of 56.23% and 57.97% respectively, showing a rapid growth trend.
According to industry sources, the existing production capacity of our biological products Dermatophagoides farinae drops can no longer meet the market demand, so we need to add new production lines to improve the company's production capacity. Once the funds are in place and the project is put into production, the annual production capacity of Dermatophagoides farinae drops will be 3 million.
Hu Yunxi said: "The pharmaceutical industry is a very special industry. The launch of new products requires strict laws and regulations in many aspects and a time-consuming and expensive clinical trial process. On the other hand, a new drug can often get long-term intellectual property protection when it goes on the market, and there is enough time to develop the market and promote the products. Therefore, many large pharmaceutical companies in the world rely on one product to reach the market value of billions or even billions of dollars in the early stage of development. In particular, the desensitization products of companies like Wuwu Bio occupy a dominant position in the domestic market, with huge demand from patients and great development potential. Only a few allergic patients know about the products, so the company will first try to promote desensitization products so that it can help more patients and improve people's health. Of course, at the same time, with abundant funds, the company will actively seek new growth points and intervene in new medical fields when the time is ripe. "
"After listing in the capital market, the Fifth Five-Year Plan gained additional capital strength in the company's development, which is conducive to the company's further development and growth. But as a high-tech biomedical company, its basic operating mode has not changed. We will operate cautiously, be determined to innovate and keep a clear head in accordance with the basic laws of enterprise development, and build an enterprise that can bear the wishes of investors. "