In June 2007, the hot summer days were coming. After years of hard work, the company finally received a fruitful result -- recombinant human parathyroid hormone (1-84) (PTH (1-84) was approved by the state food and drug administration (FDA) as a new drug for therapeutic biological products. The clinical approval also means that the company has been committed to the original development of biomedicine for many years. Under the circumstance of the reorganization of the pharmaceutical industry and the increasingly fierce competition of biomedicine, this valuable clinical approval document is bound to add a great deal of color to the development of the company.
As we all know, osteoporosis is a common and frequent disease in the population. With the aggravation of population aging, the incidence of osteoporosis is on the rise. Currently, it has jumped to the seventh place, posing a serious threat to human health. Osteoporosis is a disease of systemic bone metabolism disorder, which is caused by the damage of bone microstructure, the proportion of bone mineral composition and bone matrix, the thinning of bone, the decrease of trabecular number, the increase of bone brittleness and the increased risk of fracture. The main clinical manifestations are pain, shortening of body length, hunchback, fracture, and decreased respiratory function. The prevalence was 60.72% in males and 90.47% in females. The recombinant human parathyroid hormone (1-84) developed by our company can effectively treat osteoporosis, and preclinical studies have shown that it is more effective in increasing bone mass than any other treatment currently used in clinical practice. Compared with similar osteoporosis drugs on the market, PTH(1-84) can not only inhibit the vitality of osteoclasts, but also stimulate the formation of osteoblasts, increase bone mass, restore bone structure and fundamentally treat osteoporosis. These remarkable effects are unmatched by any other osteoporosis drugs and bring good news to the vast number of patients suffering from osteoporosis.
It is well known that the successful development of new drugs requires huge human and material investment and is known for its long development cycle and high risk. Of course, the development of biomedical products is no exception, even because of the higher technology content, it is more difficult. It is an accepted fact that it takes 8-10 years and $500m - $800m to develop a new drug. One can't tell from this simple number that the risks are significant even for big international drug companies. My company to play their own advantages to build the e. coli expression soluble fusion technology research and development of recombinant human parathyroid hormone, and on the amino acid composition and natural parathyroid hormone, with independent intellectual property rights, to fill the domestic blank in this field, both in technology and has a great innovation in terms of industrialization. The success of the development of this project reflects the firm determination of the company from the leadership to the ordinary staff to promote the project, as well as the technical advantages accumulated by the company in the field of biomedicine. At the same time, the image of the company's r&d team has been better established, and the influence and popularity of the company in the industry have been enhanced. Reviewing the whole process of project development, from project investigation and approval, upstream construction, fermentation expression, downstream purification, animal experiment to the final clinical application, each work is full of challenges, and each member of the team is not afraid of difficulties, the process of hard work. Today, we have obtained the clinical approval from the state food and drug administration, which proves once again the simple truth that hard work always pays off.
Experts predict that biotechnology, as a high-tech frontier in the 21st century, will become a pillar industry of the world economy. In many countries, biotechnology has been listed as a national priority for the development of strategic focus, biotechnology is no longer a simple slogan, the 21st century is the century of biology is getting more and more common recognition. As an important branch in the field of biotechnology, biopharmaceutical is closely related to human health. Compared with traditional pharmaceutical technology, biopharmaceutical has incomparable advantages in many aspects, such as security, targeting, effectiveness, etc., so it has attracted wide attention from various countries. With the completion of the human genome project, it is possible to elucidate the mechanism of many diseases that seriously endanger human health, and then develop effective therapeutic drugs. From the human genome project, to the proteome, to the functional proteome research, scientists are demonstrating the great charm of biotechnology to benefit mankind with practical actions. At present, China follows the development of the international situation and increases the investment in biotechnology, which indicates that biopharmaceuticals will have a better future.