Why did the three types of innovative medicines approved by the three types of 1 type of innovative medicine?
Author:Hubei Daily Time:2022.09.22
Hubei Daily All -Media reporter Zhang Zhenzhen Liu Jie Correspondent Kong Na Chen Peng
Innovative medicine is known as the "pearl in the crown" in the pharmaceutical industry. Within three years, the three new categories of national new drugs that represent the highest level of new drugs have been listed on the market.
How difficult is the development of innovative medicines? There are three "ten" claims in the pharmaceutical industry: ten years of research and development cycle, investment of 100 billion, only 10%of the success rate.
"From the project to approval from the project to be approved from the project to be approved for 21 years. Although there are too many twists and turns in the middle, I have never shaken it. Li Li'e, chief engineer of the group.
A road from "0" to "1"
Guang Qiancao was launched in "Lingnan Cao Yao Zhi", "Modern Miao Yongqi is called money grass, and the treatment of bladder stones is very strange." But what components are strange, it is not known.
Through 6 pharmaceutical tests, the researchers found that the total flavonoids in Guangqi Grass had the functions of diuretic, stones, anti -inflammatory, and analgesic. Name and structure.
There are many Chinese medicine components and many effects. A single component is often difficult to evaluate the quality of Chinese medicine products. To this end, the research team has selected five of the above -mentioned valid ingredients with high representative and high content as the quality standards for the drug extract and preparation.
Given that few people did such research before, there were 4 types of components that could not be bought.
If you ca n’t buy it, you can extract it yourself. The structure and polarity of these four ingredients are very close, and it is very difficult to separate and purify, but after unremitting efforts, it was finally successfully extracted and the "one test and multiple evaluation" method was developed.
"We have determined the content of the five ingredients. After that, the total flavonoid drugs are detected, and only one of the ingredients is measured to know the content of the other 4 types." Feng Yun, the person in charge of the Chinese Medicine Institute of Renfu Pharmaceutical and Medicine Research Institute, said Essence
According to the requirements, the standard of the 1 -category Chinese medicine innovative medicine is less than 1.2%. I haven't left the laboratory for more than 70 hours.
In the end, the team spent 2 years and controlled the burning residue content to about 0.7%.
"Each step is from '0' to '1', and I have a hard trip to develop an innovative drug research and development." Li Li'e said.
R & D investment annual increase of more than 10%
Three years of three -type 1 type of innovative medicines are listed.
"To develop innovative medicines, you must sit in a cold bench, resist loneliness, and eat hard." Li Li'e said.
Renfu Pharmaceutical has been invested in R & D and innovation for more than one billion yuan for many years, without any results, but it has not affected the investment in the development of new drugs on the development of new drugs.
"From the project to approval from the project to the approval, the Guang Money Capylus Capsule has a 21 years, which reflects our determination and determination of firm innovation and development." Li Jie, chairman of Renfu Pharmaceutical Group, said.
In the first half of this year, Renfu Pharmaceutical R & D invested 420 million yuan, an increase of 12.51%in the same period. In 2019, 2020, and 2021, the R & D investment of Renfu Pharmaceuticals was 760 million yuan, 940 million yuan, and 1.05 billion yuan, respectively, accounting for more than 10%of the company's pharmaceutical industry revenue, and the annual growth investment increased by more than 10%. In 2021, Renfu Pharmaceutical also established an Innovation Drug Research Institute in the framework of the Group Medical Research Institute to focus on innovative drugs and high -end generic drugs.
In addition to high investment, Renfu Medicine also attaches great importance to the introduction of talents. It only introduced nearly 100 people in high -level talents last year alone. At present, the company has more than 1,700 R & D personnel, including more than 190 doctors, more than 850 masters, and the number of R & D personnel accounted for 11%of the company's total.
"The talent echelon of the" four -in -one "research and development system for professional people to do professional things. For example, the four stages of research and development of new drugs such as research, development, clinical research, and registration are all done by professionals." Li Jie said. Essence
More than 20 innovative drug projects in the research type 1
Relying on the leading role of talents, Renfu Pharmaceutical has created a number of innovative R & D technology platforms such as innovative small molecular drugs, oral jacquard control, transparent administration, special drug anti -abuse, oral mucosa administration, long -acting micro -ball and liposcopic body It also establishes cooperative relations with more than 30 scientific research institutes and institutions such as the Institute of Process Engineering of the Chinese Academy of Sciences, Tsinghua, Peking University, Fudan, and Wuhan University to promote the transformation of innovation results.
At present, there are more than 200 research products in Renfu Pharmaceutical, more than 20 new drugs in the research, and 24 projects are listed as a major national new drug creation project. The approval article, 40 exclusive product products, 319 products enter the 2021 version of the national medical insurance directory, and 142 products enter the 2018 version of the national medicine catalog.
Among them, a type of biopharmaceutical reorganization of plasmids-hepatocyte growth factor injection is being promoted to phase III clinical; a type of chemical drug RFUS-144 injection solution, and a type of Chinese medicine Bai Jesha Pills were approved to conduct clinical trials. Humanfu Pharmaceutical is expected to be listed in the three major areas of chemical drugs, Chinese medicine and biopharmaceuticals, to achieve the research and development innovation pattern of innovative drugs, first imitation drugs and other imitation drug echelons.
The "Crown Pearl" of Innovation Medicine, Renfu Medicine is ready to go.
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