Huaguan Investment Advisor Chen Xiufang said investors often wonder why biotech stocks will rise as long as new drugs succeed in curing blindness?
Today, I will help you analyze: the 5 major processes of new drug research and development can be understood at the same time
On December 21, 2021, the Legislative Yuan passed the draft amendment to the “Regulations on the Development of Biotechnology and the New Drug Industry” in the third reading, and amended the name of the bill to “Regulations on the Development of the Biotechnology and Pharmaceutical Industry” This is a major milestone in the development of my country’s biotechnology and pharmaceutical industry. The main purpose In order to encourage advanced medical care, cross-disciplinary collaboration, promote “OEM” and research and development, strengthen the incentives for talent retention and talent acquisition, and finally attract private capital investment, it is hoped that a biotechnology industry and Taiwanese pharmaceuticals are booming again.
Most investment friends still have little understanding of the new drug research and development process. Analyst Chen Xiufang said that the main reason is that there are too many proper names for investment friends to read “Fog Shasha”. Next, I will explain to friends investing in simple folk that is applied for New drug R&D There is also drug discovery and pre-clinical trials before the IND.However, this article only describes the process after the submission of the application for clinical trials of new drugs.
Generally speaking, the following new drug research and development process is gradual. Unless there are special circumstances, the competent authorities of different countries will handle it on a case-by-case basis, but this article only explains the general situation . IND review is passed, clinical phase 1 can be entered, and clinical phase 1 can be unblinded successfully. Only after clinical phase 2 is entered, clinical phase 3 can be entered after successful unblinding of clinical phase 2. cleared, and only after the phase 3 clinical blinding has been successfully cleared can the NDA be recorded, and then the drug can be marketed and sold.
1. New Drug Application (IND):
For research and development of new drugs to conduct human clinical trials, it is necessary to apply to the competent authority for review and approval.to enter human clinical trials.
2. Clinical Phase I (Phase I):
Taking healthy volunteers (without disease) as the test subjects, it is mainly used to observe the safety and pharmacological effects of drugs on the human body.
To put it simply, what kind of side effects and vital signs will be abnormalities in healthy people after using the drug?
3. Clinical Phase II (Phase II):
First, small-scale patient trials to examine the safety and efficacy of the drug, and then design a Phase 3 clinical trial scale based on the trial results.
This step is simply to test whether the drug can effectively treat the target disease with a small number of patients.
4. Clinical Phase III (Phase III):
Expand the scale of the second phase of the clinical trial, increase the number of patients for the test, mainly to confirm the efficacy and safety of the drug, and finally judge the efficacy and safety of the drug through strict statistical analysis.
This step is simply to expand the number of patients to conduct trials, and verify the effectiveness of the drug through statistical validation and analysis of the data.
5. New Drug Investigation (NDA) Registration:
After the new drug has been successfully cleared by Phase 3 clinical trials, it can apply to the competent authority for a new drug marketing license, and the drug can be marketed and sold after the competent authority has examined it and to approve.
Investment friends all know that the research and development time of new drugs is very long. It is not an exaggeration to describe it as a sword for ten years. Moreover, the company needs to invest a lot of money, but once that the new drug will be Successfully launched, it will bring significant profits to the new drug company. This is also the reason why the stock prices of new drug companies that have new drugs to relieve blindness or obtain drug licenses performs well.
I hope the above brief description of the new drug research and development process can help investment friends who want to invest in new drug companies.
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References: Science Monthly, Vol. 44, No. 2, Zhongrong Medical News – Clinical Trial Special Issue (No. 124)