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introduction
Regarding new drugs, we often hear about concepts such as Me-too, Me-better, and Me-copy.
They are both new drugs, and they are also good and bad.
Their development difficulty, research and development costs, and market value are different
.
The author organizes these concepts of new drug types here for your reference.
1.
FIC
FIC (First in Class) is a first-in-class drug , which refers to the step-by-step synthesis of candidate compounds from scratch by searching for new drug targets, mechanisms of action and molecular structures.
(tolerability, pharmacokinetics) required drugs
.
The research process can be described as looking for a needle in a haystack, with a large investment and a high failure rate, but once successful, it will be a major breakthrough in the field of drug therapy, and the benefits will be huge.
2.
Tracking new drugs
Me-too, Me-better, Best in class drugs refer to the modification of the molecular structure of FIC to obtain drugs whose molecular structure is different from that of FIC, but similar in efficacy
.
Since such drugs are researched and developed on the basis of first-in-class new drugs, this new drug development model has also become a fast-track new drug model
The research and development of innovative drugs in China can be divided into the following four steps [3].
First, the transformation from "imitation" to "innovation" starts from the development of "Me-too".
For example, Hengrui Medicine's erecoxib is "Me- too" drugs; the second step is "Me-better", which is a secondary innovation based on the original NCE structure.
Although it has the characteristics of structural imitation, it also creates its own unique advantages.
The icotinib of Zhejiang Betta Pharmaceuticals, known as "Resa", and the apatinib of Hengrui Medicine, whose anti-tumor effect is superior to the similar drug PTK787 (jointly developed by Novartis and Schering, Germany), belong to such drugs ; The third step is "Best-in-class" (BIC), which is a stronger "Me-better", such as Pfizer's Lipitor; the fourth step is "First-in-class" (FIC) drugs, that is Brand-new compounds and new targets are also new.
The research and development of such drugs is extremely risky, but there are also many successful ones.
Artemisinin, which won the Nobel Prize, belongs to this category
.
3.
The main approaches of new drug research and development in my country
At present, the level of innovative drugs in China is mainly in the stage of imitation-based to combination of imitation and innovation, and there are certain differences from overseas
.
Most of the innovative drugs in overseas markets are of the first-in-class category, enjoying high returns under high costs and high risks.
Epilogue
Although the current level of innovative drug research in China is still far from the world, but with the accumulation of domestic pharmaceutical companies for many years, the continuous introduction of overseas outstanding innovative drug talents, the domestic pharmaceutical companies' innovative drug research and development capabilities have gradually upgraded, and they have high-quality innovative drug research and development capabilities.
The number of enterprises has gradually increased, and the gap with foreign excellent enterprises has gradually narrowed
.
From a quantitative point of view, in recent years, domestic innovative drugs (1.
