1, unlisted drugs at home and abroad. The breakdown is as follows:
(1) raw materials prepared by synthetic or semi-synthetic methods and their preparations;
(2) New effective monomers extracted or fermented from natural substances and their preparations;
(3) optical isomers of known drugs and their preparations prepared by methods such as resolution or synthesis;
(4) Preparing multi-component drugs that have been marketed into drugs with fewer components;
(5) New compound preparation;
(6) The preparations that have been listed in China have added new indications that have not been approved at home and abroad.
2, change the route of administration and has not yet been listed and sold at home and abroad.
3. Drugs that have been listed abroad but not listed in China. The breakdown is as follows:
(1) preparations and their raw materials that have been listed abroad, and/or preparations that change the dosage form but do not change the route of administration;
(2) Compound preparations that have been listed abroad, and/or preparations that change the dosage form but do not change the route of administration;
(3) Preparations that have changed the route of administration and have been listed abroad;
(4) The preparations listed in China have added new indications that have been approved abroad.
4. Change the acid radical, alkali (or metal element) of the listed salt drugs, but do not change their pharmacological effects and preparations.
5, change the dosage form of drugs that have been listed in China, but do not change the route of administration.
6 raw materials or preparations with national drug standards.
Extended data
Chemical pharmaceutical preparation industry has always been the dominant sub-industry of China's pharmaceutical industry, with the characteristics of high technology content, high capital investment, high risk, high income and relative monopoly. From the value chain point of view, chemicals are at the high end of the value chain, and the order of increasing value is generic drugs and patented drugs, and patented drugs are at the top of the whole value chain.
Chemical preparations are related to national health, social stability and economic development, and are a special and important industry in the national economy. Since the reform and opening up 30 years ago, China's chemical preparation industry has entered a fast lane. In recent years, the growth rate of total industrial output value has remained above 18%, and the growth rate of sales revenue has basically remained above 20%.
From the development trend, the chemical preparation industry is about to enter a period of rapid development, and there is huge room for future development, but the profit distribution will be more uneven and the industry concentration will be further improved. Enterprises with R&D, scale and product advantages will become stronger.
China's chemical industry has fully developed into a competitive industry, and its international influence has also improved. In Chinese mainland, the market competition between foreign-funded and joint-venture pharmaceutical enterprises and domestic pharmaceutical enterprises is fierce. Especially in the last two or three years, the investment of foreign-funded and joint-venture pharmaceutical enterprises in China has greatly increased, and their market strength has been enhanced.
By the end of 20 1 1, there were 1032 chemical preparation enterprises above designated size in Chinese mainland. After rapid development and fierce market competition, the basic pattern has taken shape. Foreign-funded and joint-venture pharmaceutical companies occupy the high-end market of chemicals in China, but domestic brands are gradually entering the high-end market.
Baidu Encyclopedia: Chemicals