China Small Molecule Innovative Drugs Industry Trends to 2022

An innovative drug, also known as an original drug, is a concept compared to a generic drug, and refers to a drug that is developed from the source from the mechanism, has its own intellectual property rights, has complete and sufficient safety and efficacy data as the basis for marketing, and is approved for marketing for the first time.

According to the conventional process of drug development, the entire development cycle of a drug from the identification of the target to the final approval for marketing usually takes more than ten years. After the patent protection period has expired, it is then heavily copied.

NewMoleculer Entity (NME) and Biologic License Application (BLA) are both considered innovative drugs for the purposes of the US Food and Drug Administration's (FDA) review criteria.

A new drug that has not been marketed in China or abroad and has clear clinical application and advantages

In China, new drugs are defined as drugs that have not been marketed and sold in China according to the Drug Registration Administration Measures introduced in 2007.

In March 2016, the State Drug Administration issued the Announcement on the Reform of Chemical Drug Registration Classification, which divided new chemical drugs into innovative drugs and improved new drugs, of which innovative drugs are those containing new structurally clear compounds with pharmacological effects and with clinical value.

In July 2020, the State Drug Administration also issued the "Classification of Biological Products Registration and Reporting Requirements", which classifies therapeutic biological products (biologics) into innovative biologics, modified biologics and biologics already listed in or outside China.

According to these two documents and the current development status of the domestic innovative drug industry, Class 1 and Class 2 chemical drugs and therapeutic biologics can be classified as innovative drugs.

China has entered an "innovation-driven" phase and is moving towards "global newness

China's new drug research and development has gone through three stages of development.

From the founding of the People's Republic of China to the end of the last century, China's drug research and development was at the stage of following and imitating (Copy), and the drugs available on the market were mainly low-cost generic drugs and general drugs.

Since 2015, with the introduction of a series of policies to encourage the creation of new drugs, improve drug quality and promote industrial upgrading, China's drug research began to move towards the original innovation stage.

The innovative drugs that have been approved since then have gradually moved closer to the direction of original research and innovation in the true sense of the word, and have begun to benchmark themselves against the best-in-class or first-in-class varieties, moving in the direction of "global newness".

The development of innovative drugs has started to enter the stage of concentrated explosion

Since 2018, the State Drug Administration has accepted and approved the listing of 64 innovative drugs (excluding traditional Chinese medicine and vaccines), with the number increasing year by year, and the indications are mainly anti-tumour and immune drugs, drugs for the nervous system and drugs for the digestive system.

2021, the number of approved domestic innovative drugs will reach 30, including 24 chemical drugs and 6 biological drugs, including 17 anti-tumour drugs and 7 anti-infective and anti-viral drugs.

In 2021, a total of 501 clinical trials related to innovative drugs will be registered by the National Drug Review Center, including a total of 106 phase III clinical trials. In the next 3-5 years, China's innovative drug launches will usher in an explosive phase.

The number one cause of death in China, cancer, for example, is currently the world's leading cause of cancer incidence and mortality, with 21 Chinese people among every 100 new cancer patients worldwide.

Among them, lung cancer is the cancer with the highest incidence rate in China. However, clinical treatment for lung cancer is still limited, especially for small molecule targeted therapies for advanced treatment, with few options and high prices, resulting in a deep medical burden for patients.