China Greenlit Record Number of Innovative Drugs Last Year
Wu Simin
DATE:  7 hours ago
/ SOURCE:  Yicai
China Greenlit Record Number of Innovative Drugs Last Year China Greenlit Record Number of Innovative Drugs Last Year

(Yicai) March 19 -- Chinese authorities approved a record number of Class-1 innovative drugs, which refer to medicines that have not been sold either in China or abroad before, to go to market last year, as the country’s new drug approval mechanism becomes more streamlined and as investment in the research and development of new drugs climbs.

A total of 48 Class-1 innovative drugs, which include medicines with completely new chemical structures, novel biologics as well as those aimed at new therapeutic areas, were given the green light last year, a jump of 20 percent from 2023, according to the ‘2024 Drug Review Report’ recently released by the China National Medical Products Administration.

Over 70 percent of the 48 drugs were developed by Chinese pharmaceutical companies, and the rest were imported medicines making their debut in China, the report said. Nearly 40 percent of the new drugs were included in the country’s vast basic medical insurance scheme in the same year they were approved.

Lecanemab, the world’s first groundbreaking drug targeting the underlying causes of Alzheimer’s disease, was one of the medicines approved through priority review after being available overseas for a year, the report said.

The Center for Drug Evaluation has established technical evaluation standards for the treatment of Alzheimer’s Disease and is pushing for these new drugs to go through priority review processes to enable simultaneous approvals in China and other countries, the report said.

China was the first country to give the nod to the new Crovalimab injection, which treats the rare disease "paroxysmal nocturnal hemoglobinuria," even though it was developed globally. This shows that China is speeding up its drug review and approval system, and is focusing on urgently needed drugs and rare disease treatments.

Around 40 percent of the 48 drugs were new cancer medications, the report said. There were also several new drugs for endocrine and metabolic diseases developed by domestic and foreign pharmaceutical companies, as well as a domestic drug for the treatment of adult diabetic peripheral neuralgia and postherpetic neuralgia.

Of the 48 Class-1 innovative drugs approved, the number of chemical drugs and biological agents were almost equal. There are also three traditional Chinese herbal medicines making their way to market, the report said.

Since 2018, a total of 197 innovative drugs have been approved for marketing in China, with a steady increase each year, the report said.

Editors: Tang Shihua, Kim Taylor

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