Chinese drugmakers have demonstrated growing innovative prowess and made progress toward breaking into the foreign market in the past year, according to drug regulators and industry insiders.

The National Medical Products Administration said in a report released earlier this month that 40 Class 1 new drugs were approved in 2023, compared with 21 the previous year. Class 1 new drugs refer to those that have never been marketed in China or abroad.

Fifteen out of the 40 innovative therapies target cancer, and the remaining can be used in treating chronic hepatitis C, gastric acid condition, diabetes, psoriasis and other diseases.

The number of clinical trial applications for innovative drugs reached 2,997 in 2023, up nearly 34 percent year-on-year, and the number of applications for market approval rose to 470, a year-on-year increase of about 41 percent, the administration said.

"China's pharmaceutical research and development has shown strong innovation in 2023," it added in the report.

"With the accelerated development of the new round of technological revolution and continuous breakthroughs ... a new generation of treatments, such as cell therapy, gene therapy and small nucleic acid drugs, has become increasingly mature," it said.

Bi Jingquan, executive vice-chairman of the China Center for International Economic Exchanges and a senior political adviser, said China's biopharmaceutical industry has made great strides in the past decade, and its biopharmaceutical research and development pipelines account for 35 percent of the world total.

Moreover, 11 of China's domestically produced drugs have gained market approval in the United States in the past three years, while multinational corporations invest each year in an average of 30 R&D projects led by domestic enterprises.

The second half of last year saw several domestically produced innovative drugs gaining direct market authorization from overseas authorities, including approval from US drug regulators.

Junshi Biosciences said on Feb 1 that its immunotherapy drug Toripalimab has been approved by the US Food and Drug Administration for treating nasopharyngeal cancer, and the company has submitted approval applications to drug regulators in the European Union, the United Kingdom, Australia and Singapore.

The approval of Loqtorzi (the brand name of Toripalimab in the US) was "the first approval in the United States of a drug to treat nasopharyngeal carcinoma", said Richard Pazdur, director of the FDA's Oncology Center of Excellence, after the approval was announced on Oct 29.

On Nov 9, Shanghai Hutchison Pharmaceuticals said that its self-developed Fruquintinib, an oral drug for adults with metastatic colorectal cancer, was approved by the FDA.

The domestically produced drug was approved in China in 2018, and has benefited at least 60,000 patients. Plans to launch the product in Europe and Japan this year are underway, according to the company.

On Nov 11, Chinese company Yifan Pharmaceutical said that Ryzneuta, an injection used to treat the side effects of chemotherapy, was approved by the FDA.

Wang Xiaodong, director of the National Institute of Biological Sciences in Beijing, said during an event in Hong Kong in mid-November that China's innovative medicine development has reached a turning point, according to National Business Daily.

The R&D boom in China has resulted in a number of domestically produced, high-quality innovative drugs being added to China's medical insurance list, which has benefited many people, said Wang.

He added that the increasing involvement of Chinese drugmakers in the arena of drug innovation could shake up the industry and play a major role in the future.

Bi, from the China Center for International Economic Exchanges, suggested reforming the pricing strategies for innovative drugs to boost the confidence of drug developers, as well as removing barriers to innovative drugs being used at hospitals and promoting international cooperation in the biopharmaceutical field.

wangxiaoyu@chinadaily.com.cn

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