Domestic novel drugs R&D makes headway

Development of innovative drugs in China has gathered momentum in recent years thanks to ramped-up research spending and rollout of policies that facilitate international collaboration and market authorization, said experts and industry insiders.

Bi Jingquan, chairman of the China Center for International Economic Exchanges, said during an event held in Suzhou, Jiangsu province, this month that China has become a key player in global drug innovation.

"From 2015 to last year, China has granted market approval for 451 types of innovative drugs, with about one-third of them developed by homegrown companies," he said.

Bi added that there are about 13,500 drugs undergoing clinical research around the globe, and about 35 percent of them have either been initiated by Chinese drugmakers or have seen their engagement.

In the past three years, the number of deals that license out domestic innovative medicine projects overseas — generally viewed as a sign of research capacity — has also increased significantly, he said.

Citing data released by the online data platform Pharmcube, Bi said that there were 96 out-licensing deals generating a total of $42.1 billion in 2023, compared with 45 deals leading to $14 billion in 2021.

"Since 2019, 11 domestically-developed drugs have obtained breakthrough therapy designation from the Food and Drug Administration in the United States and another 11 have obtained market approval in the US," he added.

Affordable access to innovative drugs has also become much more prompt as it now takes an average of around a year for an innovative drug to be included in the national healthcare reimbursement list, down from five years in 2018, said Bi.

Ren Jinsheng, founder and chairman of Simcere Pharmaceutical Group, said during an event held in April that China has unique strengths in innovative drug development, such as high efficiency of its medium-to-high level technical personnel, its rich stocks of clinical cases and lower costs of clinical research.

Citing his own company as an example, Ren said that since 2020, the company has created four innovative drugs and is expected to see five more obtaining market authorization in the next two years. "The company will keep dedicating 20 percent of its sales revenue to research and development," he said.

Hong Chow, executive vice-president and head of China and international businesses at Merck Healthcare, said that she sees plenty of opportunities for collaboration with domestic companies in the area of healthcare innovation.

"Last year, we closed two licensing deals with Chinese companies, one with Hengrui Pharmaceuticals and the other one with Abbisko Therapeutics," she said. "By doing that, we not only will benefit Chinese patients, but also take Chinese innovation to the global stage to benefit globalization."

Chow said that drug discovery is a high-risk project with a success rate of merely 5 percent, and one challenge confronting pharmaceuticals is the risk of their research data being rejected due to inconsistent drug regulations.

"Luckily, China became a member of the management committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, so there's continuous harmonization with international standards," she said.

Chow added that China has progressed from making the so-called "me-too" drugs that are similar to an existing treatment to "me-better" drugs that have superior efficacy or safety, and the nation is pushing for original innovation.

Bi of the China Center for International Economic Exchanges said that many homegrown innovative drugs at present are of the follow-on or imitative kinds.

The relatively low pricing of innovative drugs and low willingness of hospitals to make procurements have hampered enthusiasm of innovative drug developers and investors, he added.

Ren said that it is important to prioritize projects that are of high quality and original innovation, as well as promoting cooperation across the private sector, research and clinical centers and universities.

Contact the writers at wangxiaoyu@chinadaily.com.cn