Domestic drug R&D makes positive strides

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

Bi Jingquan, chairman of the China Center for International Economic Exchanges, said at an academic conference in Suzhou, Jiangsu province, last month that China has become a key player in global drug innovation.

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

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

Citing data from online data platform Pharmcube, Bi said there were 96 out-licensing deals, generating a total of $42.1 billion, last year, compared with 45 deals worth $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, Bi said.

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

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 obtain 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 German multinational 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 just 5 percent, and one challenge confronting pharmaceutical companies 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 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 innovation.

Bi said that many innovative domestic drugs at present are of the follow-on or imitative variety.

The relatively low pricing of innovative drugs and low willingness of hospitals to participate in procurement have reined in the enthusiasm of innovative drug developers and investors, he added.

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

Contact the writers at wangxiaoyu@chinadaily.com.cn