China's booster shot for drug innovation

Ensuring oversight

Sun Hao, a lung cancer specialist at the Guangdong Provincial People's Hospital, said clinical studies in China are moving at a faster pace than in many other countries. In global multicenter trials, data from Chinese sites often come in substantially earlier.

Sun said regulators have been stepping up oversight to keep pace with the accelerating R&D activity.

In June, the country issued a new edition of the Good Clinical Practice for Drugs guidelines, placing greater emphasis on defining clear boundaries of responsibility, risk identification, and quality management throughout trials.

In May, the nation released a data protection regulation for drugs — an important component of the pharmaceutical innovation framework. The document provides a six-year protection period for clinical trial data on innovative drugs.

"In the field of lung cancer, the volume of research focused on the Chinese population already ranks first in the world," Sun said. "Looking ahead, it is expected that both the market and the primary impetus for drug development will increasingly originate from China."

Huang Huiqiang, a professor at Sun Yat-Sen University Cancer Center, said the growing number of oral presentations delivered by Chinese researchers at international meetings reflects increasing recognition from the global medical community.

He said that for homegrown companies seeking overseas expansion, challenges persist — including high clinical trial costs abroad and a lack of familiarity with foreign markets.

"It is important to recruit talent familiar with overseas drug manufacturing and regulatory rules, and build cooperation with foreign companies for long-term development," he said.

wangxiaoyu@chinadaily.com.cn