Economic Observer reporter Zhang Ying

How to manage innovative drug BD transactions well requires respect for science and laws, cautious policies, and must not create the impression that the United States is blocking and chasing the market while we ourselves are stuck. ”At the 2026 Pharmaceutical Innovation Policy Forum on May 29th, Song Ruilin, Chief Expert of the China Association for the Promotion of Drugs, said that if the balance between management and development is not handled properly, there will be huge difficulties in China's pharmaceutical innovation in the future.

Morgan Stanley predicted in 2025 that by 2040, the proportion of new drugs approved by the US Food and Drug Administration will reach 35% from China. Song Ruilin said that this will be a historical process of rewriting the competitive landscape, and in the future, China will achieve global leadership in some cutting-edge tracks, one of which is innovative drugs.

He said that in the face of the rapid development of innovative drugs in China, the United States has both pursued and blocked them. The United States' pursuit includes using China as a benchmark to improve the timeliness of clinical trial review, such as reducing the number of participants in phase III clinical trials and empowering the evaluation of clinical trial quality and effectiveness through AI.

The blockage in the United States includes the Biosafety Act, which will be implemented in 2025, restricting US government agencies from signing contracts or providing funding to "concerned biotech companies," as well as recent proposals by US House of Representatives not to recognize clinical trial data from China.

However, Song Ruilin believes that the above-mentioned proposal by US lawmakers is actually difficult to implement, as it would be like sending a big gift to Europeans. European companies can adjust their clinical trial strategies, continue to conduct BD transactions with innovative Chinese drugs, bypass US restrictions, and achieve global drug launches and seize the market, ultimately affecting the interests of US companies.

Recently, there has been a heated discussion in the pharmaceutical industry, and relevant Chinese departments may impose review and other procedures on innovative drugs going global. Song Ruilin believes that even if there are relevant actions, they should still be in the early stages of discussion. He believes that when discussing relevant policies, the real reasons for the surge in BD transactions of innovative drugs in China in recent years should be carefully evaluated. Is it China's mastery of core technologies for global innovation that has formed hard power, or is it relying on high efficiency in clinical trials to form advantages.

From the existing BD projects, the achievements of our country mainly come from the efficiency value generated by our speed in clinical research and subject enrollment, as well as the reduction of labor costs, rather than having exclusive research and development technology advantages. ”Song Ruilin said.

He mentioned that under the current geopolitical pressure, BD transactions have become the main source of financing for innovative drugs in China, and also a development stage that China's pharmaceutical innovation internationalization must go through. If there is a need to manage BD in the future, in-depth, objective, and cautious analysis and research should be conducted to create a favorable development ecosystem for pharmaceutical innovation; We should trust the wisdom of relevant government departments to achieve the goal of building biopharmaceuticals into an emerging pillar industry as determined in the national '15th Five Year Plan', and ultimately find a balanced solution to give the market a stable development expectation