Chinese drugmakers are increasingly looking past the NMPA toward approvals in the EU, US, and Australia. Daphne Smyth of Veristat has watched this shift from the front row, guiding sponsors through the data gaps, bridging studies, and regulatory quirks that stand between a China-developed drug and a Western marketing authorisation. She spoke with DIA’s Global Forum about what’s driving the push, where it’s working, and the geopolitical undercurrents that could shape what comes next.

 

China has grown into the world’s second-largest drug producer across several dimensions: In 2025, the number of new drugs approved by the National Medical Products Administration (NMPA) reached triple digits for the first time, an increase driven primarily by domestically developed therapies, and the total annual transaction value of China-outbound licensing partnerships grew from approximately $52 billion to $138 billion. Morgan Stanley projects that annual revenue from Chinese-originated drugs could reach $34 billion by 2030 and increase to $220 billion by 2040.
Now, China’s pharmaceutical industry is growing into a new frontier: Seeking approvals for its domestic drugs outside of China, especially in the EU, US, and Australia.“What’s happening in China is a result of investment by the Chinese government,” explains Daphne Smyth, a global regulatory affairs expert who has served in various regulatory leadership roles over nearly three decades at Bayer, Labopharm Europe, ICON, and most recently at the scientific consultancy and CRO Veristat, in the Q&A below. “It has actively supported drug development, sciences, biotechnology, oncology, and medical development.”

“The question that interests me most is: What comes next?”

Global Forum: China is starting to branch outside its borders by seeking approvals in the EU and US for its own novel therapeutics. What is happening inside and outside China to drive this expansion?

Daphne Smyth: China’s expansion is becoming ever more apparent—and receiving more media attention. A few CROs have been actively working with Chinese pharma companies for several years now and in response to a notable increase in inquiries and interest in investigating approvals for their assets outside of China.

I’ve been in the industry for 35 years, so I led local APAC teams in previous lives. But I’d never been at the receiving end of China-developed products coming out of China. Initially, I assumed it was a bit of a unicorn, but this business has grown, and China clients’ interest in evaluation of potential approval paths for their drugs outside of China has grown.

What’s happening in China is a result of investment by the Chinese government. It has actively supported drug development, sciences, biotechnology, oncology, and medical development.

For example, a Chinese government five-year plan that completed in 2025 but contains long-term objectives to 2035 resulted in the establishment of massive biopharmaceutical hubs. And not only in places like Shanghai but also in neighboring cities. BioChina 2026 was held in Suzhou, which is about 40 minutes from Shanghai, and is a purpose-built science hub city with research, development, manufacturing, hospitals, universities, schools, and housing, all in one integrated environment.

We have heard there are many of these all over China; we saw for ourselves the development in Shanghai and in Suzhou for the BioChina 2026 event. Before I visited China there, I had not quite grasped the extent of the development.

 

Read the full article on the DIA Global Forum website