2016 was again another busy year on the commercial front in China, with market changes, new regulations, and ongoing pricing pressures all affecting the pharma sector. Meanwhile, the push for licensing deals, innovation, and international expansion continued apace.

The China National Biotec Group has filed the first application in China for the broad use of a COVID-19 vaccine, days after the national regulatory agency released review guidelines for the conditional approval of such products.

Increasingly looking to China to commercialize their latest therapies, multinationals may be leaping into unknown waters to navigate an intellectual property judiciary and administrative maze, in a country where some copy drugs have been approved before patent expiry. With a government trying to balance innovation and access, two recent rulings involving AstraZeneca shed rare light onto China’s protections for innovation, with advisors pointing to challenges and success factors.