R&D Executives Seek China Role In Clinical Development
What excites R&D heads and executives when it comes to China? Regulatory reforms, certainly, but emerging technologies including AI could position China for a bigger play, going by discussions at a recent forum that saw AstraZeneca, Sanofi, Beigene and Jiangsu Hengrui executives debate future biopharma development in China.
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2019 was the year that China approved the first new drug for Alzheimer's in nearly two decades and for the first US approval of an original cancer drug from China. While the simmering US trade war has been addressed by a phase one agreement to be signed, other uncertainties marked a year dominated by a large vaccine scandal and resulting bankruptcy, and increasing calls to include China in global clinical development plans.
Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home.
Once the world's factory, China has seen costs inch up while drug prices are being cut deeply by centralized procurement schemes. As uncertainties mount, companies need to focus on improving process and scale-up technology, suggested industry observers at a JPM panel discussion on innovation and market access challenges.