BeyondSpring CEO: China's New System Will Get Our Drug To Market Faster
The US/Chinese biotech expects speedier approval of its lead asset plinabulin in China thanks to the government's new drug approval policy.
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2017 may become a banner year for the China FDA as the agency officially joined the ICH process and began aligning more closely with the US FDA, approving over 25 innovative new drugs so far with an increasing focus on treatments for cancer, hepatitis and orphan diseases.
China's latest initiative to establish an innovation ecosystem replaces clinical trial site pre-certification with registration; also included are provisions allowing use of foreign data, strengthening data protection and providing conditional approvals of rare disease treatments.
Gesynta’s SEK190m ($20m) private placement allows its lead asset to enter Phase IIa studies for treating chronic inflammatory conditions in certain systemic sclerosis patients.