Insilico's AI drug hits Phase 3, and China is the reason

Alex Zhavoronkov, co-CEO of AI drug discovery startup Insilico Medicine, wears a black padded vest with a small white badge that counts the company's clinical pipeline. When Fortune sat down with him in Hong Kong in July, he pointed to a new circle beside "Phase 3" - the mark of rentosertib, Insilico's drug for idiopathic pulmonary fibrosis, a fatal lung-scarring disease. Insilico used AI to identify the disease target and design the molecule, claiming it's the first such AI-discovered drug to reach large-scale clinical trials. The first patient was dosed on Sept. 10, and the company is running the trial in China, a choice Zhavoronkov attributes to the sophistication of Chinese regulators. "They brought in a lot experts, and it felt as though they knew my drug better than I did," he said. "That shows you something about the Chinese regulators: They knew not only my drug, but all the other drugs." After 2015, China grew its reviewer corps by ten times to clear a backlog, and average drug review times fell from 900 days before the reforms to 300 by 2019. "In China, they look at the big picture," Zhavoronkov added, noting Chinese regulators focused on measurable survivability improvements and accepted some safety uncertainty. "The Chinese regulators understood the mechanism and the novelty, and they gave us a roadmap."