SHANGHAI, July 11 (Xinhua) -- Swiss pharmaceutical giant Novartis is expanding its research and development of innovative drugs in China, an executive of the company said.
Novartis is expected to submit 50 new drug applications for regulatory approval in China between 2019 and 2023, John Tsai, head of global drug development and chief medical officer for Novartis, said during an interview with Xinhua.
Benefitting from China's pharmaceutical regulatory reform, which enables pharmaceutical companies to develop drugs much faster, Novartis has received 24 approvals for new drug applications in the country in the last two years, including nine new molecular entities, according to Tsai.
One of the new drugs that will be available in the Chinese market is an orally taken asthma drug, which is described by Tsai as unique because most of the drugs for asthma are not taken orally.
Tsai said the respiratory disease is one of the top five diseases in China. The company will report the results of a 5,000-patient study for the drug before the end of the year.
"We've seen significant advancements in China's development process through the regulatory reform," Tsai said.
He took the timelines for clinical trial application as an example. The approval which used to take up to three years in China can now be shortened to three months.
"The speed is similar to other countries now. This would potentially allow the same drug development in China as the rest of the world in terms of timelines," Tsai said.
The company established China Novartis Institutes for BioMedical Research in Shanghai in 2006.
China's National Medical Products Administration approved 18 new cancer medicines in 2018, up 157 percent from 2017. The approval time for new cancer drugs has been cut in half by 2018, with an average of 12 months.
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