12:24 PM
 | 
May 17, 2019
 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

How patient prevalence and market access could encourage companies to launch their drugs first in China.

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs.

The decision to do so will primarily be informed by patient prevalence and market access, according to six company executives who spoke with BioCentury.

For instance, companies developing drugs for diseases that affect more patients in China than in the U.S., or that have been highlighted as indications of interest by the Chinese government, have an incentive to dive into the China market head first.

Domestic innovators are the most obvious ones to take this route. But there’s reason to believe it will go beyond Chinese companies.

In December, San Francisco-based FibroGen Inc. became the first company to gain its first approval in China for a first-in-class drug. The National Medical Products Administration (NMPA) approved roxadustat, a HIF-PH inhibitor, to treat anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent (see “FibroGen’s Globetrotting”).

And while multinationals historically placed China in the late second wave or early third wave of approvals following Western countries and Japan, China is coming to the forefront, according to Zhi Hong, co-founder, president and CEO of China-based Brii Biosciences. Hong was previously an SVP at GlaxoSmithKline plc, where he led the Institute for Infectious Diseases and Public Health in Beijing (see Sidebar: “Lowering Barriers, Raising the Bar”).


Sidebar: Lowering barriers, raising the bar

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