Opening the gates in China

HCV competition in China shows how regulatory changes have leveled the field

A flurry of approvals of HCV drugs in China this year illustrates how the country’s regulatory reforms have leveled the playing field for multinational drug sponsors, who had been disadvantaged compared with domestic companies.

As part of the government’s decade-long campaign to catalyze development of innovative pharmaceuticals by domestic companies, CFDA had adopted policies intended to speed their review. At the same time, it erected hurdles that only foreign companies had to clear, potentially delaying approval of their products by years.

But China did not stop reforming, and the successive flood of modernizations at CFDA, coupled with the national government’s elevation of “healthy China” to a pillar of its policy, means that multinationals are seeing the playing field dramatically level, at least for now.

The effects are evident in HCV, where multinationals have leapfrogged a domestic biotech that expected to be first to market.

In 2015, Ascletis BioScience Co. Ltd. had thought the regulatory advantages it enjoyed as a domestic biotech might enable it to get its danoprevir to market as much as two years ahead of multinationals then at a similar stage of development.

“What’s remarkable is in the last 12 months how the China FDA have changed their regulations.”

Kevin Young, Gilead

But danoprevir remains under review, while five direct-acting antivirals from foreign companies have been approved since April. These include Daklinza daclatasvir and Sunvepra asunaprevir from Bristol-Myers Squibb Co.; Viekirax ombitasvir/paritaprevir/ritonavir and Exviera dasabuvir from AbbVie Inc.; Olysio simeprevir from Johnson & Johnson; and Sovaldi sofosbuvir from Gilead Sciences Inc.

The multinationals were helped by regulatory changes CFDA began to implement in December 2015, including an expedited review pathway for treatments for serious diseases with large public health consequences.

Additional reforms adopted after the HCV approvals are expected to clear the way for multinationals to get products approved on the basis of international datasets that include some data from Chinese patients, without the necessity for Chinese Phase III trials.

In addition, this June, CFDA became a

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