5:27 PM
Dec 01, 2017
 |  BioCentury  |  Strategy

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 member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which among other things will mean the agency can no longer give preferential treatment to local companies.

More reforms could be in the offing as the National People’s Congress in August elevated national health as one of the pillars of government policy and noted that “Healthy China 2030” would be underpinned by innovation and scientific development.

Three consultants contacted by BioCentury expect these regulatory changes will result in a wave of multinationals gaining expedited review in China for novel agents.

According to their analysis, multinationals should account for the lion’s share of new drugs in China for three to five years, after which they expect the domestic sector to catch up as companies add to and advance their innovative drug pipelines and newcos continue to be formed.

Early advantage

In 2015, Gilead and Ascletis were both seeking approval to begin Phase III trials of their HCV candidates in China.

Ascletis did not respond to interview requests in time for this story. But in 2015, the company told BioCentury danoprevir would be the first direct-acting antiviral (DAA) to market in China because the biotech had access to an accelerated pathway for clinical trial authorization nicknamed the Green Channel. The pathway had been known to cut the review time for a clinical trial application (CTA) to as little as six months, compared to the average 30 months.

Additionally, in 2014, CFDA had added a step in the regulatory pathway for multinational companies that required them to submit an additional CTA prior to submitting an NDA or BLA. As a result, multinationals needed a total of three applications and approvals, compared with two for domestic companies.

In total, Ascletis expected it would take Sovaldi two years longer than danoprevir to reach the market.

“As these more recent reforms have been implemented, multinationals have more advantages.”


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