Gilead nabs Chinese nod for Sovaldi, eyeing world's largest hepatitis C patient base

Sovaldi pack shot
Gilead Sciences’ has received approval for Sovaldi from China's FDA, gaining a foothold in the world's largest hepatitis C market.

When Gilead Sciences cut deals for generics makers to sell its pricey hepatitis C cures in emerging markets at superdeep discounts, it left China out of the mix, saving it for itself. Now, as sales of its hep C franchise have gone soft in developed markets, it has gotten approval to market to China’s 10 million infected patients.   

The company announced Monday that China’s FDA has given the go-ahead in China for Sovaldi, the company’s first HCV medication, based on a China-specific phase 3 that showed the drug could treat 92% to 100% patients with genotype 1, 2, 3 or 6. Gilead also is examining single-tablet regimens Harvoni and Epclusa in the clinic at sites across China, hoping to gain approvals in the near future.

For China, hepatitis B already has long been seen as a big problem, with its infected population nearing 100 million, and until recently, authorities have channeled much of its resources in controlling that disease. But now it is trying to quickly address the emerging public health concerns over hepatitis C. While public education is still playing catchup, the CFDA has speeded up treatment approvals, putting applications on its priority review pathway. 

Bristol-Myers Squibb’s dual-drug regimen Daklinza and Sunvepra, just approved in April, became the first direct-acting antiviral agents approved in the country.  A pair from AbbVie, ombitasvir and dasabuvir, was approved at the same time as Sovaldi. And perhaps a more imminent threat to Sovaldi lies in Merck’s Zepatier, whose application for approval was accepted by CFDA last month. 

When Gilead launched Sovaldi in the U.S., its sky-high, $1,000-per-pill price aroused wide criticism. FiercePharma previously reported that Gilead started talks in 2015 with the Chinese government on pricing for Sovaldi ahead of its approval. That was on the backdrop of China being excluded from a deal that saw Gilead cut the drug’s cost to about $10 per pill that covers many emerging markets.

China’s estimated 10 million HCV patient base, as compared to the U.S.’ 3-4 million estimate by the CDC, is definitely more enticing. But as China is quite sensitive about prices, in order to reach a large enough population to compensate for sales losses in the U.S., Gilead will have to work out a careful pricing plan for those new hep C medications.

How Gilead will price Sovaldi in China is yet unknown, but the company has already found the person to accelerate its launch plans. Last September, it tapped former Roche China’s VP of corporate affairs and market access, Rogers Luo, as its new China GM. His task was pretty much laid out at that time: to “lead the build out of the commercial team across China to support the anticipated launches of Sovaldi, Harvoni, Epclusa and single agent TAF for HBV over the next several years.”

To support that effort, the company also quietly revealed earlier this year that it is building a new manufacturing site in the city of Hangzhou near Shanghai.

In the U.S., even though Gilead returned a better-than-expected $2.86 billion from its hep C business in the second quarter after sales plummeted consecutively in 2016, it is facing even more competition in the form of AbbVie’s recently approved Mavyret, which requires shorter treatment time—eight weeks vs. 12 weeks—and more importantly, a cheaper price tag.