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Gilead Breaks Into China's HCV Market

|About: Gilead Sciences, Inc. (GILD), Includes: ABBV

GILD gains approval for Sovaldi in China.

Clinical trials for Harvoni and Epclusa are underway there.

Pricing and distribution methods were not disclosed.

In a positive move that might be material to a shrinking bottom line, Gilead (GILD) has announced good news out of China for the company and patients in China with hepatitis C infection:

...the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen... [which] account for more than 96 percent of all cases.

... Gilead is studying its HCV single-tablet regimens Harvoni® (ledipasvir/sofosbuvir) and Epclusa® (sofosbuvir/velpatasvir) at clinical trials sites across China, with the aim of providing important new treatment options to Chinese HCV patients.  

China has been developing a more extensive system of health insurance.

While analysts may be up on both of the key questions of pricing and how GILD will interact with one or more Chinese sales and marketing companies, I'm not aware of these stories at this point. Also to be determined are when Harvoni and Epclusa will come to market, and where Mavyret from AbbVie (ABBV) and other competition stand.

The press release talks about 10 million HCV patients in China. My research is that no one really has a good idea of the number. Different studies I have seen show widely varying prevalence rates.

Overall, this is a nice and long-awaited positive for GILD. The company has attempted sales in other countries such as South Korea, Taiwan and elsewhere, but has not commented on commercial success, which has apparently been scarce. Best of luck is wished on behalf of GILD and its shareholders, and most importantly the pool of infected people in China and elsewhere, in the curative treatments now becoming available.

Disclosure: I am/we are long GILD,ABBV.

Additional disclosure: Not investment advice. I am not an investment adviser.