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Working for A World Free from Hepatitis C, Sovaldi® Officially Launched in China

– Gilead’s First Pan-Genotype Chronic Hepatitis C Oral Antiviral Drug –

Beijing, China -- November 25, 2017 --Gilead Sciences Inc. (NASDAQ: GILD) announced today that Sovaldi® (Sofosbuvir 400mg), the world's first chronic hepatitis C oral antiviral drug for genotype 1, 2, 3, 4, 5 or 6 is officially made available in China. Sovaldi® is approved for the indication for the treatment of adults infected with pan-genotype HCV and adolescents (aged 12 to 18 years) infected with genotype 2 or 3 as a component of a combination antiviral treatment regimen, and provides simpler treatment options for patients. The official launch of Sovaldi® also marks the first public appearance in China of Gilead Sciences, the world's leading biopharmaceutical company.

“Since its inception, Gilead Sciences has been committed to exploring innovative therapies in areas of unmet medical need to bring patients real hope for a cure” said Rogers Luo, Global Vice President and General Manager in China of Gilead Sciences. “As a global leader in the field of hepatitis C treatment, we are pleased to bring Sovaldi®,a drug that transforms HCV treatment, to China, and help Chinese patients achieve the cure earlier. Sovaldi® has been taken by 1.5 million patients worldwide, today's launch is a new start for us in China. Moving forward, we will continue to work with the governments, healthcare professionals and organizations, as well as other partners to bring more innovative medicines to China, improve patients access to healthcare, and strive to make the world free from hepatitis C!”

High Latency, High False Dismissal Rate, High Chronicity: Chinese Patients Face Multiple Challenges in Hepatitis C Treatment

Hepatitis C is a chronic liver disease caused by infection with the hepatitis C virus (HCV) and affects patients around the world, mainly spread through blood. Today, there are about 71 million people infected by hepatitis C worldwide, and approximately 399,0001 die from the disease each year. There are about 10 million HCV-infected people in China, which is one of largest patient populations in the world.

Due to the high latency and decades-long incubation period of the hepatitis C virus, the false dismissal rate is very high, many patients are not diagnosed until having developed into liver cirrhosis and even into liver cancer. The current standard treatment for hepatitis C in China is Peg-IFN-α combined with Ribavirin (the PR protocol) is yet to address some pressing challenges including efficiency, side effects, drug interactions, poor patient tolerance and long treatment duration (24-72) that causes low patient compliance with the treatment. As a result, the cure rate for hepatitis C in China is yet to be satisfying.

“Due to the high latency, high false dismissal rate and high chronicity of hepatitis C virus, many patients in China are diagnosed at an elderly age and an advanced stage of the disease,” said Wang Fusheng, Academician of the Chinese Academy of Sciences, 302 Military Hospital of China, “They may suffer from hypertension, diabetes and other diseases, or may suffer from liver damage, such as decompensated liver cirrhosis. In treatment for these patients, drug interactions and the impact of drug combination should be taken into greater considerations, and drugs with high genetic barrier to resistance and less interactions should be chosen in accordance with actual situation. Sofosbuvir is a revolutionary product in the field of hepatitis C treatment. I am happy to see that it is now available in China as a safe and efficient cure option to the patients here.”

First DAA Drug for Pan-Genotype Hepatitis C Patients Brings Simpler, Effective Cure to China

The key enzyme for hepatitis c virus replication is NS5B RNA polymerase, so without the involvement of NS5B RNA polymerase, the hepatitis C virus cannot replicate. In 2013, Gilead Sciences developed the world’s first NS5B polymerase inhibitor -- Sovaldi® (Sofosbuvir), pioneering no-interferon treatment of hepatitis C, and achieving cure of hepatitis C through the potent inhibition of viral replication2. As the targeted NS5B site cannot easily produce resistant mutations, the drug resistance is lower, less than 0.1%3. At the same time, the treatment cycle is only for 12-24 weeks, and the oral use once a day is very convenient for patients.

First approved by the U.S. Food and Drug Administration (FDA) in 2013, Sovaldi® has since been approved for use in 79 countries, benefiting more than 1.5 million people worldwide and demonstrating its unique treatment superiority as a component of a combination antiviral treatment regimen. Thanks to the reform of drug review and approval system in China, Sovaldi® received priority review and was approved by CFDA on September 25, 2017, only a few month after submitting the application. Professor Wei Lai from Peking University People’s hospital and Institute of Hepatology Peking University, the principal investigator of Sovaldi’s Phase 3 study, shared Sovaldi® 3-phase clinical data from the research carried out in China, and emphasized its outstanding advantages in the field of hepatitis C treatment, “The genotype of Chinese patients with hepatitis C includes many type 2, type 3 and type 6, except type 1. Clinical research has shown that Sofosbuvir has antiviral activity to HCV of genotype 1-6, and the cure rate is as high as 92% to 100%4. Moreover, Sovaldi® has less drug interaction, with minimal effects on patients who take other drugs at the same time.”


Gilead Sciences in China

Gilead is committed to address the unmet medical need in China through bringing forward our innovative products to the patients here. The company has been present in China since 2007, starting with manufacturing and growing over time to include the establishment of commercial operations based in Shanghai in 2016. In September 2017, the China Food and Drug Administration (CFDA) approved Gilead’s Sovaldi® (sofosbuvir 400mg), for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine to be approved in China. Along with LDV/SOF, Gilead is also studying its HCV single-tablet regimen sofosbuvir/velpatasvir in clinical trials at sites across China.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.