Gilead's Hepatitis C Drug Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Filed for Approval in China

On June 12, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced that Gilead’s hepatitis C drug “Sofosbuvir/Velpatasvir/Voxilaprevir Tablets” (Vosevi) had its marketing application accepted in China, with the acceptance number JXHS1900078.

Vosevi consists of three fixed-dose components: sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg). In July 2017, Vosevi was approved by the U.S. FDA for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with compensated cirrhosis. Demonstrating significant efficacy, it has been referred to within the industry as the “fourth-generation direct-acting antiviral.” This approval also made Vosevi the first once-daily, single-tablet regimen for HCV.

Gilead: Made by Hepatitis C, Broken by Hepatitis C

As the former undisputed leader in the field of hepatitis C treatment, Gilead Sciences launched its "fourth-generation" hepatitis C drug:

Gilead's First Generation: Sovaldi, approved by the FDA for market launch in December 2013;

Harvoni (sofosbuvir/ledipasvir): Approved by the FDA for market launch in October 2014;

Epclusa (sofosbuvir/velpatasvir): Approved by the FDA for market launch in June 2016;

Gilead’s Fourth-Generation Drug: Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir Tablets), approved by the FDA for market launch in July 2017.

Since launching its first “miracle drug” for curing hepatitis C in 2013, Gilead Sciences enjoyed a brief period of glory. At its peak, Sovaldi and Harvoni generated approximately $6 billion in sales within three months, marking an unparalleled triumph.

As the patient population shrinks due to complete cures and price competition intensifies, Gilead Sciences has gradually lost its lofty status. On June 11, Pharma Executive magazine released the “2019 Top 50 Global Pharmaceutical Companies” list. Compared with the 2018 rankings, the top 10 pharmaceutical companies saw significant fluctuations, with only two firms maintaining their positions. Among those that slipped in the rankings was Gilead Sciences, which ultimately secured the 10th spot by a narrow margin of less than $100 million.

The current downturn in the overall hepatitis C market is unstoppable, with market share shifting from a single dominant player to a triopoly (Gilead, AbbVie, and Merck & Co.). In terms of global hepatitis C business revenue at this stage, AbbVie and Gilead are neck and neck ($3.616 billion vs. $3.584 billion).

Currently, the largest growth driver in the hepatitis C market is pangenotypic hepatitis C drugs that cover genotypes 1–6. In addition to Gilead’s Epclusa and Vosevi, another approved pangenotypic hepatitis C drug is AbbVie’s Mavyret. Leveraging a shorter treatment duration (8 weeks) and a more competitive price, Mavyret has delivered strong performance since its launch and has become the best-selling hepatitis C medication globally.

Furthermore, Maviret was included in the second batch of overseas new drugs urgently needed for clinical use in China due to its “therapeutic advantages over marketed products,” and it received approval from the National Medical Products Administration last month, officially entering the Chinese market. Therefore, in terms of the Chinese market, Vosevi has lost its first-mover advantage. When it will gain approval and what measures will be taken to compete for market share after approval are worth following up on.

China Enters the Era of DAAs Therapy for Hepatitis C

Among all types of viral hepatitis, hepatitis C is the most easily overlooked, characterized by a high tendency toward chronicity following infection. Currently, there is no effective vaccine for the prevention of hepatitis C; however, it can be cured with antiviral therapy using direct-acting antivirals (DAAs). The application of DAAs has brought about revolutionary changes in the treatment of hepatitis C. DAAs clear hepatitis C virus (HCV) by directly inhibiting HCV protease, RNA polymerase, or other viral targets, thereby alleviating or resolving liver damage and preventing disease progression to cirrhosis, decompensation, and hepatocellular carcinoma. These agents have significantly improved cure rates and safety profiles, while offering fewer side effects and shorter treatment durations. Internationally, DAAs have been established as the first-line therapy for hepatitis C.

Prior to the market launch of direct-acting antivirals (DAAs), the standard regimen for hepatitis C treatment in China was pegylated interferon combined with ribavirin, a protocol characterized by low cure rates and significant interferon-related adverse effects. The approval of Bristol Myers Squibb’s Daklinza (daclatasvir hydrochloride tablets) and Sunvepra (asunaprevir soft capsules) marked the entry of China into a new era of DAA-based hepatitis C therapy.

Currently, eight direct-acting antivirals (DAAs) have been approved in China, and four DAAs are under marketing review. Notably, among the four DAAs under marketing review, two are domestically produced products from Kain Technology and Ascletis Bioscience, respectively.

In addition to Vosevi, the DAAs that have been marketed or are under marketing review in China include:

Regarding pricing, information disclosed by various companies indicates:

The price of imported drugs ranges from 58,000 to 60,000 yuan per 12 weeks;

The price of domestically produced drugs is approximately 40,000 yuan per 12 weeks.

As more DAAs are approved for marketing in China, the country will also enter a new era of complete cure with DAA + Peg-IFN-α + ribavirin or all-oral DAA regimens.

Source: Sina Medical News