Which are to Dominate the Chinese HCV Drug Market: A Review of DAAs in China

Gilead’s HCV direct-acting antiviral (DAA) Sovaldi (JXHS1700011), and AbbVie’s ombitasvir-paritaprevir-ritonavir (JXHS1700014) and Dasabuvir (JXHS1700015) combined therapy of the same kind were approved for marketing by CFDA on September 21, 2017. So far, there are four HCV DAAs marketed in Mainland China, including the above two, BMS’ Asunaprevir soft capsule and Daclatasvir Dihydrochloride Tables combined therapy, and J & J’s Simeprevir.

I have analyzed the global HCV drugs, especially the DAAs, from many perspectives including drug mechanism, HCV drug history, market pattern and clinical research progress, etc. For sure, the DAAs developed by Gilead have opened a new HCV complete healing era and brought fantastic market returns to Gilead Company. The DAAs marketed in China are nearly 4 years later than those in foreign countries, however, with the giants successfully landing the Chinese market and the overture sounded, which will dominate the Chinese HCV drug market is still unknown, and their later pricing and promotion strategies will be very important. This article focuses on the future trends of the HCV market and reviews the approval status in the Chinese HCV drug market.

I. With enormous downward pressure on earnings, competing to land the Chinese market

Since the marketing of Gilead’s DAA Sofosbuvir in December 2013, it has led HCV treatment into a new complete healing era thanks to the high sustained virologic response (SVR), Gilead’s HCV products Sofosbuvir, etc. have been touted worldwide, and DAAs have also driven Gilead’s market value to a rare high, ranking global Top 10. The following figure shows the market shares of major companies in the HCV field, and Gilead has the absolute predominance, however, it's worth noting that the downward pressure on prices of Gilead’s products is large due to 1. The particularity of the HCV disease: the DAAs have excellent SVR and the effective patients decrease rapidly; 2. The controversial pricing rule: Gilead maintains a very high market share, and ever reached 75%, but the prices are expensive, with the controversial price of nearly USD 1,000/tablet; 3. Indian generic drug enterprises, etc. obtaining Gilead’s authorization to produce generics and sell them to nearly 100 developing countries.

The above reasons result in Gilead and other companies to face enormous downward pressure and the HCV drug market to undergo a sharp contraction. Gilead’s sales will decline by nearly USD 5.0 billion just in 2017. The HCV burden is heavy in China, the most common HCV genotypes are 1b and 2a, genotypes 1, 2, 3 and 6 account for about 96%, and only 1% patients receive effective treatment, therefore, the market is undoubtedly virgin territory with promising prospects and will be land where giants scramble for supremacy.

There have been HCV DAAs of four companies approved for marketing in China, separately being

II. Ascletis Pharmaceuticals "digging gold" on the HCV drug market; HCV products of Chinese enterprises under review

Ascletis Pharmaceuticals in China is the vanguard in local HCV DAA development, and it announced on December 27, 2016 that Zhejiang Food and Drug Administration had completed onsite checking of the company and the marketing application of its first innovative HCV drug Danoprevir (ASC08) had been formally accepted by CFDA.

The Chinese HCV drug development enterprises are mainly divided into: 1. HCV drug development enterprises represented by Ascletis Pharmaceuticals, HEC Pharm and Ginkgo Pharma, etc.; 2. HCV generic drug development enterprises represented by Chiatai Tianqing, Hansoh and Huahai. CDE has taken rapid steps towards DAAs. The registration application progress of HCV products in China is summarized as follows:

Chinese HCV patients have not been effectively treated and controlled, and the HCV treatment in China is still based on drug combination of interferon and ribavirin, with the cure rate of only 44%~70%, which is quite backward. The marketing of the DAAs will certainly bring unprecedented cure rate to patients, however, it's worth noting that the promotion and pricing strategies for HCV drugs will be quite important. It is reported that BMS has carried out the "pay-per-efficacy" innovative insurance project and other marketing work with Shanghai Pharma and insurance company after the marketing approval of the combination of "Asunaprevir" + "Daclatasvir". The oral HCV drug products of the foreign and Chinese enterprises will face very intense market competition after marketing, and their respective effect will not be poor, therefore, the key lies in the pricing and promotion strategies.

Attached table 1: Latest clinical trial results of HCV products according to APASL Annual Meeting 2017

Attached table 2: Marketed HCV DAAs in the world

By Tang