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
|
Name |
Acceptance No. |
Applicant |
Status |
|
Asunaprevir soft capsule |
JXHS1600063/7 |
BMS |
Approved on June 21, 2017 |
|
Daclatasvir Dihydrochloride Tables |
JXHS1600062/8 |
BMS |
Approved on June 21, 2017 |
...
(All Rights Reserved)