Main points of investment
Event: the company announced that the company received the drug production registration approval of tenofovir fumarate raw material drug and tenofovir fumarate capsule issued by the State Food and Drug Administration.
The indication of hepatitis B was approved at last, and the therapeutic effect of hepatitis B was excellent. In 2008, tenofovir as an anti-HIV drug was approved and imported in China, the original research was Gilead Sciences Inc, and hepatitis B indications were approved in August 2013. so far, no imitation varieties of hepatitis B indications have been approved in China. Tenofovir and entecavir are the first-line drugs in the current guidelines for the treatment of hepatitis B. compared with entecavir, tenofovir has better clinical effects. Clinical trials show that tenofovir has no drug resistance for 3 years and is not affected by the history of treatment. and tenofovir has high safety for grade B pregnant women.
The first imitation has obvious advantages and may replicate Enticawe-style success. At present, the company is the only liver medicine enterprise with entecavir and tenofovir at the same time. After years of marketing, entecavir has become the largest therapeutic drug for hepatitis B in China. From 2006 to 2016, the sales of entecavir sample hospitals increased rapidly from 36 million to 1.71 billion yuan, and the whole market size was about 9 billion yuan. It has become an absolutely important variety in the domestic hepatitis B drug market. In 2010, Zhengda Tianqing "Entecavir dispersible tablets" (Runzhong) was approved to go on the market, becoming the first imitation product in China; with the advantage of the first imitation, the market share of "Runzhong" increased rapidly. According to the data of the sample hospital, the market share of "Runzhong" increased from 3.3% in 2010 to 37.7% in 2015. We believe that the listing of tenofovir or the rapid release of tenofovir is expected to replicate the success of entecavir and form a pattern on a par with entecavir.
The world's most important anti-virus varieties may greatly improve the company's performance. Tenofovir is still the most mainstream combination of anti-HIV drugs, with sales of single and compound preparations exceeding $11 billion in 2016. Tenofovir is a national drug price negotiation variety in 2016, and the original research has dropped by as much as 67%. We believe that under the strong promotion of the price reduction of the original drug, the domestic market for HBV indications of tenofovir is expected to achieve entecavir-like rapid growth, and market sales are expected to peak at 5 billion yuan. The first imitation can bring the market first-mover advantage to the company, and it is expected that the peak sales of Tinofovir will reach 1 billion yuan after listing, contributing about 300 million yuan, which will greatly improve the company's performance.
Profit forecast and investment advice. It is estimated that the EPS from 2017 to 2019 is 0.61,0.82,1.21 yuan respectively, and the corresponding PE is 71 times, 53 times and 36 times respectively. The approval of the first imitation of tenofovir hepatitis B indication is expected to achieve rapid volume, which will greatly improve the company's performance. Long-term optimistic about the company's development prospects, maintain the "buy" rating.
Risk tips: drug price decline risk, new product launch progress or lower than expected.