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广生堂(300436)点评:替诺福韦首仿获批准文号 开启发展新历程

中投證券 ·  May 23, 2017 00:00  · Researches

  On May 22, the company issued an announcement stating that the approval status of the company's product tenofovir dipyrifuroxil fumarate capsules has been updated on the CFDA official website. Currently, it has obtained an approval number, and the processing status is “under approval”. In the future, after being approved for marketing, it will be the first domestically produced tenofovir approved to treat hepatitis B. Investment points: The first domestic model has a strong competitive advantage, and volume growth can be expected. Tenofovir is an oral nucleoside antiviral drug developed by Gilead. The original research drug was called Veride, and was marketed in the US in 2001. Since its launch, this variety has become a first-line long-term drug for hepatitis B recommended by major clinical treatment guidelines due to its advantages such as strong antiviral ability, low incidence of drug resistance, long-lasting efficacy, and convenient administration. On the market side, Veride's global sales peak in 2016 exceeded 1 billion US dollars, and the domestic hepatitis B drug market also increased from 6.9 billion yuan in 2011 to 16.3 billion yuan in 2015. The compound growth rate is as high as 22%. It is expected that the domestic market will expand further in the future. In terms of application progress, among domestic manufacturers, Guangshengtang was the first manufacturer to apply for clinical applications for nofovir for hepatitis B indications according to Class 3.1 of the new drug. Currently, it is also the manufacturer with the fastest application process. In addition to Guangshengtang, manufacturers such as Anhui Beck, Zhengda Tianqing, and Qilu Pharmaceutical have also applied for hepatitis B indications. Currently, the application progress lags behind Guangshengtang, and does not pose a threat to competition in the short term. In terms of price, the price of the original research drug Veride in the domestic market has dropped from 1,500 yuan/month (300mg/30 tablets/bottle) to 499 yuan/month. We expect Guangshengtang's tenofovir will not share the domestic hepatitis B market after launch, so there is huge room for growth. Concentrate superior resources and comprehensively lay out the anti-hepatitis B drug product line. Currently, the company's main products are nucleoside anti-hepatitis B drugs, including entecavir and adefovir ester bramivudine. In the current domestic hepatitis B drug market, entecavir occupies more than half of the market share. In the future, after tenofovir is marketed, the company will become the only domestic company that also owns two major first-line drugs for hepatitis B, entecavir instead of tenofovir, further clarifying its leading position. At the same time, after tenofovir is listed, the sales difficulties of the company's existing products will also be improved, and tenofovir will contribute to greater performance flexibility. Investment advice: We forecast the company's EPS in 17-19 to be 0.66/0.93/1.36, respectively, corresponding to PE67.74/47.85/32.77. Given 80 times PE in 2017, the company's target price is 52.80 yuan. Risk warning: risk of new product promotion not meeting expectations, risk of further decline in future sales of the company's existing main products

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