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博济医药(300404):设立生物样本检测子公司 分享一致性评价红利

Boji Pharmaceutical (300404): set up a biological sample testing subsidiary to share the dividend of consistency evaluation

西南證券 ·  Sep 30, 2016 00:00  · Researches

Main points of investment

Event: recently, the company and Li Xiaochuan, Wang Li, Feng Rentian and other three people jointly contributed 10 million yuan to set up Xuhui testing. Among them, the company contributed 5.2 million yuan with its own funds, accounting for 52% of the shares. Xuhui testing has recently completed industrial and commercial registration.

Alliance new drug research and development experts set up a biological sample testing company to further improve the company's industrial layout. Dr. Li Xiaochuan, partner of Xuhui testing, has presided over and participated in a number of new drug research and development, including the pharmaceutical research of innovative traditional Chinese medicine Salvia miltiorrhiza polyphenol salt powder injection, a new drug Shuxindi sulfate, and the development of plasma homocysteine HCY detection kit, among which the Salvia miltiorrhiza polyphenol salt powder injection project won the first prize of Shanghai Science and Technology. During his tenure in Zhaoyan New Drug, he was responsible for completing the drug metabolism research of more than 30 first-class new drugs. Founded in 2014, Ningbo Benaxi is committed to the development of drugs for the treatment of non-alcoholic steatohepatitis. The joining of top experts in the industry will directly upgrade the company's pharmaceutical research level and further enhance the comprehensive service capability of new drug research and development and consistency evaluation business. The subsidiary is expected to be officially operational by the end of the year, and will enjoy a consistent evaluation dividend in 2017, further thickening the company's performance.

With the clarity of clinical trial standards and substantial price increases, the CRO industry is gradually picking up. The enthusiasm of clinical trial institutions is gradually recovering, the progress of the project is gradually warming up, and the inflection point of the industry is looming. The main changes are: 1) clinical trial data standards are clear, clinical trial institutions have rules to follow; 2) with the improvement of implementation standards, the price of large clinical new orders in the industry has been increased by about 1-2 times. The enthusiasm for the implementation of the project of clinical trial institutions is gradually recovering; 3) the record system of clinical trial base is expected to be launched by the end of the year, and the bottleneck of large-scale implementation of consistency evaluation will be completely eliminated.

The company has made full preparations, under the consistent evaluation dividend, the performance is expected to break out in 2017. The company's business covers preclinical and clinical research, and has rich experience in consistency evaluation. in order to deal with the dividend of consistency evaluation, the company has made preparations in many aspects: 1) the number of personnel has expanded by more than 120 in 2015, an increase of about 40%; 2) A consistency evaluation center has been set up at the end of 2015, and more than 10 drug evaluation studies have been carried out smoothly. 3) actively upgrade the SPF animal house and plan to apply for GLP certification to carry out preclinical animal experimental research.

Profit forecast and investment advice. It is estimated that the EPS from 2016 to 2018 will be 0.09,0.55 and 1.11 yuan respectively, and the corresponding share price PE will be 476,75 and 37 times respectively. Considering that the CRO industry in which the company is located has high bearing under the new drug policy and the company is the most flexible target for consistent evaluation, although the short-term valuation is expensive, the company has a good long-term trend, large space, and maintains a "buy" rating.

Risk hints: the time when the policy of clinical trial institutions is released or the risk that is lower than expected; the risk that the implementation of consistency evaluation by the country is strong or progress or lower than expected; the lack of normative implementation of clinical trial data after the improvement of clinical trial standards may lead to the risk of CFDA review.

The translation is provided by third-party software.


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