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红日药业(300026):KB进入II/III期临床 中药配方颗粒有望走出低谷

Red Sun Pharmaceutical (300026): KB enters the II/III phase of clinical Chinese medicine formula granules are expected to come out of the trough

財通證券 ·  Mar 12, 2018 00:00  · Researches

The only urgently needed drug in the field of sepsis in China to enter phase Ⅱ and Ⅲ clinical trials.

Picramine B mesylate (KB) is an urgent clinical drug for the treatment of sepsis and other critical diseases encouraged by the state, and it is also a major new drug creation support variety of the country. The results of phase I clinical studies show that KB is safe and well tolerated within the dose range of the trial in healthy volunteers. KB is the first natural product found in the world with multi-target antagonistic activity against bacterial pathogens-related molecules (targeted separation in traditional Chinese medicine). It has a good protective and therapeutic effect on septic model animals. The company has realized its total chemical synthesis and is currently developed and declared according to the national class 1 innovative drugs.

At present, there is a lack of specific drugs for the clinical treatment of sepsis, and recombinant human activated protein C, the only drug with the indication of sepsis in the world, was withdrawn from the market in 2011 because of its uncertain curative effect. In China, there are no similar drugs except Xuebijing. Once on the market, it will form a good synergistic effect with Xuebijing. As the only chemical in the field of sepsis treatment in China to enter the phase Ⅱ clinical trial, KB helps to enhance the company's leading position in the field of sepsis.

Formula granule business will gradually come out of the trough, and strategic cooperation is conducive to the construction of new profit growth points.

Affected by the graded diagnosis and treatment policy, the number of outpatients in large hospitals in Beijing and other areas has declined greatly, because formula particles can only be sold in hospitals at or above the second level, so the short-term impact is greater. In addition, this year, various places have begun to pilot formula granule enterprises in the province, which has a short-term impact on the company's business in some areas. However, the trend of formula granules instead of prepared slices is obvious, mainly because the quality of formula granules is easier to standardize and more convenient to take than prepared slices. At present, the domestic formula granule market is about 14 billion yuan, accounting for only about 5% of the traditional Chinese medicine market, far from reaching the ceiling, and is still a steady growth market. If the formula granule policy can be liberalized, then grass-roots hospitals and so on will be a new blue ocean market. The company is one of the domestic formula granule leaders, with nearly 600 kinds of unilateral particles, complete varieties, stable quality standards, will benefit the growth of the industry for a long time, and is expected to maintain a growth rate of at least 15% in the next three years. The company has reached a strategic cooperation intention with Lanzhou Foci Pharmaceutical to carry out strategic cooperation in the scientific research, production, sales and domestic and foreign market development of traditional Chinese medicine formula particles, so as to give full play to their respective advantages and synergy. It is conducive to the company's extension and layout of the upstream and downstream industrial chain, and is expected to build new profit growth points and further improve performance.

Profit forecast and investment suggestion

It is estimated that the company's operating income from 2017 to 2019 is 33.8 yuan, 37.2 / 4.28 billion yuan, net profit is 4.49 yuan, 5.17 yuan, 633 million yuan, respectively, and EPS is 0.15, 0.17, 0.21 yuan, PE is 30-26-21 times, maintaining the investment rating of increasing holdings.

Risk hint: the risk of increased competition among formula particles and the risk of asset impairment.

The translation is provided by third-party software.


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