[event]
Hainan Marine Pharmaceutical (000566.CH/ RMB13.73, bought) announced on the evening of November 30 that Haikou Pharmaceutical Factory, the company's holding subsidiary, received the "Drug Clinical trial approval" and the "notice of approval opinions" for flufenidone and flufenidone capsules. Flufenidone developed by the company is a 1.1 new drug, which is intended to be used in the treatment of liver fibrosis caused by viral hepatitis and alcoholic liver disease.
[opinion]
With regard to the company's important progress in the field of innovative drugs, the company's revenue is mainly composed of general medicine and cephalosporin products (API and intermediates, cephalosporins) and new specialty drugs (Changweikang, paclitaxel and Taxol). Among them, the proportion of new specialty drugs with high gross margin is 17.83%. In recent years, the company has stepped up the research and development of a class of new drugs. Flufenide is a major product jointly developed by the company and Central South University. it is a new chemical drug with no same variety at home and abroad for liver fibrosis caused by viral hepatitis and alcoholic liver disease. With reference to domestic independently innovative 1.1 new drugs such as Ectini, Apatinib and Cobasil, it will achieve a bumper harvest of both economic and social benefits after being approved for listing. If flufenidone successfully passes clinical trials in the future, it will be of great significance to enhance the company's industry status and core competitiveness. The approval of the clinical trial of flufenidone affirms the company's efforts in the field of innovative drugs and is a major progress in innovative research and development.
Flufenidone has a large number of potential patients and a considerable market prospect.
According to the statistics of the World Health Organization, 400 million people around the world are infected with hepatitis virus, including about 120 million chronic asymptomatic hepatitis B virus carriers and 30 million chronic hepatitis B patients in China. The hepatitis B infection rate in China is about 8%, ranking first in the world. Chronic hepatitis brings a high risk of liver cirrhosis and liver cancer and may lead to premature death. Flufenidone is intended to be used in the treatment of liver fibrosis caused by viral hepatitis, alcoholic liver disease and so on. Only in China, the potential patients have exceeded 150 million, and the market demand is urgent. In addition, similar drugs are used to treat organ fibrosis represented by Roche's pirfenidone, which is mainly used to treat idiopathic pulmonary fibrosis. Roche bought it for $8.3 billion in 2014 and achieved sales of $468 million in 2015. it is among the top 20 fastest growing global sales in 2015. It is expected that after the listing of flufenidone, it is likely to become an important variety for China's original research drugs to compete in the international market, which will greatly increase the business revenue and overall revenue of the company's new specialty drugs.
The company ploughs the big health industry, actively builds "medicine-medicine-device" multi-core drive company, successively participates in Chongqing Yade and Jin Shengda, sets up marine medicine big health management company, sets up Internet medical platform and large health management platform, conforms to the trend of graded diagnosis and treatment, distributes grass-roots telemedicine, sets up hospital merger and acquisition fund, actively participates in the restructuring of public hospitals, and accumulates physical medical resources. In the research project reserve, at present, the company focuses on the research and development of nervous system products, anti-tumor, heart blood guanidine products, digestive system products, antibiotics (cephalosporin, Peinan) and so on. Flufenidone, bendamustine, antineoplastic drugs and monoclonal antibody drugs are the main R & D products; the company's second-generation cochlear implant is in clinical trial stage and is expected to be available for sale by the end of next year. The company continues to push forward in the three major sectors of "medicine-medicine-equipment" to ensure the stable growth of the company.
Investment strategy
The company's main business steady development, actively create "medicine-medicine-equipment" three plates, deep ploughing big health industry. In the recently completed fixed increase, Internet health care has been strengthened, medical services have been deeply expanded, and the high proportion of participation of major shareholders (54.09%) shows confidence. The company is researching varieties, there is no lack of heavy varieties. We are optimistic about the long-term development of the company and continue to give buy ratings.
Risk hint
The progress of new drug research and development is not as expected; the impact of policy; the price reduction by bidding is higher than expected.