The share of the global biopharmaceutical market continued to increase: global biopharmaceuticals accounted for 13.7% of total drug sales from 9.9% in 2007 to 13.7% in 2013. According to EvaluatePharma, the global biopharmaceutical market continues to grow rapidly in the future, with a compound growth rate of approximately 10.1% in 2014-2015 and US$287.14 billion in 2020.
Similar to the international market, the growth rate of domestic biopharmaceuticals is also faster than the overall pharmaceutical market. From 2007 to 2013, the total output value of domestic biopharmaceuticals increased from 60 billion yuan to 246.5 billion yuan, with a compound annual growth rate of 26%, and biopharmaceuticals accounted for total drug sales. The ratio increased from 8.9% in 2007 to 11.1% in 2013.
The bio-pharmaceutical fine-molecular industry has its own merits. We mainly recommend four long-term recombinant proteins, cell therapy, gene therapy and monoclonal antibody. The stocks are recommended to be recovered, Tianshi, Nosland and Renhui.
Fine molecular industry
Recombinant protein drugs have entered the era of long-acting. Long-acting recombinant proteins have the advantages of simplicity, safety, and long-lasting effects. After 2000, recombinant protein drugs entered the era of long-acting. In 2007-2013, the market for recombinant protein drugs increased from $48.7 billion to $63.8 billion, with a compound annual growth rate of 4.6%. The high-end market for recombinant protein drugs in China is mainly based on imported recombinant protein drugs. Domestic enterprises are actively developing long-acting insulin, growth hormone, interferon, and granulocyte colony-stimulating factors. With the continuous upgrading of domestic enterprise technology, it is expected that domestic recombinant protein products will gradually replace expensive imported products. We recommend investors to pay attention to the rehabilitation, Northland, Tianjie, Renhui and the Chinese and American Fuyuan and Heyuan creatures to be listed.
The stem cell industry has broad application prospects. In 2010, the global stem cell market was about 21 billion US dollars. In 2013, it exceeded 40 billion US dollars. The annual compound growth rate reached 23%. It is estimated that the global stem cell market will reach 120 billion US dollars by 2018, and the application prospect is broad. A number of stem cell industrialization bases have been established in China, including East China Base, Tianjin Base, Qingdao Base, Taizhou Base, etc. Nearly 100 companies engaged in stem cell technology research and development, stem cell bank establishment and stem cell product development have initially formed from upstream storage to downstream. The prototype of the complete industrial chain for clinical applications. In 2010, the domestic market for stem cell industry was about 3 billion. In 2013, it exceeded 10 billion. It is estimated that 2015 will reach 30 billion, with a compound annual growth rate of over 50%. We recommend investors to pay attention to Celera and Tsing.
The timing of industrialization of gene therapy is gradually maturing. According to THEJOURNALOFGENEMEDICINE data, from 1989 to 2012, there were more than 1,800 gene therapy trials in the world, including 67 cases of stage III clinical cases, and 1174 cases of US gene therapy clinical trials, accounting for more than 60%. At the same time, more and more large pharmaceutical companies are also beginning to get involved in the field of gene therapy drugs, and the timing of industrialization of gene therapy is gradually maturing. China is one of the first countries in the world to conduct clinical trials of gene therapy. In March 2004, CFDA
Officially approved the world’s first anti-tumor gene therapy drug “now live” listed. At present, there are more than 10 gene therapy projects in China at the clinical stage, and more than 10 projects are about to enter clinical trials. We recommend investors to focus on the Northland and Gemma genes.
Monoclonal drugs have become the mainstream drug for targeted therapy. The global market for monoclonal antibody drugs has grown from US$14 billion in 2005 to US$51 billion in 2010, with a compound annual growth rate of 30%, accounting for more than 30% of biopharmaceuticals, making it the largest category among biopharmaceuticals. . Under the background of global industrial transfer and national policy support, the domestic monoclonal antibody market has a compound growth rate of 47.3% in 2005-2013 (the proportion of domestic monoclonal antibodies is from 0% to 13.3%), which is much higher than other pharmaceutical and other fine molecular industries. It is estimated that the potential market size in 2020 will reach 22 billion yuan. We believe that the overall market size of domestic monoclonal antibody drugs is small, and the growth rate is fast. The future drivers are driven by localized substitution and unsatisfied rigid demand. We recommend investors to pay attention to Zhonghe Medicine. Tumor immunotherapy is a hot spot in the field of disease treatment in the next 3-5 years. Tumor immunotherapy is called the fourth treatment after surgery, radiotherapy and chemotherapy. It is listed as the first of the top ten scientific breakthroughs in 2013 by Science magazine. It is estimated that by 2025, the scale of global cancer immunotherapy will reach 36.1 billion US dollars. . Tumor immunotherapy mainly includes immunoassay monoclonal antibody therapy, adoptive cell immunotherapy, etc.: The most potential of immunological test monoclonal antibody therapy is anti-PD1 drugs; and adoptive immune effector cell therapy shows potentially better efficacy and lower Side effects, large pharmaceutical companies have begun to increase investment and cooperation in recent years. Domestic tumor immunotherapy is in the initial stage of research and development, and there are no listed varieties at present. It needs further deepening in research and development and channel reserve. We recommend investors to pay attention to Heyi Kang and Hongrun Tianyuan (to be listed).
Potential pharmaceutical company
Northland (430047.OC) has over 3 billion domestic market for heavy gene therapy drugs. The company specializes in the research and development of recombinant protein drugs and gene therapy drugs, with a rich product line, seven research products, four new class 1 drugs, pre-clinical, phase I, phase II, and phase III products, including heavy product liver cells. Growth factors are expected to be listed in 2018, exceeding the market of 3 billion. At the same time, we expect the company’s eye syrup production plant Huien Land to be put into operation before the end of 2015, marking the company’s ability to generate revenue. We forecast that the company’s revenue in 2015-2017 is 0.24 billion, 93 million, and 235 million respectively; the net profit in 2015-2017 is -1 million, 6 million, and 19 million yuan respectively; the corresponding EPS is -0.02 yuan, 0.12 yuan, and 0.38 yuan. We give the company a reasonable one-year target price of 39.6 yuan -49.5 yuan, corresponding to a market value of 2 billion to 2.5 billion yuan. Give the company an “overweight” rating.
Rehabilitated (832,036.OC) pioneer in the development of global calcium oxalate kidney stone drugs. The company specializes in the industrialization of kidney stone medical food, has the world’s first fixed-point PEG modification technology and proprietary high-efficiency protein expression purification technology. Its world’s first calcium oxalate kidney stone drug is expected to be listed in the US in 2016, with a potential market of over US$1 billion. At present, the company’s main income comes from pre-clinical CRO services. We believe that this is an option for the company’s early development funding shortage, and its income does not fully reflect the company’s profitability. We forecast the company’s revenue for 2015-2017 to be 14.12 million, 22.59 million, and 36.14 million, respectively, with year-on-year growth rates of 30.0%, 60.0%, and 60.0%, respectively; net profit of 5.34 million, 6.1 million, and 8.42 million, respectively. 29.9%, 14.2%, 38.0%; EPS for 2015-2017 is 0.47 yuan, 0.54 yuan, 0.75 yuan. Investors are advised to pay attention.
Renhui Bio (830931.OC) is the world’s first fully human-derived GLP-1 drug developer. The company specializes in the research, development, production and sales of peptide and protein drugs. It has formed a complete set of genetic engineering preparation technology platform. Its core product is a national new class of recombinant human glucagon-like peptide-1 (rhGLP-1) Yishengtai. It is the world’s first fully human-derived GLP-1 drug. GLP-1 drugs have glucose-dependent insulin secretion, inhibit β cell apoptosis, promote β cell regeneration, reduce glucagon secretion, delay gastric emptying and other pharmacological properties, and have obvious advantages in clinical treatment. At present, the application for registration of Yishengtai pen-type water needle preparation benaglutide injection was accepted in May 2015. We expect that Benazolide injection will be available for sale in 2016 and will soon generate income-generating capacity. At the same time, the company plans to carry out in-depth development of Yishengtai, including oral dosage forms, indication expansion, and combination medication.
Tianjie Bio (430323.OC) is expected to be listed in 2017, with a potential market of over 5 billion. The company’s core variety of recombinant human tissue plasminogen activator modified “Yizhentong” has obtained the CFDA clinical approval, is undergoing phase III clinical trials, and is expected to be approved for listing by the end of 2016. According to the calculation of the product of 10% of the 2.6 million cases of myocardial infarction per year, the company’s “Yizhentong” plan price is 20,000 yuan/piece (3000$/share abroad), and the market space is about 5 billion yuan. The company’s existing products are produced and sold by Tianzin Pharmaceutical, a wholly-owned subsidiary. In 2014, its operating income was 44.46 million yuan. In 2015, its business target was sales income of 62.5 million yuan and total profit of 7.46 million yuan. We believe that the company’s sales growth rate will remain at around 40%, and the sales volume will exceed 100 million in the next three years. The company’s research projects include sustained-release agents metformin, spray-type insulin, and recombinant human follicle stimulating hormone (rhFSH).