The Chinese newspaper or forecast of the listed companies in the pharmaceutical sector has been disclosed one after another. Hanyu pharmaceutical, the first listed company in the field of polypeptide drugs in China, also handed over the answer sheet of the Chinese newspaper: net profit increased by 44.83%. At the same time, the formal construction of its innovation industry building project will solve the shortage of Hanyu pharmaceutical office and research and development site, and promote the implementation of new projects such as non-invasive continuous blood glucose monitoring bracelet and chronic disease management platform.

Yuan Jiancheng, President of Hanyu pharmaceutical industry, said in an exclusive interview with 21st century economic reporter: "Hanyu's products are mainly concentrated on chronic disease drugs such as diabetes, combined with the Internet of things entrance such as bracelets, and finally achieve the strategic development goal of chronic disease management experts."

Hanyu pharmaceutical industry is not the only one with good news. The peptide drug giant Novo Nordisk announced that one of its most important products, somaluptide, defeated dulaglutide in the key "head-to-head" experiments; the performance of Anke biology, Shuangcheng pharmaceutical industry, etc. is expected to achieve different growth in half a year.

Behind the growth of performance, it is the general trend for domestic pharmaceutical companies to develop their own API advantages to downstream peptide generic drugs. With the expiration of patents for multiple peptide heavyweight products, peptide generic drugs ushered in a wave of development opportunities, and the demand for API will also grow. However, domestic enterprises are far away from foreign countries in terms of innovative drugs, product structure and research and development of new dosage forms. The export of peptide drugs is also dominated by raw materials, and the export of preparations has not yet been realized.

Create C-end entrance
Hanyu pharmaceutical semi annual report shows that the overall business performance continues to grow, achieving a total operating revenue of 478.9647 million yuan, a year-on-year increase of 39.43%; achieving a net profit of 160.2422 million yuan, a year-on-year increase of 44.83%, attributable to shareholders of listed companies.

In recent years, Hanyu pharmaceutical has expanded its business and industrial layout through a series of industrial mergers and acquisitions, strategic cooperation, etc., and its main business has continued to expand in the field of "medicine + medical devices". The main products include peptide preparation, peptide API and customer peptide (customized service), drug combination packaging products, equipment products and solid products.

Yuan Jiancheng pointed out that "Hanyu pharmaceutical is exploring the entrance of internet medical hardware, and at the same time, combining the company's product layout in diabetes, cardiovascular and other chronic diseases drugs, to achieve the integration of drugs, devices and mobile Internet, and to cover our service and product line in the detection, treatment, rehabilitation and daily care of patients with chronic diseases."

Entering the C-terminal is a continuous signal from Hanyu pharmaceutical industry, whose main layout is acquisition and strategic cooperation.

Since January 2015, when the acquisition of all shares of Chengji pharmaceutical was completed, Hanyu pharmaceutical business has been extended from the pharmaceutical industry to "medicine + medical devices". On this basis, Hanyu pharmaceutical signed an investment agreement with Norwegian Purdue medical. According to the clinical test and registration of its "noninvasive continuous blood glucose monitoring bracelet glucpred" in Europe, Hanyu pharmaceutical invested and participated in Purdue medical in three phases.
At the same time, in order to realize the intelligence and networking of non-invasive continuous blood glucose monitoring bracelet, Hanyu pharmaceutical industry is also holding hands with Tencent, a bat giant. According to Yuan Jiancheng, "Tencent's Cross terminal Internet platform and rich mobile medical resources will help to provide better experience of chronic disease course management and social interaction experience of relatives and friends circle, and all connected Internet of things platforms will integrate hand ring hardware into it."

Hu Luobi, an analyst in the pharmaceutical industry of Dongxing securities, pointed out: "there are GLP-1 diabetes drugs such as lilalutide and exenatide in Hanyu pharmaceutical's own product line. In the future, the bracelet and drugs are expected to form a synergistic effect in the field of diabetes, and gradually build a networked and data-based" drug + device + Mobile Internet "three in one chronic disease management platform."

This layout is based on peptide drugs and the growth market behind them.

Data shows that there are more than 80 kinds of peptide drugs approved for marketing in the world, and the number of drugs is mainly distributed in tumor, diabetes, infection, immunity, cardiovascular, urinary and so on. Another 200 to 300 kinds of peptide drugs are in clinical trials, 500 to 600 kinds are in preclinical trials, and more peptide drugs are in the laboratory research stage.

In terms of drug varieties, in 2016, glatirine acetate was still the top polypeptide drug sales, with sales of more than 4 billion US dollars for many consecutive years. It is followed by lilalutide and growth hormone, with global sales exceeding US $2 billion, followed by octreotide, leuprorelin, tripatide, exenatide, goserelin, etc.

"The market demand for peptide drugs is in a rapid development stage. Every year, new peptide drugs will be approved by FDA, and the sales volume of existing peptide drugs is also growing rapidly," Yuan said. "But at present, domestic enterprises are still dominated by generic drugs, and the dosage form is mainly regular release injection. There are more varieties of dosage forms in foreign countries, including injection, oral preparations, sustained-release implants, etc. "

Significant gap between China and foreign countries

The great gap between China and foreign countries is an unavoidable pain for domestic peptide drug manufacturers. Polypeptide drugs can be divided into small peptide, medium peptide and large peptide according to their size. Polypeptides with more than 50 amino acid residues are called large peptides. Generally, polypeptides with less than 50 amino acids can be obtained by chemical synthesis.

Yuan Jiancheng told reporters that peptide drugs need to overcome many technical problems in the process of API synthesis, including default peptide, racemization, etc., which can achieve the purpose of controlling the quality of API products, reducing the generation of impurities, and obtaining high-purity multi peptide APIs. At the same time, it is necessary to improve peptide synthesis technology to reduce peptide production cost, which can be reduced by reducing waste production, improving coupling efficiency and total production.

At present, only a few enterprises, including Hanyu pharmaceutical, can produce peptide drugs on a large scale due to the complex production technology. From a global perspective, the same is true. There are only a few manufacturers of peptide drug APIs in the world, mainly in developed countries such as Europe and the United States, but the price of products is extremely expensive, and they are basically in a monopoly position.
"The rapid development of peptide drugs is also mainly reflected in the large-scale preparation technology of peptide APIs. The large-scale preparation of peptide drugs in developed countries has reached the level of 100kg, while in China, it is in the stage of small-scale technology, which directly affects the research and development of peptide drugs and industrial development in China, and has become the bottleneck problem to be solved in peptide drug industry." Yuan Jiancheng said frankly.

In terms of export, the export of peptide drugs in China is limited to APIs. Hanyu pharmaceutical semi annual report shows that its overseas revenue accounts for 25%, and in the first half of 2017, it kept increasing by 120 million, including 96 million for APIs, an increase of 80.41%, and 20 million for customer peptides, a decrease of 12.01%.

"The overseas revenue of Hanyu pharmaceutical industry is mainly the contribution of lilalutide, and in the first half of 2017, its lilalutide added new customers," Hu said In the progress of international registration of research drugs in Hanyu pharmaceutical industry, 7 out of 10 projects are API projects, and their peptide preparations are all oriented to the domestic market.

Zhang Buyong, general manager and chief researcher of minenet, told reporters that China's pharmaceutical exports were weak. In 2016, China's pharmaceutical exports decreased by 1.82% year-on-year, the first negative growth since this century. "For a long time, the export of domestic pharmaceutical products is mainly based on APIs, so is the export of peptide drugs, and the export of preparations has not been realized. This greatly reduces the pressure resistance of peptide drug export, and is not a sustainable way, which requires the transformation of pharmaceutical research and development. " He said.
The improvement of existing peptide drugs is also a major trend. Fortune Securities research report pointed out that the new dosage form and long-term preparation of polypeptide drugs are the future development direction. At present, peptide drugs are mostly injection type, and the frequency of administration is high, and patients' compliance is poor. At the same time, high-end preparations have certain technical barriers, and have greater competitive advantages compared with ordinary dosage forms.

"Most polypeptide drugs have the characteristics of direct oral ineffectiveness, short biological half-life and long treatment cycle, so it is very meaningful to develop the existing polypeptide drugs again," Yuan Jiancheng further said. "At present, the improvement idea of polypeptide drugs abroad is the long-term injection products, such as the preparation of polypeptide liposomes, polypeptide microspheres, polyethylene glycol modification and fusion Protein or subcutaneous implantation, bypass injection, oral administration, transdermal administration and inhalation administration, etc. "

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Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.