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| Polypeptide drug "achievement" absorption research and development constraints, export pressure looming |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-25 12:12:41 Number Browse：775 |
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Medical network - on August 25, medicine plate center daily news listed companies or forecast have revealed that the first listed company in the field of national polypeptide drugs of squire pharmaceutical also hand over the center daily news paper: net profit growth of 44.83%.Building project officially started, at the same time, its innovative industry will solve squire pharmaceutical office space shortage problem, research and development and facilitate noninvasive continuous blood glucose monitoring bracelet, slow disease management platform of the new project of the ground.
Squire pharmaceutical President Yuan Jiancheng an exclusive interview with 21st century economic report reporter said: "the squire's products are mainly focused on the slow disease such as diabetes drugs, combined with the bracelet and so on Internet portal, eventually slow disease management expert strategic development goals."
Heuyu is not alone in the news.The polypeptide drug giant novo nord announced one of its most important products, the somalucine, in a key "head-butt" experiment to beat the dullroup.In half a year, anke biology and bicheng pharmaceutical industry are expected to achieve different growth.
Behind growth, domestic drug firms to use its API advantage downstream polypeptide generic drug development is the trend of The Times, with multiple peptide blockbuster patents expire, polypeptide drugs generic to usher in a wave of development opportunities, will also grow demand for active pharmaceutical ingredients.However, domestic enterprises are far from abroad in the field of innovative drugs, product structure, and new dosage forms. Drug exports of polypeptide drugs are also mainly based on API, and the export of pharmaceutical products has not yet been realized.
Build C terminal
The semi-annual report showed that the overall operating performance continued to grow, achieving a revenue of 4789647 yuan, up 39.43% year on year.The net profit attributable to shareholders of listed companies increased by 44.83 per cent year on year to 16024.22 million yuan.
In recent years, the squire pharmaceutical industry through a series of industry in the form of mergers and acquisitions, strategic cooperation and business development and industrial layout, main business continue development in the field of "medicine + medical devices".The main products include polypeptide preparation, polypeptide API and customer peptide (customized service), pharmaceutical package packaging products, appliance products, solid products, six series.
Yuan Jiancheng pointed out: "change the entry of the pharmaceutical industry are exploring the Internet medical hardware, at the same time, combined with the company itself on the slow disease such as diabetes, cardiovascular drugs products layout, implementation of the fusion of drugs, devices, mobile Internet, our service and product line covers the slow disease detection, treatment, rehabilitation and daily care."
The move into C is a constant signal from hanyu pharmaceuticals, whose main layout is acquisition and strategic cooperation.
Since January 2015, after the completion of the entire equity acquisition of chengji pharmaceutical industry, hanyu pharmaceutical industry has been extended from the pharmaceutical industry to "medicine + medical equipment".On this basis, the squire pharmaceutical and medical treatment of Norway poldi investment agreement, according to its "noninvasive continuous blood glucose monitoring bracelet GlucoPred" clinical test and registered in Europe, three stage investment participation poldi medical care.
At the same time, in order to realize the intelligence and network of the non-invasive continuous glucose monitoring bracelet, han-woo is holding hands with the BAT giant tencent.According to Yuan Jiancheng: "tencent across the Internet platform and rich mobile terminal medical resources, will help provide a better experience management of slow disease progression and their family and circle of social interactive experience, connecting all hardware platform for the Internet of things will hand ring."
Large securities pharmaceutical industry analyst hu provided brigitte analysis pointed out that: "the squire pharmaceutical favorable lalu peptide in our own product lines, Essex peptide glp-1 diabetes drugs, such as the future bracelets and drug is expected to form a synergistic effect in the field of diabetes, gradually building network, digital 'drug + + mobile Internet devices' the trinity of slow disease management platform."
This type of layout is based on polypeptide drugs and the growth market behind them.
According to the data, more than 80 kinds of polypeptide drugs have been approved in the world, and the number of drugs is mainly distributed in tumor, diabetes, infection, immunity, cardiovascular and urinary.Another 200 to 300 polypeptide drugs in clinical trials, 500 to 600 are in pre-clinical trials, and more polypeptide drugs are in the laboratory phase.
In terms of drug variety, the top of the 2016 polypeptide drug sales is still the acetate gratire, with over 4 billion dollars in sales over the years.Followed for lalu peptides and growth hormone, global sales of more than $2 billion, then respectively the octreotide, bright gonadorelin c peptide, Essex, tenet that peptide, goserelin, etc.
"Polypeptide drugs market demand is in a stage of rapid development, every year new peptide drugs approved by FDA listed, while sales of existing polypeptide drugs also is in rapid growth," Yuan Jiancheng said, "but at present domestic enterprises still is given priority to with generic drugs, dosage form mainly often release injection.Foreign dosage forms are more varied, including injection, oral preparation, slow-release implantation, etc.
The gap between China and foreign countries is significant
The disparity between China and foreign countries is an unavoidable pain for domestic polypeptide drug manufacturers.Polypeptide drugs by size classification, can be divided into small peptides, large secondary peptide and peptide, peptide containing amino acid residue base mesh than 50 called big peptide, generally below 50 amino acid peptide can be achieved using the method of chemical synthesis.
Yuan Jiancheng tells a reporter, polypeptide drugs in the process of the synthesis of active pharmaceutical ingredients need to overcome many technical difficulties, including the default peptide, racemic etc, these technical problems of attack can achieve the purpose of control product quality, reduce production of impurities, high purity of peptide apis.At the same time, increasing polypeptide synthesis technology is necessary to reduce the production cost of polypeptide, which can reduce production cost by reducing waste production, increasing coupling efficiency and total production.
Due to the complex production technology of polypeptide drugs, only a few enterprises, including hanyu pharmaceutical, can scale production.As are globally, API manufacturers one of the few global peptide drugs, mainly concentrated in Europe and the United States and other developed countries, but the product price is very expensive, basically in a monopoly position.
"The rapid development of peptide drugs are mainly reflected on the scale preparation technology of peptide apis and peptide drugs in the developed countries of the large-scale preparation has reached hundreds of kg level, while our country than in a small technical level, directly affect the polypeptide drugs research and development and its industry development in our country, become a polypeptide drugs industry bottleneck problem to be solved at present."Yuan built a confession.
In terms of exports, domestic polypeptide drug exports are limited to API.According to the semi-annual report of hanyu pharmaceutical industry, 25% of its overseas revenue, 120 million additional revenue in the first half of 2017, including 0.96 billion of the original drugs, 80.41 percent growth, and the customer peptide of 0.20 billion yuan, down 12.01 percent.
"The overseas revenue of hanyu pharmaceuticals is mainly the contribution of lilalupeptide, and in the first half of 2017, it added new customers," said hu.In the development of drug international registration, hanyu pharmaceutical co., inc., seven of the 10 projects are the API, and its peptides are all geared to the domestic market.
M Intranet general manager, chief researcher Zhang Buyong told reporters, the export of Chinese medicine appear weak, China pharmaceutical products exports fell 1.82% in 2016, a negative growth for the first time since this century."For a long time, the export of domestic pharmaceutical products is mainly based on raw materials, and the export of polypeptide drugs is the same.This has greatly reduced the anti-pressure capability of polypeptide drug exports and is not a sustainable path, and requires the development and transformation of pharmaceutical preparations.He said.
The improvement of existing peptides is also a major trend.According to the wealth securities research paper, new dosage forms and long-term effects of polypeptide drugs are the future development direction.As peptide drugs is more for injection dosage forms, and dosing frequency is high, the patient's compliance is poorer, based on the development of new dosage forms and long-term preparation, is beneficial for the promotion of peptide drugs.At the same time, high-end preparations have some technical barriers, which have a great competitive advantage compared with ordinary dosage forms.
"Most of the peptide drugs have direct oral invalid, short biological half-life and long treatment cycle characteristics, for secondary development of existing peptide drugs is a very meaningful thing," Yuan Jiancheng further stated that "the current improvement ideas of overseas for polypeptide drugs is a long-term injection products, such as liposome preparation of peptide, peptide microspheres, polyethylene glycol (peg) modification, fusion protein, or subcutaneous implant, 2 it is to bypass the injection, oral, transdermal drug delivery and inhaled medication."
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