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Peptide generic drugs to meet the opportunities
Author:Administrator   |   Release time:2017-11-17   |   Category:行业动态   |   Click:3959

Data show that the current global approval of the peptide drugs have more than 80 species, the number of drugs are mainly distributed in cancer, diabetes, infection, immune, cardiovascular, urinary and so on. Another 200 to 300 kinds of peptide drugs in clinical trials, 500 to 600 are in preclinical trials, more peptide drugs in the laboratory research phase.     In terms of drug varieties, the top supplier of peptide drugs in 2016 was still glatiramer acetate, which had sales of more than 4 billion U.S. dollars for many years. Followed by liraglutide and growth hormone, global sales of more than 2 billion US dollars, followed by respectively octreotide, leuprorelin, teriparatide, exenatide, goserelin, etc. .      "The market demand for peptide drugs is in a phase of rapid growth. Every year, new peptide drugs are approved by the FDA for marketing and the sales of existing peptide drugs are also rapidly growing," said Yuan Jiancheng. "But at present, Generic drugs are the main types of dosage forms, which are mainly regular release injections. Foreign dosage forms are more diversified, including injections, oral preparations and sustained release implants.  Significant difference between China and foreign countries      The disparity between China and foreign countries is difficult to avoid the pain of domestic peptide drug manufacturers. Peptide drugs by size, can be divided into small peptides, medium peptides and large peptides, peptides containing amino acid residues greater than 50 are called peptides, generally 50 amino acids can be obtained by chemical synthesis of the following methods.      Yuan Jiancheng told reporters that peptide drugs in the synthesis of bulk drugs need to overcome many technical problems, including the default peptide, racemization, these technical problems can overcome the control of the quality of raw material medicine to achieve the purpose of reducing the generation of impurities obtained Higher purity peptide drug substance. At the same time, improving peptide synthesis is essential for reducing peptide production costs, reducing production costs by reducing waste production, increasing coupling efficiency and total yield.      Due to the complexity of polypeptide drug production technology, only a few companies, including Johnny Pharmaceutical, can now scale up production. Globally, this is also the case. There are only a few pharmaceutical peptide drug manufacturers in the world, mainly in developed countries such as Europe and the United States, but the prices are extremely expensive and are basically monopolized.      "The rapid development of peptide drugs is also mainly reflected in the large-scale preparation of peptide APIs. The scale-up preparation of peptide drugs in developed countries has reached the level of 100kg, whereas in China, it is in the stage of small-scale technology and has a direct impact on Research and development of peptide drugs in our country and its industrial development have become the bottleneck problems to be solved urgently in the peptide and drug industry. "Yuan Jiancheng said frankly.      In exports, the domestic export of peptide drugs is limited to bulk drugs. HanYu Pharmaceutical semi-annual report shows that its overseas revenue accounted for 25% of the first half of 2017 to maintain an increase of 120 million, of which 996 million for bulk drugs, an increase of 80.41%, customer peptide of 20 million, a decrease of 12.01%.      Hu Yubi pointed out: "Han Yue Pharmaceutical's overseas income is mainly the contribution of liraglutide, its liraglutide and new customers in the first half of 2017." And Han Yu Pharmaceutical research international progress in the registration of drugs, 10 There are 7 projects in the project which are APIs, and all their peptide preparations are also for the domestic market.      Michelle Zhang, general manager and chief researcher Zhang Buyong told reporters that China Medicine exports sluggish in exports. In 2016, China's pharmaceutical exports decreased by 1.82% year-on-year, causing the first negative growth for the first time in this century. "For a long time, the export of domestic pharmaceutical products is dominated by APIs, and the same is true for the export of peptide drugs, so that the export of preparations has not yet been realized. This greatly reduces the compressive capacity of the export of polypeptide drugs and is not a sustainable path that requires formulation research and development Transformation, "he said.      The improvement of existing polypeptide drugs is also a big trend. Fortune Securities research report pointed out that new formulations of peptide drugs, long-acting agents is the future direction of development. Due to the current multi-drug injection formulations, and high frequency of administration, patients with poor compliance, through the development of new formulations and long-acting formulations, the promotion of peptide drugs greatly benefit. At the same time, the high-end preparations have certain technical barriers and have a greater competitive advantage compared with the conventional dosage forms.      "Most peptide drugs have the characteristics of direct oral invalidity, short biological half-life and long treatment cycle. It is very significant for the secondary development of the existing peptide drugs," said Yuan Jiancheng. "At present, First, the idea of improving the drug injection products long-term, such as preparation of peptide liposomes, peptide microspheres, polyethylene glycol modification, fusion protein or subcutaneous implants, the second is bypass injection, oral administration, transdermal delivery And inhalation administration. “”