Behind the growth of performance, it is a general trend for domestic pharmaceutical enterprises to develop downstream peptide generic drugs with the advantages of self-produced API. With the expiration of patents of several polypeptide blockbuster products, peptide drug generics ushered in a wave of development opportunities, and the demand for API will also increase. However, domestic enterprises are far away from foreign countries in terms of innovative drugs, product structure and new dosage form research and development. The drug export of polypeptide drugs is mainly based on raw materials, and the preparation export has not been realized.
This kind of layout is based on peptide drugs and the growth market behind it.
According to the data, there are more than 80 kinds of polypeptide drugs approved for marketing in the world, and the number of drugs is mainly distributed in tumor, diabetes, infection, immunity, cardiovascular, urinary, etc. There are another 200 to 300 peptide drugs in clinical trials, 500 to 600 are in preclinical trials, and more peptide drugs are in laboratory research stage.
In terms of drug varieties, grantirel acetate still ranked first in the sales of polypeptide drugs in 2016, with sales of more than $4 billion for consecutive years. Liraglutide and growth hormone were closely followed, with global sales of more than $2 billion, followed by octreotide, leuprorelin, tripatide, exenatide, goserelin, etc.
"The market demand for peptide drugs is in the stage of rapid development. Every year, new peptide drugs will be approved by the FDA, and the sales of existing peptide drugs are also growing rapidly," said Yuan Jiancheng. "But at present, domestic enterprises are still mainly generic drugs, and the dosage forms are mainly regular release injections. Foreign dosage forms are more diversified, including injections, oral preparations, sustained-release implants, etc
The gap between China and foreign countries is significant
The huge gap between China and foreign countries is a pain that domestic peptide drug manufacturers can not avoid. Peptide drugs can be divided into small peptides, medium peptides and large peptides according to their size. Peptides with more than 50 amino acid residues are called large peptides. Generally, peptides with less than 50 amino acids can be obtained by chemical synthesis.
Yuan Jiancheng told reporters that many technical problems need to be overcome in the synthesis of polypeptide drugs, including default peptides and racemization. Overcoming these technical problems can achieve the purpose of controlling the quality of API products, reducing the generation of impurities and obtaining high purity polypeptide APIs. At the same time, it is necessary to improve the peptide synthesis technology to reduce the production cost of polypeptide, which can be reduced by reducing waste production, improving coupling efficiency and total yield.
Due to the complex production technology of peptide drugs, only a few enterprises including Hanyu pharmaceutical can produce them on a large scale. From a global perspective, the same is true. There are few manufacturers of polypeptide drugs in the world, mainly concentrated in developed countries such as Europe and the United States. However, the prices of products are extremely expensive and basically in a monopoly position.
"The rapid development of peptide drugs is also mainly reflected in the large-scale preparation technology of polypeptide raw materials. The large-scale preparation of polypeptide drugs in developed countries has reached the level of 100 kg, while China is at the stage of small-scale technology compared with China, which directly affects the research and development of polypeptide drugs in China and its industrial development, and has become a bottleneck problem to be solved in the polypeptide drug industry." Yuan Jiancheng said frankly.
The improvement of existing peptide drugs is also a major trend. According to Fortune Securities research, new dosage forms and long-term preparations of peptide drugs are the future development direction. Due to the fact that most of the peptide drugs are injection type, and the frequency of administration is high, and the patient's compliance is poor, the development of new dosage forms and long-term preparations will be of great benefit to the promotion of peptide drugs. At the same time, high-end preparations have certain technical barriers, and have a greater competitive advantage compared with ordinary formulations.
"Most peptide drugs have the characteristics of direct oral ineffectiveness, short biological half-life and long treatment cycle. It is very meaningful to carry out the secondary development of existing peptide drugs," Yuan Jiancheng further said. "At present, the first way to improve peptide drugs abroad is to make injection products long-term, such as preparation of polypeptide liposomes, peptide microspheres, polyethylene glycol modification and fusion Protein or subcutaneous implantation, the second is bypass injection, oral administration, transdermal administration and inhalation