Development History and Current Situation of Solid Phase Peptide Synthesis Raw Material Drug Production

In the late 1980s, Europe and America took the lead in the industrialized production of polypeptide raw materials based on solid-phase synthesis technology.

In recent years, with the development of technology, equipment and technology of solid phase peptide synthesis, the cost of research and development and production of polypeptide drugs has been greatly reduced. After the expiration of polypeptide drug patents, China and India have also become major producers of solid-phase synthetic polypeptide raw materials (generic drugs).

The industrialized production of solid phase peptide synthesis raw materials in China started in the new century. After more than ten years of development, it has been transformed from the one-batch production of kilogram-class products to the normal production of kilogram-class products. At the same time, the domestic generic drugs of finished products have been listed one after another, gradually getting rid of the embarrassing situation that polypeptide drugs can only rely on imports. In recent years, with the gradual incorporation of polypeptide drugs into the medical insurance payment system, once unattainable polypeptide drugs gradually benefit the majority of patients.

However, few enterprises in China have mastered the core technology of large-scale production of solid phase peptide synthesis, and only a handful of them have qualifications for product access in accordance with European and American regulations. The international competitiveness of solid phase peptide synthesis raw materials is directly determined by the quality standards, mature and appropriate technological processes and large-scale production. If we find the balance point of quality, regulation and cost, we will hopefully incubate the leading products with international competitiveness.