Insulin production technology has made new breakthroughs in recent years. SembioSys Bioengineering Co., Canada used the safflower, a high-yield oil crop widely cultivated in North America, as a “platform” for transgenic plants, and successfully produced “Safflower-derived human insulin” (codenamed SBS-1000), which passed the animal experiment last year. With the Phase I-II clinical trials, the pharmacokinetic and pharmacodynamic test results were essentially the same as the recombinant DNA human insulin produced by Eli Lilly in E. coli using the insulin gene. In theory, 1 kg of human insulin drug substance can be produced per hectare of safflower field.

The total number of confirmed diabetes patients worldwide is 320 million, and the incidence is rising rapidly. In theory, 1 kilogram of insulin drug substance can be used as an injection for 2,500 diabetics for 1 year. If diabetics use insulin, according to the above ratio, the annual demand for insulin raw materials in the international market is about 120-130 tons. But in fact, the total global insulin production is only about 40 tons, which shows that the growth of this market is very huge.

And if a major breakthrough can be made in the insulin production process, it will add a decisive chip to the market share.

Currently, SembioSys has filed a Phase III clinical application with the US FDA. The US pharmaceutical industry estimates that the new insulin product is expected to be available in the US in the next two to three years. The process of producing insulin by transgenic plants is much simpler, the input is less and the yield is higher, and the cost is inevitably lower than the human insulin products produced by the existing genetic engineering method. If the insulin raw materials and preparations produced by the method can be listed in the United States, It will definitely have a great impact on the global insulin market.

Inspired by SembioSys, researchers at the Biotechnology Research Center at the University of Ottawa in Canada have also produced a new hypoglycemic drug called insulin-like growth factor (ILGF) using two other high-yielding crops, tobacco and rice plants. . It is said that the hypoglycemic effect of ILGF is even better than that of conventional oral hypoglycemic agents. If ILGF can pass clinical trials and successfully go on the market, it will become a promising product in the international pharmaceutical market.

Tags: Transgenic Crops insulin