On the basis of achievements scored by CAS scientists, a demonstration engineering project for lumbrokinase-based drugs and industrialization of earthworm derivatives has recently passed the acceptance check under the auspices of the National Development and Reform Commission (NDRC).
Carried out by Beijing Baiao Pharmaceuticals, a spin-off company of the CAS Institute of Biophysics, the project has been supported by NDRC as a National Demonstration Engineering Project of High-tech Industrialization.
Chinese scientists succeeded in extracting lumbrokinase from earthworm and developing it into a novel thrombolytic drug of the 2nd National Category. Made from a group of proteolytic enzymes purified from specific earthworms, the drug is able to activate plasminogen to produce plasmin, increase the activity of fibrinolysis, and reduce the excessively increased fibrinogen in the plasma in order to prevent thrombosis.
The techniques for its separation and purification, according to experts, have reached the advanced level so far achieved by the international community, forming an annual manufacturing capacity of 200 million capsules, 30 million injections and two tons of raw materials. Its production line has successfully filed for its own intellectual properties and acquired the State-issued good manufacturing practice (GMP) attestation.Officially, its products have been catalogued in the national list as recommendable drugs against celebro- and cardio-vascular diseases in the national systems for medical insurance and insurance against industrial injuries. Besides, the production line can turn out other protein drugs such as the proto-enzyme of kallidin. In addition, the project succeeds in making a research breakthrough of developing the lumbrokinase injections and the patented rights for isolation of its monomer, plus the completion of various research topics such as those about the preparation of its small-dose reagents, dosage forms, chemical stability and pre-clinic tests.