Qingdao Daily/ Guanhai News on September 13, Qingdao Mingyue Seaweed Group recently completed the cde (State Drug Administration Drug Evaluation Center) registration and filing, marking that the implantable grade sodium alginate in the body broke the foreign monopoly and was officially listed.
As an excellent marine biological material, ultrapure sodium alginate for implantation in vivo can develop high-end medical device products and biomedical products for the treatment of tumors, diabetes, heart failure and other diseases, after downstream enterprises were subject to the supply of raw materials, they could only carry out preclinical research and could not declare clinical trials.
In 2020, Mingyue Seaweed broke through the large-scale preparation technology of ultrapure sodium alginate for implantation in vivo, and built the first ultrapure sodium alginate production line for implantation in China, becoming the second enterprise in the world that can produce ultra-pure sodium alginate after DuPont in the United States. According to the test, the endotoxin of the products developed by Mingyue Seaweed is as low as 50EU/g (micrograms/per gram), which is better than the industry standard of "Sodium Alginate for Tissue Engineering Medical Device Products" issued by the Us Dollars and China's NMPA, and the residues of heteroproteins, heavy metals, chlorine and calcium are lower.
After completing the registration and filing, the ultra-pure sodium alginate produced by Mingyue Seaweed can be officially used for the development of high-end medical products for in vivo implant intervention. Up to now, a number of downstream enterprises from Suzhou, Beijing, Chengdu and other places have become the application customers of Mingyue seaweed ultrapure sodium alginate, and the alginate-based implant intervention products they developed are planned to apply for clinical trials this year and next year.
At present, the design capacity of the ultra-pure sodium alginate production line is 2 kg per batch, and the annual production capacity is 200 kg, which can meet the application needs of 1 million people such as tumor embolization preparations and in vivo drug sustained release preparations, with direct economic benefits of up to 200 million yuan, driving the downstream alginate phytointermediate products 10 billion market. (Qingdao Daily/Guanhai News reporter Li Xunxiang)
【Source: Qingdao Daily】
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