Recently, Qingdao Mingyue Seaweed Group completed the cde (State Drug Administration Drug Evaluation Center) registration and filing (registration number: F20210000344) for implantable sodium alginate in the body, marking that the implantable grade sodium alginate in the body broke the foreign monopoly and officially opened the road of localization.
The product can be officially used in the development and registration application of high-end medical products involving alginate-based implantation, and the endotoxin of the product is as low as 50EU/g or less, which is better than the "Sodium Alginate for Tissue Engineering Medical Device Products" (YY/T 1654-2019) industry standards issued by the American IFF products and China's NMPA, and the residues of heteropsins, heavy metals, chlorine and calcium are also lower.
Previously, the Novumatrix series of ultrapure sodium alginate under IFF in the United States is the world's only commercialized tissue-engineered grade sodium alginate, non-sterile products are priced at $109 /g, and sterile products are priced at as high as $878/g. Last year, the industrialization of ultra-pure sodium alginate of Mingyue Seaweed Group solved the problem that the supply of ultra-pure sodium alginate has long been affected by the "card neck" of American companies, effectively filling the domestic gap and eliminating the embarrassment of standard-free products in China since 2008.
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.
Mingyue Seaweed Group undertakes the national key R&D program "Green large-scale production of medical-grade marine source biological materials and advanced functional product research and development", Qingdao High-level Talent Introduction Plan "Alginate Tissue Engineering Materials R&D industrialization" project, integrating membrane separation, high-speed centrifugation, gelatinous devotion, affinity adsorption and other separation and purification units to form a multi-component gradient eluting system, breaking through the large-scale preparation technology of ultrapure sodium alginate for implantation in vivo, and building the first ultrapure sodium alginate production line for implantation in China. Became the second company in the world to have the production capacity of ultra-pure sodium alginate for implantation in vivo.
Nowadays, ultrapure sodium alginate has completed registration and filing in the Drug Evaluation Center of the State Drug Administration, and truly realized localization.
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.