According to public announcement of listed companies, Livzon Group got approval for 6 clinical new products in 2017, including the world's most popular recombinant humanized anti-PD-1 monoclonal antibody for injection and recombinant humanized anti-RANKL single Clonal antibody injection.
High Purity Urine Gonadotropin
is a naturally-derived gonadotropin preparation that reaches the level of recombinant single-component preparations and is a highly tolerated and easy-to-use high purity product that is currently on the market for high purity Urine procaine is the imported product of Hui Ling medicine.
polymer injection micelles developed by the company, is a broad-spectrum anti-tumor drugs, compared to ordinary injection, micelles as a drug delivery system with small particle size, drug-carrying ability and reduce the pain caused by injection and so on , There is no paclitaxel micelles listed on the domestic market.
Injection of triptorelin acetate microspheres is a monthly intramuscular injection of a gonadotropin-releasing hormone agonist compared to ordinary triptorelin acetate injection, with a long onset, reducing the number of medication and other characteristics, can reduce Patients suffering and medication burden, improve drug tolerance and accessibility.
Dantrolene Sodium, for injection has been independently developed by the company for the treatment of malignant hyperthermia and malignant hyperthermia, which are rare diseases. To address the current domestic drug availability, CDE released "Proposed to be included in the priority review process on February 28, 2017 Publicity of Application for Drug Registration (13th batch) ", the product has obtained the qualification of priority review and approval. At present, only the capsule is approved for the related product approval of dantrolene sodium.
The recombinant humanized anti-RANKL monoclonal antibody injection was first submitted to clinical trial application by Livzon on April 20, 2017 and was approved by CFDA in about six months. It is initially estimated that it will take 4-6 years to complete the clinical trial. Indications for anti-RANKL monoclonal antibody are osteoporosis in women and bone metastases in solid tumors. The original product was Amgen (Denosumab, Prolia® and Xgeva®) from Amgen, which was approved by the FDA in 2010, Global sales in 2016 totaled more than 3 billion U.S. dollars. There are currently no similar listed products in the country, the domestic approved clinical targets of "RANKL" monoclonal antibody drugs, including manufacturers, including a total of seven.