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Clinical Trials of New Drug for Gout Will Be Launched in China!

2017-01-11 来源:转载自第三方
11 January 2017
Clinical trials of new drug for gout will be launched in China
  Recently, 3SBio Inc. announced that its new product PEGylated recombinant uric acid oxidase Pegsiticase (SSS11) has been issued by the China Food and Drug Administration Administration of new drug clinical trial application documents.
  The main cause of gout is the mutation of enzyme in body due to unknown causes, make the metabolic disorders, resulting in a group of syndromes caused by purine metabolic disorders or uric acid excretion disorder, hyperuricemia is the main feature clinically. Gout has the characteristics of acute onset at midnight or early morning, and significant swelling and pain in joints.
  Gout can only show a certain degree of elevated serum uric acid without clinical symptoms in early stage, or acute onset of gouty arthritis, the joint will be fully restored after the symptoms disappears, but it will be recurrent; repeated attacks of acute gout can lead to the occurrence of different degrees of bone damage and dysfunction damage, forming chronic gouty arthritis, and developing to subcutaneous tophi, uric acid nephropathy and kidney stones; In the later period, there will be obvious joint deformity and dysfunction symptoms, the number of subcutaneous tophi increased, the volume gradually increased, ulceration, there will be white urate crystals, uric acid nephropathy, kidney stones will be developed, renal function decreased significantly, severe azotemia and uremia will occur.
  3SBio Inc. is a leading biopharmaceutical company in China. The core therapeutic areas of R & D drugs are oncology, rheumatology, nephrology and dermatology. The current drug approved by CFDA for clinical trial, SSS11, is a PEGylated recombinant uric acid oxidase derived from Candida utilis, modified by linking multiple 20-kDa molecular weight polyethylene glycols (PEG). It is for the treatment of intractable gout or tumor lysis syndrome characterized by hyperuricemia. Polyethylene glycol (PEG) is a non-toxic and non-immunogenic water-soluble polymer material, to modify the protein by covalent binding way, and extend the in vivo cycle half-life of protein molecules.
  The intellectual property of SSS11 in USA has been granted to Selecta Biosciences, Inc., which has conducted one-to-one clinical trials in the USA. The results showed that SSS11 significantly reduced uric acid by intravenous and intramuscular injection, it also has a good security and well tolerated.
  The availability of clinical trial approval enable phase 1 to phase 3 clinical trials to be launched in China in early this year. If good test results are obtained and approved for marketing, SSS11 will provide a new treatment option for gout patients.
Related links: PEG 20000
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.