Date: 2017-12-22
Type of
information: Clinical trial authorisation
phase: 1
Announcement: clinical trial authorization
Company: Clover Biopharmaceuticals (China)
Product: SCB-808 (biosimilar etanercept)
Action
mechanism:
- biosimilar/TNF alpha inhibitor/fusion protein.
- SCB-808 is a proposed biosimilar of Enbrel® (etanercept)
- Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
- SCB-808 is being developed in the prefilled syringe formulation, which is ready-for-injection and can potentially be self-administered by patients in the convenience of their own homes.
Disease: rheumatoid arthritis and other autoimmune diseases
Therapeutic
area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: China
Trial
details:
Latest
news:
- • On December 22, 2017, Clover Biopharmaceuticals announced it has received Clinical Trial Application (CTA) approval from the Chinese Food and Drug Administration (CFDA) to conduct clinical trials in China with SCB-808, a proposed biosimilar of Enbrel® (etanercept) being developed in the prefilled syringe formulation for the treatment of rheumatoid arthritis and other autoimmune diseases. A phase I clinical trial is planned to initiate in China in mid-2018. The CTA approval for SCB-808 was supported by preclinical data comparing SCB-808 to both originator drug Enbrel® and other Chinese etanercept biosimilars.
Is
general: Yes
