Two new imported drugs have been approved for international multi-center clinical from Pfizer and Lilly.

China's State Drug Administration Drug Review Center (CDE) announced that two imported new drugs have been approved for clinical trials, and both are international multi-center clinical.
two products are Pfizer's new TNFSF15 blocker PF-06480605 injection, and the IL-23 monoclonal antibody mirikizumab injection developed by Eli Lilly and Company.
Screenshot Source: CDE Official Website 1, Pfizer: PF-06480605 Injection Mechanism: New TNFSF15 Blocker PF-06480605 is a new TNFSF15 blocker being developed by Pfizer to provide all-human immunoglobulin G1 monoclonal antibodies.
Pfizer's official website, the product has now progressed globally to Clinical Phase 2 and is intended to develop an indication of ulcerative colitis (UC).
studies show that the incidence of UC is closely related to a number of genes, including TNFSF15, the protein product TL1A has activated T cells, promote the secretion of inflammatory factors and other physiological activities, play an important role in immunomodulation and inflammatory diseases.
June this year, PF-06480605 filed a clinical trial application in China, the first clinical approval in China to develop a medium to severe ulcerative colitis.
on the Clinicaltrials website, the product registered four clinical trials.
two were early studies of healthy people and two were phase 2 studies of patients with moderate to severe ulcerative colitis.
in a phase 1 dose incremental study of healthy subjects, PF-06480605 showed good safety and tolerance, with higher target participation than the placebo group.
results support further research into PF-06480605 as a treatment for inflammatory bowel disease and other inflammatory diseases.
it is worth mentioning that the current clinical research on TNFSF15 blockers is relatively rare.
2, Lilly: Mirikizumab injection mechanism: IL-23 inhibitor Mirikizumab is an all-humanized monoclonal antibody developed by Lilly to target IL-23 p19 sub-base, which binds to IL-23's p19 sub-base to block the inflammatory response mediated by IL-23.
, the product is being used in a number of clinical trials to treat immunologic diseases, including psoriasis, ulcerative colitis and Crohn's disease.
mirikizumab injection was approved in three clinical trials in China, all of which are international multi-center clinical trials for moderate to severe active Crohn's disease.
, mirikizumab has obtained positive results in Phase 2 clinical trials for moderate to severe Crohn's disease, according to public information.
trial results showed that mirikizumab significantly reduced clinical and endoscopic detection of disease activity after 12 weeks of treatment compared to placebo.
in China, mirikizumab has also received implied permission from several clinical trials of CDE for moderate to severe active ulcerative colitis and moderate to severe active Crohn's disease.
It is worth noting that in July this year, mirikizumab achieved primary and all key secondary endpoints in a Phase 3 clinical study called OASIS-2, as well as all key secondary endpoints compared to active controls, for patients with moderate to severe plaque-like psoriasis.
References: The Drug Review Center (CDE) of the State Drug Administration of China. Retrieved Aug 27, 2020, from s.2. Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis. Retrieved July 17, 2020, from.