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On January 4, Tianjin Hongri Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Hongri Pharmaceutical") announced that the company's new drug under development, Picromide B mesylate for injection (also known as the "KB Project"), was approved by the United States.
Fast Track designation granted by the FDA for the treatment of sepsis
.
Previously, the drug has been approved for Phase 2 clinical trials in the United States
According to the announcement, chrysamine B mesylate is a bacterial pathogen-related molecular antagonist, which uses LPS and CpGDNA as dual targets and is intended to be developed for the treatment of sepsis
.
The mechanism of action of the drug candidate is: Picrochloride mesylate can bind to LPS and CpGDNA with high affinity, and block the binding of LPS and CpGDNA to the corresponding receptors through the high-affinity binding of the drug to LPS and CpGDNA.
In October 2021, the FDA approved a phase 2 clinical trial of chrysamine mesylate B for the treatment of sepsis
.
According to the announcement, the establishment of the Fast Track designation is intended to facilitate or accelerate the development of drugs for the treatment of serious or life-threatening diseases or conditions that have demonstrated the potential to meet current unmet clinical needs, enabling drugs to be rapidly approved for marketing
In China, Picromide B was approved for Phase 2/3 clinical trials in February 2018
.
According to the Drug Clinical Trial Registration and Information Publicity Platform, Picromide B is conducting a randomized, double-blind, parallel-group Phase 2 clinical trial in China to evaluate its efficacy and safety in the treatment of patients with sepsis sex
Sepsis is a systemic inflammatory response syndrome caused by the invasion of pathogenic microorganisms such as bacteria into the body
.
According to the severity of the disease, the disease can be divided into sepsis, severe sepsis and septic shock
References:
References:[1] Announcement of Tianjin Hongri Pharmaceutical Co.
[1] Announcement of Tianjin Hongri Pharmaceutical Co.
, Ltd.
on the KB project obtaining US FDA Fast Track qualification.
Retrieved Jan 4, 2022, from http:// 300026&announcementId=1212093836&orgId=9900008489&announcementTime=2022-01-05
