Gelonghui, April 2, 丨 Rongchang Biotech (09995.HK) announced that the US Food and Drug Administration (FDA) awarded Titacip (RC18), trade name: Taiai) Fast Track Designation (FTD) for the treatment of patients with primary dry syndrome (PSs). At the end of 2023, the FDA approved the Phase III New Drug Clinical Study (IND) application for titacipr to treat patients with pSS.
Fast Track Eligibility is an expedited approval policy set by the FDA for clinically needed products to streamline development and expedite the review of innovative drugs that may treat serious or life-threatening diseases and may address unmet medical needs. Drugs that have obtained this qualification can communicate and interact more frequently with the FDA, and may be able to obtain expedited approval.
Previously, the results of a randomized, double-blind, placebo-controlled phase II clinical trial of titacipr for PSS patients were published in the authoritative international journal “RHEUMATOLOGY”. Research findings showed good clinical benefits when treating patients with PSS with teitacipr. Compared with placebo, the taitacip treatment group significantly improved the EssDAI score and MFI-20 score of PSS patients in the 12th and 24th weeks, and reduced immunoglobulin levels. It was safe to tolerate, no serious adverse events occurred, and there were no deaths in any group during the trial.