RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA
RemeGen (NASDAQ:REGMY) has received FDA clearance for Phase II clinical trials of RC148, its independently-developed bispecific antibody targeting PD-1 and VEGF, for treating multiple advanced malignant solid tumors in the United States.
RC148 is currently undergoing clinical trials in China as both monotherapy and combination therapy for advanced solid tumor treatment. This FDA clearance represents a significant milestone in RC148's global development journey.
RemeGen (NASDAQ:REGMY) ha ottenuto l'autorizzazione dalla FDA per avviare le sperimentazioni cliniche di Fase II di RC148, il suo anticorpo bispecifico sviluppato autonomamente che mira a PD-1 e VEGF, per il trattamento di diversi tumori solidi maligni avanzati negli Stati Uniti.
RC148 猫 attualmente in fase di sperimentazione clinica in Cina sia come monoterapia che in combinazione per il trattamento di tumori solidi avanzati. Questa approvazione della FDA rappresenta una tappa importante nel percorso di sviluppo globale di RC148.
RemeGen (NASDAQ:REGMY) ha recibido la autorizaci贸n de la FDA para los ensayos cl铆nicos de Fase II de RC148, su anticuerpo bispec铆fico desarrollado de forma independiente que apunta a PD-1 y VEGF, para el tratamiento de m煤ltiples tumores s贸lidos malignos avanzados en Estados Unidos.
RC148 est谩 actualmente en ensayos cl铆nicos en China, tanto como monoterapia como en combinaci贸n, para el tratamiento de tumores s贸lidos avanzados. Esta aprobaci贸n de la FDA representa un hito importante en el desarrollo global de RC148.
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RemeGen (NASDAQ:REGMY) a obtenu l'autorisation de la FDA pour les essais cliniques de phase II de RC148, son anticorps bisp茅cifique d茅velopp茅 en interne ciblant PD-1 et VEGF, destin茅 au traitement de plusieurs tumeurs solides malignes avanc茅es aux 脡tats-Unis.
RC148 est actuellement en cours d'essais cliniques en Chine, 脿 la fois en monoth茅rapie et en th茅rapie combin茅e pour le traitement des tumeurs solides avanc茅es. Cette approbation de la FDA repr茅sente une 茅tape majeure dans le d茅veloppement mondial de RC148.
RemeGen (NASDAQ:REGMY) hat von der FDA die Zulassung f眉r Phase-II-Studien mit RC148 erhalten, einem eigenst盲ndig entwickelten bispezifischen Antik枚rper, der PD-1 und VEGF bei der Behandlung mehrerer fortgeschrittener b枚sartiger solider Tumoren in den USA anvisiert.
RC148 befindet sich derzeit in klinischen Studien in China, sowohl als Monotherapie als auch in Kombinationstherapie zur Behandlung fortgeschrittener solider Tumoren. Diese FDA-Zulassung stellt einen bedeutenden Meilenstein in der globalen Entwicklung von RC148 dar.
- FDA clearance for Phase II clinical trials in the US market
- Expansion of clinical development to international markets
- Dual-targeting capability through bispecific antibody technology (PD-1 and VEGF)
- Ongoing trials in China showing development progress
- Still in early clinical development phase with no efficacy data reported
- Faces significant competition in the crowded oncology market
RC148 is a PD-1 and VEGF-targeting bispecific antibody, an innovative molecule developed by RemeGen using its bispecific antibody technology platform. Currently, the clinical trials of RC148 as monotherapy and combination therapy for the treatment of advanced solid tumor are proceeding in
The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process.
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SOURCE RemeGen Co., Ltd
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