Delving into the Latest Updates on RC-148 with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

RC 148, RC148

Target

PD-1 x VEGF

Action

inhibitors

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF inhibitors(Vascular endothelial growth factor inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [3]

Active Indication

HR-negative/HER2-low Breast CarcinomaAdenocarcinoma of LungAdvanced Lung Adenocarcinoma+ [13]

Inactive Indication-

Originator Organization

RemeGen Co., Ltd.

Active Organization

RemeGen Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (China)

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A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Start Date10 Feb 2025

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT06016062

/ RecruitingPhase 1/2

A Multi-center Phase I/II Trial to Evaluate the Efficacy and Safety of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.

Start Date14 Sep 2023

Sponsor / Collaborator

RemeGen Co., Ltd.

100 Clinical Results associated with RC-148

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100 Translational Medicine associated with RC-148

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100 Patents (Medical) associated with RC-148

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1

News (Medical) associated with RC-148

08 Aug 2025

·www.prnewswire.com

RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA

YANTAI, China, Aug. 8, 2025 /PRNewswire/ -- On August 8th, RemeGen Co., Ltd. (688331.SH/09995.HK) announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US. 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 China. The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

INDPhase 2Phase 1

100 Deals associated with RC-148

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HR-negative/HER2-low Breast Carcinoma	Phase 2	China	RemeGen Co., Ltd.	10 Feb 2025
Adenocarcinoma of Lung	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Advanced Lung Adenocarcinoma	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
HER2-expressing Gastric Adenocarcinoma	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Metastatic Carcinoma to the Uterine Cervix	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Ovarian Serous Tumor	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Platinum-Sensitive Primary Peritoneal Carcinoma	Phase 2	China	RemeGen Co., Ltd.	14 Sep 2023
Advanced Malignant Solid Neoplasm	Phase 2	China	RemeGen Co., Ltd.	07 Sep 2023

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Biosimilar

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