Company Introduction
Company Introduction
Company Introduction
Company Introduction
Company Introduction

CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The Company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing.

 

CARsgen has internally developed a robust product pipeline with global rights. One of CARsgen’s lead candidates is zevorcabtagene autoleucel (“zevor-cel” or “CT053”), an autologous B-cell maturation antigen (BCMA) CAR T-cell product treating relapsed/refractory multiple myeloma (R/R MM). CT041, is an autologous CAR T-cell product candidate against the protein CLDN18.2, for the treatment of gastric cancer (GC), pancreatic cancer (PC), and other solid tumors. CT041 is the world’s first CAR T-cell candidate for the treatment of solid tumors that entered a confirmatory clinical trial.

To address major challenges of CAR T-cell therapies, CARsgen has also developed novel technologies and platforms, including:

 

1) CycloCAR®(Cytokine and Chemokine Loaded CAR), the next-generation technologies to increase efficacy in solid tumors;

 

2) THANK-uCAR®(Target and Hinder the Attack of NK cells on Universal CAR), a differentiated allogeneic CAR T platform;

 

3) LADAR®(Local Action Driven by Artificial Receptor), a versatile platform for precise targeting.

CARsgen Image
CARsgen Image
CARsgen Image

CARsgen has established a strong global presence and has been expanding its global manufacturing capacity in China and the U.S. to support clinical trials and commercialization. CARsgen has established in-house, vertically integrated manufacturing capabilities, including the production of plasmids, lentiviral vectors, and CAR T cells. With the clinical manufacturing facility in Xuhui, Shanghai and commercial current good manufacturing practices (CGMP) manufacturing facility in Jinshan, Shanghai, CARsgen manufactures CAR T-cell products in-house to support clinical trials in China and manufacture the lentiviral vectors in-house to support clinical trials globally. CARsgen’s RTP Manufacturing Facility, in the Research Triangle Park, Durham, North Carolina, the U.S., has started good manufacturing practices (GMP) production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials in 2022.

 

The company's diverse team of experts collaborates across borders to advance the development of CAR T-cell therapies and ensure that they meet the needs of patients around the world.

CARsgen’s vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

Milestones

2014

CARsgen was established in Shanghai

2015

Initiated the world’s first Glypican-3 (GPC3) CAR T investigator-initiated trial for hepatocellular carcinoma (HCC)

2016

Registered a subsidiary in Delaware, U.S.

2017

Initiated the world’s first CLDN18.2 CAR T clinical trial for gastric cancer or gastroesophageal junction cancer (GC/GEJ)

IND filing: Glypican-3 (GPC3) CAR T

2018

IND filing: CD19 CAR T, BCMA CAR T

2019

6 INDs

Zevor-cel was granted Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) by the Food and Drug Administration (FDA), and was granted PRIority Medicine (PRIME) by the European Medicines Agency (EMA)

CARsgen’s Jinshan facility in Shanghai got China’s first Drug Production License for CAR T

2020

CT041 INDs (China/U.S.)

Zevor-cel pivotal phase II initiated in China

Zevor-cel was granted Breakthrough Therapy Drug by the National Medical Products Administration (NMPA), and was granted Orphan Drug by the European Medicines Agency (EMA)

CT041 was granted Orphan Drug by the FDA

2021

CARsgen was listed on Hong Kong Exchanges and Clearing Limited (HKEX) (Stock Code: 2171.HK)

Zevor-cel initiated phase 2 clinical trial in the U.S./Canada

CT041 was granted Orphan Drug and PRIority Medicine (PRIME) by the European Medicines Agency (EMA)

CT011 completed phase I enrollment in China

AB011 completed enrollment of phase I monotherapy cohort

2022

Zevor-cel’s new drug application (NDA) accepted by the National Medical Products Administration (NMPA)

CT041 initiated a confirmatory phase II clinical trial in China

CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) by the Food and Drug Administration (FDA)

CARsgen’s current good manufacturing practices (CGMP) facility started operation in the RTP, U.S.

2023

Agreement with Huadong Medicine for the commercialization of the BCMA CAR T-cell product zevorcabtagene autoleucel (zevor-cel) in mainland China

Partnership with Roche to evaluate AB011 CLDN18.2 mAb

CT041 initiated Phase 2 clinical trial in the U.S.