Company Introduction
Company Introduction
Company Introduction
Company Introduction
Company Introduction

CARsgen Therapeutics is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. As one of the leading companies in the field of CAR T-cell therapies, CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production.

 

CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's pipeline includes 10 CAR-T products (4 autologous and 6 allogeneic), all of which are self-developed and possess global rights. Among autologous CAR-T products, the fully human BCMA autologous CAR-T cell product, zevor-cel (zevorcabtagene autoleucel), has been approved for marketing in China. The company's Claudin18.2 autologous humanized CAR-T therapy, satri-cel (satricabtagene autoleucel, or CT041), is poised to become the first CAR-T product for solid tumors to submit a New Drug Application globally. Beyond autologous therapies, CARsgen is advancing differentiated allogeneic CAR-T candidates.

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

 

1) THANK-uCAR® (Target and Hinder the Attack of NK cells on Universal CAR) — differentiated allogeneic CAR-T platform, enhances proliferation and persistence of the allogeneic CAR T cells;

 

2) CARcelerate® — one-day culture, produces CAR T cells that are younger;

 

3) CycloCAR® (Cytokine and Chemokine Loaded CAR) — enhance efficacy in solid tumors;

 

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

CARsgen Image
CARsgen Image
CARsgen Image

CARsgen® has established in-house GMP-compliant manufacturing capabilities to support vertically integrated CAR T manufacturing, including plasmids, lentiviral vectors, and CAR T-cell production. The vertically integrated production contributes to increased efficiency and enhanced control, resulting in improved drug product consistency and aiming for faster turnaround times for patients. The integrated manufacturing is also expected to help significantly reduce costs and improve margins for more advantageous commercialization. To further improve the manufacture efficiency, we developed a proprietary platform CARcelerate® that can shorten the manufacturing time for the CAR T cells to around 30 hours, as compared to the conventional CAR T manufacturing process. The CARcelerate® platform produces CAR T cells that are younger and are more likely to remain in a ‘naïve’ state and less likely to be exhausted; as such, these CAR T cells from the CARcelerate® platform are thought to exhibit more potent tumor killing activity.

CARsgen’s mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases 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 Claudin18.2 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

Zevor-cel was granted Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) by the Food and Drug Administration (FDA)

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)

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

CT011 completed phase I enrollment in China

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

CARsgen collaborates with Moderna to evaluate CT041 in combination with an mRNA cancer vaccine

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

2024

CT011 achieved IND clearance from the NMPA for hepatocellular carcinoma (adjuvant)

NMPA approved the NDA for zevorcabtagene autoleucel

Satri-cel ST-01 confirmatory Phase II trial for gastric cancer in China: enrollment has been completed, and the study has met its primary endpoint

2025

Introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T products development in mainland China

Satri-cel was granted Breakthrough Therapy Designation by the NMPA