Recently, according to CDEOfficial website announcement: The Investigational New Drug (IND) application for RJMty19 injection, submitted by Zhejiang Ruishun Biotech Co., Ltd. ("Ruishun Biotech"), has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It is intended for the treatment of systemic sclerosis. This candidate product has previously received three tacit approvals.。
Source of the image: CDE official website
Systemic Sclerosis (SSc) is a multi-organ involved autoimmune connective tissue disease characterized primarily by skin fibrosis. In addition to skin involvement, it can also affect internal organs (lungs, cardiovascular system, kidneys, digestive tract, etc.). The peak incidence of SSc occurs between 45 and 65 years of age, with relatively rare cases in children. It is more common in women, with a male-to-female ratio of approximately 1:4 to 1:6. However, male patients often experience more severe conditions, with a higher likelihood of exhibiting diffuse cutaneous lesions, digital ulcers, and pulmonary arterial hypertension, resulting in a relatively poorer prognosis. RJMty19 Injection (with the active ingredient being CD19-CAR-DNT cells) is a globally innovative, off-the-shelf, universal second-generation DNT cell therapy product developed by Zhejiang Ruishun Biotech Co., Ltd. based on a global patent for humanized CD19-CAR.Compared with the seven currently marketed autologous CD19-CAR-T cell therapy products, CD19-CAR-DNT cells derived from healthy donors offer numerous advantages such as standardized preparation, lower production costs, and immediate availability for patients. These features provide significant potential in future market competition and could fundamentally change the current commercial disadvantages of autologous CAR-T cell products.DNT (Double Negative T) cells refer to a subgroup of T cells that are normally present in human peripheral blood, characterized as CD3+CD4-CD8-, accounting for 1-10% of the total T cell population. DNT cells express CD3 molecules and αβ- or γδ-T cell receptors (TCR) on their surface, but do not express CD4 or CD8 molecules, nor do they bind to CD1d tetramers loaded with αGalCer, which are specific to invariant Natural Killer T (iNKT) cells. Thus, they differ from conventional T cells, NK cells, and NKT cells. DNT cells highly express surface receptors such as NKG2D and DNAM-1, and specifically recognize tumor cells expressing corresponding ligands in an MHC non-restricted manner. They achieve tumor cell killing by secreting various cytotoxic molecules and cytokines, without causing graft-versus-host disease (GvHD) or host-versus-graft reaction (HvGR).Zhejiang Ruishun Biotech Co., Ltd. envisions "Caring for Life, Benefiting Humanity" and is on a mission to "Develop Affordable Innovative Cellular Medicines for the Masses." The company focuses on developing off-the-shelf, universal immune cell products centered around the DNT cell technology platform. As the pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf, universal cell therapy products based on the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection.In order to allow everyone to learn and communicate with each other better,"WeChat Official Account 'Cell Gene Therapy' Team"A WeChat group for cell therapy and gene therapy discussions has been established. Interested friends can scan the QR code below to add the editor's WeChat and join the cell therapy and gene therapy discussion group.。
Article Recommendation(Click the article title below to open the original text)：
China's First "Development Guidelines for (Cellular) Immunotherapy Products Based on mRNA-LNP Technology" Group Standard Officially Released
MediCI R&D Center Officially Begins Operations
Former President of Innovent Biologics, Liu Yongjun, Takes New Position at CSPC Pharmaceutical Group
A Cell and Gene Therapy Industry Project in China Officially Breaks Ground, with a Total Investment of 770 Million Yuan and a Construction Area Exceeding 200,000 Square Meters
China's National Health Commission Releases 2024 Project Application Guidelines for Six Key Special Projects, Including "Stem Cell Research and Organ Repair"
A CRO Company in China Listed on the STAR Market
Keyi Pharmaceuticals' CD19/CD22 Dual-Target CAR-T Cell Therapy IND Accepted for Review
Nine Companies in China Complete New Round of Financing, Focusing on Cell and Gene Therapy Fields
NPC Deputies Suggest Including Gene-Targeted Therapy in Medical Insurance Package, National Health Commission Responds
Total construction area exceeds 140,000 square meters, Fosun Pharma's industrial base project officially launched
World's First! Impressive Data: Ruibo Biotech Releases Phase I Clinical Data for RBD4059 for the First Time
Anling Biotech Launches Two Exosome Therapy Clinical Trials Simultaneously
This company obtains the first Stem Cell "Drug Production License" in China
Effective from September 1! Shanghai Releases CAR-T Cell Therapy Drug Supervision Regulations
Cell Therapy Company Xueji Bio Completes New Round of Financing
Another Cell Gene Therapy Product Approved for Marketing in China
Gene-editing company founded by two students of Zhang Feng to cease operations, received over $200 million in financing last year
World's First mRNA Lung Cancer Vaccine Clinical Trial Launched
China's First iNKT Cell Therapy Product to Enter Pivotal Clinical Stage Completes DLT Observation for Phase I, First Dose Group with Excellent Safety Data
γ-δ T Cell Therapy: 100% of Patients Achieved Complete Tumor Disappearance Maintained for 1 Year
A platform for the clinical transformation of gene and cell industry in China officially opened, promoting the clinical transformation and application of gene and cell therapy.
CD19/CD20 Dual-Target CAR-T Approved for Clinical Trials to Treat Autoimmune Diseases
CSPC's HPV mRNA Therapeutic Vaccine IND Application Accepted by CDE
China's First iNKT Cell Therapy Product Enters Registrational Clinical Stage: Phase I, First Dose Group Completes DLT Observation with Excellent Safety Data
Disclaimer: The content is sourced from the company's official channels, etc. This article aims to share knowledge. All content is for reference only and does not constitute any advice.
