CDE Weekly Update: Six CGT Therapies Receive IND Approval

According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）According to incomplete statistics from the official website and publicly available information, last week(December 15 - December 21)About 40 Class 1 innovative drugs are proposed to be included in the breakthrough treatment category / received clinical trial approval / IND application accepted, covering fields such as CAR-T, Treg, small nucleic acids, XDC, bispecific and trispecific antibodies.

The following will introduce representative Class 1 innovative drugs approved for clinical use.

Zhejiang Ruishun Biotech Co., Ltd.'s RJMty19 Injection IND Application Approved for Clinical Use, with New Indication for ANCA-Associated Vasculitis（ANCA-AAV）。

RJMty19 Based onZhejiang Ruishun Biotech Co.,Ltd.'s exclusive DNT(Double-negative T)Cell Technology Platform Development, forOff-the-shelf universal cell therapy, with advantages in large-scale production, adopts a triple-targeting mechanism of γδTCR, NCRs, and CAR, which can better address disease heterogeneity. The humanized CD19 CAR design further enhances safety. In the registrational Phase I clinical trials for relapsed/refractory B-cell non-Hodgkin lymphoma and refractory systemic lupus erythematosus, no ≥Grade 3 cytokine release syndrome, neurotoxicity, or graft-versus-host reactions were observed in all subjects who completed the dose-limiting toxicity evaluation.

December 24, 2025 (Wednesday) 15:00-16:00, Yi Mai Ke collaborated with ACROBiosystems to specially plan"Efficient Expansion Code: Analysis of Immune Cell Culture Process Technology"Thematic Live Class. Dr. Chen Yu, Senior Product Manager of ACROBiosystems, will present fromExclusive formula precisely empowers immune cell culture, cell type switching and medium optimization, culture data of different cellsin various aspects, and sincerely invite everyone to scan the code to watch and communicate!

Sailuxin Autologous Polyclonal Regulatory T Cells（Treg）IND Application for Injection Approved, with Proposed Indication for Multiple System Atrophy（MSA）MSA is a rapidly progressive neurodegenerative disease that has been included in China's "First List of Rare Diseases." Currently, there is no specific treatment available, with symptom management being the primary clinical approach, highlighting an extremely urgent medical need.

Treg cells are an important T cell subset that regulates the immune system, maintains tolerance to self-antigens, and prevents autoimmune diseases, with roles in immune suppression, muscle tissue repair, and limiting fibrosis. In the MSA disease model mice, these Treg cells not only significantly improved the decline in motor function of the mice, but alsoPartially reversed the loss of dopaminergic neurons in the substantia nigra of the midbrain, providing critical scientific evidence for clinical application. Previously, it has been approved for clinical treatment of Amyotrophic Lateral Sclerosis (ALS).(Commonly known as ALS)。

The IND Application for UCART Mesenchymal Stem Cell Injection from YouSa Life Has Been Approved for the First Time, with the Proposed Indication Being Moderate to Severe Acute Respiratory Distress Syndrome. This indication is one of the most common clinical syndromes in critically ill patients, characterized by diffuse inflammatory alveolar and pulmonary capillary injury and rapidly progressive hypoxemia.

Previously, during the peak outbreak of severe COVID-19 cases, the umbilical cord mesenchymal stem cell preparation developed by the company was urgently used in the ICUs of multiple medical institutions: applied to over 30 patients, with 100% improvement in pulmonary CT imaging. CRP levels decreased and blood oxygen levels significantly increased the day after use, accumulating important clinical experience for this application.

Based on the existing progress, the company plans to submit additional IND projects for stem cell therapies targeting liver failure and acute ischemic stroke starting from the first quarter of 2026.

HM2002 Injection from Huanma Bio Receives IND Approval for Chronic Coronary Syndrome（CCS）It is the world's first circular RNA drug, featuring high stability and low immunogenicity, and can improve microcirculation function by promoting angiogenesis in ischemic myocardial regions. Ischemic heart disease is the leading cause of death and disability globally. Most patients are in the CCS stage, and some still experience microcirculation disorders or cannot undergo revascularization even after standard treatment, lacking effective therapeutic options.

This Clinical ProtocolFirst Introduction of Transcatheter Endocardial InjectionThe interventional drug delivery method uses an innovative adjustable bend catheter to achieve precise and quantitative delivery without the need for open-chest surgery. Combined with the already established epicardial injection pathway.(Mainly applied in surgical scenarios)HM2002 has established a drug delivery platform that administers medication through both epicardial and endocardial injection. This strategy ensures that the drug can cover a wide range of conditions, from complex lesions requiring surgical intervention to chronic ischemic lesions that only need interventional treatment, providing differentiated treatment options for patients at different stages.

YKYY032 Injection, jointly submitted by Yooking Pharmaceutical and Hangzhou Tianlong, has been approved for clinical trials for the first time, with the proposed indication being hyperlipoproteinemia.（a）（Lp(a)）Hemophilia. It is a targeted Lp(a) geneLPASubcutaneous injection siRNA drugs, which can be achieved by LPA It binds to the gene and temporarily blocks its function, thereby achieving the purpose of reducing Lp(a). In addition, its use of a self-developed novel GalNAc delivery system and new siRNA site modification technology can enhance pharmacological activity, extend the drug's action period, and greatly improve patient compliance.

HRS-5817 Injection, jointly submitted by Hengrui Medicine and Shanghai Tuojie for IND application, has been approved for clinical trials for the first time, intended for the treatment of overweight or obesity. It is an siRNA drug targeting key pathway genes in metabolism, which precisely silences the expression of pathogenic genes through RNAi technology, regulating energy metabolism imbalance from the source. Compared with traditional weight-loss drugs, it has three core advantages: long-lasting effect, high targeting, and improved compliance.

Exciting Live Broadcast Preview

Press and hold to scan the QR code to participate immediately ↓

Recommendation 1

December 23rd, 15:00-16:00

Frontier Advances in Drug Screening with Liver Organoids

Recommendation 2

December 24th, 15:00-16:00

Efficient Expansion Code: Analysis of Immune Cell Culture Process Technology

Recommendation 3

December 30, 15:00-16:00

New Breakthrough in Tumor Immunology: Automation Technology Advances the Industrialization of DC Cells

Statement and Copyright Notice

Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint and does not represent the position of Eureka Biomedical, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a regular hospital for medical advice.

Copyright Statement:Welcome to share the article on your personal Moments, but unauthorized media or organizations are prohibited from reprinting it on other platforms in any form. If you need to reprint, please leave a message below the article to obtain authorization.

Cover image source: internet. If there is any infringement of copyright, please contact us for removal.

DianDian "Share”、“Like" and "In View”

Give me a little charge~