In April 2026, the clinical trial applications in the field of cell and gene therapy (CGT) showed an active trend. 

According to the official website of CDE and industry statistics, in that month, CDE received a total of 14 new drug clinical trial applications (IND) in the CGT field. Among them, 3 applications were granted conditional approval for clinical trials. The total number of applications received and approved in that month reached 17, continuing the previous strong momentum.

Overall, the field of CGT is experiencing a dual acceleration trend of "continuous release of innovative vitality and continuous acceleration of industrialization process", with simultaneous improvement in technological diversification and clinical transformation efficiency.

Receiving end (14 items)

01 iPSC

1、Yuesai Biotechnology 

On April 23rd, the new drug application for "UX-DA003 Injection" of Shanghai Yuesai Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600438. 

Yuesai Biotechnology is a cell drug research and development technology company driven by the latest stem cell technology. It utilizes its own intellectual property-based platform for the preparation, cultivation, differentiation and gene editing of human pluripotent stem cells to conduct technological research and product development in the field of stem cell therapy, providing innovative cell-based treatment solutions for neurodegenerative diseases, rare diseases and other indications.

2、Rip Chenchuang 

On April 25th, the clinical trial supplementary application for "RGB-5088 Pancreatic Cell Injection Liquid" of Hangzhou Ruipuchenchuang Technology Co., Ltd. was accepted. The acceptance number is CXSB2600076, and it is used for the treatment of type 2 diabetes. 

This is the world's first product that uses autologous regenerative islet therapy to treat type 2 diabetes. The so-called "autologous regenerative islet therapy" refers to the process of preparing autologous cells into islet cells to replace the dysfunctional islet cells in the patient's body, thereby achieving long-term stable control of blood sugar levels. The islet cells produced by this product not only have structural and functional characteristics similar to adult islet cells, but also possess high glucose sensitivity, and can regulate insulin secretion according to changes in blood sugar concentration.

02 Exosomes

1、Stedkose 

On April 13th, the new drug application for "STX11101 Injection" of Shanghai Siderkexiu Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600403, and it is used for the treatment of acute liver failure. 

This is the first innovative exosome drug in the country that has been submitted for clinical trials.

03 MSC

1、Baizhi Gene 

On April 10th, the new drug application for "Human Umbilical Cord Mesenchymal Stem Cell Injection" of Guangzhou Baiji Genomics Technology Co., Ltd. was accepted. The acceptance number is CXSL2600388.

04 Non-gene-modified cell therapy drugs

1、Huizhen Medical Clinic 

On April 8th, the new drug application for "HCL001 Cell Injection" of Shanghai Huizhen Medical Technology Co., Ltd. was accepted. The acceptance number is CXSL2600382.

05 Immunotherapy

1、Suzhou Shali Bio 

On April 1st, the new drug application for "GT101 Injection" of Suzhou Shalili Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600365.

2、Beijing Shali Biotechnology 

On April 3rd, the new drug application for "GT307 Injection" of Beijing Shaliju Biomedical Co., Ltd. was accepted. The acceptance number is CXSL2600379.

3、Siosebo Biotechnology 

On April 4th, the new drug application for "SK-NK Injection" of Saosibo Biotechnology (Beijing/Zhengzhou) Co., Ltd. was accepted. The acceptance number is CXSL2600380.

4、Fuhong Hanlin / Fuhong Ruilin 

On April 11th, the new drug application for "HLX3902 Injection" of Shanghai Fuhong Rui Lin Biotechnology Co., Ltd. / Shanghai Fuhong Han Lin Biomedical Co., Ltd. was accepted. The acceptance number is CXSL2600400.

5、Initiating biological entity 

On April 14th, the new drug application for "QT-019C Cell Injection" of Hangzhou Qiexuan Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600405.

6、Bangyao Biotechnology 

On April 17th, the clinical trial supplementary application for "Targeted CD19 Non-viral PD1 Site-specific Integration CAR-T Cell Injection" of Shanghai Bangyao Biopharmaceutical Co., Ltd. was accepted. The acceptance number is CXSB2600067.

7、Reindeer species 

On April 21st, the supplementary application for the clinical trial of "Igicolesin Injection" by Nanjing Reindeer Biomedical Co., Ltd. was accepted. The acceptance number was CXSB2600068. 

Igiloncels (Eque-cel) is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). Autologous T cells are transfected with the gene using a lentivirus as the vector. The CAR consists of fully human scFv, CD8a hinge and transmembrane region, 4-1BB co-stimulatory molecule and CD3ζ activation domain. Based on strict molecular structure screening and comprehensive in vitro and in vivo functional evaluation, Igiloncels can provide patients with deep and long-lasting remission, while the adverse reactions are controllable.

8、Anveson Biotech 

On April 29th, the new drug application for "ReT01 ACT Injection" of Beijing Anweisen Biopharmaceutical Co., Ltd. was accepted. The acceptance number is CXSB2600078.

9、Huada Bio 

On April 30th, the new drug application for "Wanjilongsheng Injection" of Huadao (Shanghai) Biomedical Co., Ltd. was accepted. The acceptance number is CXSS2600077, and the proposed indication is refractory and relapsed non-Hodgkin's lymphoma. 

Apart from Wanjikeolonsen injection, Huadao Biotechnology has 4 other CAR-T products in clinical trials, including 2 CAR-T for solid tumors, namely HD004 (target: CLDN18.2) and HD006 (target: GUCY2C).

Permissive Mode (3 options)

01 iPSC

1、Yuesai Biotechnology 

On April 8th, the clinical trial application for "UX-GIP001 Injection" of Shanghai Yuesai Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2600259, and it is used for treating drug-resistant unilateral medial temporal lobe epilepsy. 

This drug directly targets the core pathological mechanism of epilepsy - the dysfunction of inhibitory GABAergic interneurons in the brain. By directing the differentiation of iPSCs into functional inhibitory neural progenitor cells, it achieves the repair and functional reconstruction of neural circuits in the brain, breaking through the limitations of traditional symptomatic treatment and opening up a new model of disease repair-based treatment.

02 MSC

1、Saijun Biotechnology 

On April 12th, the clinical trial application of "CG-BM1 allogeneic human bone marrow mesenchymal stem cell injection" by Guangzhou Saijun Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2501142, and it is used for the treatment of post-menopausal osteoporosis. 

Preclinical studies have shown that this product can significantly increase bone density, increase the number of bone trabeculae, effectively improve the microstructure and strength of bones, bringing new hope of "growing new bones and strengthening bones" to post-menopausal women.

2、Tuohua Biotechnology 

On April 15th, the clinical trial application for "Human Umbilical Cord Mesenchymal Stem Cell Injection" of Changchun Tuohua Pharmaceutical Co., Ltd. / Jilin Province Tuohua Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2600094. This product is a drug for kidney/urinary system diseases, and its indication is diabetic kidney disease. 

This type of stem cell can exert therapeutic effects through multiple pathways and multiple targets in a coordinated manner, inhibiting renal inflammatory responses, regulating the immune microenvironment, and alleviating glomerular and tubular damage; it can delay the process of kidney fibrosis, reduce extracellular matrix deposition, and achieve protection of renal function; at the same time, it can improve insulin resistance and promote microvascular repair, thereby delaying the progression of kidney disease from both metabolic regulation and tissue repair dimensions, reducing urinary protein levels, and stabilizing the glomerular filtration rate.

Summary

With the continuous advancement of biomedical research, the field of cell and gene therapy (CGT) has witnessed significant progress. An increasing number of new drugs have successfully entered the clinical stage, indicating the tremendous potential of CGT technology in medical applications. 

As researchers delve deeper into the characteristics of cells and the gene editing mechanisms in the CGT field, and as the industry's regulatory framework and quality standards continue to be refined, the CGT field will achieve more extensive applications in future medical scenarios. This trend not only helps to overcome medical challenges that traditional treatment methods cannot address (such as genetic diseases, cancer resistance, etc.), but also provides patients with more precise personalized treatment plans, improving their quality of life and extending their lifespan.