In March 2026, there was a vigorous trend in the submission of clinical trials in the field of cell and gene therapy (CGT).

According to incomplete statistics, the Drug Evaluation Center of the National Medical Products Administration (CDE) received 8 new drug clinical trial applications in a single month. Additionally, 18 applications received implicit approval for clinical trials. The total number of applications received and approved in a single month was 26.

Overall, in the field of CGT in March 2026, the active momentum observed since the beginning of the year continued. Many enterprises pushed their core products into the clinical application approval stage, demonstrating a dual acceleration trend of continuous release of innovation vitality and continuous acceleration of industrialization process in this field.

PART.01 Receiving end（8项）

一 Mesenchymal stem cells

1、Iwu Biotechnology 

On March 12th, the new drug application for "Human Umbilical Cord Mesenchymal Stem Cell Type II Injection" of Zhejiang Wushu Stem Cell Technology Co., Ltd. was accepted. The acceptance number is CXSL2600323. It is intended for the treatment of sepsis and/or septic shock.

2、An Ming Kangyuan / Kangyuan An 

On March 26th, the new drug application for "Human Umbilical Cord Mesenchymal Stem Cell Injection" of Anming Kangyuan Pharmaceutical (Jilin) Co., Ltd. / Ankangyuan Biotechnology (Jilin) Co., Ltd. was accepted. The acceptance number is CXSL2600351.

二 Immune cells

1、Shiwo Group 

On March 6th, the new drug application for "SYS6063 Injection" of Shigao Group Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. was accepted. The acceptance number is CXSL2600308.

2、Mid Cybersman Biology 

On March 13th, the new drug application for "HS-IT101 Injection" of Qingdao Zhongseibaiman Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600328.

3、Endurium 

On March 24th, the "IBR854 Cell Injection" of Yingbairui (Hangzhou) Biomedical Co., Ltd. received the acceptance for two new drug applications. The acceptance numbers were CXSL2600345 and CXSL2600346.

4、Gravel creatures 

On March 28th, the new drug application for "GT201 Injection" of Beijing Shali Biopharmaceutical Co., Ltd. was accepted. The acceptance number is CXSL2600355.

四 Gene therapy

1、Kaida Kyushu 

On March 3rd, the "GA002 Injection" new drug application of Jian Da Jiuzhou (Beijing) Biotechnology Co., Ltd. was accepted. The acceptance number is CXSL2600299.

PART.02 Permissive mode（18项）

一 Mesenchymal stem cells

1、Pricon Biotech 

On March 16th, the clinical trial application for "Human Umbilical Cord Mesenchymal Stem Cell Injection" of Jiangsu Pricon Biomedical Technology Co., Ltd. was granted implicit approval. The application number is CXSL2501098, and it is used for the treatment of rheumatoid arthritis.

2、Liaoning Medical Diagnosis and Treatment Technology Research and Development Center 

On March 20th, the clinical trial application for "LYW2402-NS-HK Human Stromal Cell Injection (Three-Dimensional Process Preparation)" of Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd. was granted implicit approval. The application number is CXSL2501129, and it is used for treating Parkinson's disease on the basis of conventional treatment.

This drug is the first stem cell drug for treating PD via intravenous route, the first cell drug named "Human-derived Stromal Cell Injection Solution" in accordance with the latest international standards, and the first PD cell drug prepared by a three-dimensional fully automatic process.

3、Cel Biotech 

On March 25th, the clinical trial application for "Fat Mesenchymal Stem Cell Injection" of Guangdong Sael Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2501140, and it is intended for the treatment of type 2 diabetes.

Human adipose-derived mesenchymal stem cells possess the advantages of multi-directional differentiation potential, strong immune regulatory ability, easy collection and strong proliferation capacity. They can exert hypoglycemic and islet-protective effects through various pathways: On one hand, they can differentiate into islet-like cells, promoting insulin secretion. At the same time, by inhibiting the apoptosis of pancreatic β cells, promoting the formation of pancreatic blood vessels, and improving the microenvironment of the islets, they can achieve the repair of damaged islet functions.

4、Saijun Biotechnology 

On March 26th, 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.

二 Immune cells

1、Celison Biotech 

On March 1st, the clinical trial application for "Human Autologous Polyclonal Regulatory T Cell Injection Solution" of Shanghai Celix Biomedical Technology Co., Ltd. was granted implicit approval. The application number is CXSL2501020, and it is used for treating spinal and bulbar muscular atrophy (SBMA, also known as Kennedy disease).

SBMA is an X-linked recessive genetic neuro-muscular disorder. Its clinical manifestations include: motor neuron symptoms, such as progressive muscle weakness and atrophy caused by damage to lower motor neurons; symptoms of the medulla oblongata, including dysphagia and speech disorders; non-motor symptoms, including sensory nerve involvement, autonomic nerve dysfunction and metabolic abnormalities, etc.

2、Junsai Biotechnology 

On March 3rd, the clinical trial application of "Autologous Natural Tumor-Infiltrating Lymphocytes Injection" by Shanghai Jun Sai Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2500374. It is used for the treatment of advanced solid tumors by combining autologous natural tumor-infiltrating lymphocytes injection with pembrolizumab.

The most remarkable feature of this drug lies in its natural nature. It does not require genetic editing of immune cells; instead, it directly utilizes the naturally existing TIL cells present in the patient's own tumor.

3、Purkinje Biotechnology 

On March 3rd, the clinical trial application of "Chimeric Antigen Receptor T-cell Injection Targeting BCMA" of Shenzhen Puxinkang Biopharmaceutical Co., Ltd. was granted implicit approval. The application number is CXSL2501059, and it is used for the treatment of refractory lupus nephritis. 

On March 25th, this product received two additional implied approvals for the treatment of refractory primary immune thrombocytopenia (application number CXSL2501170) and refractory IgG4-related disease (application number CXSL2501171).

This is a CAR-T cell drug targeting the BCMA target, with a chimeric heavy chain variable domain of high affinity and high specificity. The research data, production process and quality control system of this product have all been developed in accordance with international standards, featuring high production efficiency and significant cost advantages. Moreover, the production process and quality control system possess good repeatability and stability.

4、Nakang Biotechnology 

On March 18th, the clinical trial application for "NT-001 Injection" of Shanghai Nai Kang Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2501106, and it is used for the treatment of advanced breast cancer.

Nakang Biotech was established in July 2015. It focuses on the research and development of innovative cell therapy drugs, and is dedicated to providing new cell therapy drugs for major diseases such as solid tumors and liver cirrhosis.

5、Endurium 

On March 29th, the clinical trial application of "IBR854 Cell Injection" by Yingbairui (Hangzhou) Biomedical Co., Ltd. was granted implied approval. The application number is CXSL2501162. It is used for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer by combining IBR854 Cell Injection with pemetrexed and cisplatin.

This product employs a non-viral vector, non-gene editing, and "ADC concept" antibody-cell conjugation technology. It covalently couples a specific antibody targeting the tumor antigen 5T4 with homologous allogeneic NK cells. This not only achieves a "precise strike" against solid tumor cells but also completely avoids the mutation risks brought about by gene modification.

6、Axe Immunity 

On March 31st, the clinical trial application for "ICG318 CAR-T Cell Injection" of Hangzhou Aisi Immune Biomedical Co., Ltd. was granted implicit approval. The application number is CXSL2501168. It is used for the treatment of adult refractory immune thrombocytopenia: primary immune thrombocytopenia and secondary thrombocytopenia.

ICG318 is a dual-targeted CAR-T cell therapy targeting CD19/BCMA. This dual-target design aims to enhance the therapeutic accuracy by simultaneously blocking abnormal B-cell proliferation and autologous antibody secretion, significantly regulating the excessive activation of the immune system.

7、Enricaceno 

On March 31st, the three clinical trial applications for the "KN5501 Cell Injection" of Shenzhen Enrui Kaion Biotechnology Co., Ltd. were granted implied approval. The application numbers are CXSL2501181, CXSL2501182, and CXSL2501183, which are respectively used for treating refractory lupus nephritis, systemic sclerosis that does not respond to adequate treatment or has rapid progression, and primary Sjögren's syndrome that did not respond to previous standard treatments.

KN5501 is a CD19-targeted CAR-NK cell therapy drug. It precisely identifies and deeply eliminates CD19-positive B cells in the patient's body, blocking abnormal immune responses, while inducing the patient's own immune system to rebuild. This helps achieve deep remission or even complete remission of the disease at its root, enabling patients to completely escape the long-term reliance on hormones and immunosuppressants. It significantly reduces drug side effects and markedly improves long-term survival quality.

四 Gene Therapy 

1、Gene Illumination 

On March 1st, the clinical trial application for "GKL-006 Injection" of Beijing Genomics Qi Ming Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2501002, and it is used for the treatment of moderate to severe psoriasis.

The GKL-006 injection fluid regulates the immune network through iNKT cells, and is expected to fundamentally adjust the abnormal immune responses of patients with psoriasis. It provides a more effective and long-lasting treatment option for patients with moderate to severe psoriasis. 

2. De Kangmingji 

On March 12th, the "VG801" clinical trial application of Deconmingji Medical Technology (Shanghai) Co., Ltd. was granted implicit approval. The application number is CXSL2600074, and it is used for treating retinal dystrophy associated with double ABCA4 gene mutations.

The VG801 employs the dual adenovirus-related virus (AAV) vector REVeRT (reconstituted through mRNA trans-splicing) technology, which overcomes the challenge of the large DNA sequence encoding human ABCA4 (approximately 6.7 kb) that cannot be accommodated in a single AAV vector. REVeRT consists of two AAV vectors, each carrying half of the ABCA4 coding sequence, generating two independent mRNA precursors. These mRNA precursors undergo trans-splicing to form complete mRNAs, which are then translated into functional proteins. The VG801 also utilizes a novel vgAAV capsid, aiming to achieve extensive retinal transduction.

3. Jinweike Biotechnology 

On March 17th, the clinical trial application for "JWK001 Injection" of Chengdu Jinweike Biotechnology Co., Ltd. was granted implicit approval. The application number is CXSL2501116, and it is used for treating diabetic macular edema (DME).

The core mechanism of this product is to continuously and efficiently express anti-VEGF protein in retinal cells by using AAV vectors that carry a newly designed independent anti-VEGF protein expression frame. This effectively inhibits abnormal vascular proliferation and edema formation in the eyes, and is expected to achieve a treatment effect of one-time administration and long-term benefits.

PART.03 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 mechanisms of gene editing 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.