Four Cell Therapies Including CAR-T, CAR-NK, and Stem Cells Receive CDE Clinical Approval
3SBIOINC
Biopharmaceutical Manufacturer
Rui Therapeutics
A New Generation of Cell-Based Drug Developer
September 5, 2025
eMedClub News
Today, according to the announcement on the CDE official website, cell therapies from 3SBIOINC, Rui Therapeutics, Regenerative Cell Research Institute, and Zhongke Juyan have all received clinical trial implied permission. These therapies include types such as CAR-T, CAR-NK, and umbilical cord mesenchymal stem cells, covering fields like hematological tumors, autoimmune diseases, and metabolism-related diseases.
3SBIOINC: CS1/BCMA Dual-Target CAR-T
3SBIOINC's SA102-CAR-T Injection Receives Clinical Tacit Approval from CDE for the Treatment of Relapsed/Refractory Multiple Myeloma.
▲ Screenshot from the CDE official website
According to publicly available information, SA102-CAR-T Injection is a CS1/BCMA dual-target CAR-T developed by Wuhan Sian Biotech. In December 2023, 3SBio Group, a subsidiary of 3SBIO INC, obtained exclusive rights for the development, registration, production, and commercialization of the product in Greater China. The agreement includes an upfront payment, milestone payments, sales royalties, and the right of first refusal for other products from Sian.
As the world's first CS1/BCMA dual-target CAR-T with clinical data demonstrating safety and efficacy, SA102 can address antigen escape and high recurrence issues associated with single-target BCMA CAR-T.
IIT Study Completed by Wuhan Union Hospital Shows: Among 16 Patients 81%(13 cases)Achieve Overall Relief（ORR）And MRD-negative, including stringent complete response（sCR）Rate38%; The ORR and sCR rates reached in 13 patients with MM cells detected in bone marrow 100%、46%, The median time to first remission is only1.0 Months.
Rui Therapeutics: Universal CD19-Targeted CAR-NK
Rui Therapeutics' KN5501 Cell Injection Receives CDE Clinical Trial Approval, Intended for Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus.
▲ Screenshot from the CDE official website
KN5501 is a CD19-targeted CAR-NK designed to achieve deep depletion of CD19+B cells by targeting the CD19 antigen, inducing autoimmune reconstitution in subjects to reach a state of deep or complete remission, enabling subjects to discontinue long-term hormone and immunosuppressant treatments. Currently, no CAR-NK therapies with the same target have been approved for marketing in China or globally.
KN5501 also adopts the unique HTAS-RV™ delivery system and CAR-NK cell expansion cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.
Data from the 2025 EULAR Annual Meeting Show: SRI-4 Response Rate in 13 Systemic Lupus Erythematosus Patients with Follow-up Over 12 Months100%, LLDAS response rate 76.9%, Doris remission rate 69.2%, longest remission exceeding21 monthsNo recurrence; meanwhile, 6 patients with systemic sclerosis were followed up for 9 months, showing significant improvement in ACR-CRISS and mRSS scores.
Regenerative Cell Research Institute: Human Umbilical Cord Mesenchymal Stem Cell Injection
Rui Therapeutics'申报的人脐带间充质干细胞注射液获 CDE 临床默示许可，拟治疗既往治疗失败的 2 型糖尿病引起的勃起功能障碍（DIED）。
▲ Screenshot from the CDE official website
Human Umbilical Cord Mesenchymal Stem Cell Injection utilizes the unique biological properties of cells to precisely target damaged nerve and vascular tissues, promoting cell repair and regeneration, improving blood circulation in the penile corpus cavernosum, and effectively restoring erectile function. Compared with traditional treatment methods, cell-based drugs have significant advantages such as strong targeting, long-lasting efficacy, and minimal side effects.
In 2024, Yuan Chunhui, the president of the hospital, led a research team to publish "Experimental Study on Human Umbilical Cord Mesenchymal Stem Cells Restoring Cavernous Nerve Function in Diabetic Erectile Dysfunction Rats," confirming that human umbilical cord mesenchymal stem cells can restore cavernous nerve function in diabetic rats, providing preclinical data support for this therapy.
CAS Research: Umbilical Cord Mesenchymal Stem Cell Injection
CDE Grants Clinical Trial Approval to Zhongke Juyan's Umbilical Cord Mesenchymal Stem Cell Injection for Knee Osteoarthritis Treatment.
▲ Screenshot from the CDE official website
The prevalence of knee osteoarthritis in people over 40 years old in China is as high as 46.3%. Although there are many traditional treatment methods, they are mostly focused.Focus on "symptom relief". MSC achieves "fundamental treatment" through three mechanisms: 1. MSC can differentiate into chondrocytes to directly regenerate damaged cartilage; 2. Exert paracrine effects, such as secreting growth factors.(TGF-β, etc.)Promote cartilage matrix synthesis; 3. Inhibit inflammatory factors such as IL-1 and TNF-α through anti-inflammatory regulation to alleviate pain.
Zhongke Juyan is a full-industry biotechnology company focusing on stem cell storage, research and development, and clinical transformation applications, with multiple GMP-standard laboratories across China. The company is composed of a scientific research team led by Academician Randy W. Schekman, a Nobel Prize winner in Physiology or Medicine.
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