Four Cell Therapies Receive IND Approval in China: From Trisal Biopharma, Enrechaino, and Others

Today, according to the announcement on the CDE official website, cell therapies from 3SBIOINC, Rui Therapeutics, Regenerative Cell Research Institute, and Zhongke Juyan have received clinical trial implied permission. These therapies include types such as CAR-T, CAR-NK, and umbilical cord mesenchymal stem cells, covering the fields of hematological tumors, autoimmune diseases, and metabolism-related diseases.

3SBIOINC's SA102-CAR-T Injection Receives CDE Clinical Trial Approval, Intended for 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 Biotechnology. In December 2023, Shenyang 3SBio, 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 grants 3SBio 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 Research Completed by Wuhan Union Hospital Shows: Among 16 Patients 81%(13 cases)Achieve Overall Relief（ORR）And MRD-negative, with stringent complete response（sCR）Rate38%; The ORR and sCR rate of 13 patients with MM cells detected in bone marrow reached 100%、46%, The median time to first remission is only1.0 Months.

Rui Therapeutics' KN5501 Cell Injection Receives CDE Clinical Tacit Approval for Treating 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 immune reconstitution in subjects to reach a state of deep or complete remission, freeing subjects from 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 exceeded21 monthsNo recurrence; meanwhile, 6 patients with systemic sclerosis were followed up for 9 months, showing significant improvement in ACR-CRISS and mRSS scores.

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.

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

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.

In order to enable everyone to learn and communicate with each other better, the media platformWeChat Official Account "Cell Gene Therapy" TeamA 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.。