Congratulations! The Mycoplasma detection kits from Baorui and others have contributed to the domestic approval for clinical trials of Chengdu Yousanuo's universal CAR-T product derived from umbilical cord blood

Recently, Chengdu Yousanuo Biotechnology Co., LTD. (hereinafter referred to as "Chengdu Yousanuo") announced that the new drug clinical trial application (IND) for its independently developed chimeric antigen receptor (CAR) allogeneic universal T-cell injection targeting CD19 (UC101) has been officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China.

This is another milestone in the global regulatory process following the IND approval of the product by the US Food and Drug Administration (FDA) on January 11, 2025. It marks that this globally pioneering umbilical cord blood-derived allogeneic universal CAR-T drug has been recognized by the review institutions of both China and the United States. It brings breakthrough treatment hope for patients with acute B-lymphoblastic leukemia (B-ALL) and other indications.

About UC101

UC101 uses neonatal umbilical cord blood as the starting material and achieves allogeneic universal design through multi-gene editing technology, breaking through the core bottleneck of traditional CAR-T treatment. It is the world's first allogeneic universal CAR-T derived from umbilical cord blood to receive FDA IND approval.

The core indication of UC101 is acute B-cell lymphocytic leukemia. Based on its unique B-cell clearance ability, UC101 plans to expand into exploratory research on autoimmune diseases.

The approval of the IND in China and the United States marks a breakthrough in the world's first universal CAR-T derived from umbilical cord blood, verifying the internationally leading gene editing and production technology. This CDE approval indicates that China's independent innovation ability in the field of universal CAR-T has been officially recognized, paving the way for subsequent indication expansion and commercialization.

AboutChengdu Yousainuo 

Chengdu Yousainuo Biotechnology Co., Ltd. was established in 2020, dedicated to the research and development and industrialization of allogeneic universal CAR-T cell therapy drugs, providing more cost-effective treatment options for a wider range of patient groups.

The IND of the UC101 project of UCenor has been approved by the review institutions of both China and the United States, indicating that the allogeneic universal CAR-T cell development technology platform of Ucenor has been recognized. This means that more immune-compatible allogeneic cell therapy drugs can be developed by using this technology platform. This breakthrough not only brings new hope to patients with acute B lymphoblastic leukemia, It also marks China's transformation from "following" to "taking the lead" in the global cell therapy field, bringing hope to millions of patients and their families around the world.

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Mycoplasma(Mycoplasma)DNADetection kit

货号: BP-QN08-50、BP-QN22-50

The traditional method for detecting mycoplasma requires at least 28 days of cultivation to reach a conclusion, which is quite time-consuming. The EP guidelines point out that if the sensitivity of the NAT detection protocol can reach the same level as the classical culture method and it has good robustness and specificity, then the NAT method can be used as a mycoplasma detection protocol to replace the classical culture method. The qPCR kit offers a very rapid and easy-to-use solution for mycoplasma control in laboratories or on production lines.

1. Rapid testing: The testing time is short, and the entire test can be completed in as fast as 1.5 hours.

2 /High sensitivity: The detection limit reaches 5CFU/mL, fully complying with the requirements of EP 2.6.7 regulations.

3 /Simple operation: Single-tube PCR reagents, the extracted nucleic acid can be directly added to the PCR reaction solution without the need for multiple components to be mixed.

4 /Internal standard system: Introduce internal quality control (internal standards) and positive quality control (PC) to effectively prevent the occurrence of false negative and false positive results. Improve the quality of testing.

5 /Good specificity: The optimized TaqMan probe covers more than 200 mycoplasma 16S rRNA genes and has high specificity; More than 30 structural analogues of mycoplasma and commonly used cell lines were verified, and none of them had cross-reactions with mycoplasma detection reagents.

6 /Strong applicability: Compatible with multiple PCR instruments, no new equipment is required; Multiple types of matrix samples were verified, and different sample matrices had no effect on the detection sensitivity, especially suitable for high-concentration cell samples.

7 /Anti-contamination: The UDG enzyme anti-contamination system is adopted to effectively prevent contamination of amplification products.

8 /Professional: Performance verification is strictly carried out in accordance with the provisions of the pharmacopoeia, and a complete set of performance evaluation materials can be provided.