Hycells Warmly Congratulates Ucardi on Obtaining Implicit Clinical Approval for Its Innovative CAR-T Therapy for Solid Tumors
Release Date:
2024-07-01 14:23
On June 28, 2024, the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration announced that the Investigational New Drug (IND) application for U87 Injection, an innovative drug independently developed by Shanghai Youcardi, has officially been granted tacit approval (Acceptance Number: CXSL2400222), with Trop2-positive advanced malignant tumors as its intended indication.
Hycells Bio warmly congratulates Ucardi on this significant milestone! In collaboration with Beike Pharmaceuticals, Hycells Bio provided RCL testing for this project, demonstrating its expertise in compliant, standardized, end-to-end, and China–U.S. regulatory‑compliant professional services that empower innovation and jointly advance the field of cell therapy.
Regarding U87 Injection
U87 injection is independently developed by Ucardi. Class 1 therapeutic cell therapy product with fully independent intellectual property rights Currently, no CAR-T cell therapy targeting Trop2 has been approved for marketing worldwide. The approval of the U87 injection for this clinical trial is expected to bring new hope and treatment options to patients with Trop2-positive advanced malignancies.
The 2022 National Cancer Report indicates that an estimated 4.8247 million new malignant tumor cases were diagnosed nationwide in 2022, with an estimated 2.5742 million deaths from malignant tumors. The top five cancers in terms of incidence are lung cancer, colorectal cancer, thyroid cancer, liver cancer, and gastric cancer, while the top five in terms of mortality are lung cancer, liver cancer, gastric cancer, colorectal cancer, and esophageal cancer. Furthermore, research data show that trophoblast cell surface antigen 2 (Trop2) is specifically overexpressed in all of the top five cancers by mortality, demonstrating “Pan-cancer” Biomarker potential.
Trop2 is encoded by the TACSTD2 gene located on chromosome 1 and consists of 323 amino acids. The protein structure of Trop2 comprises a hydrophobic signal peptide, an extracellular domain, a transmembrane domain, and a cytoplasmic tail. Trop2 is a cell membrane glycoprotein that is specifically overexpressed in tumor tissues but poorly expressed in normal tissues; it is overexpressed in most malignant solid tumors and is significantly associated with tumorigenesis, progression, invasion, and metastasis.
The Trop2-targeted ADC drug sacituzumab govitecan is now on the market, breaking the long-standing therapeutic impasse in triple-negative breast cancer. Meanwhile, several other Trop2-targeted ADCs are actively under development, with the hope of expanding treatment options for patients with urothelial carcinoma, non-small cell lung cancer, and other malignancies.
U87 injection, the world’s first fully human, Trop2-targeted CAR-T product, is an innovative CAR-T therapy developed on Youcadia’s MADDS antibody–based drug discovery platform, and holds promise in bringing new hope to patients with advanced solid tumors, including triple-negative breast cancer, lung cancer, pancreatic cancer, colorectal cancer, and thyroid cancer.
About Ucardi Biotech
Shanghai Ucardi Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Ucardi”) was founded in February 2015 at the Zhangjiang Biotechnology Incubator in Shanghai. It is a biopharmaceutical company dedicated to the innovation and translation of global cell therapy technologies, with several first-in-class and first-in-safety products currently in clinical trials.
Youcardi boasts several proprietary core technology platforms, including the SMART small-nucleotide gene-regulation empowerment platform, the MADDS antibody innovation and drug-development platform, and the 6H manufacturing quality-control platform. In addition, the company has established a closed-loop CAR-T manufacturing system in Baoshan, spanning approximately 10,000 square meters, to build an internationally advanced, multi-billion-dollar research, industrialization, and commercialization hub for gene and cell therapies. This center is designed to become a world-class platform for translating innovative immunotherapy technologies for cancer treatment into clinical applications, as well as a leading, cutting-edge hub for the gene-engineered immune-cell industry chain. Its core functions include the industrial-scale production of CAR-T products and CDMO services for plasmids, viral vectors, and CAR-T cells.
Ucardi’s product pipeline is broadly diversified, encompassing autologous CAR technology, allogeneic CAR technology, and in vivo CAR induction, with indications spanning hematologic malignancies, solid tumors, and autoimmune diseases. The company has collaborated with numerous renowned clinical institutions both domestically and internationally, successfully treating over a thousand patients with advanced cancer. Ucardi’s innovative ssCART-19 injection represents a breakthrough approach for treating central nervous system leukemia—commonly referred to as “brain leukemia”—a condition that typically contraindicates conventional CAR-T therapy. This product has been included on the CDE’s Breakthrough Therapy Designation list and has received FDA Orphan Drug Designation, currently advancing into the pivotal clinical phase. Another innovative product, U16 injection, is a non–CD19-targeted CAR-T therapy indicated for lymphoma, demonstrating remarkable efficacy and now in Phase 1 registrational clinical trials.
Advantages of the RCL Testing Platform
| Platform Advantages | Technical Service Platform |
| HIV True Toxicity Control | √ |
| P3 Biosafety Laboratory | √ |
| Inhibition control group | √ |
| P24 detection method | √ |
| P24 Quantitative Analysis | √ |
| Psi-gag detection method | √ |
| VSV-G detection method | √ |
| PERT testing method | √ |
| VSV-G plasmid transfection positive control |
√ |
The team at Shanghai Hycells Biotechnology Co., Ltd. has been deeply engaged in the field of cell therapy for many years, continuously refining its quality management system and upgrading and optimizing its technology service platform. Upholding a corporate culture and attitude characterized by innovation, openness, and inclusiveness, the team remains committed to addressing clinical needs and industry pain points through continuous product and service innovation, delivering truly valuable, differentiated offerings to its clients. With the collective support of all stakeholders, the company aims to strengthen its pipeline of R&D products and services, further empower its industry partners, and jointly advance the development of the cell therapy sector.
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