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On March 1, 2024, CARsgen Therapeutics announced that the National Medical Products Administration ("NMPA") has officially approved the New Drug Application ("NDA") for ZaiKaiZe® (Zevorcabtagene Autoleucel Injection, Product Code: CT053), a BCMA-targeted autologous CAR-T (Chimeric Antigen Receptor T-cell) candidate product.

ZaiKaiZe® is a fully human anti-BCMA autologous CAR-T cell product indicated for the treatment of relapsed or refractory multiple myeloma (RRMM). On March 1, 2024, CARsgen Therapeutics received a notification from the NMPA (approval date: February 23, 2024) approving the NDA for ZaiKaiZe®, for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least 3 lines of prior therapy (with the use of at least one proteasome inhibitor and one immunomodulatory agent). CARsgen Therapeutics is advancing a Phase 1b/2 clinical trial (LUMMICAR STUDY 2) in North America to evaluate the safety and efficacy of ZaiKaiZe® in the treatment of relapsed or refractory multiple myeloma.

As the digital service provider for CARsgen Therapeutics,  Hippocrates fully supported the company in systematically building a sound cell therapy manufacturing facility during the project, contributing to the successful NDA approval of ZaiKaiZe®. Going forward,  Hippocrates will continue to uphold its mission of "Creating Health Value through Technology" and help more enterprises accelerate the launch of high-quality pharmaceuticals.

Extended Reading: Singedi’s Digital Solutions for Cell Therapy

Hippocrates’s Digital Platform for Cell Therapy is designed to optimize the development and manufacturing of complex cell therapy processes. It provides a unified digital platform to monitor the manufacturing processes and production supply chain of your facility, helping cell therapy enterprises ensure compliance, mitigate risks, and improve management efficiency. The four core features of the Digital Cell Manufacturing Facility are as follows:

• Full-process Traceability: Covers the entire lifecycle, from the receipt, transportation, production, testing, and release of donor materials to the transportation of finished products and their administration to patients.
• Comprehensive Management: Seamlessly integrated with the Maitai® Smart Manufacturing Solution, it enables end-to-end management of the "5M1E" elements (Man, Machine, Material, Method, Measurement, Environment) in production.
• Risk Mitigation & Efficiency Enhancement: Improves operational efficiency while reducing the risks of confusion and errors during production, storage, and transportation.
• Regulatory Compliance: Meets the regulatory requirements for Chain of Identity (COI) and Chain of Custody (COC) for cell therapy products.

Four Phases of Digital Cell Manufacturing Facility Construction

1. Phase 1: Establishment of Chain of Identity (COI)/Chain of Custody (COC).
2. Phase 2: Digitalization of clinical production, testing, and traceability.
3. Phase 3: Assisting enterprises in building smart manufacturing facilities during the commercial production stage.
4. Phase 4: Supporting enterprises in developing digital systems that meet the requirements for overseas market approval in the future.