智通财经网·2025-06-13 00:04Core Insights - Cell and gene therapy (CGT) is currently the most promising development direction in the biopharmaceutical field, entering a phase of result realization [1] - The industry is characterized by a rich pipeline of ongoing research and development, with a continuous increase in market activity and investment [1][2] - The high outsourcing ratio and market concentration in CGT suggest that CXO companies are likely to benefit first [3] Group 1 - CGT is a new generation of precision therapy following small molecule and large molecule targeted therapies, leading a new wave in biopharmaceuticals, divided into cell therapy and gene therapy [1] - CGT has a high clinical success rate and offers long-term efficacy from single treatments, providing new options for difficult-to-treat diseases, with various products like CAR-T, stem cells, TCR-T, and TIL launched recently [1] - The CAR-T cell therapy has been the most groundbreaking in tumor immunotherapy since 2013, with six products approved in China and more potential products expected to launch soon [1][2] Group 2 - The first globally approved TCR-T cell therapy is expected in 2024, with a 43% overall response rate (ORR) for advanced synovial sarcoma, and companies like Xiangxue Pharmaceutical and Northeast Pharmaceutical are leading in this area [2] - Stem cell therapy is a significant branch of regenerative medicine, expanding its treatment scope from leukemia to anti-aging and cardiovascular diseases, with approvals for mesenchymal stem cell therapies in both China and the U.S. in 2024 [2] - Gene therapy primarily targets rare diseases, genetic disorders, and malignant tumors, with Ultragenyx Pharmaceutical submitting a Biologics License Application for a treatment in December 2024 [2] Group 3 - The high outsourcing ratio in CGT, with over 65% penetration in gene therapy compared to 35% in traditional biopharmaceuticals, indicates a greater demand for CXO services due to the complexity and regulatory challenges in the industry [3]