Core Viewpoint - The article highlights the ongoing issues and risks associated with unapproved cancer treatments, particularly the use of NKT immune cells in hospitals, which have not received regulatory approval in China [1][7]. Group 1: Current Situation in the Industry - Recently, multiple departments of Tianqiao People's Hospital in Jinan, Shandong, were reported to provide NKT immune cell therapy for cancer patients, charging over 100,000 yuan per treatment, despite the product not being approved by the National Medical Products Administration [1]. - The Jinan Health Commission has mandated the hospital to cease these unauthorized treatment activities [1]. - A South China stem cell industry insider noted that prior to the "Wei Zexi incident," many tertiary hospitals offered stem cell and immune cell therapies at prices ranging from 20,000 to 30,000 yuan, but only a few private hospitals continue to do so now [1][2]. Group 2: Market Potential and Risks - The immune cell therapy market, particularly TCR-T cell therapy, shows significant potential in treating various cancers, with a global total of 6,448 clinical trials registered as of August 2024, of which China accounts for 2,687 trials, representing 41.7% [5]. - The Chinese cell immune therapy market reached 10 billion yuan in 2019 and is expected to exceed 30 billion yuan by 2025, indicating rapid growth [5]. - The cost of stem cell preparation is under 3,000 yuan, while market prices can exceed 100,000 yuan, leading to substantial profit margins [5]. Group 3: Compliance and Regulatory Challenges - Despite the potential of NKT therapy, no products have received formal approval in China, and the industry faces significant compliance challenges, including technical standardization and product quality concerns [7][8]. - The dual-track regulatory system complicates the standardization of cell and gene therapies, as the health commission oversees clinical research while the drug administration manages drug registration [8]. - Industry insiders advocate for improved legal frameworks and expedited processes from laboratory to clinical application to foster industry growth [8][9].