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On May 15, 2025, Shenzhen Xiankangda Life Science Co., Ltd. (hereinafter referred to as "Xiankangda Life") independently developedPBMC-Derived Allogeneic NK Cell (PANK) TherapyThe hepatocellular carcinoma (HCC) indication has officially received the Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This is also the world's first NK cell therapy to receive FDA ODD recognition for HCC indication.'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
The Dilemma of Liver Cancer Treatment
Hepatocellular Carcinoma (HCC) is the sixth most common cancer globally, with Chinese patients accounting for 55% of cases, and over 900,000 new cases annually. Currently, the useAfter the failure of first-line targeted drugs (Donafenib/Lenvatinib) or immunotherapy combined with angiogenesis inhibitors (Atezolizumab combined with Bevacizumab) in treating HCC, the efficacy of choosing other subsequent treatments is not ideal.There is still a lack of effective second-line treatment drugs.。Advanced patients will also face severe challenges such as intolerance to current treatments, drug resistance after treatment, and recurrence.。PANK Expected to Bring Affordable Innovative Treatment Options for Liver Cancer PatientsThe Three Core Advantages of PANK: "Ready-to-Use" Universal Design
PANK does not require the collection of autologous cells, can be produced at scale, and is ready for immediate use, reducing treatment costs.Based on Shenzhen Xiankangda Life Science Co., Ltd.'s proprietary NK cell culture technology platform, the purity of PANK cells exceeds 99%, and the tumor-killing effect is approximately 50% higher than that of umbilical cord blood NK cells. Compared with traditional allogeneic processes, the killing effect is also about 50% higher. By optimizing donor-recipient matching strategies, it overcomes immune tolerance limitations and reduces the risk of tumor escape.Strictly screen donors, strictly control release standards, and use pure factor culture to improve cell purity while avoiding the risk of carcinogenesis caused by feeder cells.The Significance of Orphan Drug Designation⚪ Policy Dividend: 7-year market exclusivity, 50% tax credit for clinical trial expenses, and exemption from new drug application fees;
⚪ Accelerate the Process: Priority review, breakthrough therapy designation and other expedited pathways to market;⚪ Global Layout：To lay the foundation for subsequent applications in China, the EU, and other regions.
Source of the article: Shenzhen Xiankangda Life Science Co., Ltd.
