Core Viewpoint - The article highlights the significant breakthrough of Kanjia Pharmaceutical in expanding CAR-T cell therapy from hematological cancers to solid tumors, with the submission of a new drug application for Shurijiaolun's injection [1][2][5][7]. Group 1: Company Developments - Kanjia Pharmaceutical submitted the new drug application (NDA) for Shurijiaolun's injection to the National Medical Products Administration (NMPA) on June 25, 2023, which was accepted on June 26 [1][3]. - The successful development of Shurijiaolun's injection positions Kanjia Pharmaceutical to potentially become the first company globally to offer CAR-T therapy for solid tumors, specifically targeting Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients [5][8][9]. - The company has seen its stock price surge nearly tenfold from a low of 2.48 HKD to around 25 HKD, driven by research advancements rather than market speculation [3][22]. Group 2: Clinical Trial Results - The NDA submission is based on a Phase II clinical trial (CT041-ST-01) that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard treatments for patients with advanced gastric cancer [9][10]. - The trial results have garnered international attention and recognition, providing a solid evidence base for the NDA application [10][12]. Group 3: Market Potential and Financial Health - The global market for CAR-T therapies is expected to expand significantly, as solid tumors account for approximately 90% of new cancer cases, compared to less than 10% for hematological cancers [11]. - Kanjia Pharmaceutical's financial health is robust, with cash reserves projected to remain above 1.08 billion HKD by the end of 2025, indicating a strong foundation for sustainable growth [12][13]. Group 4: Future Outlook - The company is preparing to build a commercialization team for Shurijiaolun's injection, aiming for a clear path to market and reduced trial costs [14]. - Kanjia Pharmaceutical is also developing universal CAR-T therapies using its THANK-u Plus™ platform, which shows promise in treating various cancers [18]. - The company is expected to leverage its successful commercialization of its first CAR-T product, Zewokaiolun's injection, to enhance the market entry of Shurijiaolun's injection [12][13]. Group 5: Industry Context - The Chinese innovative drug sector is experiencing a favorable environment, with increased investor enthusiasm and a trend of value reassessment among listed companies [16][22]. - Kanjia Pharmaceutical's unique approach contrasts with many peers that rely on overseas business development, as it focuses on self-sustaining growth through successful product commercialization [16].
股价大涨10倍后，科济药业CAR-T疗法实现全球实体肿瘤领域新突破