Core Viewpoint - The announcement highlights that JMT101, developed by the company, has received breakthrough therapy designation from the National Medical Products Administration of China for treating advanced colorectal cancer that has failed second-line or higher standard treatments [1][3]. Group 1: Clinical Significance - Colorectal cancer is the third most common cancer globally, with 517,000 new cases and 240,000 deaths reported in China in 2022, ranking second and fourth respectively in new cases and deaths from malignant tumors [1]. - Current standard treatment for advanced colorectal cancer that has failed second-line or higher therapies has a low objective response rate (ORR) of ≤5% and a median progression-free survival (mPFS) of approximately 3 months, indicating a significant unmet clinical need [1]. Group 2: JMT101 Characteristics - JMT101 is a recombinant humanized monoclonal antibody with a novel molecular structure, exhibiting antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) [2]. - JMT101 shows significantly higher target affinity compared to similar products and reduces immunogenicity and infusion reactions [2]. Group 3: Clinical Trial Results - In a randomized, controlled, open-label Phase II study, the combination of JMT101 and irinotecan demonstrated superior ORR, disease control rate (DCR), and mPFS compared to the control group, with an mPFS of 7.4 months versus 2.9 months for the control [2]. - The study results will be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [2]. Group 4: Future Prospects - JMT101 has shown preliminary breakthrough efficacy and good safety in clinical studies, indicating a potential to become the standard treatment for post-line colorectal cancer [3]. - The company is advancing JMT101 in a pivotal Phase III clinical trial for this indication and is also conducting multiple Phase II and III clinical studies for other solid tumors, including lung cancer and nasopharyngeal carcinoma [3]. - The breakthrough therapy designation is expected to expedite the development process of JMT101 based on its promising efficacy and safety data [3].
石药集团(01093.HK)：JMT101在中国获突破性治疗认定用于治疗结直肠癌