Group 1 - The core point of the article is that Sihuan Pharmaceutical's subsidiary, Xuan Bamboo Biotech, has received acceptance for a new drug application (NDA) for the innovative drug Palbociclib (brand name: Xuan Yue Ning®) for a new indication in treating HR+/HER2- advanced breast cancer patients [1][2] - The new indication involves using Palbociclib in combination with aromatase inhibitors as initial endocrine therapy and as subsequent treatment for patients who have progressed after tamoxifen or toremifene adjuvant therapy [1] - Palbociclib is a CDK4/6 inhibitor with a unique multi-target synergistic mechanism that significantly reduces hematological toxicity compared to traditional CDK4/6 inhibitors, enhancing patient tolerance to treatment [1] Group 2 - Breast cancer is the most common malignant tumor among women globally, with 2.3 million new cases reported in 2022, and projections indicate 3.2 million new cases by 2050, with approximately 70% being HR+/HER2- subtype, indicating a substantial treatment demand [2] - The global market for CDK4/6 inhibitors is expected to reach nearly $13 billion in 2024, reflecting an approximate 18% year-on-year growth [2] - The acceptance of the NDA for the new indication of Palbociclib demonstrates the company's strong innovative research capabilities and commitment to providing more effective treatment options for breast cancer patients [2]
四环医药(00460.HK)：吡洛西利片联合芳香化酶抑制剂一线治疗HR+╱HER2-晚期乳腺癌新适应症NDA获NMPA受 理