Core Viewpoint - The approval of the new drug Pyrocilin (XZP-3287) by the National Medical Products Administration of China marks a significant advancement for the company and provides a new treatment option for patients with HR+/HER2- advanced breast cancer [1][2]. Group 1: Drug Approval and Indications - The new drug application (NDA) for Pyrocilin has been granted for two indications: (1) as a monotherapy for adult patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after two or more endocrine therapies and one chemotherapy; (2) in combination with Fulvestrant for adult patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy [1]. - Pyrocilin is the only CDK4/6 inhibitor approved in China for monotherapy in HR+/HER2- advanced breast cancer after prior lines of treatment [2]. Group 2: Clinical Trial Data and Efficacy - Clinical trial data indicates that the median age of breast cancer patients in China is younger than in Western countries, with a higher proportion of Luminal B type tumors, primary resistance, and chemotherapy patients, leading to poorer prognosis [2]. - In the clinical study, 23.9% of patients had previously received late-stage chemotherapy, 25.6% were primary resistant, 37% were premenopausal, and 68.2% had visceral metastases [2]. - The median progression-free survival (mPFS) for patients receiving Pyrocilin in combination with Fulvestrant reached 14.7 months (investigator assessment) and 17.5 months (BIRC assessment), while the mPFS for monotherapy reached 11 months, setting a new record for similar therapies globally [2]. Group 3: Company Strategy and Future Outlook - The approval of Pyrocilin is a strong testament to the company's innovative research and development capabilities and represents a significant step towards providing effective treatment options for breast cancer patients [2]. - The company plans to continue its innovation-driven development strategy, increasing research and development investment, and accelerating the translation of innovative results to contribute more to global health [2].
四环医药(00460.HK)：轩竹生物自主研发的1类创新药吡洛西利片单药及联合氟维司群治疗HR+╱HER2－晚期乳腺癌的两个适应症获国家药监局上市批准