新药氟唑帕利胶囊 作为具有明显治疗优势创新药被国家药品监督管理局药品审评中心纳入拟优先审评品种公示名单。 Recently, Hengrui Pharmaceutical's new class 1 drug, fluzopalyl capsules, as an innovative drug with obvious therapeutic advantages, has been included in the publicity list of priority varieties for review by the Drug Evaluation Center of the State Drug Administration.
Fluroxaparil is a poly (ADP-ribose) polymerase (PARP) inhibitor, which specifically kills BRCA-mutated tumor cells and is used to treat patients who have undergone second-line or higher chemotherapy Recurrent ovarian cancer with a BRCA1 / 2 pathogenic or suspected pathogenic mutation. This product was declared for marketing in October this year based on single-arm, multi-center clinical research data for recurrent ovarian cancer with BRCA1 / 2 pathogenic or suspected pathogenic mutations that have previously undergone second-line chemotherapy and above. Bureau acceptance.
Previously, Hengrui Pharmaceutical's fluzopalyl related clinical research has emerged in the international community. A study led by Professor Wu Lingying of the Cancer Hospital of the Chinese Academy of Medical Sciences on the efficacy and safety of fluzopalyl in platinum-sensitive ovarian cancer with BRCA1 / 2 mutations The exploratory multi-center Phase Ib study was included in the 2019 ESMO (European Society of Oncology Annual Meeting) conference (Abstract # 4168 2019 ESMO) and won the Best Poster Award. This is the first time a PARP inhibitor has been used as a monotherapy in a Chinese population. The treatment of patients with recurrent ovarian cancer carrying BRCA1 / 2 mutations is an important achievement achieved by PARP inhibitors in China.
Ovarian cancer is one of the three most common malignant tumors in the female reproductive system. The onset is hidden and difficult to detect. The mortality rate is the highest in gynecological malignancies. Hengrui Pharmaceutical's flurazole-palli capsules were included in the announcement of priority review varieties, which is expected to promote the early launch of the product and provide more treatment options for patients with ovarian cancer.
10 多项临床研究。 At the same time, Hengrui Medicine is conducting more than 10 clinical studies on fluzoparib involving multiple indications including small cell lung cancer, solid tumors, recurrent and metastatic triple negative breast cancer, prostate cancer, recurrent ovarian cancer, and gastric cancer .