Recently, Hengrui Medicine received the "Clinical Trial Notification" for the company's pirlotinib tablets, SHR6390, and SHR-1316 injections approved by the State Drug Administration and approved the combination of pirlotinib maleate tablets A randomized, double-blind, parallel-controlled, multicenter, phase III clinical study of tolzumab plus docetaxel versus placebo combined with trastuzumab plus docetaxel for early or locally advanced HER2-positive breast cancer A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of pirlotinib maleate for adjuvant therapy with trastuzumab in HER2-positive early or locally advanced breast cancer. SHR6390 in combination with fulvestrant A clinical trial for the treatment of HR-positive, HER2-negative relapsed or metastatic breast cancer that progresses after endocrine therapy. SHR-1316 combined with fluzopalyl is a clinical trial for small cell lung cancer that has previously received platinum-containing chemotherapy and disease progression.
Pirlotinib maleate is a class 1.1 innovative drug independently developed by Hengrui Medicine. It was approved for marketing in August 2018. It was included in the national medical insurance list this year and is currently undergoing clinical trials in the United States. It is China's first original research EGFR / HER2 targeted drug, and it is also China's first innovative drug that has been conditionally approved by the CFDA for its Phase II clinical research, and has become a model for China's priority research and development of innovative drugs. Phase II clinical studies of pirlotinib have shown obvious clinical advantages compared with existing domestic standard treatment drugs for advanced HER2-positive breast cancer, lapatinib, with a PFS of 18.1 months vs 7.0 months; pirlotinib combined with capecitabine The plan is the longest PFS treatment plan among registered anti-HER2 drugs in China.
片是恒瑞医药研发的1类新药，是一种口服、高效、选择性的小分子CDK4/6抑制剂，该产品此前已获批开展联合来曲唑或阿那曲唑对比安慰剂联合来曲唑或阿那曲唑治疗HR阳性、HER2阴性晚期乳腺癌的双盲、多中心、随机III期临床研究 。 SHR6390 tablet is a new class 1 drug developed by Hengrui Medicine. It is an oral, highly effective and selective small molecule CDK4 / 6 inhibitor. This product has been previously approved for combined letrozole or anastrozole versus placebo. A double-blind, multi-center, randomized phase III clinical study of trazole or anastrozole in the treatment of HR-positive, HER2-negative advanced breast cancer.
是恒瑞医药自主研发的PD-L1 单抗药物，可以解除PD-L1 介导的免疫抑制效应，增强杀伤性T 细胞的功能，发挥调动机体免疫系统清除体内肿瘤细胞的作用，已获批开展III期临床试验。 SHR-1316 is a PD-L1 monoclonal antibody drug independently developed by Hengrui Medicine, which can relieve PD-L1-mediated immunosuppressive effects, enhance the function of killer T cells, and play a role in regulating the body's immune system to clear tumor cells in the body. Approved for Phase III clinical trials. Fluroxaparil is a new class of drug developed by Hengrui Medicine. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It can specifically kill BRCA-mutated tumor cells. The product was declared for production in October this year.
Breast cancer and lung cancer are both high-incidence malignant tumors in China. Lung cancer ranks first in China, and it is known as the largest cancer in China, which seriously threatens the lives and health of Chinese patients. Over the years, Hengrui Medicine has based on the needs of life sciences and people's livelihood, closely followed the cutting-edge technology in the field of medicine, continued to increase research and development investment, stimulated the vitality of innovation, focused on the investment and development of the Chinese disease spectrum, and will provide more cancer patients in the future Treatment options bring new hope to cancer patients.