Core Viewpoint - Beijing Shuanglu Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for Regorafenib tablets, enhancing its portfolio in the oncology sector [1][2]. Group 1: Drug Information - Drug Name: Regorafenib Tablets - Dosage Form: Tablets - Specification: 40mg - Registration Category: Class 4 Chemical Drug - Approval Number: National Drug Approval No. H20253676 - Approval Conclusion: The drug meets the registration requirements as per the relevant laws and regulations [1][2]. Group 2: Market and Application - Regorafenib is a multi-targeted tyrosine kinase inhibitor used for treating various advanced cancers, including: - Metastatic colorectal cancer (mCRC) in patients previously treated with fluorouracil, oxaliplatin, and irinotecan-based chemotherapy [2]. - Gastrointestinal stromal tumors (GIST) in patients previously treated with imatinib and sunitinib [2]. - Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib [2]. - The original Regorafenib was developed by Bayer and Onyx, approved by the FDA in September 2012, and entered the Chinese market in March 2017 [2]. Group 3: Impact on the Company - The approval of Regorafenib will enrich the company's oncology product offerings, potentially increasing its market competitiveness [3].