China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence in the US market.
Background on Sorafenib
Sorafenib is an oral multi-target, multi-kinase inhibitor used in the treatment of renal cell carcinoma, hepatocellular carcinoma, and thyroid carcinoma. The drug generated global sales of USD 536 million in 2021, with USD 68.29 million and USD 85.38 million in the US and China, respectively. Yabao previously received temporary approval for the drug in July 2019, and the recent ANDA clearance from the FDA solidifies its position in the market.-Fineline Info & Tech
