宣泰医药：恩杂鲁胺片获得美国FDA暂时批准

Core Viewpoint - The company has received temporary approval from the U.S. FDA for its abbreviated new drug application for Enzalutamide tablets, which is a significant step for expanding its market presence in the U.S. [1] Group 1: FDA Approval - The U.S. FDA has granted temporary approval for the company's Enzalutamide tablets, which are indicated for castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer [1] - This approval is expected to positively impact the company's long-term operations and sales growth in the U.S. market [1] Group 2: Patent Challenge - The company has initiated a patent challenge, and the related patent litigation is currently under review [1]