Sou Hu Cai Jing·2025-12-18 14:33Core Viewpoint - Hainan Shuangcheng Pharmaceutical Co., Ltd. has received FDA approval for its injectable Bortezomib ANDA, marking a significant milestone in its international expansion and product portfolio enhancement [1] Group 1: Company Performance - As of December 18, 2025, *ST Shuangcheng (002693) closed at 6.58 yuan, down 0.3% from the previous trading day, with a total market capitalization of 2.729 billion yuan [1] - The stock opened at 6.59 yuan, reached a high of 6.79 yuan, and a low of 6.55 yuan, with a trading volume of 32.0879 million yuan and a turnover rate of 1.17% [1] Group 2: Regulatory Approvals - The injectable Bortezomib ANDA has been recognized by the FDA as being bioequivalent and therapeutically equivalent to the reference drug [1] - The product has also received approval from the National Medical Products Administration of China and has passed the consistency evaluation, along with obtaining listing permission from Australia's TGA [1] Group 3: Strategic Implications - The FDA approval signifies that the company's product meets international standards, which is expected to enhance its international influence and operational performance [1] - This development will enrich the company's international sales product line and advance its globalization strategy [1] - The announcement also notes that overseas sales may be affected by regulations, policies, market conditions, and exchange rate fluctuations [1]