醋酸伏诺拉生注射液

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浙江医药股份有限公司 关于XC2309注射液获得药物临床试验批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-22 19:35
Group 1 - The company has received approval from the National Medical Products Administration for the clinical trial of XC2309 injection, which is intended for treating gastrointestinal ulcer bleeding [1][2] - XC2309 injection is classified as a Class 1 chemical drug with a specification of 5ml:10mg [1] - The clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and bioavailability of XC2309 in healthy adult subjects [1][2] Group 2 - The company has invested a total of 83.96 million yuan in the development of the XC2309 project, which includes costs for both the injection and the tablet form of the drug [2] - The global sales of a similar drug, Fumaric Acid Vonoprazan Tablets, are projected to reach 936 million USD in 2024, with domestic sales in China estimated at 825 million yuan [2] - There are 23 domestic companies, including Takeda Pharmaceutical, that have received production licenses for similar oral solid dosage forms [2]