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复方利多卡因乳膏
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西藏卫信康医药股份有限公司 关于子公司获得药物临床试验批准通知书的公告
Zheng Quan Ri Bao· 2025-12-04 04:53
Core Viewpoint - The company, Tibet Weixin Kang Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of Lidocaine and Dicaine Cream, which is intended for local anesthesia in adult skin surgeries [1][2]. Drug Basic Information - Drug Name: Lidocaine and Dicaine Cream - Dosage Form: Cream - Specification: Each gram contains 70mg of Lidocaine and 70mg of Dicaine - Application: Clinical trial approval - Acceptance Number: CYHL2500168 - Approval Conclusion: The clinical trial application meets the requirements for drug registration and is approved for use in local anesthesia for intact skin prior to adult skin surgeries [1]. Other Relevant Information - The drug was developed by Zars Company and was approved by the FDA in the U.S. on June 29, 2006, under the brand name Pliaglis [2]. - Currently, there are no domestic listings for this product, but four companies have received clinical trial approvals: Jiangsu Yingke Biological Pharmaceutical Co., Ltd., Zhejiang Funuo Pharmaceutical Co., Ltd., Beijing Nobot Biological Technology Co., Ltd., and Kedi Biopharmaceuticals (Wuxi) Co., Ltd. [2]. - The company has invested approximately RMB 8.9453 million in the research and development of this drug as of October 2025 [3]. - The total sales amount for similar products, including Compound Lidocaine Cream and Dapiprazole Cream, in urban public hospitals and county-level public hospitals in China was approximately RMB 422 million in 2024 [3].
“10秒,我症状还没说,处方药就开好了”
Zhong Guo Xin Wen Wang· 2025-06-15 15:31
Core Viewpoint - The rapid growth of online healthcare in China has led to significant issues in the sale of prescription drugs on e-commerce platforms, posing serious risks to consumer safety due to lax regulations and practices [1][5]. Group 1: Prescription Drug Sales Issues - The process for purchasing prescription drugs online is alarmingly simple, with consumers not required to provide medical history or prescriptions, leading to "instant prescriptions" without proper medical evaluation [1][2][3]. - In a practical test, the time taken from consultation to prescription issuance was as short as 10 seconds, highlighting the lack of meaningful interaction between patients and online doctors [2][3]. - Some platforms allow for prescription issuance at any hour, with no restrictions on the timing of orders, further exacerbating the issue of oversight in prescription practices [5]. Group 2: Regulatory Violations - Online platforms are found to be in violation of regulations by displaying prescription drug packaging and information that should not be publicly accessible before prescription approval [6][8]. - Certain platforms promote prescription drugs for uses that exceed their approved indications, misleading consumers and potentially endangering their health [8][10]. - There are instances of products being marketed under names and packaging that closely resemble approved medications, raising concerns about counterfeit drugs and misleading advertising [10][12]. Group 3: Legal Implications - The sale of drugs with altered names and packaging may violate multiple laws, including those against unfair competition and drug management regulations, potentially leading to severe penalties for the sellers [12][13]. - Third-party platforms are urged to enhance their oversight of drug sales to prevent the distribution of unapproved or counterfeit medications, as failure to do so could result in shared liability for regulatory breaches [12].