I类生物技术药(多肽)非临床安全性评价研究服务
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美迪西遭1.59亿元索赔,鸿绪生物发声明:交付滞后,蒙受严重损失
Xin Lang Cai Jing· 2025-09-19 07:02
Core Viewpoint - Hongxu Biopharmaceutical Technology (Beijing) Co., Ltd. has filed a lawsuit against Medici, claiming significant losses due to Medici's failure to meet contractual and industry standards in their service delivery [2][4]. Group 1: Lawsuit Details - The lawsuit stems from a technical service contract signed on December 18, 2020, where Medici was to conduct non-clinical safety evaluations for Hongxu's Class I biopharmaceuticals [4]. - Hongxu claims that Medici failed to deliver the required safety evaluation reports on time, leading to delays in obtaining clinical trial approvals from both domestic and U.S. regulatory bodies [4][5]. - Hongxu is seeking approximately 159 million yuan in damages, including 150 million yuan for various losses incurred due to Medici's alleged breach of contract [5]. Group 2: Financial Performance of Medici - Medici reported a total revenue of 540 million yuan for the first half of the year, but still faced a net loss of 13 million yuan [6][7]. - The company has been in a loss position for two consecutive years, with a total profit of -21 million yuan this year [6][8]. - Medici's accounts receivable stood at approximately 540 million yuan, representing 37.24% of its current assets as of June [8]. Group 3: Industry Context - The pharmaceutical industry in China categorizes companies based on their research and registration capabilities, with a significant portion relying on Contract Research Organizations (CROs) like Medici for specialized services [3]. - The transition to a strong research and registration capability is challenging and costly, making the use of CROs a common practice among many pharmaceutical companies [3].
上海CRO“小巨人”美迪西子公司陷合同纠纷案:被索赔约1.59亿元,公司称将依法积极应诉
Mei Ri Jing Ji Xin Wen· 2025-09-04 15:53
Core Viewpoint - Medisi (688202.SH) announced a legal dispute involving its wholly-owned subsidiary, Medisi Puyah Pharmaceutical Technology (Shanghai) Co., Ltd., with a lawsuit amounting to approximately 159 million yuan initiated by Hongxu Biopharmaceutical Technology (Beijing) Co., Ltd. The company expects that this lawsuit will not significantly impact its daily operations [1][4][8]. Group 1: Legal Dispute Details - The lawsuit involves a technical service contract dispute, with Hongxu Biopharmaceutical claiming breach of contract by Medisi Puyah, which was contracted to conduct non-clinical safety evaluations for a biopharmaceutical project [6][7]. - The total amount claimed in the lawsuit is approximately 159 million yuan, which includes various requests such as contract termination, compensation for damages, and return of service fees [7][8]. Group 2: Financial Performance - In the first half of 2025, Medisi reported revenues of approximately 540 million yuan, a year-on-year increase of 3.64%, while the net loss attributable to shareholders was about 12.9 million yuan, a significant reduction compared to the previous year's loss [4][5]. - The company attributes the narrowing of net losses to increased revenue and strict cost control measures, with operating costs decreasing year-on-year [4][5]. Group 3: Company Background - Medisi is a specialized CRO (Contract Research Organization) providing comprehensive preclinical research services in the biopharmaceutical sector, recognized as a "small giant" enterprise in Shanghai [4][6]. - The project in question received clinical trial approval from the National Medical Products Administration (NMPA) on December 14, 2023, indicating that the company has complied with industry standards and regulations [8].