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细胞与基因治疗药物安全性评价CRO服务
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提供CGT产品安全性评价服务,「唯可生物」获近亿元A轮融资|早起看早期
36氪· 2025-11-27 00:09
Core Viewpoint - Weike Bio has recently completed nearly 100 million yuan in Series A financing, primarily to accelerate the establishment of a CGT safety evaluation center in the U.S. and expand overseas business in CGT safety evaluation, clinical services, and biobreeding services [3]. Group 1: Company Overview - Weike Bio focuses on providing CRO services based on safety evaluation for cell and gene therapy (CGT) drugs, with a core team from Heidelberg University and the German Cancer Research Center, possessing extensive experience in CGT safety evaluation [3]. - The company has served over 70 pharmaceutical and research clients, covering more than 100 domestic and international pipelines, and supports multiple companies in achieving dual submissions in China and the U.S. [5]. Group 2: Services Offered - Currently, Weike Bio offers a full range of CRO services for CGT drugs, including early clinical research, CMC development, IIT clinical trials, long-term follow-up, and market application submissions [4]. - The company provides project management, drug safety evaluation, research and quality control services, and clinical communication, data collection, and follow-up testing services during the registration clinical phase [4]. Group 3: Market Position and Strategy - The CGT safety evaluation market in China is still in its early stages due to the late start of the domestic CGT industry, presenting challenges for Weike Bio as a startup to enter the supply chain of major downstream companies [4]. - Weike Bio emphasizes the importance of technical barriers for market competition and aims to customize testing solutions based on past cases and risks to assist clients in regulatory inquiries [4]. Group 4: Future Prospects - Recently, an increasing number of clients are approaching Weike Bio during the early research phase to assess project suitability for further advancement, indicating a gradual opening of the market [4]. - In addition to CGT, Weike Bio is also expanding into biobreeding, synthetic biology, and early diagnosis and screening, having established a subsidiary in Qingdao to serve hundreds of enterprises and research clients in the biobreeding sector [5].