Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2026
Brii Biosciences discloses central lab test kit recall affecting ENHANCE trial HBsAg data
Hazard disclosure
Brii Biosciences announced that on August 19, 2026, it received an email notice from a central laboratory service provider regarding a recall of a commercially available test kit batch (Roche Elecsys HBsAg II quant II) used for HBsAg testing in the ENHANCE study. The company stated that the potential impact on its published clinical trial data appears limited to the end-of-treatment HBsAg data from ENHANCE Part A-2, and that it is working with the provider to identify affected samples and arrange retesting with unaffected kits.
Company response
Ongoing disclosure — 腾盛博药
公司将继续评估此事件，并将在出现任何重大进展时适时作出进一步更新。
Remediation — 腾盛博药
本公司正与服务提供商协作，以确定可能受影响的样本，并安排使用未受影响的检测试剂盒进行复检。
Source excerpt
根据目前可获得的信息及本公司的初步评估，对本公司申办的已公开发布的临床试验数据可能产生的影响，目前看来仅限于ENHANCE研究A-2部分的治疗结束时HBsAg数据。
2026年8月19日，本公司收到其一家中央实验室服务提供商发来的电子邮件通知，内容涉及一起市售检测试剂盒产品
[1] 涉及的试剂盒为罗氏Elecsys HBsAg II quant II。