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亚虹医药(688176.SH):APL-1706已达到Ⅲ期临床试验主要研究终点 上市申请已获受理

Yahong Pharmaceutical (688176.SH): APL-1706 has reached the main research endpoint of phase III clinical trials. The application for marketing has been accepted

Zhitong Finance ·  Apr 8 03:49

Yahong Pharmaceutical (688176.SH) announced that the company APL-1706 is a multi-center for bladder cancer diagnosis...

Zhitong Finance App News, Yahong Pharmaceutical (688176.SH) issued an announcement. The results of the company's APL-1706 multi-center clinical trial for the diagnosis of bladder cancer were selected for the 39th Annual Meeting of the European Urology Medical Association (EAU) in 2024, and phase III clinical trial data was released in the form of an oral report. APL-1706 is currently the only developer drug approved in the world to aid bladder cancer diagnosis or surgery. Through combined use with a blue light cystoscope, it can effectively improve the detection rate of bladder cancer (especially the detection rate of cancer in situ (CIS)), make surgical resection more complete, thereby reducing the recurrence rate of tumors.

At present, the above products have reached the main research end of phase III clinical trials, and the marketing application (NDA) has been accepted. There is uncertainty about whether the clinical trial results can support the submission of a marketing application for the drug, whether it can finally obtain marketing approval, and when. There is also some uncertainty about whether the product can finally achieve commercial purposes after approval.

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