CSPC Pharmaceutical Group Launches Phase III Trial of Aprocitentan Tablets, Challenging for First-to-File Generic of Novel Oral Antihypertensive

On May 6, the Drug Clinical Trial Registry and Information Disclosure Platform showed that CSPC registeredOne itemAprocitentan Tablets TreatmentRefractory HypertensionPhase III clinical trial.

Source:Drug Clinical Trial Registry and Information Disclosure Platform

This is aA multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial plans to enroll 382 participants in China. The primary objective is to evaluate the efficacy of Aprocitentan tablets in treating participants with resistant hypertension, while the secondary objectives are to assess the effects of Aprocitentan tablets on other efficacy endpoints and its safety in participants with resistant hypertension.

Aptuitan Tablets are aDual Endothelin A/B Receptor（ETA/ETB）Antagonist`, Original Research`By Idorsia and Johnson & Johnson(2023 Equity Returned)Joint R&D.

Insight database shows,In March 2024, the drug received FDA approval.BecomeNearly 40 yearsThe First ApprovedAn oral antihypertensive drug that works through a novel therapeutic pathway, which was subsequently approved for marketing in the European Union, Canada, and other regions. However, it is worth mentioning that this drug has not yet been approved in China, where the highest current status remains in Phase III clinical trials.

Screenshot source:Insight Database

According to statistics from the Insight database, there are currently only two Apixaban products under development in China, one of which is the original drug, and the other is CSPC's Apixaban Tablets that have just entered Phase III clinical trials. This means that CSPC has officially begun its push to be the first to launch a generic version of Apixaban.

Source of screenshot:Insight Database

Insight database compiled a monthly list of new drugs entering Phase III globally for the first time in 2026.，Scan the QR code below and reply with the keywordPhase III of New DrugCan be obtained(Updated once at the beginning of each month, currently updated to March)。

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