Analysis of aprocitentan’s domestic launch time and registration approval status

Aprocitentan (aprocitentan) is a new endothelin receptor antagonist that has attracted much attention in the international cardiovascular field in recent years. Its domestic marketing and registration progress has always been a topic of focus for patients and doctors. Especially as the drug is approved overseas for the treatment of refractory hypertension, domestic patients' expectations for its accessibility continue to rise. However, the current public drug registration information shows that aprecitentan has not yet received formal marketing approval in mainland China, nor does it appear in the approved drug list of the National Food and Drug Administration (NMPA). Therefore, there is currently no original research version officially launched in the domestic market, and its supply channels do not yet fall within the scope of formal clinical application.

Internationally, the registration of apremicitentan is advancing rapidly. The drug was approved for marketing in the United States in 2024 and was developed by the Swiss company Idorsia. It is used in combination with other antihypertensive drugs to treat refractory hypertension. Its mechanism is unique and exerts its antihypertensive effect by blocking endothelinA/B receptors. It is of great significance to patients whose blood pressure cannot be controlled by triple or multiple combinations of drugs. Because of its innovative mechanism and solid research data, the Chinese pharmaceutical industry generally believes that it has high introduction value and is very likely to enter the domestic registration process in the future. However, so far, there has been no official release of a clear timetable or registration progress announcement.

Since Aprecitentan is not yet on the market in China, some patients may be exposed to information about the "overseas version" or "generic version". However, it is important to emphasize that these products do not represent official approval from China, and their quality control, ingredient consistency and safety cannot be completely equivalent to those of the original drugs. In particular, so-called "foreign versions" or "overseas generic drugs" purchased through online channels may have risks such as failing to pass strict review and having opaque sources. Therefore, it is not recommended to purchase or try to use them through informal channels. When patients are concerned about new drugs, they should always refer to the official information released by the drug regulatory department to ensure drug safety.

Overall, apremicitentan is still in the status of “not yet on the market and not yet approved” in China. Whether it will be introduced into the Chinese market in the future depends on enterprise application, technical review process and relevant regulatory requirements. For patients with refractory hypertension, they still need to follow the existing standard treatment plan and make individualized combination medication adjustments under the guidance of a doctor. While looking forward to the arrival of new drugs, maintaining standardized treatment and regular follow-up are still the most critical strategies for controlling blood pressure. To learn about the latest registration progress, continue to pay attention to the drug review updates released by the State Food and Drug Administration.

Reference materials:https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217686s000lbl.pdf