Treprostinil

Pulmonary arterial hypertension (PAH) is a rare cardiovascular disease with rapid progression and high mortality. Patients with PAH suffer from progressive elevation of pulmonary vascular resistance, which can eventually lead to right heart failure. For a long time in the past, there was a lack of effective long-term intervention methods in clinical practice. Treprostinil is a synthetic prostacyclin analog. It directly dilates pulmonary and systemic arterial vessels and inhibits platelet aggregation, so as to reduce pulmonary artery pressure and improve exercise tolerance. It is one of the core medications for the treatment of PAH at present. It is not only suitable for patients with idiopathic and hereditary PAH with NYHA cardiac function class Ⅱ-Ⅳ, but also can be used for the long-term treatment of PAH associated with connective tissue disease and congenital heart disease. In some clinical scenarios, it is also used for symptom control of chronic thromboembolic pulmonary hypertension.

At present, the global market size of treprostinil has exceeded USD 1.2 billion, and the compound annual growth rate (CAGR) in the past five years has maintained at around 8.2%. The growth momentum mainly comes from the improvement of the diagnosis rate of rare diseases and the expansion of indication scope. In terms of the domestic market, as PAH is included in the rare disease catalogue and high-value drugs are covered by medical insurance policies, the domestic market size of treprostinil reached RMB 780 million in 2023, with a CAGR of more than 35% in the past three years. In terms of the competitive landscape, the original research product has long occupied a dominant position. At present, generic preparations of 3 domestic enterprises have been approved for marketing, and the API registrations of another 4 enterprises are in the public notice stage. Under the expectation of centralized procurement, the accessibility of drugs will be further improved in the future.

The original research enterprise of treprostinil is United Therapeutics Corporation, and the original brand name is Remodulin. Its core compound patent in the United States expired in 2017, and its preparation patent in China expired in 2021. The main dosage forms approved by the original research include injection, inhalant and subcutaneous implant. The injection specifications include 20mg/20ml, 50mg/20ml, etc., which have been included in the China Listed Medicines Catalogue as reference preparations, and also included in the FDA Reference Preparations Catalogue. Up to now, 8 domestic enterprises have obtained CDE registration numbers for treprostinil APIs, among which 5 registration statuses are "A" and can be associated with preparation declarations. In addition, 6 domestic treprostinil injections have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of treprostinil, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the relevant technical needs of pharmaceutical enterprises in impurity research, quality standard establishment and registration.