On October 22, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, the beraprost sodium sustained-release tablets submitted by Beijing Tide Pharmaceutical Co., Ltd. were approved for marketing. It is mainly used to treat pulmonary hypertension and improve symptoms such as ulcers, intermittent claudication, pain and coldness caused by chronic arterial occlusive disease.Pulmonary hypertension is a cardiovascular disease with high rates of disability and mortality. Patients experience progressively increasing pulmonary vascular load, eventually leading to heart failure. Idiopathic pulmonary arterial hypertension (IPAH), which has been included in my country's first batch of rare disease catalogs, is an important type of PAH. Research data shows that without targeted treatment, the median survival of IPAH patients after the onset of symptoms is only 2.8 years.According to publicly available information, beraprost sodium is the world's first oral prostacyclin (PGI2) derivative . It has the effects of vasodilation, antiplatelet aggregation, vascular endothelial protection, smooth muscle cell growth inhibition and anti-inflammatory effects. It can significantly improve symptoms such as ulcers, intermittent claudication, pain and coldness caused by chronic arterial occlusive disease, and protect tissue blood flow without increasing myocardial oxygen consumption.Beprost sodium tablets were originally developed by Toray Industries, Inc. and were first approved in Japan in 1992 for the treatment ofsymptoms such as ulcers, intermittent claudication, pain, and coldness caused by chronic arterial occlusive disease. It can also be used for primary pulmonary hypertension. In 2007, beprost sodium extended-release tablets were reintroduced in the Japanese market for the treatment of pulmonary hypertension. Beprost sodium extended-release tablets were approved for marketing in China in 2022 for the treatment of pulmonary hypertension patients with WHO functional classification I-III, to improve their exercise capacity.
On June 14, 2025, the marketing application for beraprost sodium extended-release tablets submitted by Beijing Tide Pharmaceutical Co., Ltd. was accepted. After more than a year, on October 22, 2026, the first generic version of beraprost sodium extended-release tablets was successfully approved for marketing, breaking the monopoly of the original drug in this dosage form.It is understood that multiple guidelines and consensus statements at home and abroad recommend beraprost sodium for use in diseases such as arterial occlusive disease, diabetic neuropathy and diabetic foot, and pulmonary hypertension, such as the "Inter-society Consensus on the Management of Peripheral Artery Disease in the United States", "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China", "European Society of Cardiology/European Society of Respiratory Medicine Guidelines: Diagnosis and Treatment of Pulmonary Hypertension", and "Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension in China".Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening cardiovascular disease characterized by proliferative remodeling of small arteries in the lungs and progressive narrowing of the lumen. It is estimated that there are approximately 40 million PAH patients worldwide, with a 5-year mortality rate as high as 43%. Currently, PAH treatments on the market primarily alleviate symptoms by promoting pulmonary vasodilation, but they cannot fundamentally address the problem of pulmonary vascular remodeling.Beraprost sodium extended-release tablets, as a new generation of oral prostacyclin (PGI₂) derivative formulations, have demonstrated unique clinical advantages in the treatment of pulmonary arterial hypertension (PAH) and certain vascular diseases. Especially for PAH patients requiring long-term management, its balanced efficacy, safety, and convenience make it a preferred dosage form of oral prostacyclin drugs, providing a new treatment option for pulmonary arterial hypertension patients in China.

Source: https://mp.weixin.qq.com/s?__biz=MzI1NTM5MDg5Ng==&mid=2247518651&idx=2&sn=45d93a1c56c86da5590ef1c9b26f0e1d&chksm=ebbb7c6e343a695b2225653ffd2ddafbcf6796c0787954acd2e0ab107ff5d6629f8938038195&scene=126&sessionid=0#rd