Merck's Innovative Pulmonary Arterial Hypertension Drug Sotatercept (WINREVAIR) Launched at Ruijin Hainan Hospital

      Shanghai, China, March 17, 2025 – MSD (the corporate name of Merck & Co., Inc., Kenilworth, NJ, USA) announced that it had officially received approval from the Hainan Provincial Drug Administration for the import of the urgently needed clinical drug sotatercept (WINREVAIR). The approval allows Ruijin Hospital Hainan Branch (Hainan Boao Research Hospital, hereinafter referred to as "Ruijin Hainan Hospital"), affiliated with Shanghai Jiao Tong University School of Medicine, to import this urgently needed clinical drug, providing a new option for the clinical treatment of pulmonary arterial hypertension. Currently, the first batch of the drug has completed the import process.

      Pulmonary Arterial Hypertension (PAH, WHO Group 1) is a rare, progressive, and life-threatening vascular disease caused by multiple factors. It is characterized by the over-proliferation of pulmonary arterial wall cells, leading to pulmonary artery narrowing and abnormal constriction, which ultimately results in the contraction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Without timely and effective treatment, it can progress to right heart failure and even become life-threatening.^[1]Among them, idiopathic pulmonary arterial hypertension, as a type of pulmonary arterial hypertension, has been included in the "First List of Rare Diseases" published by the National Health Commission of China.^[2]In the era of traditional treatment lacking targeted drugs, idiopathic pulmonary arterial hypertension has a poor natural prognosis, with a median survival of only 2.8 years.¹, and is therefore known as the "cancer of cardiovascular diseases."

      Sotatercept is a "first-in-class" novel activin signaling inhibitor, and the first therapeutic biologic to regulate vascular proliferation by rebalancing pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signaling. Sotatercept consists of a recombinant homodimeric activin receptor IIA-Fc (ActRIIA-Fc) fusion protein, which acts as a ligand trap to clear excess activin A and other ligands of ActRIIA, thereby inhibiting activin signaling. Thus, sotatercept can rebalance pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signaling to regulate vascular proliferation.

      Professor Li Qingyun from Ruijin Hospital, affiliated with the Shanghai Jiao Tong University School of Medicine, introduced: "Pulmonary arterial hypertension is a serious disease characterized by pulmonary vascular remodeling, continuously increasing pulmonary vascular resistance and pulmonary artery pressure, ultimately leading to right heart failure and death. Sotatercept represents a new milestone in the treatment of pulmonary arterial hypertension. As a medical institution focused on innovative therapies, Ruijin Hospital will make full use of this breakthrough drug to actively address the clinical needs of patients and provide more effective treatment options."

      Jia Ning, Secretary of the Party Committee and Director of the Administration of Boao Lecheng International Medical Tourism Pilot Zone in Hainan, emphasized: "The Boao Lecheng International Medical Tourism Pilot Zone is a key window for cutting-edge innovative drugs to accelerate their entry into China. The introduction of sotatercept is another achievement resulting from the effective implementation of the 'pilot first' policy measures. In the future, we will continue to provide comprehensive support for the introduction and implementation of innovative drugs, allowing Chinese patients to benefit more quickly from advanced international medical achievements."

      Facing the severe challenges posed by rare diseases and the urgent needs of patients in China, MSD has consistently adhered to the principle of "patient-centeredness," relying on a solid foundation of innovation. MSD remains committed to R&D investment in the field of rare diseases, striving to provide more treatment options for "the minority of life." At the same time, MSD actively collaborates with all partners in China's healthcare ecosystem to enhance the accessibility of cutting-edge treatment solutions, hoping to bring new hope to more Chinese patients with rare diseases and help them regain the beauty of life.

*This product has not yet been officially approved in China.

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[1]Pulmonary Thromboembolism and Pulmonary Vascular Disease Group of the Respiratory Disease Society of the Chinese Medical Association, Pulmonary Thromboembolism and Pulmonary Vascular Disease Working Committee of the Respiratory Physicians Association of the Chinese Medical Doctor Association, National Cooperative Group for Prevention and Treatment of Pulmonary Thromboembolism and Pulmonary Vascular Disease, et al. Guidelines for Diagnosis and Treatment of Pulmonary Hypertension in China (2021 Edition) [J]. Chinese Medical Journal, 2021, 101(1): 11-51. DOI: 10.3760/cma.j.cn112137-20201008-02778.

[2] National Health Commission Releases Rare Disease Catalog (nsfc.gov.cn)