Merck Sharp & Dohme’s Sotatercept (for injection) launches as a breakthrough, leading pulmonary arterial hypertension (PAH) toward a new milestone of “treating the root cause.”

ShanghaiJune 8, 2026 /PRNewswire/ — Merck Sharp & Dohme (MSD, the company name of Merck & Co., Inc., headquartered in Rahway, New Jersey, USA) today announced that the world’s first* fully human biologic targeting the core pathological mechanism of pulmonary arterial hypertension, Xinruilai^® (Sotatercept for injection), has officially been launched in China. It is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH, WHO Group 1) classified as World Health Organization Functional Class (WHO FC) II-III^[1], filling a therapeutic gap in addressing the root cause of PAH.

MSD Global Senior Vice President and MSD China President, Kaiyu Tang stated: “Pulmonary arterial hypertension, as a relatively complex cardiovascular disease, severely impacts patients’ daily activities, quality of life, and even poses life-threatening risks. The five-year mortality rate for newly diagnosed patients is as high as 40%^[2], casting a constant shadow over patients and their families. The launch of Xinruilai^® (Sotatercept for injection) provides Chinese PAH patients with a novel mechanism-based treatment option, which is expected to break the long-term constraints of the disease, allowing patients not only to survive but also to reclaim their lives. In the future, we will actively work to improve drug accessibility, enabling more patients to breathe freely and achieve a reversal of their condition.”

Pulmonary arterial hypertension is a cardiovascular disease with high disability and mortality rates^[3]. Patients experience progressive increases in pulmonary vascular load, ultimately leading to heart failure^[4]. Idiopathic pulmonary arterial hypertension (IPAH), included in China’s First List of Rare Diseases, is a significant subtype of PAH^[5],[6]. Research data indicates that without targeted treatment, the median survival time for IPAH patients after symptom onset is only 2.8 years^[7].

“PAH symptoms lack specificity, primarily presenting as exertional dyspnea and fatigue. As the disease progresses, patients’ exercise capacity continuously declines, severely affecting their quality of life^[7]. Excessive cell proliferation leading to pulmonary vascular remodeling is the core pathological mechanism of PAH. Traditional targeted vasodilator therapies cannot reverse the progressive occlusion of pulmonary vessels^[8], and approximately 70% of patients still fail to reverse disease progression even after receiving adequate doses of combined vasodilator therapy^[9]. Patients urgently need innovative treatments to improve quality of life and long-term prognosis.” Professor Zhicheng Jing, Vice President of Guangdong Academy of Medical Sciences, Chairman of the Cardiovascular Disease Committee of Guangdong Medical Association, and Director of the Department of Cardiology at Guangdong Provincial People’s Hospital, stated: “Sotatercept, as the first fully human fusion protein targeting pulmonary vascular remodeling, has been shown in experiments to inhibit cell proliferation, thereby reversing vascular remodeling and improving heart failure^[10]. The clinical application of Sotatercept marks a new era in China’s PAH treatment, transitioning from ‘symptom management’ to ‘root cause treatment.’ We look forward to this innovative therapy bringing comprehensive improvements in quality of life and survival for domestic PAH patients.”