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ImmuneOnco Subsidiary ImmuneCare Holds National Investigators’ Meeting for the Phase Ib/IIa Study of IMC-003 in Pulmonary Arterial Hypertension
2026-11-03
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Shantou, Guangdong, China, October 31, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco”; HKEX: 01541) announced that its subsidiary, ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. (“ImmuneCare”), held the National Investigators’ Meeting for the Phase Ib/IIa study of IMC-003 for injection in pulmonary arterial hypertension (PAH), in Shantou, Guangdong Province. The meeting was chaired by Prof. Zhicheng Jing of Guangdong Provincial People’s Hospital, principal investigator of the study, and brought together investigators from 26 participating sites across China. Also attending was the study’s scientific advisor, Prof. Stephan Rosenkranz, a globally recognized expert in pulmonary hypertension and heart disease. Prof. Rosenkranz chairs the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and co-chaired the task force behind the current ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension.

 

The extracellular domain of the ActRIIA receptor in IMC-003 has been engineered to give the molecule greater selectivity for Activin A than sotatercept, which may allow robust efficacy at lower exposure and potentially reduce the risk of bleeding. In Sugen5416/hypoxia and monocrotaline (MCT)-induced PAH models, IMC-003 significantly lowered right ventricular systolic pressure (RVSP) and reduced the medial wall area of pulmonary arterioles.


Uniting Investigators Around a Shared Vision

The meeting opened on the morning of October 31. In a video address, Dr. Wenzhi Tian, Chairman, Chief Executive Officer and Chief Scientific Officer of ImmuneOnco and Founder of ImmuneCare, thanked investigators from all participating sites, the project team and partners for their long-standing support of the IMC-003 program, and acknowledged the patients and families taking part in the study.

 

Dr. Tian noted that the differentiated design of IMC-003 is already being borne out in early clinical data. Its pharmacokinetic profile is particularly favorable: maximal suppression of follicle-stimulating hormone (FSH) — an established pharmacodynamic marker of ActRII pathway blockade — is achieved at relatively low drug exposure, pointing to a potentially wider therapeutic window. The company will continue to work closely with all sites to accelerate enrollment of patients with PAH while advancing development in additional indications, in pursuit of better outcomes and safety for more patients.

 

Prof. Jing noted that PAH is a progressive, fatal cardiovascular disease for which new therapies are urgently needed. He spoke positively of the design rationale behind IMC-003 and of its clinical data to date, and commended ImmuneCare for its commitment to independent innovation and to developing internationally competitive medicines, saying he expected Chinese-developed therapies to one day stand alongside the best in the world. Noting that this Phase Ib/IIa study is the first trial of IMC-003 in patients, Prof. Jing said he would lead the 26 sites in completing it efficiently and to a high standard, providing a reliable scientific basis for the molecule’s future development.

 

Expert Dialogue on Differentiation and Trial Design

That afternoon, the study’s Steering Committee convened. Dr. Qian Zheng, co-founder and Senior Vice President of ImmuneCare, led the sponsor’s clinical development team in discussion with the study’s scientific advisor Prof. Stephan Rosenkranz, the team of Prof. Zhicheng Jing, and pulmonary hypertension experts including Prof. Qiushang Ji and Prof. Lan Wang. Talks centered on the differentiated profile of IMC-003’s preclinical and available clinical data and on the design of the Phase II study; the group also covered differences in exposure between patients and healthy volunteers, ethnic pharmacokinetics, Phase III design and endpoints, safety monitoring for ActRII-pathway agents, and regulatory strategies in China and the United States. Prof. Rosenkranz and Prof. Jing each offered constructive recommendations on the product’s clinical development strategy, providing valuable input for dose selection and the global development pathway.


Charting a Global Development Path

ImmuneCare focuses on cardiovascular and metabolic diseases, including PAH, and is advancing IMC-004, IMC-011 and IMC-015 alongside IMC-003. In August 2026 the company completed a strategic capital increase in the tens of millions of RMB, marking its first external commercial financing. Separately, the Investigational New Drug (IND) application for IMC-003 in CpcPH-HFpEF (combined post- and pre-capillary pulmonary hypertension associated with heart failure with preserved ejection fraction) was accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration in October 2026 (acceptance number: CXSL2601112), making it the molecule’s second pulmonary hypertension indication after PAH.

 

In her closing remarks, Dr. Zheng said the meeting had served two purposes: aligning investigators on study progress and standardized procedures, and providing a strategy discussion on global development. The company will work closely with all sites, focusing on enrollment efficiency, imaging and data quality, and the timeliness of safety reporting, to advance the Phase Ib/IIa study. The meeting gave investigators across China a common understanding and a firmer basis for standardized multi-center execution, while the expert discussion charted a course for clinical development and international expansion. ImmuneCare looks forward to working with investigators in China to bring this differentiated ActRIIA molecule to patients with pulmonary arterial hypertension as early as possible.