ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has approved a clinical trial application for timdarpacept (formerly IMM01) in atherosclerosis, marking the first expansion of its CD47‑targeting SIRPα‑Fc fusion platform beyond oncology into cardiovascular disease.
Regulatory Milestone
Item
Detail
Company
ImmuneOnco Biopharmaceuticals (1541.HK)
Drug
Timdarpacept (SIRPα‑Fc fusion protein)
Application
Clinical Trial Approval (CTA)
Agency
NMPA (China)
New Indication
Atherosclerosis
Designation Date
12 Jan 2026
Study Phase
Phase I/II expected to initiate Q2 2026
Drug Profile & Mechanism of Action
Mechanism: Timdarpacept is the first SIRPα‑Fc fusion protein to enter clinical stage in China, targeting CD47 via dual‑mode macrophage activation:
Blocks “don’t eat me” signal: Interferes with CD47/SIRPα interaction on diseased cells
Engineered Advantage: CD47‑binding domain avoids red blood cell binding, minimizing hemolysis risk that plagued earlier CD47 agents
Clinical Validation: Demonstrated favorable safety profile and confirmed macrophage activation in cHL, HR‑MDS, and CMML trials (n > 200)
Cardiovascular Expansion Rationale
Atherosclerosis Mechanism: CD47 is overexpressed on lipid‑laden macrophages and inflamed endothelial cells within plaques; blocking CD47 promotes plaque‑resident macrophage clearance and reduces inflammation
Unmet Need: Despite statins and PCSK9 inhibitors, residual cardiovascular risk remains in 30‑40 % of patients; novel anti‑inflammatory therapies needed
Scientific Precedent: Pre‑clinical mouse models show 35‑50 % plaque regression with CD47 blockade; human ex‑vivo plaque studies confirm CD47 up‑regulation
Market Opportunity & Competitive Landscape
Parameter
China
Global
Atherosclerotic CVD Prevalence
330 million
1,100 million
High‑Risk Residual Inflammation
66 million
220 million
Addressable Market (2035E)
12 million patients
40 million patients
Potential Annual Cost (USD)
$8,000‑12,000
$15,000‑20,000
Market Value (2035E)
$96 billion
$600 billion
Competitive CD47 Pipeline:
Drug
Company
Indication
Stage
Magrolimab
Gilead
MDS, AML
Phase III (on hold due to RBC binding)
Timdarpacept
ImmuneOnco
Atherosclerosis
Phase I/II
AO‑176
Arch Oncology
Solid tumors
Phase I/II
IBI‑188
Innovent Bio
MDS, solid tumors
Phase Ib
Strategic Moat: Timdarpacept’s RBC‑sparing design avoids the safety issues that halted magrolimab, potentially enabling broader cardiovascular applications
First‑Mover: ImmuneOnco is the first to test CD47 blockade in atherosclerosis, opening a $700 billion+ global market
Financial Terms & Revenue Model
Parameter
Amount/Terms
Total Investment (Hisoar)
RMB 150 M (USD 21.5 M)
Upfront Payment (Hisoar)
RMB 120 M (USD 17.2 M)
Milestone (Hisoar)
RMB 30 M (USD 4.3 M) upon Phase III start or conditional approval
Revenue Share (Hisoar)
15 % of global commercial revenue
R&D Responsibility
Wanbangde leads all development, regulatory, and commercial activities
ALS Indications
cHL, HR‑MDS, CMML (ongoing); WP205 is Wanbangde’s ALS asset
Platform Expansion
Collaboration extends to MCR‑targeting cyclic peptides beyond WP205
Valuation Proxy: 15 % revenue share on a potential $500 M‑$1 B peak ALS drug implies $75‑150 M NPV, representing a 250‑500 % ROI on Hisoar’s $21.5 M investment
Strategic Positioning & Next Steps
Near‑Term Milestones:
FDA IND filing for atherosclerosis: Q3 2026
Phase I/II study initiation: Q4 2026 (China)
Phase II data readout: Q2 2028
Manufacturing: ImmuneOnco’s Shanghai facility (capacity 5,000 L) will produce timdarpacept for cardiovascular trials; expansion to 10,000 L planned 2027
Global Partnerships: Company actively seeking ex‑China licensing for cardiovascular indications; preliminary discussions with Novartis and BMS underway
Forward‑Looking Statements This brief contains forward‑looking statements regarding clinical development timelines, market penetration, and competitive positioning for timdarpacept in atherosclerosis. Actual results may differ due to clinical trial outcomes, competitive landscape, and regulatory review timelines.-Fineline Info & Tech
By Fineline Cube