By Fineline Cube ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has approved a Phase II/III study for IMM2510 (palverafusp α), a PD‑L1×VEGF bispecific antibody, in primary advanced or recurrent endometrial cancer as monotherapy and in combination with chemotherapy. The company regained full global rights following the termination of its ex‑Greater China licensing agreement with Axion Bio, Inc. on 6 Jan 2026.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | ImmuneOnco Biopharmaceuticals (HKEX: 1541) |
| Drug | IMM2510 (palverafusp α) |
| Application | Phase II/III Clinical Trial Approval |
| Agency | NMPA (China) |
| Indication | Primary advanced/recurrent endometrial cancer (1L) |
| Design | Monotherapy and combination with chemotherapy |
| Approval Date | 10 Jan 2026 |
| Previous Indication | NSCLC (Phase I/II approved) |
| Licensing Update | Ex‑China rights from Axion Bio terminated; full rights regained |
Drug Profile & Mechanism of Action
- Mechanism: IMM2510 is a PD‑L1×VEGF bispecific antibody (BsAb) that simultaneously blocks PD‑L1 immune checkpoint and inhibits VEGF‑driven angiogenesis, creating synergistic anti‑tumor activity
- Differentiation: Dual targeting in a single molecule offers convenience vs. combination regimens and potential for enhanced efficacy with manageable safety
- Clinical Rationale: Endometrial cancer frequently exhibits PD‑L1 expression and VEGF pathway activation; limited 1L options for advanced disease beyond chemo‑immunotherapy combos
- Pipeline Status: NSCLC trials ongoing; full rights regained enable global development strategy
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Endometrial Cancer Incidence (2026E) | 82,000 | 320,000 |
| Advanced/Recurrent Cases | 19,000 | 75,000 |
| 1L Treatment‑Eligible | 12,000 | 48,000 |
| Current Standard | Carboplatin + paclitaxel ± pembrolizumab | |
| Market Gap | No approved PD‑L1×VEGF bispecific | |
| Addressable Market (2030E) | ¥3.5 billion | $2.8 billion |
- Competitors:
- Keytruda + Lenvima (Merck/Eisai) – combo approved but requires two agents
- Dostarlimab (GSK) – PD‑1 monotherapy approved in 2L; limited 1L data
- Ivonescimab (Summit/Akeso) – PD‑1/VEGF bispecific in Phase III for multiple tumors; not yet in endometrial cancer
- Strategic Moat: IMM2510 is the first PD‑L1×VEGF bispecific entering Phase III for endometrial cancer; full rights enable ex‑China licensing in 2027
Strategic Positioning & Next Steps
- Trial Design: Phase II/III will enroll ~400 patients across 25 Chinese centers; primary endpoint: PFS by BICR; secondary: OS, ORR, safety
- Global Development: ImmuneOnco plans ex‑China partnership discussions in H2 2026; US IND filing targeted for 2027 leveraging China data
- Manufacturing: Shanghai GMP facility (capacity 2,000 L) already producing IMM2510 for NSCLC trials; scalable to 10,000 L by Q4 2026
- Financial Impact: Deal termination with Axion Bio removes royalty obligations; full revenue retention in key markets boosts valuation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial timelines, regulatory pathways, and commercial strategies for IMM2510. Actual results may differ due to competitive dynamics, clinical outcomes, and partnership negotiations.-Fineline Info & Tech