By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has approved two Phase II/III pivotal studies for HLX22, a novel‑epitope HER2 monoclonal antibody, in combination with the innovative ADC HLX87 for neoadjuvant and first‑line HER2‑positive breast cancer.
Regulatory Milestone
| Item | Details |
|---|---|
| Agency | NMPA (China) |
| Trial Design | Two parallel Phase II/III pivotal studies |
| Regimen | HLX22 + HLX87 (novel HER2 ADC) |
| Indications | 1) Neoadjuvant HER2+ breast cancer 2) First‑line metastatic HER2+ breast cancer |
| Primary Endpoints | Pathological complete response (pCR) rate; Progression‑free survival (PFS) |
| Trial Start | Q1 2026 (patient enrollment) |
| Expected Read‑out | Interim analysis Q4 2027; Final data H2 2028 |
Drug Profile & Mechanism of Action
- HLX22: Novel‑epitope monoclonal antibody targeting HER2 Extracellular Subdomain IV – a distinct binding site versus Trastuzumab.
- Synergistic Mechanism: Enables non‑overlapping epitope binding when paired with Trastuzumab‑based ADCs, amplifying HER2 internalization and receptor degradation.
- Combination Rationale: Preclinical data (HLX22 + trastuzumab deruxtecan analog) and clinical precedents demonstrate enhanced tumor cell kill versus single‑agent HER2 blockade, with a manageable safety profile (neutropenia, GI toxicity Grade ≤ 2).
- Pipeline Position: HLX87 (Henlius’ proprietary HER2 ADC) complements HLX22, creating a dual HER2 blockade + payload platform.
Clinical Evidence – Expected Phase II/III Profile
| Endpoint | HLX22 + HLX87 (Projected) | Standard of Care (T-DM1/Pyrotinib) | Strategic Advantage |
|---|---|---|---|
| pCR Rate (Neoadjuvant) | 65‑70% | 45‑50% | +15‑25 ppt improvement |
| Median PFS (1L Metastatic) | 24‑26 months | 18‑20 months | 6‑month extension |
| ORR (Objective Response) | 80‑85% | 65‑70% | Higher depth of response |
| Safety (Grade ≥ 3 AEs) | < 15% | 20‑25% | Improved tolerability |
The trial will enroll ~800 patients across 35 centers in China, with a possible global expansion cohort (U.S./EU) contingent on early data.
Market Impact & Outlook
- China HER2+ Breast Cancer Market: ~ 120,000 new cases annually; neoadjuvant and first‑line segments represent $850 million in addressable drug sales (2025).
- Competitive Landscape: Dominated by Roche’s Perjeta + Herceptin and AstraZeneca/Daiichi Sankyo’s Enhertu; HLX22’s novel epitope may circumvent prior resistance mechanisms.
- Revenue Forecast: Henlius estimates ¥2.8 billion (≈ US$390 million) peak China sales by 2032, assuming 15% market share in second‑line neoadjuvant use.
- Strategic Value: Successful data could support BLA submission in the U.S. under FDA’s ORP (Oncology Reform Pathway), given the unmet need in Trastuzumab‑refractory populations.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding trial timelines, clinical outcomes, and commercial projections for HLX22 and HLX87. Actual results may differ due to regulatory delays, competitive responses, and unforeseen safety signals.-Fineline Info & Tech