By Fineline Cube 
Qilu Pharmaceutical Company Limited announced that its Panitumumab N01 Injection has received marketing approval from China’s National Medical Products Administration (NMPA), becoming the first fully human anti‑EGFR monoclonal antibody developed and commercialized in China.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 09 Dec 2025 |
| Agency | NMPA (China) |
| Product | Panitumumab N01 Injection |
| Molecule Type | Recombinant fully human IgG2 monoclonal antibody |
| Target | Epidermal Growth Factor Receptor (EGFR) |
| Approved Indication | In combination with FOLFOX for first‑line treatment of RAS wild‑type (KRAS/NRAS) metastatic colorectal cancer (mCRC) |
| Launch Timeline | Q1 2026 (hospital formulary placement) |
Mechanism of Action & Clinical Profile
- Mechanism: Panitumumab N01 binds specifically to EGFR on tumor cell surfaces, inhibiting ligand‑induced receptor autophosphorylation and downstream kinase activation, thereby blocking MAPK and PI3K/Akt pathways to suppress proliferation and induce apoptosis.
- Differentiation: As a fully human IgG2 antibody, it offers reduced immunogenicity compared with chimeric or humanized EGFR inhibitors, potentially lowering infusion‑reaction rates.
- Clinical Validation: The approval was supported by a Phase III bridging study (NCT05982345) in 428 Chinese patients with RAS wild‑type mCRC, demonstrating non‑inferiority to the reference product (Amgen’s Vectibix®) in median overall survival (OS: 23.8 vs 24.1 months, HR = 1.02) and objective response rate (ORR: 55 % vs 57 %), with a comparable safety profile.
China Market Opportunity & Competitive Landscape
| Metric | Value | Implication |
|---|---|---|
| China mCRC Incidence | 190,000 new cases (2024) | ~40% are RAS wild‑type, eligible for anti‑EGFR therapy |
| Current anti‑EGFR Market | ¥1.8 billion (≈ US$250 M) | Dominated by imported Vectibix® and Erbitux® |
| Panitumumab N01 Pricing | Projected 30‑35% discount to Vectibix® WAC | Drives hospital formulary adoption |
| Peak Sales Forecast (2029) | ¥600 million (≈ US$84 M) | 15% share of RAS wild‑type mCRC segment |
| Biosimilar Threat | No panitumumab biosimilars approved in China until 2028 | 2‑year first‑mover window |
Strategic Implications
- For Qilu: Entry into the oncology biologics market with a first‑in‑class domestic asset; leverages existing 70‑person oncology field force and relationships with 1,200 tier‑1/2 hospitals.
- For Patients: Provides a lower‑cost, fully human alternative to imported EGFR inhibitors, critical for National Reimbursement Drug List (NRDL) inclusion bid in 2026.
- Pipeline Expansion: Qilu is developing a panitumumab‑ADC conjugate (QL2101) and EGFR‑cMET bispecific (QL2202), creating a comprehensive EGFR‑targeted franchise.
Forward‑Looking Statements
This brief includes forward‑looking statements regarding launch timing, sales projections, and NRDL inclusion for Panitumumab N01. Actual results may differ due to pricing negotiations, competitive responses, and changes in treatment guidelines.-Fineline Info & Tech