By Fineline Cube Johnson & Johnson (J&J, NYSE: JNJ) announced that its Amivantamab Injection (Subcutaneous), marketed as RYBREVANT, received approval from China’s National Medical Products Administration (NMPA) for patients with advanced non‑small cell lung cancer (NSCLC) harboring EGFR mutations. The subcutaneous formulation offers an 80% reduction in infusion‑related reactions and 5‑minute administration versus the intravenous version.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 26 Dec 2025 |
| Agency | NMPA (China) |
| Product | Amivantamab subcutaneous injection (RYBREVANT) |
| Indication | Advanced NSCLC with EGFR mutations |
| Key Advantages | 5‑minute SC administration; 80% fewer infusion reactions vs. IV |
| Basis | Phase 3 PALOMA‑3 and Phase 2 PALOMA‑2 studies |
| Pharmacokinetics | Non‑inferior drug exposure vs. IV formulation |
Clinical Evidence & Indications
SC Formulation Efficacy:
- PALOMA‑3 & PALOMA‑2: Met primary PK endpoints; confirmed non‑inferiority to IV
- Dosing: 5‑minute subcutaneous injection
IV Formulation Prior Approvals (Feb 2025):
- 1L EGFR exon 19 deletion/L858R: Combined with lazertinib for locally advanced/metastatic NSCLC
- Post‑TKI progression: Combined with carboplatin/pemetrexed for non‑squamous NSCLC after EGFR TKI failure
- EGFR exon 20 insertion: Combined with carboplatin/pemetrexed for locally advanced/metastatic NSCLC
Market Opportunity
| Metric | Value | Context |
|---|---|---|
| China NSCLC Market | ¥45‑55 billion (≈ US$6.3‑7.7 B) | EGFR mutations in ~40‑50% of cases |
| Amivantamab Peak Sales | ¥8‑12 billion (≈ US$1.1‑1.7 B) by 2030 | 15‑20% share of EGFR‑targeted segment |
| SC Formulation Advantage | Outpatient convenience reduces hospital burden | Addresses infusion center capacity constraints |
| Pricing | Premium SC formulation justified by QoL improvement | NRDL negotiation slated for 2026 |
Strategic Implications
- For J&J: SC formulation expands patient access and adherence; first EGFR bispecific with SC delivery in China; strengthens RYBREVANT franchise vs. competitors (AstraZeneca’s Tagrisso).
- For Patients: 5‑minute injection enables same‑day treatment; reduced infusion reactions improve tolerability; maintains efficacy of IV version.
- For Market: SC oncology trend accelerates (e.g., Herceptin SC); EGFR bispecific class gains traction beyond TKI failures; China approval sets precedent for global filings.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding amivantamab’s commercial rollout, market penetration, and NRDL negotiations. Actual results may differ due to competitive responses, pricing pressures, or regulatory changes.-Fineline Info & Tech