By Fineline Cube RemeGen Ltd (SHA: 688331, HKG: 9995) announced that its core product, Disitamab Vedotin (RC48/Aidixi), has been granted its fourth Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The designation applies to first‑line treatment of HER2‑high expressing advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab and toripalimab, reinforcing RC48’s leadership position in the HER2 ADC landscape.
Product & Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Disitamab Vedotin (RC48/Aidixi) |
| Company | RemeGen Ltd (688331.SH/9995.HK) |
| Mechanism | HER2‑targeted antibody‑drug conjugate (ADC) |
| Designation | 4th Breakthrough Therapy Designation (CDE/NMPA) |
| New Indication | 1L HER2‑high GC/GEJC with trastuzumab + toripalimab |
| Previous BTDs | 3 prior BTDs (gastric 3L, urothelial carcinoma, breast cancer) |
| Regulatory History | Conditionally approved June 2021 (3L gastric), Dec 2021 (2L urothelial), Apr 2025 (breast cancer liver mets) |
Clinical Evidence & Differentiation
RC48’s Clinical Profile:
- HER2 Specificity: Targets HER2‑overexpressing tumors (IHC 2+/3+)
- Payload: Microtubule inhibitor MMAE with bystander effect
- Combination Rationale: Synergizes with trastuzumab (HER2 mAb) and toripalimab (PD‑1 inhibitor) for dual HER2 blockade + immune activation
Market Significance: This marks the first BTD for a HER2 ADC triple‑combination in first‑line gastric cancer, addressing a ¥8‑10 billion market opportunity.
Market Opportunity: HER2‑Positive Gastric Cancer
Disease Burden:
- China GC Incidence: ~480,000 new cases annually (50% of global total)
- HER2‑High Expression: 15‑20% of GC patients → ~72,000‑96,000 eligible
- First‑Line Setting: 60‑70% of eligible patients receive first‑line therapy → ~50,000 addressable patients
- Current Standard: Trastuzumab + chemotherapy (ORR ≈ 47%, mOS ≈ 13.5 months)
RC48 Revenue Potential:
- 2026 Launch: ¥500‑800 million (partial year)
- 2027 Peak: ¥2.5‑3.5 billion (assuming 15‑20% market share)
- Ex‑China Opportunity: ¥5‑7 billion potential via partnerships (US/EU rights still available)
Competitive Landscape
| Drug | Company | Mechanism | Stage (China) | Key Limitations |
|---|---|---|---|---|
| RC48 | RemeGen | HER2 ADC + combo | 4x BTD | First triple‑combo BTD |
| Enhertu | Daiichi/AZ | HER2 ADC | Approved (3L) | Moving to 1L, monotherapy focus |
| Keytruda + chemo | MSD | PD‑1 + chemo | Approved | No HER2 targeting |
| Toripalimab + chemo | Junshi | PD‑1 + chemo | Approved | No HER2 ADC component |
Differentiation: RC48’s ADC + mAb + PD‑1 triple combination offers synergistic HER2 blockade and immune activation, potentially superior to monotherapy or doublets.
Strategic Implications
For RemeGen:
- Platform Validation: 4 BTDs establish leadership in HER2 ADC innovation
- NRDL Pathway: BTD enables priority review (130 days) and 2027 NRDL negotiation
- Global Licensing: Ex‑China rights for RC48 remain available, with potential $800M‑1.2B deal value
- Pipeline Leverage: Success supports RC88 (HER2 ADC for breast cancer) and RC108 (c‑Met ADC) programs
For China Market:
- Safety Standard: RC48’s manageable toxicity (ocular events, neuropathy) vs. competitors
- Cost‑Effectiveness: Triple combo projected at ¥180,000‑220,000 per patient, competitive with PD‑1 + chemo alone
- Manufacturing: Yantai facility (capacity: 500 kg/year) ready for commercial scale
Financial Projections
| Metric | 2026E | 2027E | 2028E |
|---|---|---|---|
| China GC Patients Treated | 8,000 | 15,000 | 25,000 |
| Market Share | 16% | 30% | 42% |
| Revenue (¥ million) | 1,440 | 2,700 | 3,780 |
| Gross Margin | 85% | 87% | 88% |
| Royalty to Partners | 12% | 10% | 8% (trastuzumab + toripalimab) |
Peak Valuation: RC48 could contribute ¥45‑50 per share to RemeGen’s valuation, representing 30‑35% upside.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding RC48’s clinical development, regulatory approvals, market penetration, and revenue forecasts. Actual results may differ materially due to competitive dynamics, pricing negotiations, NRDL inclusion outcomes, and partnership discussions for ex‑China rights.-Fineline Info & Tech