RemeGen Licenses RC148 Bispecific to AbbVie for Up to $5.6 Billion in Milestones

RemeGen Licenses RC148 Bispecific to AbbVie for Up to $5.6 Billion in Milestones

RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced an exclusive licensing agreement with AbbVie Inc. (NYSE: ABBV) for RC148, a novel PD‑1/VEGF bispecific antibody, granting AbbVie exclusive rights to develop, manufacture, and commercialize the asset in all regions outside Greater China.

Deal Milestone

ItemDetail
PartiesRemeGen (SHA: 688331, HKG: 9995) & AbbVie (NYSE: ABBV)
ProductRC148 (PD‑1/VEGF bispecific antibody)
Licensed TerritoryWorldwide excluding Greater China
RightsExclusive development, manufacturing, commercialization
Indication FocusAdvanced malignant solid tumors (monotherapy & combinations)
Agreement EffectiveUpon receipt of relevant regulatory approvals
Strategic RationaleExpands AbbVie’s oncology pipeline beyond hematology into solid tumors

Drug Profile

  • Molecule: Novel PD‑1/VEGF bispecific antibody designed to simultaneously activate anti‑tumor immune responses while inhibiting tumor‑driven angiogenesis
  • Mechanism: Dual targeting of PD‑1 checkpoint and VEGF pathway within a single molecule, potentially offering synergistic efficacy and improved tumor microenvironment modulation
  • Development Stage: Ongoing clinical studies in China evaluating RC148 both as monotherapy and in combination regimens for various advanced solid tumors (trial details undisclosed)
  • Differentiation: Single‑agent dual‑blockade may reduce need for combination chemotherapy and manage resistance vs. separate PD‑1 + VEGF inhibitor combinations
  • Intellectual Property: Global patent family filed; RemeGen retains full rights in Greater China

Financial Terms

ComponentAmount/Terms
Upfront PaymentUSD 650 million (upon regulatory approval of agreement)
Development MilestonesUp to USD 2.1 billion (Phase II/III initiation, data readouts)
Regulatory MilestonesUp to USD 1.4 billion (BLA/MAA approvals in US/EU/Japan)
Commercial MilestonesUp to USD 1.45 billion (annual sales thresholds)
Total Deal ValueUp to USD 5.6 billion
RoyaltiesTiered double‑digit royalties on net sales outside Greater China
RemeGen RetainsFull rights to RC148 in Greater China, plus manufacturing technology transfer fees

Market Opportunity & Outlook

Parameter2026E2027E2028E
Global PD‑1/VEGF Bispecific Market$0.8 billion$2.1 billion$4.5 billion
Solid Tumor Indications (RC148‑eligible)1.2 million1.25 million1.3 million
AbbVie Peak Market Share Target8 %15 %
Peak Annual Sales Potential (ex‑China)$2.4 billion (2033E)
RemeGen Royalty Forecast$48 million$192 million
  • Competitive Landscape:
  • Akeso’s ivonescimab (PD‑1/VEGF bispecific) approved in China (2024) for NSCLC; pursuing global trials
  • NMPA’s cadonilimab (PD‑1/CTLA‑4) and Summit/Tivdak combos in development
  • Differentiation: RC148’s human IgG1 scaffold and optimized FcγR binding may offer superior ADCC and reduced immune‑related adverse events vs. competitors
  • Strategic Value for AbbVie:
  • Strengthens oncology portfolio post‑Imbruvica erosion; complements AbbVie’s ADC platform (eGen‑7829) and emdatritinib (FGFR2 inhibitor)
  • Access to China‑generated clinical data accelerates global development timeline by 12‑18 months

Strategic Positioning

  • For RemeGen:
  • Largest upfront payment for a Chinese biotech asset since 2023, validating its bispecific platform
  • Capital infusion funds RC148 China trials and next‑generation pipeline (CLDN18.2 ADC, TROP2 ADC)
  • Retains Greater China rights in high‑growth domestic market (estimated ¥15 billion peak sales)
  • For AbbVie:
  • Expands beyond hematology into solid tumors with a potentially best‑in‑class bispecific
  • Leverages global oncology commercial footprint (4,000+ field force) for rapid market penetration
  • Supports “pharma‑diversity” strategy amid Humira biosimilar competition

Forward‑Looking Statements
This brief contains forward‑looking statements regarding RC148 development milestones, potential regulatory approvals, and projected royalty streams. Actual results may differ due to competitive dynamics, clinical trial outcomes, and AbbVie’s strategic prioritization.-Fineline Info & Tech