Yifan Pharmaceutical Licenses ACT001 for SCLC Brain Metastases Across 12 Asian Markets

Yifan Pharmaceutical Licenses ACT001 for SCLC Brain Metastases Across 12 Asian Markets

Yifan Pharmaceutical Co., Ltd. (SHE: 002019) announced exclusive commercial cooperation and cornerstone investment agreements with Tianjin Accendatech Co., Ltd. for ACT001, a Category 1 new‑generation immunomodulator for small cell lung cancer (SCLC) with brain metastases. The deal grants Yifan exclusive rights across 12 Asian markets and first‑negotiation rights for additional indications.

Transaction Summary

ItemDetail
LicensorTianjin Accendatech Co., Ltd.
LicenseeYifan Pharmaceutical Co., Ltd. (002019.SZ)
ProductACT001 (Category 1 new‑generation immunomodulator)
IndicationSmall cell lung cancer with brain metastases (initial)
TerritoryChina (including HK/Macau/Taiwan), Thailand, Malaysia, Singapore, Indonesia, Myanmar, Vietnam, Philippines, Cambodia, Laos, South Korea
MechanismInhibits NF‑κB and STAT3 pathways, reduces tumor cell DNA repair capacity
Clinical StatusMultiple trials ongoing in China, US, Australia for SCLC brain mets and glioma
RightsExclusive commercial rights + first negotiation for other indications

Financial Terms

ComponentAmount/Terms
Upfront Payment¥100 million
Investment OptionChoice of: ¥100 million cornerstone investment OR ¥50 million milestone payment
RoyaltiesTiered net sales royalties (undisclosed rates)
SublicensingRevenue share on sublicensing outside Chinese region (if any)
Total Deal Value¥150‑200 million upfront + milestones + double‑digit royalties

Strategic Rationale

For Yifan Pharmaceutical:

  • Oncology Expansion: Entry into CNS oncology and immunotherapy with a first‑in‑class asset
  • Geographic Leverage: Exclusive access to 12 high‑growth Asian markets with limited competition
  • Pipeline Depth: First‑negotiation rights provide optionality on broader ACT001 development

For Accendatech:

  • Non‑dilutive Funding: ¥150‑200 million accelerates global clinical trials and China registration
  • Regional Expertise: Yifan’s established commercial infrastructure in Southeast Asia and South Korea

Market Opportunity

SCLC Brain Metastases Burden:

  • China incidence: 25,000‑30,000 new cases annually
  • Regional markets: 15,000‑20,000 patients across 11 additional countries
  • Current Standard of Care: Limited chemo‑immunotherapy options with poor CNS penetration
  • Unmet Need: No approved therapies specifically for SCLC brain metastases in the region

ACT001 Potential:

  • Mechanism: Dual NF‑κB/STAT3 inhibition offers synergistic anti‑tumor and immunomodulatory effects
  • Clinical Evidence: Phase IIa data (unpublished) suggests intracranial response rate >40%
  • Market Value: ¥1.5‑2.0 billion peak sales potential in licensed territory by 2030

Development Pathway

MilestoneTarget DateResponsibility
China NDA submissionQ4 2026Accendatech (with Yifan support)
Regional regulatory filings2027‑2028Yifan Pharmaceutical
Commercial launch (China)2028Co‑promotion (terms to be negotiated)
Regional market entry2029‑2030Yifan Pharmaceutical

Forward‑Looking Statements

This brief contains forward‑looking statements regarding the Yifan‑Accendatech partnership, ACT001’s clinical development, and market potential. Actual results may differ materially due to clinical trial outcomes, regulatory decisions, and competitive dynamics.-Fineline Info & Tech