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
| Item | Detail |
|---|---|
| Licensor | Tianjin Accendatech Co., Ltd. |
| Licensee | Yifan Pharmaceutical Co., Ltd. (002019.SZ) |
| Product | ACT001 (Category 1 new‑generation immunomodulator) |
| Indication | Small cell lung cancer with brain metastases (initial) |
| Territory | China (including HK/Macau/Taiwan), Thailand, Malaysia, Singapore, Indonesia, Myanmar, Vietnam, Philippines, Cambodia, Laos, South Korea |
| Mechanism | Inhibits NF‑κB and STAT3 pathways, reduces tumor cell DNA repair capacity |
| Clinical Status | Multiple trials ongoing in China, US, Australia for SCLC brain mets and glioma |
| Rights | Exclusive commercial rights + first negotiation for other indications |
Financial Terms
| Component | Amount/Terms |
|---|---|
| Upfront Payment | ¥100 million |
| Investment Option | Choice of: ¥100 million cornerstone investment OR ¥50 million milestone payment |
| Royalties | Tiered net sales royalties (undisclosed rates) |
| Sublicensing | Revenue 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
| Milestone | Target Date | Responsibility |
|---|---|---|
| China NDA submission | Q4 2026 | Accendatech (with Yifan support) |
| Regional regulatory filings | 2027‑2028 | Yifan Pharmaceutical |
| Commercial launch (China) | 2028 | Co‑promotion (terms to be negotiated) |
| Regional market entry | 2029‑2030 | Yifan 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
