By Fineline Cube 
Sino-US biotech Laekna Therapeutics (HKG: 2105) and Qilu Pharmaceutical Co., Ltd. announced today an exclusive licensing agreement that gives Qilu Pharma sole rights to research, develop and commercialise Laekna’s AKT‑targeted drug LAE002 (afuresertib) across Mainland China, Hong Kong SAR, Macau SAR and Taiwan.
Deal Highlights
| Item | Details |
|---|---|
| Licensed product | LAE002 (afuresertib) – a pan‑AKT inhibitor (AKT1/2/3) |
| Territory | China (Mainland, HK, Macau, Taiwan) |
| Scope | Research, development, regulatory filing, and commercialisation |
| Up‑front / Milestone payments to Laekna | Up to RMB 530 m on NDA approval for the first indication; total potential RMB 2.045 bn in upfront + milestones |
| Royalty structure | Tiered royalties on net sales, ranging low‑teens % to low‑twenties % |
| Clinical responsibility | Laekna will complete the Phase 3 AFFIRM‑205 trial in HR⁺/HER2‑ breast cancer |
| Projected timeline | • Enrollment complete: Q4 2025 • NDA submission to NMPA CDE: 2026 |
Scientific & Commercial Rationale
- Pan‑AKT inhibition: LAE002 blocks all three AKT isoforms, positioning it as one of only two AKT inhibitors in late‑stage development for breast and prostate cancers worldwide.
- Unmet need: HR⁺/HER2‑ breast cancer patients who progress on endocrine therapy lack effective targeted options; AKT inhibition addresses a key resistance pathway.
- Market potential: The Chinese HR⁺/HER2‑ breast cancer market is valued at ≈ ¥120 bn and is expected to grow > 8 % CAGR through 2032. Successful NDA filing could unlock a multi‑billion‑yuan revenue stream for Qilu Pharma.
Regulatory Pathway
- Phase 3 AFFIRM‑205: Currently enrolling; recruitment on schedule with > 80 % of target sites activated.
- NMPA CDE filing: Laekna plans to submit a New Drug Application (NDA) in 2026, leveraging its existing Chinese clinical infrastructure and data from earlier Phase 2 studies.
Strategic Implications
- Accelerated market entry for Qilu Pharma: The exclusive licence eliminates domestic competition for a high‑value oncology asset.
- Milestone‑driven upside for Laekna: Up‑front cash and milestone payments de‑risk Laekna’s pipeline while retaining upside through royalties.
- Strengthened China‑centric oncology pipeline: Both parties deepen their foothold in China’s fast‑growing cancer‑drug market, aligning with government incentives for innovative therapies.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the licensing agreement, clinical timelines, regulatory approvals, and commercial expectations for LAE002. Actual results may differ due to risks including clinical outcomes, regulatory review, market acceptance, and execution of the partnership.-Fineline Info & Tech