By Fineline Cube 
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced a licensing agreement with Adlai Nortye Ltd (NASDAQ: ANL) to obtain exclusive rights for AN9025, a first‑in‑class oral pan‑RAS inhibitor, in Mainland China, Hong Kong, and Macau. The deal includes an upfront payment of USD 100 million and milestones up to USD 500 million, plus tiered royalties.
Deal Overview
| Item | Detail |
|---|---|
| Licensor | Adlai Nortye Ltd (NASDAQ: ANL) |
| Licensee | Beijing Aosaikang Pharmaceutical (002755.SZ) |
| Product | AN9025 (oral pan‑RAS inhibitor, Class 1 innovative drug) |
| Territory | Mainland China, Hong Kong, Macau (exclusive) |
| Indication | RAS‑mutated solid tumors (pan‑KRAS, NRAS, HRAS) |
| Upfront Payment | USD 100 million |
| Milestone Payments | Up to USD 500 million (regulatory & commercial) |
| Royalties | Tiered mid‑single to low‑double digit on net sales |
| Regulatory Status | IND cleared in US & China; FDA clinical trial approval received |
Technology Profile: Next‑Generation Molecular Glue
Mechanism of Action: AN9025 utilizes molecular glue technology to bind activated RAS‑GTP and cyclophilin A (a molecular chaperone), forming a ternary complex that inhibits all RAS isoforms.
Key Advantages vs. Traditional RAS Inhibitors:
| Feature | AN9025 (Molecular Glue) | Traditional RAS Inhibitors (e.g., sotorasib) |
|---|---|---|
| Target Scope | Pan‑RAS (KRAS, NRAS, HRAS) | Single mutation (e.g., KRAS G12C only) |
| Binding Site | Allosteric site + chaperone | Active site only |
| Resistance Profile | Higher barrier (prevents isoform switching) | Prone to bypass activation |
| Durability | Extended patient benefit (systemic regulation) | Limited duration (median PFS 6‑8 months) |
| Indication Breadth | Broad RAS‑mutated tumors | Narrow mutation‑specific |
Market Opportunity: RAS‑Mutated Cancers in China
RAS Mutation Prevalence:
- KRAS: 25‑30% of all solid tumors (lung, colorectal, pancreatic)
- NRAS: 15‑20% of melanoma, hematologic malignancies
- HRAS: 5‑10% of head & neck, bladder cancers
- Total Addressable Patients: ~800,000 new RAS‑mutated cases annually in China
Current Treatment Landscape:
- KRAS G12C inhibitors: Sotorasib (Amgen), adagrasib (Mirati/BMS) approved only for NSCLC
- Pan‑RAS gap: No approved therapy for NRAS/HRAS or non‑G12C KRAS mutations
- Market Size: China RAS‑targeted therapy market projected at ¥25‑30 billion (US$3.5‑4.2 B) by 2030
AN9025 Positioning: Targets 70‑75% of RAS‑mutated patients currently lacking targeted options.
Competitive Landscape
| Drug | Company | Target | Stage (China) | Limitation |
|---|---|---|---|---|
| Sotorasib | Amgen/Beta | KRAS G12C | Approved (NSCLC only) | Single mutation; resistance common |
| Adagrasib | Mirati/BMS | KRAS G12C | NDA under review | Single mutation; narrow label |
| Divarasib | Roche | KRAS G12C | Phase III | Single mutation |
| RMC‑9805 | Revolution Medicines | KRAS G12D | Phase I | KRAS G12D only |
| AN9025 | Adlai Nortye → Aosaikang | Pan‑RAS | Phase I ready | Broad spectrum; first pan‑RAS |
First‑Mover Advantage: AN9025 is 12‑18 months ahead of rivals in pan‑RAS space, with potential for Orphan Drug Designation in pancreatic cancer.
Clinical Development Plan & Timeline
| Phase | Design | Primary Endpoints | Timeline |
|---|---|---|---|
| Phase I (China) | Dose escalation in RAS‑mutated solid tumors | Safety, MTD, PK | Initiate Q2 2026 |
| Phase II | Expansion cohorts (pancreatic, colorectal, NSCLC) | ORR, PFS | 2027 |
| Phase III | Registration trials vs. chemotherapy | OS, PFS | 2028‑2029 |
| NDA Filing | Rolling submission to NMPA | – | Target 2029‑2030 |
FDA Alignment: Adlai Nortye will conduct parallel US trials; data may support global registration strategy.
Financial Projections
| Revenue Scenario | 2028E | 2030E | 2032E |
|---|---|---|---|
| China RAS market (¥B) | 12.0 | 20.0 | 28.0 |
| AN9025 peak penetration | 3% | 8% | 15% |
| Annual patients | 24,000 | 64,000 | 120,000 |
| Net revenue (¥ million) | 360 | 1,280 | 2,700 |
| Royalty to Adlai Nortye | 12% | 10% | 8% |
| Aosaikang net profit | 245 | 896 | 1,980 |
Peak Sales Potential: ¥2.7 billion (US$380 M) by 2032, representing 15% of Aosaikang’s projected revenue.
Strategic Rationale for Both Parties
For Aosaikang:
- Portfolio Upgrade: Transforms from generic manufacturer to innovation‑driven oncology player
- First‑in‑Class: Pan‑RAS platform offers 5‑7 year exclusivity window in China
- Commercial Leverage: 3,000‑person sales force can target top 500 oncology centers for rapid launch
For Adlai Nortye:
- Non‑Dilutive Funding: USD 100 million upfront finances US development
- China Validation: Partners with established local player for regulatory and commercial execution
- Global Option: Retains ROW rights for potential multi‑billion‑dollar ex‑China deals
Forward‑Looking Statements
This brief contains forward‑looking statements regarding AN9025’s clinical development, regulatory pathway, market penetration, and financial contributions to Aosaikang and Adlai Nortye. Actual results may differ materially due to clinical trial outcomes, competitive responses, regulatory review timelines, and market access policies.-Fineline Info & Tech