By Fineline Cube 
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced it has granted AirNexis Therapeutics exclusive worldwide rights (excluding Greater China) for the development, production, and commercialization of HSK39004, its self‑developed dual PDE3/4 inhibitor for chronic obstructive pulmonary disease (COPD). The deal, valued at up to USD 1.063 billion, includes USD 108 million upfront, USD 955 million in milestones, and tiered royalties. HSK39004 features a 5‑second inhalation powder that significantly improves patient compliance versus competitors.
Deal Overview
| Item | Detail |
|---|---|
| Licensor | Haisco Pharmaceutical Group Co., Ltd (002653.SZ) |
| Licensee | AirNexis (founded by Frazier Life Sciences) |
| Product | HSK39004 (dual PDE3/4 inhibitor) |
| Indication | Chronic Obstructive Pulmonary Disease (COPD) |
| Territory | Worldwide (excluding Greater China) |
| Upfront Payment | USD 108 million |
| Milestone Payments | USD 955 million |
| Royalties | Tiered royalties upon commercialization |
| Dosage Forms | Inhalation suspension and inhalation powder |
Product Profile: HSK39004
Mechanism: Dual PDE3/4 inhibitor providing synergistic bronchodilation + anti‑inflammatory effects for COPD maintenance therapy.
Innovative Formulations:
- Inhalation Powder: 5‑second administration from start to completion (vs. 30‑60 seconds for competitors)
- Inhalation Suspension: Alternative for patients preferring nebulized delivery
Clinical Status: Both formulations in Phase II trials in China.
Clinical Profile: Excellent airway relaxation, strong anti‑inflammatory effects, favorable safety profile demonstrated in preclinical and Phase I studies.
Intellectual Property: Independent IP rights; first dual PDE3/4 inhibitor in clinical development globally.
Market Opportunity: COPD
Global COPD Burden:
- Prevalence: 300 million patients worldwide
- Market Size: $15 billion (2025), growing at 6% CAGR
- Unmet Need: 40‑50% of patients remain symptomatic on bronchodilators alone; need for dual‑mechanism therapy
Ex‑China Market:
- US/EU/Japan: ¥80 billion (US$11 billion) addressable market
- Pricing: Projected ¥12,000‑15,000 annual cost (competitive with LAMA/LABA combos)
AirNexis: Partner Profile
Founded by: Frazier Life Sciences (globally renowned biopharmaceutical investor)
Major Investors: OrbiMed, Goldman Sachs Alternatives (Life Sciences), SR One, Longitude, Enavate
Strategic Rationale: AirNexis provides specialized respiratory expertise and global commercial infrastructure for COPD market penetration.
Competitive Landscape
| Drug | Company | Mechanism | Stage | Administration Time |
|---|---|---|---|---|
| HSK39004 | Haisco/AirNexis | Dual PDE3/4 inhibitor | Phase II | 5 seconds (powder) |
| Roflumilast | AstraZeneca | PDE4 inhibitor | Marketed | Oral (once daily) |
| Trelegy | GSK | LAMA/LABA/ICS | Marketed | 30‑60 seconds |
| Incruse | GSK | LAMA | Marketed | 30‑60 seconds |
Differentiation: HSK39004’s 5‑second inhalation offers significant compliance advantage.
Financial Projections
| Metric | 2027E | 2028E | 2029E |
|---|---|---|---|
| Ex‑China Market Share | 2% | 5% | 8% |
| Patients Treated | 600,000 | 1.5 million | 2.4 million |
| Revenue (¥ billion) | 7.2 | 18.0 | 28.8 |
| Royalty to Haisco | 8‑10% | 8‑10% | 8‑10% |
Peak Sales Potential: ¥30 billion (US$4.2 billion) ex‑China by 2030; Haisco’s royalty stream could reach ¥2.4 billion annually.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding HSK39004’s clinical development, regulatory pathway, market penetration, and financial projections. Actual results may differ materially due to clinical trial outcomes, competitive dynamics, regulatory review timelines, and market access policies.-Fineline Info & Tech