What changed, and when

AirNexis launched on 09 Jan 2026 with a $200 million Series A and an ex-China license to Haisco’s dual PDE3/4 COPD asset HSK39004, re-coded as AN01, led by CEO Maria Fardis and chairman James Li, with $40 million upfront, 19.9% Haisco equity and up to $955 million milestones. (Business Wire press release)

Independent coverage confirms the financing, license terms and positioning versus PDE3/4 class leaders. (Fierce Biotech, BioPharma Dive deals tracker)

60-second thesis frame

AN01 targets a validated COPD mechanism, dual PDE3/4, where Merck’s Ohtuvayre, ensifentrine, set a regulatory and commercial precedent in 2024, and Merck doubled down by acquiring Verona in 2025. (Reuters FDA approval brief, Merck acquisition release)

Haisco is already running Phase 2 trials of HSK39004 in China in both inhalation suspension and dry-powder forms, giving AirNexis a head start on dose form flexibility and human data. (ClinicalTrials.gov HSK39004 DPI Phase 2, ClinicalTrials.gov suspension vs DPI Phase 2, Haisco pipeline page)

The key diligence hinge is whether AN01 can differentiate on efficacy, exacerbation reduction, convenience or safety relative to Ohtuvayre and pipeline PDE3/4s, and whether AirNexis can efficiently globalize a China-derived asset and navigate ex-China development and payer pathways. (Fierce Biotech, Open-access PDE3/4 review)

The seven diligence questions

Clinical

• Does AN01 show clinically meaningful bronchodilation and exacerbation reduction versus standard of care and, critically, versus ensifentrine, on endpoints aligned to FDA and EMA guidance for COPD maintenance treatment? (EMA COPD guideline)
• Do the two dosage forms, inhalation suspension and DPI, yield comparable exposure and effect, and is there a clear go-forward form for global Phase 3, informed by Haisco’s Phase 2 designs in China? (ClinicalTrials.gov suspension vs DPI Phase 2, ClinicalTrials.gov DPI Phase 2)

Payer or Access

• If efficacy is non-inferior to Ohtuvayre, what payer-relevant advantages could support access, for example device preference, dosing convenience or COPD subgroup benefits that translate into fewer exacerbations or hospitalizations? (Reuters FDA approval brief)
• What is the likely pricing and step-edit landscape given the first-mover’s formulary position, and which health-economic claims would be needed to displace or complement existing nebulized or inhaler regimens in the US and EU? (Merck acquisition release)

Ops or Adoption

• Can AirNexis rapidly stand up global CMC, device supply and ex-China trial operations, while harmonizing with Haisco’s China program to avoid divergent formulations or devices that complicate a global Phase 3? (Business Wire press release)

Competitive

• How will AN01 compete against a marketed PDE3/4, Ohtuvayre, and other inflammation-modulating COPD entrants such as anti-TSLPs, and what differentiation claims are plausible from dual-acting bronchodilation plus anti-inflammatory effects? (Merck acquisition release, Open-access PDE3/4 review)

Team or Cap table

• Does the board and management, led by Maria Fardis and backed by Frazier, OrbiMed, Goldman Sachs Alternatives, SR One, Longitude and Enavate, have the respiratory, device and global registrational experience to execute quickly, and how does Haisco’s 19.9% equity and milestone stack shape governance and future financing flexibility? (Business Wire press release, Fierce Biotech)

Red flags

• Class headwind, comparator bar is high after ensifentrine’s 2024 FDA approval and Merck’s scale in commercialization. (Reuters FDA approval brief, Merck acquisition release)
• Formulation divergence risk between China Phase 2 programs and ex-China plans could delay a unified global registrational strategy. (ClinicalTrials.gov suspension vs DPI Phase 2, ClinicalTrials.gov DPI Phase 2)
• Deal economics include 19.9% equity to Haisco and up to $955 million milestones, which may constrain future partnering or require outsized commercial delivery to clear returns. (Business Wire press release)

Next catalyst

Watch for additional Phase 2 readouts from Haisco’s Chinese trials of HSK39004 across DPI and suspension in 2026 and for first ex-China protocol postings or IND-related disclosures from AirNexis. (ClinicalTrials.gov DPI Phase 2, ClinicalTrials.gov suspension vs DPI Phase 2, Business Wire press release)

FAQ

• What exactly changed by AirNexis’s Series A launch news on 09 Jan 2026, and why does it matter for the COPD market?
  AirNexis raised $200 million and licensed HSK39004, now AN01, ex-China from Haisco, positioning another dual PDE3/4 entrant to compete in a validated class for COPD. (Business Wire press release, Fierce Biotech)
• What is the regulatory path after the January 9, 2026 announcement by AirNexis, and what are the next steps in the US, UK and EU?
  With class precedent set by ensifentrine, AirNexis will need robust Phase 3 data on lung function and exacerbations aligned to regional guidance before filings. (Reuters FDA approval brief, EMA COPD guideline)
• Which endpoints in Haisco’s Phase 2 program were cited in the January 9, 2026 news by AirNexis, and how meaningful could the effect be?
  The China Phase 2 studies compare DPI and inhalation suspension in COPD, expected to track spirometry and symptom measures typical for mid-stage trials, informing go-forward dose form and magnitude of effect. (ClinicalTrials.gov DPI Phase 2, ClinicalTrials.gov suspension vs DPI Phase 2)
• What safety issues matter post–AirNexis’ Series A launch news on January 9, 2026, and do they change real-world use?
  PDE3/4 inhibitors carry class considerations including gastrointestinal and vasculitis signals, so AN01’s tolerability versus ensifentrine and roflumilast analogues will be scrutinized. (Open-access PDE3/4 review)
• How will major US payers treat access after a future approval of AirNexis’ AN01 asset, including prior auth or step edits?
  Ohtuvayre’s market entry provides coverage and coding benchmarks for a nebulized PDE3/4, which AN01 must match or beat on outcomes and patient convenience to gain favorable positioning. (Reuters FDA approval brief)

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 10 Jan 2026, 00:00 London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2026 LucidQuest Ventures Ltd.

Entities / Keywords

AirNexis Therapeutics; AN01; HSK39004; Haisco Pharmaceutical Group; Frazier Life Sciences; OrbiMed; Goldman Sachs Alternatives; SR One; Longitude Capital; Enavate Sciences; Maria Fardis; James Li; COPD; dual PDE3/4 inhibitor; inhalation suspension; dry powder inhaler; ClinicalTrials.gov NCT07108699; ClinicalTrials.gov NCT07140328; NCT07331402; Merck; Ohtuvayre; ensifentrine; Verona Pharma; FDA; EMA; EMA COPD guideline; payer access; exacerbations; bronchodilation; China trials; ex-China license; milestones; royalties; JPM 2026