China Biopharma Deals, 2019–2025: Part 3 — Respiratory/Immunology, CNS, Infectious and More

Beyond oncology and metabolic, partnering has matured in respiratory and immunology, CNS, and infectious diseases. This article explains why “bundled” multi-program options help both sides, how regional split deepens, and what operational hurdles (HGR, PIPL, cross-border data, special dosage forms) must be solved early.

Overview Table: Notable “Other Area” Deals

1. Why bundle multi-program options

Where single-asset read-through is low (for example inhaled COPD or some I&I programs), portfolio risk drops when you select winners early and redeploy capital aggressively. For big pharmas, this creates a steady, wide intake from China innovation; for China biotechs, it funds broad exploration and early clinical at scale. Success conditions belong in the option triggers: numeric PK/PD milestones, exposure-response thresholds, or early efficacy signals.

2. Regional split: why “Greater China vs ex-China” shows up repeatedly

The split reflects asymmetric pricing and reimbursement systems. Contracts should lock in who runs MRCTs, when bridging is needed, and how evidence packages will be synchronized for regulators and HTA bodies. The China party typically owns rapid early data and domestic commercialization; the global party handles US/EU approvals and broader launch. The economics are complementary.

3. HGR, cross-border data, and PIPL: design the process, not just the clause

Respiratory and infectious programs move sensitive samples and data. HGR and PIPL compliance must be operationalized: define the line between collaborative research and commercial use; specify data storage, access control, and transfer; document import/export SOPs for samples. Put this in the main agreement and in annexed SOPs with named owners and timelines.

4. CNS: a realistic blueprint

CNS endpoints are multidimensional and noisy. Use digital biomarkers and wearables to enhance signal capture, and bring RWD to validate clinical relevance. A practical split is China-led exploration through PoC on large sites and datasets, followed by global partner leadership in late-stage regulatory design and payer strategy. Pre-specify how digital measures map to clinical benefit to support labeling and HTA.

5. Execution tips

• Quantify option triggers (PK/PD, exposure-response, early efficacy) with numeric thresholds.
• Audit device compatibility and lot consistency for inhaled or biologics products; document remediation paths and timelines.
• Expect exogenous shocks (for example infection waves) and pre-plan RWD sensitivity analyses with clear governance.

Next up

Part 4 synthesizes the whole story: regulatory history, why deals surged, a practitioner adoption checklist, and a forward-looking outlook that connects ICH-GCP alignment, capital market flywheels (HKEX 18A/STAR), HGR/PIPL operations, and the institutionalization of ex-China models.

世界最先端の治療薬を創る〜製薬会…

China Biopharma Deals, 2019–2025: Part 2 — Obesity and Metabolic (Oral GLP-1, Dual Agonists) – Creat… Obesity and type 2 diabetes are massive in clinical burden and market size. China-origin programs are notable in oral GLP-1 design and in practical, scalable

世界最先端の治療薬を創る〜製薬会…

China Biopharma Deals, 2019–2025: Part 1 — Oncology (ADC, Bispecifics, IO, Cell Therapy) – Create th… Oncology is the tip of the spear for China-origin innovation in global partnering. This article gives you a bird’s-eye view of the major deals, then goes deep

Edited by the Morningglorysciences team.