By Fineline Cube 
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a core subsidiary of Sino Biopharmaceutical Limited (HKG: 1177), announced an expanded cooperation agreement with Shionogi China Co., Ltd.. The joint effort will cover registration, regulatory approval, regional supply, medical‑support services, and commercial rollout of naldemedine across mainland China, with a focus on the Hainan Boao Lecheng International Medical Tourism Pilot Zone and the Guangdong‑Hong Kong‑Macao Greater Bay Area.
Deal Highlights
| Aspect | Details |
|---|---|
| Scope | Registration, NMPA approval, regional distribution, medical‑support, marketing |
| Geographic Focus | Hainan Boao Lecheng Pilot Zone & Guangdong‑Hong Kong‑Macao Greater Bay Area |
| Strategic Goal | Fast‑track launch of naldemedine and build a rapid‑deployment platform for clinically urgent imported drugs |
| Regulatory Milestone | NDA for naldemedine accepted by the NMPA on 29 May 2025 |
| Policy Leverage | Utilisation of special‑policy incentives in Boao Lecheng (clinical‑urgency pathway) and Greater Bay Area (tax & customs facilitation) |
About Naldemedine
- Mechanism – Peripherally acting μ‑opioid receptor antagonist that reverses opioid‑induced constipation (OIC) by blocking opioid effects on the enteric nervous system, thereby normalising intestinal motility and secretion.
- Global Approvals – United States (FDA), European Union (EMA), Japan (PMDA), Taiwan, Hong Kong, and Macao.
- China Status – Approved for clinical use in the Lecheng Branch of Hainan Provincial People’s Hospital as a clinically urgent drug (2022). The formal Chinese NDA was accepted by the NMPA in May 2025.
Strategic Rationale
- Regulatory Speed – Boao Lecheng’s “clinically urgent” pathway shortens the time from NDA acceptance to market entry, a critical advantage for a drug addressing a high‑unmet‑need indication.
- Market Access – The Greater Bay Area’s integrated customs and tax framework enables smoother cross‑border logistics, reducing lead times for imported biologics and specialty drugs.
- Portfolio Expansion – For CTTQ, the partnership adds a best‑in‑class OIC therapy to its gastrointestinal pipeline; for Shionogi, it secures a reliable Chinese commercial partner with deep local expertise.
Outlook
- Launch Timeline – Both parties target a Q1 2026 commercial roll‑out in the Boao Lecheng pilot zone, followed by phased expansion throughout the Greater Bay Area and nationwide distribution.
- Revenue Potential – Market analysts estimate the Chinese OIC market to exceed $1.2 B by 2028; naldemedine could capture a 10‑15 % share, translating to $120‑180 M in annual sales.
- Future Collaboration – The framework established for naldemedine is expected to serve as a template for other clinically urgent imported therapies, expanding the CTTQ‑Shionogi pipeline.
Forward‑Looking Statements
This brief contains forward‑looking statements that involve risks and uncertainties, including regulatory outcomes, market acceptance, and commercial performance. Actual results may differ materially.-Fineline Info & Tech