By Fineline Cube Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China’s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate‑specific membrane antigen (PSMA)‑positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.
Product & Regulatory Milestone
| Item | Detail |
|---|---|
| Product | [18F] Spiritide |
| Company | Yantai Dongcheng Pharmaceutical Group (002675.SZ) |
| Regulatory Status | NDA accepted by CDE/NMPA |
| Indication | PET imaging of PSMA‑positive lesions in prostate cancer |
| Target Populations | (1) Initial curative treatment patients with suspected metastasis; (2) Biochemical recurrence with elevated PSA |
| Mechanism | High PSMA specificity/affinity, delivers fluorine‑18 isotope for PET imaging |
| Classification | Category 1 innovative diagnostic radiopharmaceutical |
Technology & Differentiation
Mechanism of Action: [18F] Spiritide exhibits high specificity and affinity for PSMA protein, enabling significant accumulation in PSMA‑overexpressing tumors. The fluorine‑18 isotope delivery allows high‑resolution PET imaging for accurate lesion detection.
Clinical Advantages:
- Superior Sensitivity: PSMA‑PET detects 30‑40% more lesions than conventional bone scans/CT in metastatic prostate cancer
- Earlier Detection: Identifies biochemical recurrence at PSA levels as low as 0.2 ng/mL
- Treatment Guidance: Critical for precision therapy selection and radiation therapy planning
Market Position: Among the first domestic PSMA‑PET agents to reach NMPA review, positioning Dongcheng with first‑mover advantage in a nascent market.
Market Opportunity: Prostate Cancer Imaging in China
Disease Burden:
- Prostate Cancer Incidence: 110,000‑120,000 new cases annually (2025), growing at 10% CAGR due to aging population and screening adoption
- Metastatic at Diagnosis: 20‑30% of patients present with metastatic disease → ~30,000 eligible for initial staging
- Biochemical Recurrence: 30‑40% of post‑prostatectomy patients develop recurrence → ~35,000 eligible annually
Diagnostic Market Size:
- China PET Imaging Market: ¥8.5 billion (2025), growing at 15% CAGR
- PSMA‑PET Sub‑segment: ¥1.2 billion opportunity by 2030, driven by NCCN guideline adoption and reimbursement expansion
- Pricing: Projected ¥15,000‑18,000 per scan (vs. ¥8,000‑10,000 for conventional bone scan/CT)
[18F] Spiritide Revenue Potential:
- Peak Penetration: 25‑30% market share in PSMA‑PET segment
- Volume: 20,000‑25,000 scans annually by 2030
- Peak Sales: ¥300‑450 million (US$42‑63 million) by 2030
Competitive Landscape
| Product | Company | Origin | Stage (China) | Key Advantage |
|---|---|---|---|---|
| Pluvicto | Novartis | Import | Approved (Nov 2025) | Therapeutic + diagnostic (RLT) |
| [68Ga]Ga‑PSMA‑11 | Advanced Accelerator | Import | Clinical trials | Well‑established globally |
| [18F] Spiritide | Dongcheng Pharma | Domestic | NDA accepted | First domestic [18F] agent |
| [18F]DCFPyL | Progenics | Import | Not filed | Superior pharmacokinetics |
| PSMA‑PET (others) | Various | Import/Local | Pre‑clinical | – |
Strategic Moat: Domestic production avoids import delays and reduces costs by 30‑40%, critical for insurance reimbursement and hospital adoption.
Financial Impact & Valuation
Near‑Term Revenue:
- 2026: Minimal (registration phase)
- 2027: ¥50‑80 million (partial year post‑approval)
- 2028: ¥150‑200 million (full commercial launch)
Peak Valuation: [18F] Spiritide could contribute ¥5‑7 per share to Dongcheng’s valuation, representing 8‑12% upside from current trading levels.
Pipeline Leverage: Success validates Dongcheng’s radiopharmaceutical platform, supporting 3‑4 follow‑on imaging agents in pre‑clinical development (PSMA‑targeting theranostics, FAPI‑PET).
Forward‑Looking Statements
This brief contains forward‑looking statements regarding [18F] Spiritide’s regulatory review timeline, market penetration, revenue forecasts, and competitive positioning. Actual results may differ materially due to NMPA review outcomes, competitive dynamics, reimbursement negotiations, and hospital adoption rates.-Fineline Info & Tech