By Fineline Cube Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a first‑in‑class diagnostic radiopharmaceutical, for marketing in China for the diagnosis of prostate cancer.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Grand Pharmaceutical Group Limited (HKEX: 512) |
| Drug | TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11) |
| Application | Marketing filing submitted |
| Agency | NMPA (China) |
| Indication | Diagnosis of prostate cancer (initial and recurrent) |
| Filing Date | 14 Jan 2026 |
| Technology | Radionuclide-small molecule conjugate targeting PSMA |
Drug Profile & Mechanism
- Target: Prostate‑specific membrane antigen (PSMA), highly expressed on prostate cancer cells
- Technology: Ga‑68 labeled PSMA‑11 radiotracer for PET imaging
- Mechanism: Binds PSMA with high affinity, internalizes into tumor cells, and enables precise tumor detection
- Key Characteristics:
- Cell internalization capability
- Stable biological activity
- Short circulatory half‑life
- Good tumor parenchyma penetration
- Rapid clearance from non‑target tissues
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Prostate Cancer Incidence (2026E) | 120,000 | 1.4 million |
| PSMA PET Imaging Penetration | <5 % | 18 % |
| Addressable Market (2030E) | ¥3.2 billion | $2.1 billion |
| TLX591-CDx Peak Share | 15 % | 8 % |
| Peak Revenue (2032E) | ¥480 million | $168 million |
Key Competitors:
- Illuccix (Telix/Grand Pharma) – ** First‑in‑class PSMA diagnostic **; approved in US, EU, Australia
- Pylarify (Lantheus) – F‑18 PSMA tracer, US market leader
- Locametz (Novartis) – F‑18 PSMA tracer, EU approved
- TLX591-CDx – First Ga‑68 PSMA filing in China; advantage in logistics (shorter half‑life = faster turnover)
Strategic Positioning
- First‑Mover Advantage: First PSMA‑targeting diagnostic filed in China, positioning Grand Pharmaceutical as leader in prostate cancer imaging
- Commercial Pathway: Boao Pilot Zone approval enables early access while NMPA review proceeds; NRDL inclusion targeted for 2028
- Manufacturing: Grand Pharma’s Guangzhou radiopharmacy (GMP certified) will produce TLX591-CDx for China; capacity for 50,000 doses/year by 2027
- Global Rights: Grand Pharma holds exclusive China rights from Telix Pharmaceuticals; potential for ex‑China expansion in Southeast Asia
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch, market penetration, and revenue forecasts for TLX591-CDx in China. Actual results may differ due to regulatory approval timelines, competitive responses, and market adoption rates.-Fineline Info & Tech