Grand Pharmaceutical Group Limited (HKG: 0512) announced that its China‑based Phase III clinical trial for TLX591‑CDx (Illuccix, gallium Ga 68 PSMA‑11) achieved positive topline results and met its primary endpoint. The investigational Radiopharmaceutical Drug Conjugate (RDC) for prostate cancer diagnosis is a global‑first diagnostic agent based on radionuclide‑small molecule conjugation technology.
Regulatory Milestone
Item
Details
Trial Completion
Positive topline results; primary endpoint met
Product
TLX591‑CDx (Illuccix)
Mechanism
Targets Prostate‑Specific Membrane Antigen (PSMA)
Innovation
Global‑first diagnostic RDC for prostate cancer
Key Attributes
Internalization, stable activity, short half‑life, tumor permeability, rapid non‑target clearance
Indication
Diagnosis of newly diagnosed and recurrent prostate cancer
Global Commercial Footprint
Year
Markets/Approvals
2021
Australia (Nov), United States (Dec)
2022
Canada (Oct)
2023‑2024
Expanded indications in US, Australia, Canada for PSMA‑targeted therapy screening
2025
21 European/international markets (UK, Germany, France, Italy, Spain, Brazil, Norway)
2026 (Projected)
China NDA submission based on Phase III data
Market Opportunity & Competitive Landscape
Metric
Value
Context
China Prostate Cancer Incidence
~120,000 new cases (2025)
Growing diagnosis rate; high recurrence risk
China RDC Market
¥2‑3 billion (≈ US$280‑420 M)
Radiopharmaceuticals gaining traction in oncology
PSMA‑Targeted Market
$1.2 billion globally (2025)
Dominated by PET/CT imaging agents
TLX591‑CDx Peak Sales
¥500‑800 million (≈ US$70‑112 M) by 2030
40‑50% share of China PSMA‑RDC segment
Competitive Advantage
First global RDC with proven efficacy across 25+ markets
Regulatory pathway validated; cost vs. PET/CT favorable
Strategic Implications
For Grand Pharmaceutical:Phase III success validates proprietary RDC platform; global footprint creates regulatory bridge for China filing; RDC pipeline (diagnostic + therapeutic) positions company in high‑growth radiopharma sector.
For Patients:PSMA‑targeted imaging improves accuracy of prostate cancer staging vs. conventional imaging; short half‑life reduces radiation exposure; enables selection for PSMA‑targeted radionuclide therapy.
For Market:China Phase III demonstrates global trial execution capability; massive global approvals support faster NMPA review; RDC platform could expand to other tumor types (e.g., FAP, HER2).
Forward‑Looking Statements This brief contains forward‑looking statements regarding TLX591‑CDx’s China NDA timeline, market penetration, and regulatory approval. Actual results may differ due to NMPA feedback, competitive responses, or pricing negotiations.-Fineline Info & Tech
By Fineline Cube 