China’s First Original Radiopharmaceutical Approved: 99mTc-Pexidartide (Giluntai)

In April 2026, China’s nuclear medicine field reached a major milestone.
The National Medical Products Administration (NMPA) approved technetium [99mTc] pexidartide peptide injection (Giluntai) through a priority review pathway.

This marks:

• China’s first Class 1 original radiopharmaceutical
• A true “0-to-1” innovation breakthrough
• A new approach to precision lung cancer diagnosis

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Clinical Challenge: Lymph Node Metastasis in Lung Cancer

Lung cancer remains one of the leading causes of cancer-related mortality globally.

👉 A critical issue:

Accurate detection of lymph node metastasis

Current tools:

• CT
• PET/CT

Limitations:

• False positives (inflammation)
• False negatives (micrometastasis)

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👉 This is where radiopharmaceutical imaging becomes essential.

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Mechanism of Action: Integrin αvβ3 Targeted Imaging

Giluntai is a radiopharmaceutical drug conjugate (RDC).

It works by:

• RGD peptide → targets integrin αvβ3
• 99mTc → emits detectable signal
• SPECT/CT → captures imaging

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Key Advantages:

• Detects biological activity, not just structure
• Identifies early metastasis
• Improves diagnostic specificity

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Technology Shift: SPECT vs PET

Historically:

• PET/CT = gold standard
• SPECT = limited sensitivity

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👉 Giluntai changes this:

• Expands SPECT oncology applications
• Reduces reliance on PET
• Improves accessibility

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Healthcare Impact:

• Lower cost
• Wider hospital adoption
• Strong value in emerging markets

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Clinical Value: Precision + Accessibility

Giluntai delivers:

• Comparable accuracy to PET/CT
• Reduced false positives
• Lower radiation exposure
• Better cost-effectiveness

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👉 This is critical for:

Real-world clinical adoption

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Industry Significance: China’s “Original Innovation” Moment

Historically, China relied on imports in:

• Target discovery
• Radiolabeling
• Molecular design

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This approval demonstrates:

• Independent R&D capability
• Full innovation chain
• Industrial maturity

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👉 It signals:

China entering the radiopharmaceutical innovation era

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Future Outlook: From Diagnosis to Theranostics

Radiopharmaceuticals are evolving into:

👉 Theranostics platforms

Future direction:

• Diagnosis + therapy integration
• More tumor targets
• Expansion into treatment

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👉 Similar evolution seen in:

• ADCs
• Immunotherapy

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Conclusion

The approval of 99mTc-Pexidartide (Giluntai):

• Advances lung cancer diagnosis
• Expands molecular imaging
• Marks China’s innovation milestone

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Radiopharmaceuticals are now emerging as:

👉 Next-generation oncology growth engine