InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed next‑generation TRK inhibitor, Zurletrectinib (ICP‑723), has received approval from China’s National Medical Products Administration (NMPA) for adult and adolescent patients (aged ≥12) with solid tumors harboring NTRK gene fusions. The milestone marks China’s first domestically developed next‑generation TRK inhibitor.
Regulatory Milestone
Item
Details
Approval Date
11 Dec 2025
Agency
NMPA (China)
Product
Zurletrectinib (ICP‑723) tablets
Indication
NTRK fusion‑positive solid tumors in patients ≥12 years
Significance
First China‑developed next‑generation TRK inhibitor
Dosing
Oral, two tablets once daily (QD)
Drug Profile & Differentiation
Attribute
Zurletrectinib
Competitive Context
Mechanism
Next‑generation pan‑TRK inhibitor
Targets NTRK1/2/3 fusions
Efficacy
Superior vs. first‑generation TRK inhibitors
Long‑term, deep remission
CNS Activity
Strong brain‑penetrant activity
Addresses CNS metastases, a key limitation of earlier agents
Resistance
Potential to overcome first‑gen TRK inhibitor resistance
Critical for patients who progress on larotrectinib/entrectinib
Safety
Favorable overall safety profile
Improved therapeutic index
Convenience
Oral QD dosing (two tablets)
Patient‑friendly vs. multi‑dose regimens
Clinical Evidence & Market Opportunity
Metric
Value
Implication
NTRK Fusion Prevalence
~1% of solid tumors; 5,000‑8,000 new cases annually in China
Significant unmet need in rare cancer population
First‑Gen TRK Inhibitors
Larotrectinib (Bayer/Loxo), Entrectinib (Roche)
Approved in China but limited by resistance and CNS penetration
Resistance Rate
~50% develop on‑target resistance within 12‑18 months
Drives need for next‑generation agents
China TRK Market Size
¥1.2‑1.5 billion (≈ US$170‑210 M) by 2030
Growing diagnosis rate; limited competition
Zurletrectinib Peak Sales
¥600‑800 million (≈ US$85‑112 M) by 2032
40‑50% share of China NTRK market if priced competitively
For InnoCare:First‑mover advantage in China’s next‑gen TRK space; validates internal discovery engine; strengthens oncology franchise ahead of potential NRDL negotiations in 2026.
For Patients:Oral, CNS‑active therapy addressing resistance; eliminates need for intravenous/intracranial interventions in many cases.
For Physicians:Novel option for NTRK‑fusion patients post‑progression; convenient dosing supports adherence in adolescent and adult populations.
Forward‑Looking Statements This brief contains forward‑looking statements regarding Zurletrectinib’s commercial launch timeline, market penetration, and potential global partnerships. Actual results may differ due to pricing negotiations, competitive responses, and adoption rates among oncologists.-Fineline Info & Tech
By Fineline Cube 