By Fineline Cube Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that furmonertinib has been added to the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The designation covers a new first‑line indication for adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring EGFR PACC mutations.
Regulatory Milestone
| Item | Detail |
|---|---|
| Designation | Breakthrough Therapy (China) |
| Review Body | CDE of NMPA |
| Drug | Furmonertinib (third‑generation EGFR TKI) |
| New Indication | First‑line treatment of EGFR PACC‑mutated advanced NSCLC |
| Designation Date | 26 Dec 2025 |
| Fast‑Track Benefits | Rolling review, priority CDE consultation, accelerated approval pathway |
Drug Profile & Partnership Structure
- Mechanism: Irreversible, selective, third‑generation EGFR tyrosine‑kinase inhibitor (TKI)
- Discovery: In‑house discovery by Allist; global IP retained in Greater China
- Ex‑China Partnership: Co‑developed with ArriVent Biopharma under a 2021 licensing agreement covering all territories outside Greater China
- Differentiation: Designed to target uncommon EGFR mutations, including PACC (non‑classical) variants, where first‑/second‑generation TKIs show limited activity
Clinical Evidence – FURMO‑002 Study
| Endpoint | Result | Clinical Significance |
|---|---|---|
| Best Objective Response Rate (ORR) | 81.8 % | High initial tumor shrinkage |
| Confirmed ORR | 68.2 % | Per RECIST 1.1 independent review |
| Disease Control Rate (DCR) | 100 % | All evaluable patients achieved disease control |
| Median Duration of Response (mDOR) | 14.6 months | Durable efficacy |
| Median Progression‑Free Survival (mPFS) | 16.0 months | Outperforms conventional TKIs in this setting |
Study Design: Multicenter, single‑arm Phase II trial enrolling 88 patients with locally advanced or metastatic EGFR PACC‑mutant NSCLC across 15 Chinese sites.
Commercial Status & Prior Approvals
| Approval Date | Indication | NRDL Status |
|---|---|---|
| Mar 2021 | EGFR T790M‑positive NSCLC post prior EGFR‑TKI progression | Reimbursed (2022) |
| Jun 2022 | First‑line EGFR exon 19 deletion or exon 21 L858R NSCLC | Reimbursed (2023) |
| Dec 2025 | BTD granted for first‑line EGFR PACC‑mutant NSCLC | Under review (potential 2026 NRDL listing) |
Cumulative domestic sales of furmonertinib exceeded ¥1.8 billion (≈ US$250 million) through Q3 2025.
Market Impact & Competitive Outlook
- Target Population: EGFR PACC mutations represent ~10‑15 % of all EGFR‑altered NSCLC in China, translating to an estimated 30,000‑40,000 newly eligible patients annually.
- Revenue Forecast: Allist projects incremental peak sales of ¥2.5‑3.0 billion (US$350‑420 million) from the PACC indication by 2028, assuming 60 % penetration and NRDL inclusion.
- Competitive Landscape: Current standard of care for PACC mutations includes chemotherapy or off‑label TKIs; amivantamab (Rybrevant) is approved for EGFR exon 20 insertions but requires IV infusion, giving furmonertinib an oral administration advantage.
- Valuation Catalyst: BTD status de‑risks the regulatory pathway and may support a secondary listing or partnership expansion discussions in ex‑China markets.
Forward‑Looking Statements
This brief includes forward‑looking estimates regarding patient population, revenue forecasts, and regulatory timelines for furmonertinib. Actual results may differ materially due to clinical, regulatory, or market access variables.-Fineline Info & Tech