By Fineline Cube 
Zhejiang Jianfeng Group Co., Ltd. (SHA: 600668) announced that its subsidiary Jianfeng Yien Biotechnology has obtained approval from the National Medical Products Administration (NMPA) to begin a clinical trial of JFAN‑1001 Mesylate Capsules in combination with Vinorelbine Tartrate Soft Capsules for patients with advanced non‑squamous non‑small cell lung cancer (NSCLC).
Product Overview
- JFAN‑1001 – a third‑generation epidermal growth factor receptor (EGFR) inhibitor designed to target the T790M secondary mutation that commonly drives resistance to first‑ and second‑generation EGFR‑TKIs.
- Indication – Locally advanced or metastatic non‑squamous NSCLC harboring an EGFR‑T790M mutation.
- Combination Rationale – Pairing JFAN‑1001 with the microtubule‑targeting agent Vinorelbine aims to leverage complementary mechanisms of action, potentially improving disease control in a population with limited treatment options.
Regulatory Timeline
| Date | Authority | Milestone |
|---|---|---|
| Oct 2023 | FDA | Clinical‑trial approval granted in the United States |
| 15 Nov 2025 | NMPA | Approval granted for Phase II trial in China (combined JFAN‑1001 + Vinorelbine) |
| Ongoing | NMPA | Phase II study currently recruiting in China |
Clinical Development Snapshot
- Phase II Enrollment – Expected to enroll 200‑250 patients across major oncology centers in Hangzhou and Shanghai.
- Trial Design – Open‑label, single‑arm study evaluating overall response rate (ORR) and progression‑free survival (PFS) with the combination therapy.
- Global Context – JFAN‑1001’s U.S. FDA approval in 2023 positioned it as a frontline option for T790M‑positive NSCLC, and its Chinese registration now offers a first‑in‑class targeted therapy to mainland patients.
Market & Strategic Implications
The EGFR‑T790M mutation accounts for ~50 % of acquired resistance in EGFR‑mutant NSCLC. Current treatment options in China are limited to re‑biopsy‑guided osimertinib rechallenge or chemotherapy alone, leaving a sizable unmet need. Jianfeng’s combination strategy anticipates a 12‑month overall survival (OS) advantage of 10–15 % over monotherapy, aligning with industry benchmarks for novel dual‑modality regimens.
Forward‑Looking Statements
This briefing contains forward‑looking statements concerning regulatory approvals, trial conduct, and commercial prospects. Actual results may differ materially.-Fineline Info & Tech