By Fineline Cube 
Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The designation applies to the use of ivonescimab in combination with chemotherapy as a first‑line treatment for locally advanced, unresectable or metastatic triple‑negative breast cancer (TN‑BC).
Key Highlights
| Item | Details |
|---|---|
| Drug | ivonescimab (AK112) – first‑in‑class PD‑1/VEGF bispecific immune‑checkpoint inhibitor |
| Designation | Fourth CDE Breakthrough Therapy Designation (BTD) |
| Indication | First‑line chemo‑plus‑ivonescimab for locally advanced/unresectable or metastatic TN‑BC |
| Previous BTDs | 1️⃣ NSCLC (EGFR‑TKI‑resistant) – approved & on NRDL 2️⃣ NSCLC (PD‑L1‑positive) – approved 3️⃣ NSCLC (post‑PD‑1/L1 + platinum) – Phase III enrollment accelerating |
| Regulatory Impact | Faster clinical‑development pathways, priority review, and potential accelerated market entry in China |
| Commercial Outlook | Adds a high‑value oncology asset to Akeso’s pipeline; strengthens positioning in the rapidly growing Chinese immuno‑oncology market (projected > $3 B by 2028) |
Scientific Rationale
- Bispecific Mechanism – Simultaneous blockade of PD‑1 (restoring T‑cell activity) and VEGF (normalising tumour vasculature) creates a synergistic anti‑tumour micro‑environment.
- TN‑BC Unmet Need – Triple‑negative disease lacks hormone‑receptor targets; current options are limited to chemotherapy and, more recently, antibody‑drug conjugates. Early data suggest ivonescimab plus chemotherapy improves objective response rates and progression‑free survival.
Development Timeline
- May 2025 – CDE accepts NDA for ivonescimab in TN‑BC (first‑line combo).
- Nov 2025 – Fourth BTD granted, enabling priority review and accelerated clinical milestones.
- 2026‑2027 – Planned Phase III registration trial (≈ 600 patients) to support Chinese market filing and potential global expansion.
Strategic Implications
- Regulatory Momentum – Four BTDs within a single product line underscore the CDE’s confidence in ivonescimab’s clinical benefit.
- Pipeline Leverage – Success in TN‑BC could accelerate development of additional bispecific indications (e.g., colorectal, gastric cancers).
- Investor Impact – The designation is expected to reinforce Akeso’s valuation narrative, with analysts projecting a +15 % uplift in the company’s market‑cap upon eventual approval.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties, including regulatory approvals, clinical trial results, and commercial performance. Actual results may differ materially from those expressed herein.-Fineline Info & Tech