By Fineline Cube Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105) announced that the New Drug Application (NDA) for LAE002 (afuresertib hydrochloride tablets) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2‑ breast cancer with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor).
NDA Overview
| Item | Detail |
|---|---|
| Company | Laekna Therapeutics Shanghai Co., Ltd. (HKG: 2105) |
| Product | LAE002 (afuresertib hydrochloride tablets) |
| Modality | Potent AKT inhibitor (AKT1, AKT2, AKT3) |
| Regulatory Agency | CDE, NMPA (China) |
| Status | NDA accepted |
| Indication | Locally advanced or metastatic HR+/HER2‑ breast cancer with PIK3CA/AKT1/PTEN alterations, after recurrence or progression on endocrine therapy ± CDK4/6 inhibitor |
| Announcement Date | 12 Aug 2026 |
Drug Profile & Clinical Evidence
- Mechanism: Afuresertib is a potent AKT inhibitor that inhibits AKT1, AKT2, and AKT3, targeting a key node in the PI3K/AKT/mTOR signaling pathway implicated in endocrine resistance.
- Phase 3 Read‑Out: The AFFIRM‑205 trial met its primary endpoint of progression‑free survival (PFS), demonstrating statistically significant and clinically meaningful benefits in patients with HR+/HER2‑ breast cancer.
- Biomarker‑Defined Population: The targeted indication focuses on tumors harboring PIK3CA/AKT1/PTEN alterations, aligning with the precision‑oncology approach of AKT pathway inhibition.
Qilu Pharmaceutical Licensing Deal
- Deal Date: November 2025 — Laekna entered into an exclusive licensing agreement with Qilu Pharmaceutical, granting Qilu the rights to afuresertib in China.
- Deal Value: Laekna is eligible to receive up to RMB 2,045 million in total in upfront and milestone payments.
- Royalties: Tiered royalties on future net sales in the licensed territory, ranging from the low teens to the low twenties percentage.
- Global Strategy: Laekna plans to pursue strategic partnerships in ex‑China regions to accelerate development and commercialization of afuresertib in international markets.
Market Impact & Outlook
- Endocrine‑Resistant Breast Cancer: HR+/HER2‑ breast cancer patients progressing on endocrine therapy plus CDK4/6 inhibitors represent a large population with limited subsequent targeted options — AKT inhibition is emerging as a validated strategy, notably alongside approved capivasertib.
- China Commercialization Partnered: With Qilu Pharmaceutical — one of China’s largest generic and oncology marketers — as its China partner, Laekna has de‑risked local commercialization while retaining upside through milestones and royalties.
- Ex‑China Upside: Retaining rights outside China preserves optionality for out‑licensing deals in global markets, where the biomarker‑defined positioning could support differentiated regulatory strategies.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timing, milestone achievement, and partnership plans for afuresertib. Actual results may differ due to risks including the NMPA decision, market adoption, and competitive dynamics.-Fineline Info & Tech