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Laekna says China regulator accepts NDA for afuresertib in HR+/HER2- breast cancer

PUBT·08/12/2026 00:19:47
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Laekna says China regulator accepts NDA for afuresertib in HR+/HER2- breast cancer
  • China’s NMPA accepted Laekna’s NDA for LAE002 (afuresertib) in HR+/HER2- advanced breast cancer with PIK3CA/AKT1/PTEN alterations.
  • Filing backed by Phase III AFFIRM-205 results showing a statistically significant progression-free survival gain versus control.
  • China rights are licensed to Qilu Pharmaceutical, with up to RMB 2.05 billion in upfront and milestones, plus tiered royalties.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Laekna Inc. published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260812-12280732), on August 12, 2026, and is solely responsible for the information contained therein.