Laikai Pharmaceutical-B (02105): LAE 002 (Afuresertib)'s new drug marketing application was accepted by the China Drug Administration

Zhitong Financial App News, Lai Kai Pharmaceutical-B (02105) announced that the new drug marketing application (NDA) for LAE002 (afuresertib) has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) to treat patients with recurrent or progressive disease (LA/MBC) after receiving previous endocrine (with or without CDK4/6 inhibitors) treatment, accompanied by any PIK3CA/AKT1/PTEN changes.

This new drug marketing application is based on the positive results of a phase III clinical trial (AFFIRM-205) conducted by the Group in these patients. The key study successfully reached its primary end point, progression-free survival (PFS), showing a highly statistically significant and clinically significant improvement compared to the control group. LAE002 (afuresertib) also showed good safety and tolerability.

The group and Qilu Pharmaceutical signed an exclusive licensing agreement for the Chinese region in November 2025. According to the license agreement, the Group is eligible to receive a total down payment and milestone payment of up to RMB 2,045 billion. It also has the right to receive a gradient sales share for future net sales within the licensed area. The share ratio ranges from more than 10 percentage points to more than 20 percentage points.

Furthermore, the Group plans to seek strategic partnerships outside of China to accelerate the development and commercialization of LAE002 (afuresertib) in international markets. The world's first marketed AKT inhibitor, AstraZeneca capivasertib (Truqap), was approved by the US FDA for HR+/HER2- breast cancer in November 2023. In June 2026, the US FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (MHSPC). The approval significantly broadens the scope of treatment of AKT inhibitors and highlights their huge potential to address unmet treatment needs in many tumor types.