On May 23, Ge Longhui Pharmaceutical-B (02105.HK) announced that the Group has obtained approval from the US Food and Drug Administration (“US FDA”) for LAE 002 (afuresertib, an AKT inhibitor) combined with LAE 001 (CYP17A1/CYP11B2 dual inhibitor) (“LAE201”) for patients with metastatic castration-resistant prostate cancer (mCRPC) after standard treatment.

The Group initiated an international multi-center phase II clinical trial of LAE201 in the US in June 2021 and in Korea in September 2022 for patients with M CRPC after standard treatment. The trial is an open label, dose escalation, and dose extension study to evaluate the efficacy and safety of this combination drug candidate. The study showed positive treatment outcomes for patients with m CRPC. As of November 21, 2023, under the recommended phase II dose, 40 patients progressing in line 1 to 3 standard treatment were enrolled, including patients receiving at least first-line abiraterone or second-generation AR antagonists. The median r PFS was 8.1 months. This is a significant improvement compared to the median r PFS of 2 to 4 months for patients with m CRPC under standard treatment in the past. The combination therapy is generally well tolerated, adverse events that occur during treatment are manageable, and can be recovered after routine treatment. The Group has discussed the subsequent Phase III key trial design with the US FDA, and the test plan was approved in May 2024. The Group plans to bring this precision therapy to m CRPC patients in need of novel treatment options.