【Company Research】Kintor Pharmaceutical (9939 HK) – Proxalutamide’s 2L+ mCRPC Phase III trial needs to wait for OS data

Kintor announced Phase III clinical trial of Proxalutamide monotherapy on 2L+ mCRPC didn’t meet interim rPFS endpoint, and need to wait for the OS endpoint. The double-blind, placebo-controlled phase III trial started patient enrollment in Sep 2018 and completed the enrollment in Aug 2020. A total of 330 eligible patients were randomly assigned to the test group and the control group in the proportion of 2:1. Radiographic progression free survival (rPFS) and overall survival time (OS) are the co-primary endpoints and either of them reaches statistical significance can be used for filing new drug application (NDA) to the NMPA. In Sep 2020, the independent data monitoring committee (IDMC) confirmed that interim rPFS data didn’t reach statistical significance. Kintor will continue the study and target to submit the NDA to the NMPA for Proxalutamide in 1H21E based on the final analysis of OS endpoint.

Proxalutamide’s multiple trials in China and the US are progressing smoothly. The Phase III trial assessing Proxalutamide in combination with abiraterone in treating 1L mCRPC in China has enrolled around half of the total 606 patients. We expect Kintor to file NDA for 1L mCRPC indication to the NMPA by end-2021E. In Jul 2020, Kintor finished the patient enrollment for Proxalutamide Phase II trial in the US targeting mCRPC patients failed either Abiraterone or Enzalutamide. Kintor targets to complete this phase II trial in the US by end-2020E. In addition, the phase Ic trial of Proxalutamide in combination with Exemestane, Letrozole and Fulvestrant in AR+ metastatic breast cancer has completed patient enrollment in Jun 2020. Moreover, Proxalutamide is under clinical trial in Brazil for COVID-19 with first patient entrolled on 20 Aug. 381 male study subjects aged 50 years or above and present with androgenetic alopecia are estimated to be enrolled in the study with 127 patients in each of the Dutasteride Arm, the Proxalutamide Arm and the Controlled Arm, respectively. This trial may complete by Jan 2021E.

Rich pipeline progress. On 3 Aug, Kintor completed the phase Ib clinical trials of Pyrilutamide in the US with data to be released in 4Q20E. Pyrilutamide’s phase II trial on androgenetic alopecia may start in 3Q20E in China. On 17 Sep, Kintor obtained the IND approval of Pyrilutamide gel formula for acne vulgaris from the NMPA while the study may start in 1Q21E. On 20 Aug, Kintor obtained from Gensun an exclusive license of a pre-clinical stage PD-L1/ TGF-β bispecific antibody (GS19 PLB-1C).

Maintain BUY. To reflect the delay in Proxalutamide’s 2L+ mCRPC indication approval in China, we revised our 10-year DCF model (WACC: 11.8%, terminal growth rate: 2.0%) and derived TP of HK$19.38. We remain positive given Kintor’s robust pipelines including Proxalutamide, Pyrilutamide, ALK1 antibody, PD-L1/ TGF-β bispecific antibody, AR degrader (PROTAC), etc.