Kintor announced Phase III clinical trial of Proxalutamide monotherapyon 2L+ mCRPC didn’t meet interim rPFS endpoint, and need to wait forthe OS endpoint. The double-blind, placebo-controlled phase III trial startedpatient enrollment in Sep 2018 and completed the enrollment in Aug 2020. Atotal of 330 eligible patients were randomly assigned to the test group and thecontrol group in the proportion of 2:1. Radiographic progression free survival(rPFS) and overall survival time (OS) are the co-primary endpoints and eitherof them reaches statistical significance can be used for filing new drugapplication (NDA) to the NMPA. In Sep 2020, the independent data monitoringcommittee (IDMC) confirmed that interim rPFS data didn’t reach statisticalsignificance. Kintor will continue the study and target to submit the NDA to theNMPA for Proxalutamide in 1H21E based on the final analysis of OS endpoint.
　　Proxalutamide’s multiple trials in China and the US are progressingsmoothly. The Phase III trial assessing Proxalutamide in combination withabiraterone in treating 1L mCRPC in China has enrolled around half of thetotal 606 patients. We expect Kintor to file NDA for 1L mCRPC indication tothe NMPA by end-2021E. In Jul 2020, Kintor finished the patient enrollmentfor Proxalutamide Phase II trial in the US targeting mCRPC patients failedeither Abiraterone or Enzalutamide. Kintor targets to complete this phase IItrial in the US by end-2020E. In addition, the phase Ic trial of Proxalutamidein combination with Exemestane, Letrozole and Fulvestrant in AR+ metastaticbreast cancer has completed patient enrollment in Jun 2020. Moreover,Proxalutamide is under clinical trial in Brazil for COVID-19 with first patiententrolled on 20 Aug. 381 male study subjects aged 50 years or above andpresent with androgenetic alopecia are estimated to be enrolled in the studywith 127 patients in each of the Dutasteride Arm, the Proxalutamide Arm andthe Controlled Arm, respectively. This trial may complete by Jan 2021E.
　　Rich pipeline progress. On 3 Aug, Kintor completed the phase Ib clinicaltrials of Pyrilutamide in the US with data to be released in 4Q20E.
　　Pyrilutamide’s phase II trial on androgenetic alopecia may start in 3Q20E inChina. On 17 Sep, Kintor obtained the IND approval of Pyrilutamide gelformula 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-clinicalstage PD-L1/ TGF-β bispecific antibody (GS19 PLB-1C).
　　Maintain BUY. To reflect the delay in Proxalutamide’s 2L+ mCRPC indicationapproval 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 positivegiven Kintor’s robust pipelines including Proxalutamide, Pyrilutamide, ALK1antibody, PD-L1/ TGF-β bispecific antibody, AR degrader (PROTAC), etc.
　　Risks: Delay in pipeline progress; Competition from peers.