【Company Research】Kintor Pharmaceutical (9939 HK) – Enrollment completed for proxalutamide for hospitalized COVID-19 patients in Brazil

• Patients enrollment of proxalutamide for the treatment of hospitalised COVID-19 patients in Brazil completed. Considering previous promising data of proxalutamide for COVID-19 outpatients (mild or moderate), the Company and its partner quickly initiated a clinical study of Proxalutamide for the treatment of hospitalized COVID-19 male and female patients since the end of Jan 2021. By 22 Feb 2021, the trial has finished the recruitment of a total of 588 patients (294 male and 294 female). This trial is an investigator initiated multi-center, randomized, double-blinded, placebo-controlled parallel assignment study assessing Proxalutamide for hospitalized COVID-19 patients in Brazil. The primary endpoint is the effectiveness of Proxalutamide Arm relative to the Control Arm as assessed by the 8-point COVID-19 ordinal scale on day-14. Full set of data are expected to be available in Mar 2021.

 

• Promising results of proxalutamide for the treatment of COVID-19 outpatients. This is an investigator initiated randomized, double-blind and placebo-controlled clinical trial (NCT04446429) in Brazil conducted by Kintor and Applied Biology. In the male cohort, the hospitalization rate of proxalutamide arm is 0.0% (0/134) which is significantly lower than the Controlled Arm (27.0%, 35/138). In the female cohort, the interim analysis showed that the percentage of hospitalization, admission to ICU, mechanical ventilation requirement and death was 1.7% vs. 17.1%, 0% vs. 8.6%, 0% vs. 5.7% and 0% vs. 2.9% in Proxalutamide arm and control arm, respectively.

 

• Efficient R&D progress. For GT90001 (ALK-1 antibody): The IND application of GT90001 for a multiregional phase II clinical trial for combination treatment of GT90001 and Nivolumab for the second-line treatment of advanced HCC was approved by the US FDA in Feb 2021. The results from phase II clinical trial of GT90001 and Nivolumab combination treatment for HCC patients in Taiwan was presented at the ASCO-GI meeting in Jan 2021. For GT20029 (AR-degrader): The IND applications of GT20029 for androgenetic alopecia and acne vulgaris were accepted by the NMPA in Feb 2021. This is the first clinical stage PROTAC product developed by Kintor's in-house platform. For Pyrilutamide: Kintor obtained NMPA’s IND approval of Pyrilutamide gel formula for acne vulgaris in Sep 2020, while the trial may start in 1Q21E. Phase II trial on androgenetic alopecia in China has completed patient enrollment in Dec 2020 and registrational phase III trial will start in 2H21E.

 

• Maintain BUY. Considering the positive progress of Proxalutamide in treating COVID-19, we raised our TP to HK$21.41 based on a 10-year DCF model (WACC: 11.8%, terminal growth rate: 2.0%). We like Kintor given its robust pipelines including Proxalutamide, Pyrilutamide, ALK-1 antibody, PD-L1/TGF-β bispecific antibody, AR degrader, etc. Risks: Delay in pipeline progress; Competition from peers.