Kintor Pharmaceutical Limited (“Kintor Pharmaceutical” or the “Company”, stock code 9939.HK) announced the completion of patients enrolment according to the clinical protocol for phase II clinical trials (NCT03899467) of Proxalutamide (GT0918) in the United States for treating metastatic castration-resistant prostate cancer (“mCRPC”).

Proxalutamide, a class 1 innovative drug developed with proprietary intellectual property rights around the world under Kintor Pharmaceutical, is currently conducted a number of phase I-III clinical trials of mCRPC (metastatic castration-resistant prostate cancer) and mBC (metastatic breast cancer) in China and the United States. The results of phase I clinical trials in the United States, completed in early 2019, showed good safety and certain efficacy in the treatment of patients with failed treatments, such as Abiraterone or Enzalutamide. Following that, the Company decided to conduct multicenter, randomized and open phase II clinical trials in ten centers in the United States, aiming to evaluate the safety and tolerability of Proxalutamide in patients with mCRPC who have failed Abiraterone or Enzalutamide treatment and providing guidance on the dose judgement and strategy of subsequent clinical studies of Proxalutamide.

The incidence of prostate cancer in the United States is the highest among men, and the mortality rate is among the top three. The market for therapeutic drugs is vast. At present, the most commonly used drugs are Abiraterone or Enzalutamide, both of which have a tendency to move from late metastatic castration to early sensitized hormones in patients with prostate cancer, which in turn leads to a lack of effective medication for patients with prostate cancer when eventually developed into mCRPC after treatment.

Dr. Tong Youzhi, the Founder, Chairman and CEO of Kintor Pharmaceutical, said: “Premoxamide is an AR antagonist with a unique ‘dual-effect mechanism’ developed by Kintor Pharmaceutical. The completion of patients enrolment for phase II clinical trials in the United States is an important milestone in the study, especially at the moment when the United States faces the outbreak of COVID-19, and we are especially grateful to the clinical researchers in the US and the US clinical team of our Company for their participation in this trial, overcoming many difficulties and finally completed patients enrolment for phase II clinical trials in the US.”

【About Kintor Pharmaceutical Limited】

Founded in 2009, Kintor Pharmaceuticals concentrates on the R&D and industrialisation of “best-in-class” and “first-in-class” innovative drugs, and strives to become a leading enterprise in the R&D and commercialization of innovative therapies. The Company, after years of development, centered upon androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. Kintor Pharmaceuticals has prospectively deployed a diversified product pipeline that includes small molecule innovative drugs, bioinnovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as AR-Degrader, c-Myc inhibitors and IDO inhibitors that are undergoing preclinical research. Globally, the Company owns more than 60 patents, many of which are listed as the “Major New Drugs Discovery” in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK.