Pyrilutamide

SUZHOU, China, July 19, 2023 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the company has initiated the long-term safety trial (the "Long-term Safety Trial") of KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA) developed in-house, in China and has completed the first patient enrollment today. The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023. The Long-term Safety Trial is a multi-center, open-label Phase III clinical trial, which involves a total of 16 clinical research centers in China, with Professor Jianzhong Zhang of Peking University People's Hospital as the leading principal investigator (leading PI). A total of 270 male and female AGA patients will be enrolled to evaluate the long-term safety of the topical use of KX-826 for the treatment of AGA patients in China (treatment period of 52 weeks). The primary endpoint of the trial is the incidence of treatment emergent adverse events (TEAE). Secondary endpoints include efficacy as measured by the change in target area non-vellus hair count (TAHC) from baseline and other safety indicators. Previously, Kintor Pharma has successfully completed the Phase II clinical trial for male in China, the Phase II clinical trial for female in China and the Phase II clinical trial for male in the United States for KX-826 in the treatment of AGA. In each trial, after 24-week administration, KX-826 improved hair growth and showed a good safety profile. Most of the adverse events occurred during the study were mild, and similar to placebo, no TEAE resulting in patient withdrawal from the trial, nor death was reported. The Long-term Safety Trial will further explore the long-term safety and efficacy of KX-826 in the treatment of AGA on the basis of the safety profile and efficacy of above mentioned trials, which will help provide more data to support the use of such medication for long-term treatment for AGA patients. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for oncology and androgen-receptor-related disease areas with unmet medical needs, including alopecia, acne, COVID-19, prostate cancer, liver and breast cancers. For more information, visit . SOURCE Kintor Pharma

SUZHOU, China, May 11, 2023 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the Phase II clinical trial of in-house developed KX-826 for the treatment of male androgenetic alopecia ("AGA") in the US has been completed successfully. The results are statistically and clinically meaningful, and demonstrated a favorable safety profile. The company is preparing for subsequent FDA meetings on the results of the Phase II clinical trial, and intends to commence Phase III clinical trial in the US/globally. Results of the Phase II clinical trial showed that KX-826 promotes hair growth compared to baseline and demonstrated statistical and clinically meaningful as measured by target area non-vellus hair count ("TAHC"). KX-826 has indicated an improvement in TAHC versus placebo, and a dose-response relationship was observed from different KX-826 dosage groups. The Phase II clinical trial is a randomized, double-blind, placebo-controlled and parallel group study designed to evaluate the efficacy and safety of KX-826 for the treatment of male AGA. A total of 123 male AGA patients, who were classified into stage III vertex, IV or V using the Hamilton-Norwood scale, were enrolled in the Phase II clinical trial. Among them, 93 patients were randomly assigned to different dosage groups, including 0.25% once daily ("QD"), 0.5% QD and 0.5% twice daily ("BID"); and 30 patients were randomly assigned to placebo groups receiving different dosages. The results showed that: The TAHC of the 0.5% BID KX-826 group has increased by about 10 hair counts per cm2 compared with baseline after the treatment of 24 weeks, which was statistically significant (P=0.0088). KX-826 has indicated an improvement in TAHC versus placebo, and a dose-response relationship was observed from different KX-826 dosage groups. Other relevant results indicated that KX-826 promotes hair growth clinically in male AGA patients. Same with the Phase II clinical trial in China, 0.5% BID KX-826 was determined to be the optimal dose in the Phase II clinical trial. 0.5% BID KX-826 was also determined to be the recommended dose for Phase III clinical trial for male AGA in the US/globally. KX-826 demonstrated a favorable safety profile in male AGA treatment. In our study, most of the treatment emerged adverse events ("TEAE") were mild and local scalp sensitivity similar to those of placebo in terms of occurrences. No TEAE resulting in patient withdrawal from the trial, nor death was reported. Multiple clinical trials on KX-826 in China and the US for male and female AGA treatments are currently ongoing. On 1 December 2022, the company announced that the primary endpoint of Phase II clinical trial of KX-826 in China for the treatment of female AGA patients was met. On 28 March 2023, the company announced that the enrollment of patients for the Phase III clinical trial KX-826 in China for the treatment of male AGA was completed, and the top-line data of which was expected to be released in the fourth quarter of 2023. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for oncology and androgen-receptor-related disease areas with unmet medical needs, including alopecia, acne, COVID-19, prostate cancer, liver and breast cancers. For more information, visit . SOURCE Kintor Pharma