Pyrilutamide

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

SUZHOU, China, March 30, 2023 /PRNewswire/ -- Kintor Pharmaceutical Limited (Kintor Pharma, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced business highlights and financial results for the year ended 31 December 2022. Business Highlights Kintor Pharma has made rapid progress on global clinical development, and achieved positive data read-outs of core products during the reporting period. Kintor Pharma has rolled out the clinical pipeline in dermatology area globally. Kintor Pharma is actively promoting the business development opportunities in China and globally to accelerate the commercialization progress. Kintor Pharma has raised about $100 million through 2 top-up placements during the reporting period. The company's stock has been included in MSCI China Index and Shanghai-Hong Kong Stock Connect, which increased the stock's liquidity in the capital market. The company's R&D outcome has been accepted by reputable academic conferences including AACR, ASH and AAD of the U.S., which has demonstrated its R&D capabilities. Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma, commented, 2022 has been a challenging year for the global biotech industry. Under the difficulty market conditions, Kintor Pharma has made rapid progress in R&D, financing and academic publications. In terms of R&D, the company has made steady progress in its pipeline and achieved positive data read-outs of its core products, including Pyrilutamide (KX-826) for androgenetic alopecia (AGA) indication, GT20029 for AGA and acne vulgaris indications. The Phase II clinical trials of KX-826 for male and female AGA in China have reached the primary endpoints, respectively. Kintor Pharma has rolled out the clinical pipeline in dermatology area globally, and is actively promoting the business development opportunities in China and globally to accelerate the commercialization progress. In capital market, the company has raised net proceeds of $100 million through two top-up placements during the reporting period. In addition, the company's stock has been included in the MSCI China Index and the Shanghai-Hong Kong Stock Connect, further enhanced the stock's liquidity in the capital market. In academics, the company's research results have been presented at important academic conferences such as AACR, ASH and AAD of the U.S., proving that the company's innovation ability and its international influence. Looking forward, Kintor Pharma will continue to execute the development of the core products in China and globally, expecting to accelerate its commercialization process. The company strives to bring safe and effective therapeutics to the patients around the globe, and create value for its shareholders and employees. Rapid Progress on Global Clinical Development and Positive Data Read-outs of Core Products As a Biotech company focusing on the R&D and industrialization of potential First-in-Class and Best-in-Class innovative drugs, Kintor Pharma has developed a diversified product pipeline including small-molecule drugs, biologics innovative drugs and combination therapies. At present, the company has seven novel drug candidates with First-in-Class or Best-in-Class potential in Phase I-III clinical stages in China and around the world. Since 2022, the company has released positive clinical results of core products, including the Phase II clinical trials of KX-826 for male and female AGA in China, respectively, and the Phase I clinical trials of GT20029 for the treatment of AGA and ance in both China and the U.S.. Pyrilutamide (KX-826) is a topical androgen receptor (AR) antagonist that is under clinical development for the potential treatment of AGA and acne. KX-826 is the world's first AR antagonist for AGA treatment which entered the Phase III clinical trial stage. On 27 August 2022, one of the leading principal investigators of the Phase II clinical trial of KX-826 in China for the treatment of male AGA adults, Professor Jianzhong Zhang (张建中) from Peking University People's Hospital, released the trial's positive results at the 6th Annual Meeting of Chinese Hair Research Society (第六届全国毛发学术会议). The results showed that after 24 weeks of treatment, the non-vellus target area hair counts (TAHC) in the 5mg (0.5% concentration) twice daily (BID) KX-826 group increased by 15.34/cm2 compared with the placebo group from baseline, with a statistical difference (P=0.024). On 1 December 2022, the company announced that the primary endpoint of Phase II clinical trial of KX-826 for female AGA adults in China was met. After 24 weeks of treatment, the non-vellus TAHC in the 5mg (0.5% concentration) once daily (QD) KX-826 group increased by 11.39/cm2 compared with the placebo group from baseline, with a statistical difference (P=0.0087). KX-826 has showed a good safety pro both trials. GT20029 is a topical AR-Proteolysis Targeting Chimera (PROTAC) compound that is under clinical development for the potential treatment of AGA and acne. GT20029 is the world's first topical PROTAC compound which entered the clinical stage. On 24 November 2022, the company announced the top-line data of the Phase I clinical trial of GT20029 for the treatment of AGA and acne in China. The results showed that GT20029 demonstrated good safety, tolerability and pharmacokinetics in healthy subjects. On 10 February 2023, the company announced the top-line data of the Phase I clinical trial of GT20029 for the treatment of AGA and acne in the U.S.. The results showed that GT20029 demonstrated good safety, tolerability and pharmacokinetics following topical single ascending dose (SAD) administration in healthy subjects and multiple ascending dose (MAD) administration in subjects with AGA or acne. In addition, the company's product pipeline includes Pruxelutamide, GT1708F, GT0486, ALK-1 antibody (GT90001) and GT90008 in the clinical stage, and c-Myc inhibitor, compound of other targets out of PROTAC platform and ALK-1/VEGF bispecific antibody in the preclinical stage. The company's Hedgehog/SMO inhibitor GT1708F is being explored for both idiopathic pulmonary fibrosis (IPF) indication and combination therapy in blood cancer. The company is now preparing for clinical trial application for the IPF indication. The Growing Visibility in the Capital Market Since its listing on the Hong Kong Stock Exchange on 22 May 2020, the company's development has received long-term support from investors around the world. In 2022, the company successfully completed two top-up placements in the capital market and raised about $100 million. After being included in the Hong Kong Stock Connect program in September 2021, the company's stock has been included in the Shanghai-Hong Kong Stock Connect in March 2023, further expanding the company's mainland investor pool, improving its liquidity and the market influence. Thus benefits the company's future development prospects. In addition, Kintor Pharma's stock have been included in the MSCI China Index during the reporting period. Increasing Presence in Reputable Academic Seminars and Conferences Since 2022, Kintor Pharma's R&D outcome has been accepted by reputable academic conferences and journals, proving that the company's innovation ability and its international influence, and further demonstrating the First-in-Class and Best-in-Class potential of the company's product pipeline. Kintor Pharma's KX-826 and GT20029 for treatment of AGA and acne presented at AAD 2023 Kintor Pharma's Hedgehog/SMO inhibitor GT1708F for the treatment of Acute Myeloid Leukemia (AML) presented at AACR 2023 Oral Presentation highlighting the data from novel dual c-Myc/GSPT1 degrader GT19715 at ASH 2022 Pruxelutamide for treatment of COVID-19 and a c-Myc degrader for treatment of blood cancer and small cell lung cancers (SCLC) presented at AACR 2022 The study result of GT19715, a novel dual-target degrader of C-Myc/GSPT1, was published in the journal Clinical Lymphoma, Myeloma & Leukemia The study result of the Phase Ib clinical trial of Pruxelutamide for treatment of breast Cancer was published in the European Journal of Cancer (EJC) Industry and Capital Market Awards Kintor Pharma's persistent efforts in R&D has been widely recognized in the industry and has won many industry and capital market awards. Top 15 Biotech of the Top 100 Hong Kong Listed Companies Top 10 Innovative Pharmaceutical Companies in 2022 R&D Innovation Outstanding Contribution Award in 2021 Top 20 Biomedical Innovation Potential List in 2022 TOP 30 Innovative Small Molecule Pharmaceutical Companies in China in 2021 TOP 20 Most Influential Small Molecule Pharmaceutical Innovation Companies in 2022 Jishi Cup Top 10 Pharmaceutical Innovation Companies in 2021 Most Valuable Pharmaceutical and Medical Companies Other Business Updates In August 2022, Dr. Lu Qun, our Chief Technology Officer, was elected as a "2022 Gusu Innovation and Entrepreneurship Leading Talent". In May 2022, the company has received the approval to set up a Doctors workstation in Guangdong Province by the Human Resources and Social Security Department of Guangdong Province. Financial Highlights As of 31 December 2022, the company's research and development costs increased by RMB828 million, up by 7.8%, from RMB767.9 million for the year ended 31 December 2021. The increased R&D costs were mainly attributable to the ongoing Phase III clinical trials, including those of Pruxelutamide for the indication of COVID-19 and mCRPC, and KX-826 for the indication of AGA during the reporting period. The company had cash and cash equivalents and time deposits of RMB875.3 million as at 31 December 2022, including utilised bank facilities of RMB 276.5 million. In addition, the company also had unutilised bank facilities of RMB 120.0 million as at 31 December 2022. The company has sufficient cash on hand to support the advancement of the clinical trials and R&D. *For more details, please refer to the 2022 annual results announcement. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancers, alopecia and acne. For more information, visit . Company Codes: HongKong:9939