SUZHOU, China, March 31, 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
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 profile in 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.
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.
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 www.kintor.com.cn.
