Introduction to Proxalutamide
Proxalutamide, also known as GT0918, is a promising drug candidate developed by Kintor Pharmaceutical. It is an androgen receptor antagonist that has been explored for various therapeutic applications, including the treatment of metastatic prostate cancer, breast cancer, and COVID-19.
Clinical Development Overview
Metastatic Prostate Cancer
Proxalutamide has been undergoing extensive clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase III clinical trials in China were initiated in May 2018, with interim analysis results expected by the second half of 2020. Kintor aims to apply for an accelerated New Drug Application (NDA) for Proxalutamide in the treatment of mCRPC by the end of 2020 and expects approvals from the National Medical Products Administration (NMPA) in 2021 and 2022 for second-line and first-line therapies, respectively[4].
Breast Cancer
In addition to prostate cancer, Proxalutamide is being investigated for the treatment of breast cancer. Phase I/Ib clinical trials as a monotherapy for metastatic breast cancer were completed in China in 2019. Kintor is targeting the completion of phase Ic clinical trials in combination therapy with other drugs like Exemestane, Letrozole, and Fulvestrant by 2020. The company plans to focus on androgen receptor-positive (AR+) triple-negative breast cancer (TNBC) for its phase III clinical trials[4].
COVID-19
Proxalutamide has also been studied for its potential in treating COVID-19. Kintor Pharma has conducted multiple phase III multi-regional clinical trials (MRCTs) for both inpatients and outpatients with COVID-19. These trials, approved by regulators in the United States, Brazil, and other countries, aim to evaluate the efficacy and safety of Proxalutamide in preventing the progression to severe forms of COVID-19, shortening recovery time, and reducing mortality rates[3][5].
Efficacy and Safety Data
COVID-19 Trials
The phase III trials for COVID-19 involve comparing Proxalutamide plus standard of care (SOC) with placebo plus SOC. Preliminary data indicate that Proxalutamide can effectively inhibit infections caused by various SARS-CoV-2 variants, including Alpha, Delta, and Gamma. The study involves approximately 762 subjects randomized in a 1:1 ratio to either the treatment or placebo group[3].
Prostate Cancer Trials
In the context of mCRPC, Proxalutamide has shown promising results. Phase III trials have demonstrated that Proxalutamide in combination with usual care can reduce the risk of hospitalization and death compared to the placebo group[2].
Regulatory Approvals and Authorizations
Proxalutamide has received significant regulatory support. In 2021, it was granted its first emergency use authorization (EUA) by Paraguay for treating COVID-19 inpatients. Additionally, Kintor Pharma received approvals from the U.S. FDA and the Brazilian Health Regulatory Agency (ANVISA) to conduct phase III clinical trials for COVID-19[5].
Market Projections
China Market
Kintor expects Proxalutamide to receive approvals from the NMPA for the treatment of mCRPC and AR+ TNBC in China. The company forecasts that Proxalutamide will reach risk-adjusted peak sales of RMB 2.9 billion in China by 2028[4].
Global Market
In the United States, Kintor anticipates receiving FDA approvals for the treatment of mCRPC in 2023 and AR+ TNBC in 2025. The risk-adjusted royalty income from the U.S. is projected to peak at RMB 156 million in 2025[4].
Strategic Partnerships
To enhance its market presence, Kintor has entered into strategic partnerships. For instance, the company has partnered with Shanghai Fosun Pharmaceutical Development Ltd. for the commercialization of Proxalutamide in India and 28 African countries, and with PT Etana for commercialization in Indonesia[5].
Production and Manufacturing
To meet the anticipated demand, Kintor has expanded its production capacity at its own Good Manufacturing Practice (GMP) factory. The company has also entered into a strategic partnership with Hainan Visum Pharmaceutical Limited to further increase production capacity[5].
Conclusion
Proxalutamide is a versatile drug candidate with significant potential across multiple therapeutic areas. With ongoing phase III clinical trials and recent regulatory approvals, it is poised to make a substantial impact in the treatment of mCRPC, breast cancer, and COVID-19.
Key Takeaways
- Therapeutic Applications: Proxalutamide is being developed for mCRPC, breast cancer, and COVID-19.
- Clinical Trials: Multiple phase III trials are ongoing for COVID-19 and mCRPC.
- Regulatory Approvals: Received EUA in Paraguay and approvals from FDA and ANVISA for COVID-19 trials.
- Market Projections: Projected peak sales of RMB 2.9 billion in China by 2028 and risk-adjusted royalty income of RMB 156 million in the U.S. by 2025.
- Strategic Partnerships: Partnerships for commercialization in various regions including India, Africa, and Indonesia.
FAQs
Q: What is Proxalutamide used for?
A: Proxalutamide is an androgen receptor antagonist being developed for the treatment of metastatic prostate cancer, breast cancer, and COVID-19.
Q: What stage are the clinical trials for Proxalutamide in?
A: Proxalutamide is in phase III clinical trials for mCRPC and COVID-19, and phase I/Ib trials for breast cancer.
Q: Has Proxalutamide received any regulatory approvals?
A: Yes, Proxalutamide received its first EUA in Paraguay for treating COVID-19 inpatients and has approvals from FDA and ANVISA for conducting phase III trials.
Q: What are the market projections for Proxalutamide?
A: Proxalutamide is projected to reach peak sales of RMB 2.9 billion in China by 2028 and risk-adjusted royalty income of RMB 156 million in the U.S. by 2025.
Q: Who are Kintor Pharma's partners for Proxalutamide?
A: Kintor Pharma has partnered with companies like Shanghai Fosun Pharmaceutical Development Ltd., PT Etana, and Hainan Visum Pharmaceutical Limited for commercialization and production.
Sources
- Kintor Pharmaceutical (9939 HK) - [PDF] Kintor Pharmaceutical (9939 HK)[4]
- Patsnap Synapse - Proxalutamide - Drug Targets, Indications, Patents[2]
- Reagan-Udall Foundation - A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized Adults Diagnosed with COVID-19[3]
- ACN Newswire - Kintor Pharma Announces 2021 Interim Results[5]
