The Independent Data Monitoring Committee (IDMC), concluded that the Phase III clinical trial of Deutenzalutamide (HC-1119) in China met the predefined primary endpoint.

Hinova (STAR: 688302) announced on June 26, 2022 that the multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial (protocol No. HC-1119-04) of the company's self-developed deutenzalutamide (HC-1119) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) completed a predefined interim analysis, and the Independent Data Monitoring Committee (IDMC) reviewed the results and concluded that the trial met the predefined primary endpoint. Based on the IDMC recommendations, Hinova will submit a pre-NDA meeting application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China soon.

Deutenzalutamide softgel capsule showed an overall favorable safety profile and statistically significant rPFS improvement as expected. This may reduce the risk of disease progression in patients with metastatic castration-resistant prostate cancer. A trend of clinical benefits on overall survival (OS) and death risk reduction had been observed.

“AR is a clinically validated target in prostate cancer treatment, and the phase III clinical study of deutenzalutamide (HC-1119) as an AR antagonist in China targets the 2/3L treatment of metastatic castration-resistant prostate cancer (mCRPC), and is expected to meet the unmet medical need in China!” Said Dr. Yuanwei Chen , President and CEO of Hinova, “Deutenzalutamide (HC-1119) is expected to be our first product to be commercialized, and the survival benefit showed in the Phase III clinical study in China is encouraging! We sincerely thank the principal investigator, Professor Ye Dingwei from the Affiliated Cancer Hospital of Fudan University, and other investigators, as well as patients participated in the clinical study, and we look forward to and will be even more active in making deutenzalutamide (HC-1119) available to doctors and patients as a new treatment option!”

About deutenzalutamide (HC-1119)

Deutenzalutamide (HC-1119) is a Class 1 new drug independently developed by Hinova for the treatment of metastatic castration-resistant prostate cancer (mCRPC), which is a deuterated agent of enzalutamide, a second-generation androgen receptor (AR) antagonist, and has been awarded by Ministry of Science and Technology of the People’s Republic of China as one of National Major Projects of “Significant New Drugs Creation”.

Deutenzalutamide (HC-1119), as an AR inhibitor, competitively inhibits the binding of androgens to AR, blocks the AR signaling pathway, inhibits the proliferation of prostate cancer cells and induces apoptosis in prostate cancer cells. Previous clinical and preclinical results had shown that deutenzalutamide (HC-1119) has the potential for higher efficacy, better safety profile and stronger patient adherence than its counterparts on the market, and that its compound patent will last until 2032 with a longer validity period.

According to the statistics, the total global sales of second-generation AR inhibitors (enzalutamide, apalutamide, and darolutamide) was approximately $6.3 billion in 2021, with enzalutamide accounting for approximately $4.8 billion.

For mCRPC patients who have failed treatment with abiraterone acetate and docetaxel or who are intolerant to or ineligible for the treatment with docetaxel, there is no drug approved in China at present. The Phase 3 clinical trial of deutenzalutamide (HC-1119) in China is targeted at those patients and is expected to provide a new therapeutic option for clinical treatment, which probably leads to differentiation and a competitive advantage of deutenzalutamide in the domestic market.

About the Phase III clinical study of Deenluamide (HC-1119) in China

The Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HC-1119 Softgels in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Failing Abiraterone Acetate and Docetaxel Treatment was conducted by Professor Ye Dingwei from the Affiliated Cancer Hospital of Fudan University as the principal investigator in patients with mCRPC who had failed abiraterone acetate and docetaxel treatment or were intolerant to or ineligible for docetaxel treatment.

The study was initiated in April 2019 with 37 study sites participating in the trial, randomized according to 2:1, with a total of 417 patients enrolled. The current study demonstrated that deutenzalutamide (HC-1119) softgel treatment contributes to an expected and statistically significant rPFS improvement and significantly reduces the risk of disease progression in patients with metastatic castration-resistant prostate cancer; the overall survival (OS) events were under continuous observation and a trend towards clinical benefit has been observed with reduced risk of death among patients.

About prostate cancer

Prostate cancer is one of the most common malignant tumors worldwide, ranking second in incidence and fifth in mortality of male malignant tumors worldwide; in the United States, it ranks first in incidence and second in mortality of male malignant tumors; in China, prostate cancer ranks sixth in incidence of male malignant tumors and is the fastest growing male tumor in terms of incidence and mortality in China. According to Frost & Sullivan, the number of prostate cancer patients in China grew from 88,000 in 2015 to 108,000 in 2019, at a CAGR of 5.3%, and the number of new cases is expected to reach approximately 200,000 by 2030. The market size for prostate cancer drugs in China grew from RMB 2.2 billion in 2015 to RMB 5.3 billion in 2019, at a CAGR of 24.5%, and is expected to reach RMB 15.5 billion by 2024, at a CAGR of 24.1%. The prostate cancer drugs market in China will further grow to RMB 50.6 billion by 2030, at a CAGR of 21.8% from 2024 to 2030.

Patients with early-stage prostate cancer (hormone-sensitive prostate cancer, HSPC) are treated primarily by androgen deprivation therapy (ADT), but mostly continuing to experience recurrence and evolving into sufferers of castration-resistant prostate cancer (CRPC) and then metastatic castration-resistant prostate cancer (mCRPC) in later stages.