China's Pharma Leader Fuels Growth in $11 Billion Prostate Cancer Market with New Combination Therapy Filing

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the combination therapy of Hengrui Pharma's Rivoceranib (Aireen®) and Hansoh Pharma's ADC drug HS-20093 has been approved by the CDE to conduct clinical trials, drawing significant market attention.

Figure 1. Source: CDE Official Website

It is reported that the indication for Rivoceranib is high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is the second most common tumor in men. Currently, both the incidence and mortality rates of prostate cancer in China are continuously increasing, and more than half of the patients are already at the mHSPC stage at their first clinical diagnosis, indicating an urgent clinical need.Hengrui Pharma's exploration of combining Rivoceranib with ADC may usher in a new phase for domestic drug innovation in the field of combination therapy for prostate cancer.

Hengrui Pharma Explores Combination Therapy

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) refers to the stage where cancer cells have spread beyond the prostate but remain sensitive to treatments that lower androgen levels. In the past, Androgen Deprivation Therapy (ADT) was the standard treatment, but its efficacy was limited.The current treatment has entered the "ADT+" combination era, where the addition of second-generation androgen receptor signaling inhibitors (ARSIs) has significantly improved patient survival.

Hengrui Pharma's Reviralumab is the firstChina's Self-Developed Second-Generation AR Inhibitor, which was approved for marketing in June 2022. The key Phase III CHART study data showed that compared with the first-generation AR inhibitor bicalutamide (bicalutamide + ADT), rivoceranib + ADT significantly reduced the risk of radiographic progression and death in patients, with hazard ratios of 0.56 and 0.42, respectively, demonstrating excellent efficacy.

The combination of Hengrui Pharma's Rivilutamide and HS-20093 has been approved for clinical trials. HS-20093, developed by Hansoh Pharma, is a novel ADC drug targeting B7-H3 (CD276). It has received the CDE’s "Breakthrough Therapy Designation" and is currently undergoing clinical research for solid tumors such as small cell lung cancer, sarcoma, and head and neck cancer.

The industry believes that Rivoceranib inhibits cancer cell growth from the source of the hormone signaling pathway, while HS-20093 precisely delivers potent cytotoxic drugs by targeting the B7-H3 antigen, which is highly expressed in solid tumors, directly killing cancer cells. This "internal block and external kill" combination strategy,Expected to overcome the challenge of treatment resistance in prostate cancer, thereby further enhancing the treatment efficacy.

Blue Ocean Market Potential Awaits Release

Globally, prostate cancer is the second most common malignant tumor in men, with approximately 1.468 million new cases and about 397,000 deaths in 2022. Data from GLOBOCAN 2022 shows that the world population age-standardized incidence rate is 29.4 per 100,000, and the mortality rate is 7.3 per 100,000.

In China, the incidence and mortality of prostate cancer are rising rapidly. The "China Prostate Cancer Screening Research Report (White Paper)" shows that in 2022, there were approximately 134,000 new cases, with an incidence rate of 9.7/100,000; about 48,000 deaths, with a mortality rate of 3.3/100,000. Notably, a high proportion of Chinese patients are diagnosed at an advanced stage of prostate cancer for the first time, and 54% of patients are initially diagnosed with mHSPC. This results in a lower five-year survival rate for Chinese patients compared to those in developed countries, highlighting significant and urgent clinical needs.

According to Evaluate Pharma and the annual reports of various companies,As a representative of emerging therapies, second-generation AR inhibitors have created an $11 billion market with strong growth.。

From the perspective of global sales in 2024,Astellas' Enzalutamide Tops the List with $5.93 Billion, a Year-on-Year Increase of 21.6%. Janssen's Apalutamide Generated $2.999 Billion in Sales, a Year-on-Year Increase of 25.96%. Darolutamide, Co-Developed by Bayer and Orion, Ranked Third with $1.645 Billion in Sales and a Year-on-Year Increase of 75.3%.

From the data in China,RivoceranibIs a true market leaderAccording to the data from CKDM CMH (Figure 2), in the third quarter of 2025, Rivoceranib ranked first with sales of 148 million RMB, followed by Apalutamide, Enzalutamide, and Darolutamide, with sales of 63.5 million, 51.3 million, and 41.7 million RMB respectively.

Figure 2. Quarterly sales of four second-generation AR inhibitors in the Chinese out-of-hospital market. Information sourced from Sino Health CMH.