XuanZhu Bio-B (02575) announced that its self-developed innovative drug, piroplocilib tablets (brand name: Xuan Yue Ning®), in combination with an aromatase inhibitor (AI) for the first-line treatment of HR+/HER2- advanced breast cancer, has received new indication marketing approval (sNDA) from the National Medical Products Administration (NMPA) of China. This marks the third approved indication for piroplocilib in China, following previous approvals for use in combination with fulvestrant and as a monotherapy. With this approval, piroplocilib becomes the first and only drug of its kind in China to cover the entire treatment course—first-line, second-line, and later-line therapy—for HR+/HER2- advanced breast cancer. The expansion of piroplocilib's indications to include first-line treatment significantly broadens patient coverage, enhances the drug's clinical value and accessibility, and provides strong support for future sales growth. Breast cancer is the most commonly diagnosed malignant tumor among women globally. According to a CIC report, the number of new breast cancer cases in China increased from 322,200 in 2018 to 374,700 in 2024 and is projected to reach 435,000 by 2032. HR+/HER2- breast cancer is the most prevalent subtype in China, accounting for approximately 75% of all cases, with about 30% of HR+/HER2- breast cancer patients diagnosed at an advanced stage. In China, CDK4/6 inhibitors combined with endocrine therapy have become the standard first-line treatment for HR+/HER2- advanced breast cancer. The market size for CDK4/6 inhibitors in China is expected to reach RMB 13 billion by 2032. The approval of this new indication is primarily based on data from the BRIGHT-3 study (NCT05257395). BRIGHT-3 is a randomized, double-blind Phase III clinical trial conducted across 58 centers in China, designed to evaluate the efficacy and safety of piroplocilib in combination with letrozole or anastrozole as a first-line treatment for HR+/HER2- advanced breast cancer. Previously, results from the BRIGHT-3 study were first presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The results showed that, in terms of efficacy, the median progression-free survival (mPFS) assessed by both investigators and an independent review committee had not yet been reached in the piroplocilib group, compared to 18.43 months and 19.55 months in the control group, respectively. The fact that mPFS has not been reached suggests that more patients in the piroplocilib group have not experienced disease progression, reflecting its durable efficacy advantage. Compared to placebo combined with endocrine therapy, the piroplocilib regimen reduced the risk of disease progression or death by 47%. Notably, in patients with liver metastases, who generally have a poorer prognosis, the risk of disease progression or death was substantially reduced by 64%, demonstrating its significant potential in difficult-to-treat populations. In the intent-to-treat population, the objective response rate (ORR) in the piroplocilib group reached 63.5%, significantly higher than the 42.5% observed in the control group. Regarding safety, common adverse events associated with the piroplocilib combination regimen, such as diarrhea and neutropenia, were mostly Grade 1–2 and could be effectively managed with supportive care or dose adjustments, indicating an overall manageable safety profile.
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