Recently, the biomarker exploration findings from Xuanzhu Biopharma's BRIGHT-2 study of pyrrolitinib (Xuanyuening®) were published online in the internationally renowned journal Nature Communications.

BRIGHT-2 is a nationwide multicenter, randomized, double-blind Phase III clinical study led by Academician Xu Binghe. It evaluates the efficacy and safety of pyrrolitinib combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer that has progressed after prior endocrine therapy. A total of 305 patients from 64 centers across the country were enrolled, with a population highly representative of the real-world clinical characteristics of breast cancer in China. Study data showed that, as assessed by blinded independent central review, the median progression-free survival (mPFS) of the pyrrolitinib plus fulvestrant group reached 17.5 months, significantly superior to the control group, with excellent antitumor activity and manageable safety.

Supported by the solid clinical evidence from BRIGHT-2, the domestic Class 1 innovative drug pyrrolitinib (Xuanyuening®) has been approved for multiple indications. It is the first and currently only CDK2/4/6 inhibitor in China to achieve full-line coverage—first-line, later-line, and monotherapy—for HR+/HER2- advanced breast cancer, filling the gap in later-line monotherapy in China. It has now been included in the national medical insurance scheme, improving patient access to medication.

The biomarker study published this time conducted longitudinal dynamic analysis of ctDNA based on clinical samples from BRIGHT-2, identifying molecular features that can predict treatment benefit from pyrrolitinib, aiding clinical precision screening of benefiting populations and advancing individualized precision diagnosis and treatment of breast cancer.

In the future, Xuanzhu Biopharma will continue to deepen its efforts in innovative oncology drug development, continuously advance translational medicine and biomarker research, and produce more high-quality evidence-based evidence to bring better treatment options to breast cancer patients in China.

About Xuanzhu Biopharma

Xuanzhu Biopharma (Stock Code: 02575.HK) is an innovative pharmaceutical company rooted in China with a global vision, focusing on major disease areas such as digestion, oncology, and non-alcoholic steatohepatitis, and dedicated to the R&D, production, and commercialization of Class 1 new drugs with core independent intellectual property. The company has a first-class R&D team, and its core personnel all have many years of new drug R&D experience. As an emerging commercialization-oriented innovative drug company driven by R&D and empowered by AI, the company has formed a product pipeline rare in China that simultaneously covers multiple types such as small molecule chemical drugs, large molecule biologics, and antibody-drug conjugates. Guided by unmet clinical needs, the company is committed to developing into a first-class innovative drug enterprise with independent R&D, production, and sales capabilities.