The global biotech sector continues to evolve amid the interplay of rational capital allocation and innovative fervor, while China's pharmaceutical industry undergoes a profound reassessment of value. The competitive landscape has shifted fundamentally—from reliance on "narrative-driven" strategies to a focus on "product validation," and from homogeneous competition to pursuing original innovation and global value. Against this backdrop, XUANZHUBIO-B (02575) has entered a pivotal phase in 2025 with the concentrated realization of its oncology pipeline. Its self-developed CDK4/6 inhibitor, piroxiclib, and ALK inhibitor, deloracib, were approved for market launch this year, joining the previously approved digestive product, anelaprazole sodium, to form the "triple engine" driving the company's commercialization.
In terms of market performance, the company's stock price has steadily risen since its IPO, reflecting market recognition of its product prospects and confidence in its future growth. But what exactly underpins this market confidence?
**From Second-Line to First-Line: Piroxiclib’s Full-Spectrum Indication Strategy Takes Shape** Piroxiclib, a CDK4/6 inhibitor, recently showcased its potential at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting. Data from the BRIGHT-3 Phase III trial—a randomized, double-blind study involving 397 patients across 58 Chinese centers—demonstrated its clinical promise in first-line treatment for HR+/HER2- advanced breast cancer.
Key efficacy metrics stood out: as of January 10, 2025, median progression-free survival (mPFS) had not yet been reached after 20.7 months of median follow-up, significantly outperforming the control group's 18.43 and 19.55 months. The objective response rate (ORR) reached 63.5%, a 21-percentage-point improvement over the control, while the risk of disease progression or death was reduced by 47%, with liver metastasis patients seeing a 64% reduction. Safety profiles were manageable, with common adverse events like diarrhea and neutropenia mostly graded 1-2 and controllable through supportive care or dose adjustments.
Backed by these results, China’s National Medical Products Administration (NMPA) accepted the new drug application (NDA) for first-line treatment in May, marking piroxiclib’s entry into the frontline breast cancer market. Notably, this milestone is part of a broader "full-cycle treatment strategy." Earlier this year, piroxiclib secured approvals for two indications: second-line use with fulvestrant for endocrine therapy-resistant patients and monotherapy for heavily pretreated patients. With the first-line NDA under review, piroxiclib is poised to cover the entire treatment spectrum—from salvage therapy to first-line intervention—while offering both monotherapy and combination options.
**Deloracib: A Breakthrough for ALK-Positive NSCLC Brain Metastases** While piroxiclib establishes a competitive edge in HR+/HER2- breast cancer, deloracib targets an unmet need in ALK-positive non-small cell lung cancer (NSCLC) with brain metastases, boasting an intracranial ORR (IC-ORR) exceeding 91%.
Despite advances in ALK-targeted therapies, brain metastases remain a critical challenge due to the blood-brain barrier’s limiting effect on drug penetration. Deloracib’s optimized molecular structure enhances blood-brain barrier penetration, addressing this bottleneck. Clinical data from the NCT05204628 trial highlight its superiority: an ORR of 88.5% and mPFS of 31.3 months (more than double that of crizotinib’s 12.9 months). Most strikingly, in brain metastasis patients, deloracib achieved an IC-ORR of 91.7% (versus crizotinib’s 11.1%) with a median intracranial duration of response (IC-DoR) not yet reached, compared to crizotinib’s 3.55 months.
**Conclusion** Amid the industry’s shift toward product-driven value, XUANZHUBIO-B’s 2025 approvals for piroxiclib and deloracib mark a critical validation of its innovation. Piroxiclib’s differentiated positioning in breast cancer and deloracib’s breakthrough in brain metastases—complemented by anelaprazole sodium—form a robust commercialization framework, laying a solid foundation for long-term growth.
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