Sihuan’s Bireociclib Delivers Strong Phase 3 Breast Cancer Data Published in JAMA Oncology

Sihuan Pharmaceutical Holdings Group ( (HK:0460) ) has shared an announcement.

Sihuan Pharmaceutical announced that the final results of the Phase 3 BRIGHT-2 trial of its novel CDK2/4/6 inhibitor Bireociclib combined with Fulvestrant in HR+/HER2- advanced breast cancer have been published in leading journal JAMA Oncology. The China-based randomized, double-blind, placebo-controlled study showed that the combination significantly extended median progression-free survival versus placebo, with blinded independent review indicating mPFS of 17.5 months versus 7.3 months and a 53% reduction in the risk of disease progression or death.

The trial also demonstrated a markedly higher objective response rate of 50.3% for Bireociclib versus 16.7% for control, with durable tumor shrinkage and median duration of response not yet reached at data cutoff. Subgroup and exploratory biomarker analyses indicated consistent benefits across high-risk populations, including patients with primary endocrine resistance, short disease-free intervals and ESR1, PIK3CA or TP53 mutations, underscoring Bireociclib’s potential to strengthen Sihuan’s position in the competitive HR+/HER2- breast cancer treatment landscape and support more individualized treatment strategies.

The most recent analyst rating on (HK:0460) stock is a Hold with a HK$1.50 price target. To see the full list of analyst forecasts on Sihuan Pharmaceutical Holdings Group stock, see the HK:0460 Stock Forecast page.

More about Sihuan Pharmaceutical Holdings Group

Sihuan Pharmaceutical Holdings Group is a China-focused pharmaceutical company engaged in the research, development and commercialization of innovative therapies, with a growing emphasis on oncology. Through its non-wholly-owned subsidiary Xuanzhu Biopharmaceutical, the group develops novel targeted treatments such as Bireociclib for hormone receptor-positive, HER2-negative advanced breast cancer.

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