Accessibility StatementSkip Navigation In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program in CLL Results from BRUIN CLL-313 and B ...

HIBRUKA (Orelabrutinib) Approval of HIBRUKA (Orelabrutinib) for the Treatment of R/R MZL in Singapore BEIJING, Sept. 07, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL). Dr. Jasmine Cui, Co-foun ...

药物批准与适应症 - 美国FDA批准Wayrilz用于对先前治疗反应不足的持续性或慢性免疫性血小板减少症成人患者[1] - 阿联酋于2025年6月批准相同适应症[5] - 欧盟和中国正在对ITP适应症进行监管审查[8] 临床数据表现 - LUNA 3三期研究显示23%的Wayrilz组患者在25周实现持久血小板反应 显著优于安慰剂组的0%[7] - Wayrilz组达到首次血小板反应的中位时间为36天 安慰剂组未达到[7] - Wayrilz组血小板反应持续时间的最小二乘均值为7周 显著优于安慰剂组的0.7周[7] - 基于ITP患者评估问卷 Wayrilz组在九项健康相关生活质量指标上总体改善10.6分 优于安慰剂组的2.3分提升[4] 药物特性与机制 - 作为首款用于ITP的BTK抑制剂 通过多免疫调节靶向疾病根本原因[11] - 采用创新TAILORED COVALENCY技术实现选择性BTK抑制[11] - 口服可逆性BTK抑制剂 作用于B细胞、巨噬细胞和其他先天免疫细胞[2][11] 市场潜力与患者群体 - 美国超过25,000名成人患者可能受益于该先进治疗方案[6] - 公司提供HemAssist患者支持计划 协助保险覆盖和财务援助[9] - 药物已获得FDA快速通道和孤儿药认定 在欧盟和日本也有类似认定[8] 研发进展与扩展适应症 - 药物正在研究用于温抗体自身免疫性溶血性贫血、IgG4相关疾病和镰状细胞病等罕见病[8][12] - FDA最近授予这三个额外罕见病的孤儿药认定[8] - IgG4相关疾病还获得FDA快速通道认定和欧洲药管局孤儿药认定[8] 疾病背景 - ITP是复杂的免疫失调疾病 导致血小板计数低于100,000/μL[12] - 除瘀伤和出血外 患者可能经历身体疲劳和认知障碍等生活质量下降问题[12]

Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients. This important subpopulation (n=225) had the longest follow-up and a particularly pronounced PFS effect size in favor of pirtobrutinib. The overall safety profile of pirtobru ...