该研究II期部分的结果近期已于2025年欧洲肿瘤内科学会(ESMO)亚洲大会上公布。至数据截止日2025 年7月 24日，中位PFS随访时间为8.15个月。S+C+AG方案组的中位PFS为7.20个月，而AG组则为5.52个 月(分层风险比 [HR] 0.499 ，log-rank检验p=0.0407)，意味着疾病进展或死亡风险降低了50.1% 。其他关 键疗效终点也观察到了类似的获益，包括ORR (67.7%对比41.9% ，p=0.0430)和DCR (93.5%对比71.0% ，p=0.0149)。尽管在分析时总生存期数据尚未成熟，但已观察到积极趋势(未达到对比8.48个月，未分 层HR 0.555)，S+C+AG组发生了9例事件(N=31)，AG组则发生了15例事件(N=31)。治疗展示出可控的安 全性特徵，S+C+AG组中80.6%的患者发生3级或以上治疗期间不良事件(TEAE)，而AG组则为61.3%。 该研究是一项多中心、随机、开放标签、阳性对照的II/III期临床试验，旨在评估索凡替尼联合卡瑞利珠 单抗、白蛋白结合型紫杉醇和吉西他滨 ( S+C+AG方案)对比白蛋白结合型紫杉醇和吉西他滨 ( ...

该研究II期部分的结果近期已于2025年欧洲肿瘤内科学会(ESMO)亚洲大会上公布。至数据截止日2025 年7月24日，中位PFS随访时间为8.15个月。S+C+AG方案组的中位PFS为7.20个月，而AG组则为5.52个 月(分层风险比[HR]0.499，log-rank检验p=0.0407)，意味着疾病进展或死亡风险降低了50.1%。其他关键 疗效终点也观察到了类似的获益，包括ORR(67.7%对比41.9%，p=0.0430)和DCR(93.5%对比71.0%， p=0.0149)。尽管在分析时总生存期数据尚未成熟，但已观察到积极趋势(未达到对比8.48个月，未分层 HR0.555)，S+C+AG组发生了9例事件(N=31)，AG组则发生了15例事件(N=31)。治疗展示出可控的安全 性特徵，S+C+AG组中80.6%的患者发生3级或以上治疗期间不良事件(TEAE)，而AG组则为61.3%。 和黄医药(00013)公布，公司今日宣布启动索凡替尼(surufatinib)联合卡瑞利珠单抗(camrelizumab)、白蛋 白结合型紫杉醇(nab-paclitaxel)和吉西他滨(gemcitabine)用 ...

格隆汇1月5日丨和黄医药(00013.HK)宣布启动索凡替尼(surufatinib)联合卡瑞利珠单抗(camrelizumab)、 白蛋白结合型紫杉醇(nab-paclitaxel)和吉西他滨(gemcitabine)用于一线治疗转移性胰腺导管腺癌(PDAC) 患者的中国II/III期研究的III期部分。首名患者已于2025年12月30日接受首次给药治疗。 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 11, 2025 [1]. Core Insights - The A-share innovative drug sector saw a weekly increase of 2.33%, outperforming the CSI 300 index by 0.33 percentage points, while the biopharmaceutical sector rose by 0.75% [2][17]. - In the past six months, the A-share innovative drug sector has cumulatively increased by 5.43%, outperforming the CSI 300 index by 9.13 percentage points, whereas the biopharmaceutical sector has decreased by 10.55% [2][17]. - The Hong Kong innovative drug sector experienced a decline of 2.14%, underperforming the Hang Seng Index by 3.75 percentage points, with a cumulative increase of 22.08% over the past six months [2][20]. - The XBI index in the US fell by 8.59% this week, with a cumulative decline of 22.72% over the past six months [2][23]. Summary by Sections Domestic Key Innovative Drug Progress - In May, one new drug was approved for market launch in China, with no new indications approved [3][41]. Overseas Key Innovative Drug Progress - In May, there were no NDA or BLA approvals in the US, Europe, or Japan for innovative drugs [4][45]. Global Key Innovative Drug Transaction Progress - A total of 12 key transactions occurred globally this week, with one disclosed transaction amounting to 415 million USD between Alchemab Therapeutics and Eli Lilly [5]. Market Performance - The report indicates that 39 stocks in the innovative drug sector rose while 67 fell during the week, with the top gainers being HaiChuang Pharmaceutical-U (22.76%), Changchun High-tech (8.99%), and Zhongsheng Pharmaceutical (8.98%) [2][16]. - The top decliners included Fuhong Hanlin (-12.64%), Connaught-B (-12.40%), and Boan Biotechnology (-11.77%) [2][16]. Clinical Trials and Approvals - In May, there were 23 newly announced clinical trials in China, including 17 in BE/I phase, 4 in II phase, and 2 in III phase [31].