证券日报网讯 10月20日晚间，信立泰发布公告称，公司收到子公司美国SalubrisBiotherapeutics，Inc.的 通知，其在2025年欧洲肿瘤内科学会年会（ESMO）展示了JK06在I/II期临床试验中的部分剂量递增数 据。初步的数据显示，JK06在包括非小细胞肺癌（NSCLC）和乳腺癌在内的不可切除的局部晚期或转 移性肿瘤患者中，展现出良好的安全性和疗效。 （文章来源：证券日报） ...

格隆汇10月20日丨信立泰(002294.SZ)公布，收到子公司美国SalubrisBiotherapeutics,Inc.（下 称"SalubrisBio"）的通知，其在2025年欧洲肿瘤内科学会年会（ESMO）展示了JK06在I/II期临床试验中 的部分剂量递增数据。初步的数据显示，JK06在包括非小细胞肺癌（NSCLC）和乳腺癌在内的不可切 除的局部晚期或转移性肿瘤患者中，展现出良好的安全性和疗效。 ESMO会议上报告的数据，涵盖了JK06在欧洲（部分国家）入组的34例晚期复发性/难治性实体瘤患 者。所有患者均为接受肿瘤标准治疗方案失败后入组，其中83%曾接受过三线或以上治疗，59%曾接受 过四线或以上治疗。在剂量递增阶段入组的患者按每三周（Q3W）一次的频率接受JK06治疗，覆盖五 个剂量水平（1.5-8.0mg/kg）。其中，29例患者经过肿瘤临床疗效评估，并获得关键疗效性数据。 ...

ESMO会议上报告的数据，涵盖了JK06在欧洲（部分国家）入组的34例晚期复发性/难治性实体瘤患 者。所有患者均为接受肿瘤标准治疗方案失败后入组，其中83%曾接受过三线或以上治疗，59%曾接受 过四线或以上治疗。在剂量递增阶段入组的患者按每三周（Q3W）一次的频率接受JK06治疗，覆盖五 个剂量水平（1.5-8.0mg/kg）。其中，29例患者经过肿瘤临床疗效评估，并获得关键疗效性数据。 格隆汇10月20日丨信立泰(002294.SZ)公布，收到子公司美国SalubrisBiotherapeutics,Inc.（下 称"SalubrisBio"）的通知，其在2025年欧洲肿瘤内科学会年会（ESMO）展示了JK06在I/II期临床试验中 的部分剂量递增数据。初步的数据显示，JK06在包括非小细胞肺癌（NSCLC）和乳腺癌在内的不可切 除的局部晚期或转移性肿瘤患者中，展现出良好的安全性和疗效。 ...

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - The study is an open-label, dose-escalation trial aimed at evaluating the safety, efficacy, and tolerability of JK07 in patients with cpcPH, planning to enroll up to 30 patients [2] - Epidemiological studies indicate that up to 50% of HFrEF or HFpEF patients exhibit varying degrees of pulmonary hypertension, which significantly worsens prognosis [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently undergoing Phase I clinical trials in Europe, with plans for dose expansion studies by the end of the year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - This open-label, dose-escalation study will evaluate the safety, efficacy, and tolerability of JK07 in patients with cpcPH, aiming to enroll up to 30 patients [2] - The study duration is 6 months, with patients receiving four doses of JK07 over 13 weeks, followed by a 12-week follow-up [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently in a Phase I clinical trial in Europe, with plans for dose expansion later this year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]