信立泰：创新生物药JK07、JK06取得阶段性进展

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]