sotiburafusp alfa (HB0025) / Zhejiang Huahai Pharma - LARVOL DELTA

A phase II efficacy and safety study of HB0025 (a PD-L1/VEGF bispecific antibody) in combination with chemotherapy as first-line treatment for advanced or recurrent endometrial cancer. (ASCO 2025) - P1/2 | "Carboplatin and paclitaxel (CP) alone or in combination with PD-(L)1 is a recommended regimen for first-line treatment of advanced endometrial carcinoma (EC) that the ORRs were 40%-68% regardless MMR status. HB0025 in combination with chemotherapy demonstrated promising anti-tumor efficacy with good safety profile. Regardless MMR status, ORR with HB0025 plus CP improved significantly over histologically reported data. A multicentre, randomized, double-blind, controlled phase III trial will commence in 2025."

Clinical • Combination therapy • Metastases • P2 data • Endometrial Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

HB0025-C-01: A Phase Ib/II Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=282 | Recruiting | Sponsor: Huabo Biopharm Co., Ltd.

New P1/2 trial • Endometrial Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase 1/2 study to evaluate the efficacy and safety of HB0025 monotherapy for patients (pts) with advanced renal cell carcinoma (RCC). (ASCO 2024) - P2 | "HB0025 10mg/kg monotherapy showed an acceptable safety profile and promising anti-tumor activity in prior multiple treated RCC, which supports further studies to explore the safety and efficacy of HB0025 as a monotherapy or in combination with other anti-tumor agents. HB0025 20mg/kg monotherapy study are currently ongoing. Clinical trial information: NCT06222125."

Clinical • Metastases • Monotherapy • P1/2 data • Dyslipidemia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor

A Study of HB0025 Injection in Patients With Advanced Renal Cancer (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Huabo Biopharm Co., Ltd.

Metastases • New P2 trial • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Huahai Pharmaceutical (600521.SH): HB0025 Injection Combined with HB0030 Injection Obtained Drug Clinical Trial License [Google translation] (Zhitong Finance) - "Zhitong Finance APP news, Huahai Pharmaceutical...announced that the company's subsidiaries Shanghai Huaaotai Biopharmaceutical Co., Ltd. and Huabo Biomedical Technology (Shanghai) Co., Ltd. Food and Drug Administration) approved HB0025 injection combined with HB0030 injection for the treatment of advanced non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC) and other types of advanced solid tumors 'drug clinical trial approval Notice'."

New trial • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Hua Ao Tai, a subsidiary of Huahai Pharmaceutical (600521.SH), obtained the drug clinical trial license [Google translation] (Zhitong Finance) - "Zhitong Finance APP news, Huahai Pharmaceutical...announced that the company's subsidiary Shanghai Huaaotai Biopharmaceutical Co., Ltd. Approved the New Drug Clinical Trial (IND) application for a phase Ib/II study of HB0025 injection combined with HB0030 injection in patients with advanced solid tumors."

IND • Oncology • Solid Tumor

The antineoplastic drug HB0025 injection, a subsidiary of Huahai Pharmaceutical (600521.SH), obtained the drug clinical trial license [Google translation] (Zhitong Finance) - "Zhitong Finance APP news, Huahai Pharmaceutical...announced that recently, the company's subsidiary Shanghai Huaaotai Biopharmaceutical Co., Ltd. (hereinafter referred to as 'Huaotai') and Huabo Biomedical Technology (Shanghai ) Co., Ltd. (hereinafter referred to as 'Huabo Bio') received the 'Notice of Drug Clinical Trial Approval' for HB0025 injection approved and issued by the State Drug Administration (hereinafter referred to as 'NMPA')."

New trial • Oncology • Solid Tumor

A Study of Injection HB0025 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=154 | Recruiting | Sponsor: Huabo Biopharm Co., Ltd. | N=54 ➔ 154 | Trial completion date: Dec 2021 ➔ May 2024 | Trial primary completion date: Oct 2021 ➔ Feb 2024

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Novel Bispecific Antibody Targeting PD-L1 and VEGF With Combined Anti-Tumor Activities. (PubMed, Front Immunol) - "Preclinical data demonstrated that HB0025 was more effective in inhibiting cancer growth than anti PD-L1 mAb or VEGFR1D2 fusion protein. Thus, our bispecific antibody may bring about greater clinical benefits and broader indications."

Journal • Immune Modulation • Inflammation • Oncology • FLT1

A Study of Injection HB0025 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Huabo Biopharm Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Invested more than 40 million Huahai Pharmaceuticals’ new liver cancer drug approved for clinical trials [Google translation] (Sina Corp) - "...Huahai Pharmaceutical issued an announcement that the anti-cancer drug HB0025 developed by its subsidiary Huaaotai Biopharmaceutical and Huabo Biopharmaceuticals was approved for clinical trials for the treatment of advanced solid tumors and Hematological malignancies. Huahai Pharmaceutical has invested approximately 44.42 million yuan in research and development expenses in the HB0025 project."

Commercial • Non-US regulatory • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor