GSK5764227 / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

A phase 1 dose escalation/expansion study of GSK5764227, a B7-homolog 3 protein targeted antibody-drug conjugate, in combination with standard of care in patients with advanced solid tumors (AACR 2025) - P1, P2 | "Patients will receive intravenous GSK'227 every 3 weeks (Q3W) as monotherapy or in combination with SoC (Combination [Comb.] 1: cisplatin/carboplatin + atezolizumab/durvalumab/pembrolizumab; Comb...3: folinic acid + fluorouracil [FOLF] + bevacizumab; Comb. 4: FOLF + cetuximab) until progression, toxicity, loss to follow-up, or death...Curigliano G, et al. Presented at ESMO-IO 2024 (Poster 168TiP), 11-13 Dec, Geneva, Switzerland."

Clinical • Combination therapy • Metastases • P1 data • Oncology • Solid Tumor • CD276

Overall safety of HS-20093, a B7-H3-directed antibody-drug conjugate in Chinese patients with advanced solid tumors [WITHDRAWN] (AACR 2025) - P1, P2 | "HS-20093 at doses ranging from 8.0 to 12.0 mg/kg consistently showed an acceptable safety profile across different types of solid tumors. These doses are being further evaluated in a variety of studies for solid tumors.Overall safety of HS-20093 at 8.0 to 12.0 mg/kg dose8 mg/kg (N=330)10 mg/kg (N=114)12 mg/kg (N=64)Total (N=508)Median follow-up time, months4.88.79.35.8TEAE, %99.1100.098.499.2Grade ≥3 TEAE, %57.674.695.366.1TEAE leading to dose interruption, %32.449.156.339.2TEAE leading to dose reduction, %11.541.256.323.8TEAE leading to treatment discontinuation, %3.98.810.95.9SAE, %33.054.460.941.3Treatment related TEAE leading to death, %1.54.46.32.8"

Clinical • Metastases • Castration-Resistant Prostate Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • CD276

Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure (clinicaltrials.gov) - P3 | N=117 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P3 trial • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=780 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF

HANSOH PHARMA ANNOUNCES NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE HS-20093 FOR nsNSCLC (Hansoh Pharma Press Release) - "On April 17,2025,Hansoh Pharmaceutical Group Co., Ltd...announces that the Group's self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver mutations, progressed or recurred following platinum-based chemotherapy....The Designation is supported by preliminary clinical data from the ARTEMIS-001 study."

Breakthrough therapy • Non Small Cell Lung Cancer

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: GlaxoSmithKline | N=627 ➔ 120

Enrollment change • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

A Phase 1 dose escalation/expansion study of GSK5764227 (GSK'227), a B7-homologue 3 (B7-H3) protein-targeted antibody-drug conjugate (ADC), in combination with standard of care (SoC), in patients with advanced solid tumours, including lung cancers (ELCC 2025) - P1, P2 | "In the combination arm, patients will receive intravenous GSK'227 every 3 weeks (Q3W) combined with SoC (for lung cancers: atezolizumab/durvalumab/pembrolizumab ± cisplatin/carboplatin) until progression, toxicity, loss to follow-up or death. Safety follow-up will be assessed at 30, 60 and 90 (±7) days after the last dose. Safety, tolerability and efficacy analyses will be conducted using descriptive statistics and, for efficacy analyses, point estimates with 2-sided 95% confidence intervals."

Clinical • Combination therapy • Metastases • P1 data • Lung Cancer • Oncology • Solid Tumor • CD276

Hansoh Pharmaceuticals' $1.7 billion license-out of B7-H3-targeted ADC is approved for clinical trials [Google translation] (bydrug.pharmcube.com) - "On March 11, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the B7-H3 targeted antibody-drug conjugate (ADC) HS-20093 for injection...has obtained implicit clinical approval. The proposed indications are combined with adebelimumab (with or without platinum)/cetuximab (with or without adebelimumab or platinum)/combined with enzalutamide or revilutamide or abiraterone (II)/combined with HS-20117 ± adebelimumab ± platinum for the treatment of patients with advanced solid tumors."

New trial • Oncology • Solid Tumor

ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=560 | Recruiting | Sponsor: Hansoh BioMedical R&D Company

New P1 trial • Colorectal Cancer • Oncology • Solid Tumor

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (clinicaltrials.gov) - P1/2 | N=627 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1/2 trial • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

HANSOH PHARMA ANNOUNCES NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE HS-20093 FOR OSTEOSARCOMA (Hansoh Pharma Press Release) - "Hansoh Pharmaceutical Group Co., Ltd...announces that the Group's self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for the treatment of patients with osteosarcoma who have progressed on at least two prior lines of therapy."

Breakthrough therapy • Osteosarcoma

Hansoh Pharmaceuticals plans to include its new ADC drug in the breakthrough therapy category for osteosarcoma [Google translation] (bydrug.pharmcube.com) - "On February 17, the CDE official website announced that the HS-20093 for injection applied by Hansoh Pharmaceuticals is planned to be included in the breakthrough therapy category, and is intended to be used to treat osteosarcoma patients who have progressed after at least two lines of treatment."

Breakthrough therapy • Osteosarcoma

A phase 1 dose escalation/expansion study of GSK5764227 (GSK'227), a B7-homolog 3 (B7-H3) protein targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors, including gastrointestinal (GI) cancers. (ASCO-GI 2025) - P1, P2 | "Safety, tolerability, and efficacy analyses will be conducted using descriptive statistics and, for efficacy analyses, point estimates with 2-sided 95% confidence intervals. This abstract was previously submitted to the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2024 and is submitted on behalf of the original authors with their permission."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD276

HS-10502 Combination Treatment in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=154 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Breast Cancer • Gastric Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives US FDA Breakthrough Therapy Designation in late-line relapsed or refractory osteosarcoma (GSK Press Release) - "GSK plc...announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy....The US FDA’s Breakthrough Therapy Designation is supported by data from the ARTEMIS-002 study."

Breakthrough therapy • Osteosarcoma

GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) Designation in relapsed extensive-stage small-cell lung cancer (GSK Press Release) - "GSK plc...announced today that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) Designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of patients with relapsed extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation supports the development of medicines with potential to offer a major therapeutic advantage for patients....The EMA’s PRIME Designation is supported by preliminary clinical data from the ARTEMIS-001 study. This is an ongoing phase I open-label, multi-centre trial of more than 200 patients evaluating the safety, tolerability, and preliminary anti-tumour activity in locally advanced or metastatic solid tumours, including relapsed ES-SCLC, conducted by Hansoh Pharma."

PRIME • Small Cell Lung Cancer

A phase I dose escalation/expansion study of GSK5764227 (GSK'227), a B7-homolog 3 (B7-H3) protein targeted antibody-drug conjugate (ADC), in patients with advanced solid tumours (ESMO-IO 2024) - P1, P2 | "Safety, tolerability, and efficacy analyses will be conducted using descriptive statistics and, for efficacy analyses, point estimates with 2-sided 95% confidence intervals. Funding: GSK (Study 223054)."

Clinical • Metastases • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma. (clinicaltrials.gov) - P1 | N=448 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

Combination therapy • New P1 trial • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Case 448: Hansoh Pharmaceuticals launches Phase 1b clinical trial of B7H3 ADC combination therapy for osteosarcoma [Google translation] (vbdata.cn) - "Hansoh Pharmaceuticals has launched a Phase 1b clinical trial of B7H3 ADC combination therapy for osteosarcoma, with plans to enroll 448 patients, and is expected to be completed by the end of 2026."

Trial completion date • Trial status • Oncology • Osteosarcoma • Solid Tumor

A Study of GSK5764227 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2026 ➔ Jul 2026

Enrollment open • Metastases • Trial primary completion date • Oncology • Solid Tumor

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=141 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2026 ➔ Sep 2028 | Trial primary completion date: Oct 2026 ➔ Sep 2028

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE HS-20093 (HKEXnews) - "The board of directors...of Hansoh Pharmaceutical Group Company Limited...is pleased to announce that on November 1, 2024, the Group’s self-developed B7-H3-targeted antibody-drug conjugate ('ADC') HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration ('NMPA') of China, with the proposed indication being extensive stage small cell lung cancer ('ES-SCLC') developed after standard first-line treatment (platinum doublet chemotherapy combined with immuno-therapy)."

Breakthrough therapy • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Hong Kong Stocks Move | Hansoh Pharmaceutical (03692) rose nearly 3%; new lung cancer ADC drug HS-20093 is planned to be included in CDE breakthrough therapy category [Google translation] (Sina Corp) - "On the news front, on October 24, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Hansoh Pharmaceutical's HS-20093 for injection is planned to be included in the breakthrough therapy category, and the proposed indication is: extensive-stage small cell lung cancer (ES-SCLC) that has progressed after standard first-line treatment (platinum-containing double-drug chemotherapy combined with immunotherapy)."

Breakthrough therapy • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Hansoh Pharmaceutical's innovative ADC is approved for clinical trials again, multi-drug combination therapy for cancer [Google trnaslation] (bydrug.pharmcube.com) - "On October 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Hansoh Pharmaceutical's Class 1 new drug HS-20093 for injection has been approved for a new clinical trial implied license. The indications are: this product combined with immunotherapy (such as adebelimumab)/vascular endothelial growth factor receptor tyrosine kinase inhibitors (such as anlotinib hydrochloride capsules) with or without anthracyclines (such as epirubicin) for the treatment of advanced bone and soft tissue sarcoma."

New trial • Oncology • Soft Tissue Sarcoma

ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor