▎WuXi AppTec Content Team Report

On October 22, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) revealed thatHansoh Pharma's Class 1 New Drug HS-20093 for Injection Granted New Clinical Trial Implied Permission, Indication: This ProductCombination immunotherapy (e.g., Adebrelimab)/vascular endothelial growth factor receptor tyrosine kinase inhibitor (e.g., Anlotinib Hydrochloride Capsules) with or without anthracyclines (e.g., Epirubicin) for the treatment of advanced bone and soft tissue sarcomaHS-20093 is an antibody-drug conjugate (ADC) targeting B7-H3. Hansoh Pharma previously reached a collaboration with GlaxoSmithKline (GSK) for this investigational new drug, valued at over $1.7 billion.Authorization Cooperation。

Screenshot source:CDE Official Website

For InjectionHS-20093 is composed of a fully humanized B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload.。

B7-H3: A Promising New Target in Cancer Treatment. As a transmembrane protein in the B7 family, B7-H3 is frequently overexpressed in various types of cancer.According to publicly available information, currently multiple products withB7-H3 isNew drugs targeting have entered phase 2 or 3 clinical research stages globally, including those from Hansoh Pharma.HS-20093 is one of the products with faster progress.

According to the official website of China Drug Clinical Trial Registration and Information Disclosure,HS-20093 has more than ten clinical studies ongoing, including those targetingRecurrent Small Cell Lung CancerAndLimited-stage small cell lung cancerThe two Phase 3 clinical studies, andMultiple Phase 1 and Phase 2 clinical studies for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors.

This approval granted to Hansoh Pharma is for a multi-drug combination therapy, namely, combination immunotherapy/vascular endothelial growth factor receptor tyrosine kinase inhibitor, with or without anthracyclines (such as epirubicin), for the treatment of advanced stages.Bone and Soft Tissue Sarcoma。

HS-20093 was previously inRecurrent or Refractory Bone and Soft Tissue SarcomaThe Phase 2 study (ARTEMIS-002 study) has achieved positive results and was orally presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.The study was divided into two cohorts:Cohort 1 enrolled patients with advanced osteosarcoma who progressed after standard treatment, and they were randomly assigned to receive HS-20093 at a dose of 8.0 mg/kg or 12.0 mg/kg.Cohort 2 enrolled patients with other unresectable, non-standard treatment options or standard treatment failure/intolerance of bone and soft tissue sarcoma, receiving 12.0mg/kg of HS-20093 treatment.The dosing regimen is intravenous injection, once every 3 weeks (Q3W).。The primary endpoint of the study is the objective response rate (ORR) assessed by the investigators according to RECIST 1.1.

As of March 20, 2024, Cohort 1 enrolled a total of 42 patients with osteosarcoma, with a median of 3 prior treatment lines. Among them, 35 patients (83.3%) had lung metastases; 38 patients had undergone at least one tumor assessment after baseline.The ORR of the 12.0mg/kg group was 17.4%, and the median progression-free survival (PFS) was not reached.; The median PFS for the 8mg/kg group was 4.0 months. Cohort 2 enrolled a total of 20 patients with other bone and soft tissue sarcomas, with a median of 3 prior treatment lines. Among them, 18 patients (90%) had lung metastases; all 20 patients with other bone and soft tissue sarcomas were evaluable for efficacy.ORR was 25%, with a median PFS of 7.1 months.In terms of safety, common Grade ≥3 adverse events (incidence rate ≥10%) included decreased neutrophil count, decreased white blood cell count, decreased lymphocyte count, decreased platelet count, and anemia.

Researchers believe that the preliminary data from this Phase 2 small-sample study indicate that HS-20093 has demonstrated strong anti-tumor activity in patients with relapsed or refractory bone and soft tissue sarcoma who have undergone extensive prior treatment. The results surpass historical data of existing standard treatments and show good safety and tolerability. Clinical research data support the continued development of HS-20093 for bone and soft tissue sarcoma.

Osteosarcoma mostly occurs in children and young adults. Patients with recurrent/refractory osteosarcoma usually have a poor prognosis and limited treatment options. We look forward to the smooth progress of Hansoh Pharma's new drug research and hope it can bring new treatment options to patients as soon as possible.

[1] Official of the Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Oct 22, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]2024 ASCO | Hansoh Pharma's Multiple Innovative Studies Selected for International Academic Conference. Retrieved July 30, 2024, from https://mp.weixin.qq.com/s/j-Tkw6gxMlZa6DvFr_Yxjg