April 18,The China Drug Clinical Trial Registry and Information Disclosure Platform shows that Hansoh Pharma has registered a clinical trial for HS-20093 injection compared to gemcitabine combined with docetaxel in the treatment of patients who failed second-line treatment.OsteosarcomaPhase III Clinical Study（CTR20251474）. This is also theFirst Phase III Clinical Trial for Osteosarcoma。InterceptImage source:Drug Clinical Trial Registry and Information Disclosure Platform
This is aRandomized, Controlled, Open-label, Multi-center Phase III Clinical Study, Aiming toEvaluation of the Efficacy and Safety of HS-20093 for Injection Compared with Gemcitabine Combined with Docetaxel in the Treatment of Osteosarcoma Patients Who Failed Second-line Treatment Previously. Approximately 117 participants are planned to be enrolled in China.The primary endpoint of the study is PFS.。HS-20093 is a B7-H3 ADC,Using a clinically validated topoisomerase inhibitor（TOPOi）Payload. In March 2023, Hansoh Pharma initiated a Phase II clinical trial of the drug for the treatment of osteosarcoma.（ARTEMIS-002）. The resultFirst disclosed at the 2024 ASCO Annual Meeting.From June to December 2023, a total of 34 patients with recurrent/refractory osteosarcoma were enrolled, with a median age of 21.5 years. At baseline, most patients were clinically staged as stage IV.（32/34，94.1%）And Pulmonary Metastasis（28/34，82.4%）A total of 22 patients had previously received ≥3 lines of treatment. 26 patients had received four standard chemotherapy regimens, including platinum-based drugs, anthracyclines, ifosfamide, and methotrexate.As of December 25, 2023, 21 evaluable patients(11 cases received 8 mg/kg treatment, 10 cases received 12.0 mg/kg treatment)The median follow-up time was 4.1 months:- Patients in the 12.0 mg/kg HS-20093 dose groupORR was 20.0%. Two confirmed partial responses were observed in patients receiving a dose of 12.0 mg/kg and persisted until the last follow-up, among whichThe longest duration of remission was 4.0 months.。
- 8 mg/kg and 12.0 mg/kg dose groupsThe disease control rates were 81.8% and 100%, respectively.。
- The median progression-free survival data for 21 patients have not yet matured.
In terms of safety, 33 patients experienced treatment-emergent adverse events.（TEAE）Common Grade 3/4 TEAEs（≥5%）For neutropenia, leukopenia, thrombocytopenia, lymphopenia, and anemia. No TEAE leading to death.InterceptImage source: Insight DatabaseIn December 2023, GSK and Hansoh Pharma reached an agreement on this drug.Exclusive License Agreement, GSK obtains the global exclusive rights to the drug(Excluding mainland China, Hong Kong, Macao and Taiwan), to advance the development and commercialization of HS-20093.According to the terms of this agreement, Hansoh will obtain$185 millionThe prepayment, and is eligible to receive up to$1.525 billionThe milestone revenue. After the commercialization of HS-20093, GSK will also pay tiered royalties based on global net sales outside of mainland China, Hong Kong, Macao, and Taiwan.Insight database shows that there are 28 B7-H3 ADCs under research globally.(Only active status is counted), 13 products have entered the clinical stage, with the fastest having advanced toPhase III Clinical Trial, respectively MHB088C(Minghui Pharmaceuticals)、YL201（Yilian Biologics、HS-20093(Hansoh)AndIfinatamab deruxtecan(Daiichi Sankyo)。Notably, the Phase III clinical indications previously initiated for these four drugs include small cell lung cancer, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and prostate cancer.HansohHS-20093 is the world's first osteosarcoma Phase III clinical trial initiated globally.B7-H3 ADC。Cover Source:Corporate LogoDisclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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