● HS-20093 (licensed to GSK as GSK5764227) administered at 12 mg/kg every 3 weeks showed promising efficacy signal in patients with relapsed or refractory (R/R) osteosarcoma and soft tissue sarcoma (STS)；
● HS-20093 administered at 12.0 mg/kg every 3 weeks showed a manageable safety profile in patients with R/R osteosarcoma and STS, and no new safety signal was identified.
● A confirmatory phase 3 study is evaluating HS-20093 12 mg/kg every 3 weeks for the efficacy and safety in R/R osteosarcoma in China. Outside of China, HS-20093 (also known as GSK5764227) is under early clinical development for R/R osteosarcoma and STS.
October 20, 2025
Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced that the encouraging results from the phase 2 study of HS-20093, a B7-H3-targeted antibody-drug conjugate (ADC), in patients with relapsed or refractory (R/R) sarcomas, were presented in a proffered paper session at the ESMO 2025 Annual Meeting (October 17-21, Berlin, Germany). The data were presented on October 19 (CEST).
ARTEMIS-002 was designed as an open label, three-cohort phase 2 study in patients with R/R osteosarcoma or other sarcomas that had progressed on standard systemic treatments. Adult patients with osteosarcoma in cohort 1 were enrolled to receive HS-20093 at 8 mg/kg or 12 mg/kg every 3 weeks (Q3W). Adult patients with other sarcomas and adolescent (12~17 years) patients with osteosarcoma received 12 mg/kg Q3W until disease progression in cohort 2 and 3, respectively. The primary endpoints were ORR per RECIST v1.1 by investigator in cohort 1 and cohort 2 and safety profile in cohort 3.
By the cutoff date (July 1, 2025), 48 patients with osteosarcoma and 20 patients with other sarcomas (including 13 patients with soft tissue sarcoma) were enrolled. Most patients had extensive metastasis and were heavily treated with median 2 - 3 prior lines of therapy.
Study results showed:
● Anti-tumor activity in osteosarcoma: HS-20093 administered at 12 mg/kg Q3W showed a trend towards better survival benefit compared to 8 mg/kg in patients with osteosarcoma. With a median follow-up duration of 19.6 months for those receiving 8.0 mg/kg and 16 months for those receiving 12.0 mg/kg, The confirmed objective response rate (cORR) was 6.7% in the 8.0 mg/kg group and 20.0% in the 12.0 mg/kg group. The disease control rate (DCR) was 66.7% in the 8.0 mg/kg group and 86.7% in the 12.0 mg/kg group. The median progression-free survival (PFS) was 4.0 months in the 8.0 mg/kg group and 8.4 months in the 12.0 mg/kg group. The 15-month overall survival (OS) rate was 58.7% in the 8.0 mg/kg group and 85.7% in the 12.0 mg/kg group.
● Promising anti-tumor activity observed in patients with soft tissue sarcoma (STS): A total of 13 STS patients were enrolled. With a median follow-up duration of 19.0 months, cORR was 23.1%, DCR was 92.3%, the median PFS was 9.4 months, and median OS was 22.6 months.
● Manageable safety profile: HS-20093 administered at 12.0 mg/kg Q3W showed a manageable safety profile in patients with R/R osteosarcoma and R/R STS, and no new safety signal was identified. The most common CTCAE Grade≥3 Treatment Related Adverse Events (TRAEs) were hematological toxicities, which were largely reversible and manageable with standard supportive care. The incidence of Treatment Related-Serious Adverse Events (TR-SAEs), dose-reducing TRAEs and dose-discontinuation TRAEs was 31.3%, 31.3%, and 4.2% in osteosarcoma patients and 69.2%, 61.5% and 0 in STS patients, respectively. Treatment-related Interstitial Lung Disease (ILD)* events were observed in only 2 osteosarcoma patients (CTCAE Grade 1) and 1 Ewing sarcoma patient (CTCAE Grade 2). Two CTCAE Grade 5 Treatment Emergent Adverse Event (TEAE) cases were reported, with only 1 assessed by the investigator as possibly related to study drug, occurring in a patient with chondrosarcoma.
*Search strategy for ILD: Interstitial lung disease SMQ (Narrow).
About HS-20093
HS-20093, a B7-H3-targeted ADC self-developed by the Group, is composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. As of now, HS-20093 has entered phase 3 clinical research for the treatment of osteosarcoma indication and small cell lung cancer indication in China, and is also undergoing multiple proofs of concept (PoC) clinical studies for the treatment of non-small cell lung cancer, head and neck cancer, prostate cancer, esophageal squamous cell carcinoma, colorectal cancer and other solid tumors.
In December, 2023, the Group entered into an exclusive license agreement with GlaxoSmithKline Intellectual Property (No.4) Limited (“GSK”), granting GSK an exclusive worldwide license (excluding the Chinese Mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture and commercialize the Product（also known as GSK5764227）, which is currently undergoing Phase I and Phase 3 clinical trials overseas by GSK.
In February 2025, the NMPA listed HS-20093 as a BTD Drug, with the proposed indication for the treatment of patients with osteosarcoma who have progressed on at least two prior lines of therapy.
In January 2025, GSK disclosed that the US Food and Drug Administration granted Breakthrough Therapy Designation for GSK5764227 being evaluated for the treatment of adult patients with relapsed for refractory osteosarcoma who have progressed on at least two prior lines of therapy.
About Osteosarcoma
Osteosarcoma is the most common primary malignant bone tumor, accounting for 35% of all malignant bone tumors and it has been included in China's “List of Rare Diseases-Second batch" [1].The median onset age of osteosarcoma is 20 years old, making it the most prevalent primary malignant bone tumor in children and adolescents. Approximately 20-30% of patients who present with localized (non-metastatic) osteosarcoma and 80% of those who present with metastatic osteosarcoma will progress to an advanced stage (recurrence or metastasis) [2]. The 5-year survival rate for patients with advanced osteosarcoma is only about 20% [3]. Globally, treatment options for relapsed or refractory osteosarcoma following first-line chemotherapy are extremely limited, with no standard of care available [4-5], which highlighting a significant unmet clinical need.
About Soft Tissue Sarcoma
Soft tissue sarcomas (STS) represent a heterogeneous group of cancers, comprising over 100 distinct histotypes and accounting for less than 1% of all adult solid tumors[6]. The primary management strategy for localized disease typically involves surgery, however, despite optimal local treatment, up to 40% of STS patients develop metastatic disease, which often results in fatal progression [7]. The standard first-line treatment for STS involves anthracycline-based regimens, which are used across nearly all subtypes and result in a median PFS of approximately six months [8]. Upon disease progression, second-line treatments such as gemcitabine, dacarbazine, ifosfamide and target treatment (e.g. Anlotinib, Pazopanib, Regorafenib) are selected based on tumor isotype[5]. Upon disease progression following two prior lines of therapy, available therapeutic alternatives dwindle substantially, with an absence of sanctioned treatment options – a reality that underscores a critical gap in patient care.
About ESMO
The ESMO Congress is a leading global platform uniting clinicians, researchers, patient advocates, journalists, and industry professionals in oncology.
ESMO 2025 will showcase groundbreaking research, innovative treatments, and foster collaboration to shape the future of cancer care.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical company headquartered in China. The company is committed to addressing significant unmet medical needs in oncology, central nervous system (CNS) disorders, metabolic diseases, and autoimmune conditions. Hansoh Pharma has launched seven innovative drugs that generate product sales in the PRC, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top three pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
Statements
1. This announcement is intended for healthcare professionals only and not for advertising purposes.
2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.
3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.
4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional.
Forward-Looking Statements
This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.
The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.
Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.
All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).
References
1. 《第二批罕见病目录》，国家卫健委，国卫医政发〔2023〕26号，2023年9月18日
2. Durfee RA, Mohammed M, Luu HH. Review of Osteosarcoma and Current Management. Rheumatol Ther. 2016 Dec;3(2):221-243. doi: 10.1007/s40744-016-0046-y. Epub 2016 Oct 19. PMID: 27761754; PMCID: PMC5127970.
3. Meltzer PS, Helman LJ. New Horizons in the Treatment of Osteosarcoma. N Engl J Med. 2021;385(22):2066-2076.
4. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology (NCCN Guidelines): bone cancer. August 20, 2024. Version 1.2025. Accessed 24 October 2024.https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf
5. Chinese Society of Clinical Oncology (CSCO). CSCO clinical practice guidelines: bone and soft tissue cancer (2024)
6. Sbaraglia M, Bellan E, Dei Tos AP. The 2020 WHO classification of soft tissue tumours: news and perspectives. Pathologica. 2021;113(2):70–84
7. Coindre JM, Terrier P, Bui NB, Bonichon F, Collin F, Le Doussal V, et al. Prognostic factors in adult patients with locally controlled soft tissue sarcoma. A study of 546 patients from the French Federation of Cancer Centers Sarcoma Group. J Clin Oncol. 1996;14(3):869–77
8. Italiano A, Mathoulin-Pelissier S, Cesne AL, Terrier P, Bonvalot S, Collin F, et al. Trends in survival for patients with metastatic soft-tissue sarcoma. Cancer. 2011;117(5):1049–54.
