Docetaxel

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (“CNS”) and anti-infectives. Hansoh Pharma, a leading innovation-driven pharmaceutical company in the PRC, is committed to improving human health through unremitting innovation, focusing mainly on such areas as oncology, metabolism, immunology, central nervous system (“CNS”) and anti-infectives. After more than 20 years of continuous investment in R&D, Hansoh Pharma has marketed 7 innovative drugs and has over 30 innovative drug programs in different clinical stages with over 50 clinical trials in progress, forming a rich pipeline. Find the latest and most complete information about Hansoh Pharma! Hansoh Pharma, a leading innovation-driven pharmaceutical company in the PRC, is committed to improving human health through unremitting innovation, focusing mainly on such areas as anti-tumor, anti-infectives, CNS diseases, metabolic diseases, autoimmune diseases. Hansoh Pharma has always focused on corporate governance, corporate behavior, product safety and quality, access to healthcare, human resource development, environmental protection and community enhancement as the focus and the basis of ESG management, and has been continually committed to improving the medicine availability and the innovative development in fields with unmet clinical needs. We welcome talents worldwide to join us with their entrepreneurship and achieve new levels of success in their career! Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Release Date：2026/10/27 Font Size    - Risvutatug Rezetecan (HS-20093), administered at 12.0 mg/kg once every three weeks, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in heavily pretreated patients with relapsed or refractory (R/R) osteosarcoma. SHANGHAI, October 27, 2026 — Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) announced that the primary results from the Phase 3 ARTEMIS-011 study of risvutatug rezetecan (“Ris-Rez”) (HS-20093/GSK5764227) were presented orally as a Late-Breaking Abstract (LBA) at the Presidential Symposium of the 2026 European Society for Medical Oncology (ESMO) Congress, held in Madrid, Spain, from October 23 to 27. The study evaluated Ris-Rez versus gemcitabine plus docetaxel (GD) in heavily pretreated patients with R/R osteosarcoma following failure of at least two prior lines of therapy. At the prespecified analysis, the study met its primary endpoint of PFS as assessed by blinded independent central review (BICR), demonstrating a statistically significant and clinically meaningful improvement, with a 67% reduction in the risk of disease progression or death. Ris-Rez is a proprietary B7-H3—directed antibody-drug conjugate (ADC) independently developed by Hansoh Pharma. It consists of a fully human anti-B7-H3 IgG1 monoclonal antibody conjugated to a topoisomerase I inhibitor (TOP1i) payload (rezetecan) through a cleavable linker. In China, Ris-Rez is currently being evaluated in pivotal Phase 3 studies in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), osteosarcoma and oesophageal cancer. On September 24, 2026, the National Medical Products Administration (NMPA) of China accepted the Biologics License Application (No. CXSS2600155) for Ris-Rez in the treatment of osteosarcoma and granted it Priority Review status. To date, Ris-Rez has received 12 regulatory designations, including Breakthrough Therapy Designation and Orphan Drug Designation, across China, the United States, Japan and Europe. Primary results from ARTEMIS-011 presented at ESMO 2026 showed that Ris-Rez significantly improved PFS in patients with R/R osteosarcoma compared with GD -- an improvement that was both statistically significant and clinically meaningful. This is the first positive Phase 3 study in R/R osteosarcoma in nearly 30 years. Ris-Rez is also the first and only B7-H3—directed ADC to demonstrate a statistically significant benefit across multiple tumour types. With positive Phase 3 results now achieved, Ris-Rez has reached a key milestone in the clinical development of B7-H3—directed ADCs, advancing from clinical study towards two regulatory submissions in China. Hansoh Pharma is continuing to advance the development of Ris-Rez across multiple tumour types and treatment lines, fully exploring the therapeutic potential of the B7-H3 ADC and bringing China’s innovations to benefit more patients. GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan, and is advancing a broad global clinical development programme across lung cancer, prostate cancer and other solid tumours. LBA Presentation Details: Presentation Title: Risvutatug Rezetecan Versus Gemcitabine and Docetaxel in Heavily Pretreated Patients With Relapsed or Refractory Osteosarcoma: Primary Results From the Phase 3 ARTEMIS-011 Study Session: Presidential Symposium III Abstract No.: LBA9 Date/Time: Monday, October 26, 2026, 16:30–16:42 CET / UTC +1 Presenter: Prof. Lu Xie, Peking University People's Hospital About the ARTEMIS-011 Study ARTEMIS-011 is a multi-centre, open-label, randomised (2:1), controlled Phase 3 study in which 122 patients with R/R osteosarcoma after failure of at least two prior lines of therapy were randomised to receive risvutatug rezetecan (12.0 mg/kg IV once every three weeks) or gemcitabine plus docetaxel, with as of the data cutoff date of June 17, 2026 (median follow-up: 7.1 months). Efficacy Progression-free survival (BICR, primary endpoint): Median PFS was 5.5 months with Ris-Rez vs 1.4 months with gemcitabine plus docetaxel (HR=0.33; 95% CI: 0.20-0.55; p<0.0001), a 67% reduction in the risk of disease progression or death. Investigator-assessed PFS also showed a consistent benefit vs GD: median PFS was 5.6 months with Ris-Rez vs 1.0 months with GD (HR=0.30; 95% CI: 0.19-0.50; p<0.0001). Benefit was consistent across all prespecified subgroups, including age, sex, lung metastasis, baseline tumour burden, ECOG PS, and number of prior lines of therapy. Response (BICR): ORR was 15% vs 2% and DCR was 76% vs 33%; median duration of response was 7.6 months with Ris-Rez. Investigator-assessed ORR, DCR and DOR were consistent with BICR-assessed results. Overall survival: OS data were immature but suggested a numerical trend toward an OS benefit with Ris-Rez (median not reached in either arm; HR=0.51; 95% CI: 0.21-1.23). Safety Ris-Rez showed a manageable safety profile in this heavily pretreated population. The most common treatment-related adverse events (TRAEs) of any grade and of Grade ≥ 3 in both arms were haematological; no Grade 5 (fatal) event occurred in either arm. Grade ≥ 3 TRAEs occurred in 93% of patients with Ris-Rez and 83% with GD, and serious TRAEs in 64% versus 29%, which were predominantly haematologic. Treatment-related interstitial lung disease (ILD) was observed in only 1 patient (Grade 2) in the Ris-Rez arm, and it resolved with supportive management. Longer treatment duration was observed with Ris-Rez (median 4.5 vs 1.5 months). These results suggest that Ris-Rez represents a promising potential treatment option for patients with previously-treated R/R osteosarcoma About Osteosarcoma Osteosarcoma is the most common malignant bone tumour, accounting for 35% of all malignant bone tumours, and has been included in the Second Batch of Rare Disease Catalogue issued by the National Health Commission of China [1]. The median age at onset of osteosarcoma is 20 years, and it is the most common primary malignant bone tumour in children and adolescents. Approximately 20%-30% of patients with localised (non-metastatic) osteosarcoma and 80% of patients with metastatic osteosarcoma will progress to an advanced stage (relapse or metastasis), whereas the 5-year survival rate of patients with advanced osteosarcoma is only about 20% [2,3]. Globally, patients with relapsed or refractory osteosarcoma after first-line chemotherapy have limited treatment options and lack a clear standard of care [4,5]. For patients whose osteosarcoma progresses after two or more prior lines therapy, treatment options are even more limited, representing a substantial unmet clinical need. References [1] National Health Commission of the People's Republic of China. Second Batch of Rare Disease Catalogue, Document No. 26 (2023), September 18, 2023. [2] Durfee RA, Mohammed M, Luu HH. Review of Osteosarcoma and Current Management. Rheumatol Ther. 2016 Dec;3(2):221-243. [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. July 21, 2026. Version 1.2027. [5] Chinese Society of Clinical Oncology (CSCO). CSCO Clinical Practice Guidelines: Bone and Soft Tissue Cancer (2025). About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (CNS) and anti-infectives. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, 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 3 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). - Risvutatug Rezetecan (HS-20093), administered at 12.0 mg/kg once every three weeks, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in heavily pretreated patients with relapsed or refractory (R/R) osteosarcoma. About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (CNS) and anti-infectives. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, 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 3 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). If you would like to report any adverse event involving Hansoh's products, please contact us by: Tel：+86-400-828-5227or+86-518-83096666 E-mail：PV.SERVICE@hspharm.com

GSK said Monday that a B7-H3-targeting antibody-drug conjugate (ADC) it is co-developing with Hansoh Pharmaceutical reduced the risk of disease progression or death by 67% versus chemotherapy in a Phase III trial involving patients with a rare bone cancer.The open-label ARTEMIS-011 study included 122 patients in China aged 12 and older whose osteosarcoma had progressed or relapsed after at least two prior lines of systemic therapy. Participants received either risvutatug rezetecan (Ris-Rez) or a combination of gemcitabine and docetaxel.The trial, conducted by Hansoh, was toplined in July, shortly after an earlier clinical win in advanced or relapsed small-cell lung cancer (SCLC)Detailed results from ARTEMIS-011, presented Monday at the European Society for Medical Oncology (ESMO) congress, showed that after a median follow-up of 7.1 months, the primary endpoint of progression-free survival was 5.5 months with Ris-Rez versus 1.4 months with chemotherapy.Although overall survival data remain immature, researchers reported a "favourable trend" for Ris-Rez, with a hazard ratio of 0.51, according to the study abstract."The magnitude of effect is substantial," Eric Richards, who heads oncology product development at GSK, told Reuters. "It gives us a ⁠lot of confidence that what we're hoping for — activity across these different tumours — is likely to come to fruition."However, the efficacy benefit came alongside a higher rates of toxicity, with grade ≥3 treatment-related adverse events (TRAEs) reported in 93% of patients receiving Ris-Rez, compared to 83% for chemotherapy; in both arms, most were haematologic events. TRAEs leading to discontinuation occurred in 4% and 2% of patients, respectively.GSK noted that Ris-Rez was administered at 12 mg/kg in ARTEMIS-011, compared to a dose of 8 mg/kg in the earlier SCLC trial, ARTEMIS-008, with the higher dose selected "to account for potential difficulty in penetrating bone tissue."GSK licensed ex-China rights to Ris-Rez (formerly HS-20093) from Hansoh in 2023, alongside the B7-H4–targeting ADC mocertatug rezetecan (HS-20089), through separate deals worth up to $1.7 billion and $1.6 billion, respectively.GSK began the Phase Ib/II EMBOLD Sarcoma-202 trial of Ris-Rez earlier this year in previously treated unresectable advanced or metastatic sarcomas, including osteosarcoma.