HANSOH PHARMA ANNOUNCES ARTEMIS-008 TRIAL OF RISVUTATUG REZETECAN (HS-20093) MET ITS PRIMARY ENDPOINT OF OVERALL SURVIVAL IN SMALL CELL LUNG CANCER
- Risvutatug rezetecan(HS-20093) achieves statistically significant and clinically meaningful overall survival improvement over topotecan in pivotal phase 3 clinical trial (ARTEMIS-008).
- First positive phase III clinical trial demonstrating OS benefit for a B7-H3 directed ADC in any tumour type, full data to be presented at an upcoming medical congress.
- Hansoh plans to engage in regulatory discussions to support a future BLA submission in China.
SHANGHAI, July 10, 2026—Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announces that risvutatug rezetecan (Ris-Rez/HS-20093), the Group’s self-developed B7-H3 directed antibody-drug conjugate (ADC), met the primary endpoint of overall survival (OS) in a pivotal Phase 3 clinical trial (ARTEMIS-008) for patients with advanced or relapsed small cell lung cancer (SCLC) after prior platinum-based therapy. At a pre-specified interim analysis, Ris-Rez provided statistically significant and clinically meaningful OS improvements compared with topotecan. Consistent benefit was also observed across secondary clinical endpoints, including progression-free survival (PFS). The safety profile was consistent with prior findings, and no new safety signals were identified.
These results represent the first positive Phase III clinical trial to demonstrate an OS benefit for a B7-H3 directed ADC in any tumour type. Based on these findings, Hansoh Pharma will initiate communications with the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) in China. in the near term to advance preparations for a Biologics License Application(BLA). Concurrently, the detailed data from ARTEMIS-008 study will be presented at an upcoming international oncology conference.
Breaking Through Treatment Bottlenecks in SCLC
SCLC[1] accounts for approximately 15% of all lung cancers and is the most aggressive subtype, characterized by high malignancy, rapid disease progression, high relapse rates, and a generally poor prognosis. Although platinum-based chemotherapy remains the standard first-line treatment for SCLC, the vast majority of patients experience rapid relapse or develop resistance post-treatment. With extremely limited options for second-line and subsequent therapies, a substantial unmet clinical need exists.
As a core ADC in Hansoh Pharma’s B7-H3 pipeline, Ris-Rez is designed to precisely target the B7-H3 antigen on the surface of tumor cells and deliver a topoisomerase inhibitor payload directly into the tumor cells. This directed approach aims to achieve potent tumor cell killing while significantly reducing systemic toxicity. The clinically meaningful improvement in OS and PFS demonstrated by Ris-Rez in the ARTEMIS-008 study, , conducted in SCLC patients who failed platinum-based therapy, may support a novel treatment strategy in this highly refractory tumor type.
About Risvutatug Rezetecan
Risvutatug rezetecan is a B7-H3 directed ADC discovered and developed by Hansoh Pharma. It comprises a fully human anti-B7-H3 monoclonal antibody conjugated to a number of topoisomerase I inhibitor (TOP1i) payloads via tetrapeptide-based cleavable linkers.
The program has entered Phase 3 clinical development in China for osteosarcoma, SCLC and NSCLC, and is also being evaluated in multiple proof-of-concept studies across additional indications, including head and neck cancer, prostate cancer, esophageal squamous cell carcinoma and colorectal cancer.
In December 2023, Hansoh Pharma granted GSK an exclusive worldwide license, excluding Chinese mainland, Hong Kong, Macau and Taiwan, to develop, manufacture and commercialize Ris-Rez. The program is being advanced globally by GSK, with Phase 1 and Phase 3 clinical studies ongoing outside of China.
References
[1] Saltos A, Shafique M, Chiappori A. Update on the biology, management, and treatment of small cell lung cancer(SCLC) [J]. Front Oncol, 2020, 10: 1074. DOI: 10.3389/fonc.2020.01074.
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, anti-infectives, central nervous system (CNS), metabolism and immunology. 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).
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