● Risvutatug rezetecan showed anti-tumor activity with a generally manageable safety profile in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after prior novel hormonal agents.
February 28 2026, Shanghai, China
Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the presentation of Phase 2 study data of risvutatug rezetecan (HS-20093 / GSK5764227) at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU 2026), held February 26–28, 2026, in San Francisco, California.
Risvutatug rezetecan is a B7-H3-targeted antibody–drug conjugate (ADC) under clinical development for multiple solid tumors. At ASCO GU 2026, data were presented from ARTEMIS-003 (NCT06001255), an open-label, multicenter Phase 2 study evaluating risvutatug rezetecan in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after at least one prior line of systemic therapy.
In the study, risvutatug rezetecan was administered at 8.0 mg/kg every three weeks until disease progression or other treatment discontinuation criteria were met. The study was designed to evaluate efficacy, safety, pharmacokinetics and immunogenicity, with the primary endpoint being objective response rate assessed per combined RECIST v1.1 and PCWG3 criteria.
● Encouraging anti-tumor activity：Risvutatug Rezetecan demonstrated encouraging antitumor activity in both taxane-pretreated and taxane-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).
ￚ In taxane-pretreated patients, the cORR was 38.9%, with a cPSA50 response rate of 40.7%.
ￚ Among taxane-naïve patients, the uORR was 41.7% and uPSA50 rate 23.8%; enrollment in this cohort remains ongoing as of the data cutoff date, with updated results pending.
● Manageable safety profile: The safety profile is in line with previous reports in other solid tumors. Most common grade ≥3 TRAEs (incidence ≥20%) were neutrophil count decreased and anemia.
The details are as follows:
◆ Poster Title: ARTEMIS-003: A Phase 2 study of risvutatug rezetecan (HS-20093 / GSK5764227) in patients with metastatic castration-resistant prostate cancer
◆ Session: Poster Session A: Prostate Cancer
◆ Abstract No.: 150
◆ Presentation time: February 26, 2026, 11:30 AM–12:45 PM; 5:45 PM–6:45 PM (PST)
◆ Presenting author: Xiaojie Bian (Department of Urology Surgery, Fudan University Shanghai Cancer Center, Shanghai, China)
About Risvutatug Rezetecan
Risvutatug rezetecan (HS-20093) is a B7-H3–targeted antibody–drug conjugate (ADC) discovered and developed by Hansoh Pharma. It comprises a fully human anti-B7-H3 monoclonal antibody conjugated to a topoisomerase inhibitor (TOPi) payload and is being evaluated for the treatment of multiple solid tumors.
The programme has entered Phase 3 clinical development in China for osteosarcoma and small cell lung cancer (SCLC) and is also being evaluated in multiple proof-of-concept studies across additional indications, including non-small cell lung cancer, 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 Mainland China, Hong Kong, Macau and Taiwan, to develop, manufacture and commercialize risvutatug rezetecan. The programme is being advanced globally by GSK, with Phase 1 and Phase 3 clinical studies ongoing outside China.
Risvutatug rezetecan has received multiple regulatory designations from the NMPA, EMA and FDA, including Breakthrough Therapy and Orphan Drug designations in select solid tumor indications.
About metastatic castration-resistant prostate cancer (mCRPC)
Prostate cancer is one of the most common male genitourinary system tumors, with about 134.200 new cases in 2022 in China [1]. In China, about 30% of prostate cancer patients are in metastasis stage at initial diagnosis and almost all patients will progress to metastatic castration-resistant prostate cancer (mCRPC) ultimately [2]. Patients with mCRPC who progress after first-line therapy have limited effective later-line options and poor outcomes [3], with contemporary data showing median overall survival of about 18-25 months [4-6]. Therefore, there remains high unmet needs for mCRPC patients who progressed after one line of prior therapy and new therapeutics are urgently needed.
About Hansoh Pharma
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, anti-infectives, central nervous system (CNS), metabolism and autoimmunity. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs 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
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References
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2. 中国前列腺癌研究协作组(CPCC),叶定伟,黄健. CPCC晚期前列腺癌中国专家共识——转移性激素敏感性前列腺癌起始应用新型内分泌治疗的全程管理(2022年版)[J]. 中国癌症杂志,2022,32(12):1242-1258. DOI:10.19401/j.cnki.1007-3639.2022.12.013..
3. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 4. 2026
4. Freedland SJ, Davis M, Epstein AJ, Arondekar B, Ivanova JI. Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis. 2024 Jun;27(2):327-333. doi: 10.1038/s41391-023-00725-8. Epub 2023 Oct 2. PMID: 37783836; PMCID: PMC11096091.
5. Sayegh N, Tripathi N, Nussenzveig RH, Thomas VM, Tandar C, Goel D, Nordblad B, Sahu KK, Li H, L Maughan B, Agarwal N, Swami U. Survival of Patients with Metastatic Prostate Cancer After Disease Progression on an Androgen Receptor Axis-Targeted Therapy Given in the Metastatic Castration-Sensitive Versus Metastatic Castration-Resistant Prostate Cancer Setting. Eur Urol Focus. 2023 Jan;9(1):106-109. doi: 10.1016/j.euf.2022.06.015. Epub 2022 Jul 11. PMID: 35835693.
6. Caram MEV, Kumbier K, Tsao PA, Burns J, Sparks JB, Stensland KD, Reichert ZR, Alumkal JJ, Hollenbeck BK, Shahinian V, Tsodikov A, Skolarus TA. Survival by first-line therapy and prognostic group among men with metastatic castration-resistant prostate cancer. Cancer Med. 2024 Jun;13(12):e7334. doi: 10.1002/cam4.7334. PMID: 39143030; PMCID: PMC11193054.
