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    ASCO GU 2026 | HANSOH PHARMA PRESENTED PHASE 2 DATA OF RISVUTATUG REZETECAN IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    Release Date：2026/02/28
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    - 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.



    SHANGHAI, February 28, 2026 — 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 Chinese mainland, 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.


    References

    1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751.

    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.


    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 immunology. 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).

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    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).



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