On May 1,2025,Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK),announces that the Group's self-developed B7-H4-targeted antibody-drug conjugate (ADC) HS-20089 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer patients.
The designation is supported by results from the Phase I HS-20089-101 study and the Phase II HS-20089-201 study. The HS-20089-101 study is a multi-center, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20089 for injection in patients with advanced solid tumors. The HS-20089-201 study is a multi-center, open-label Phase II clinical trial to evaluate the efficacy, safety, pharmacokinetic profile, and immunogenicity of intravenous HS-20089 in patients with recurrent or metastatic ovarian cancer and endometrial cancer.
HS-20089 is a B7-H4-targeted ADC with a topoisomerase inhibitor (TOPOi) payload being developed for the treatment of ovarian cancer and other gynecological tumors in multiple clinical trials in China, with the highest research stage being Phase III clinical trials. B7-H4 is a transmembrane immune checkpoint glycoprotein that is highly expressed in multiple solid tumors, including endometrial cancer and ovarian cancer, but with limited expression in normal tissues. On October 20, 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, which is currently undergoing Phase I clinical trials overseas by GSK.
About Ovarian Cancer
Ovarian cancer (OC) is one of the most prevalent gynecological malignancies. In 2022, approximately 324,603 new cases of ovarian cancer were diagnosed worldwide, making it the eighth most common malignancy among women. With around 206,956 deaths that year, ovarian cancer was the eighth leading cause of cancer-related mortality among female patients. In China, the incidence in 2022 was 61,060, with a mortality of 32,646[1].
The current standard treatment for ovarian cancer involves surgery combined with platinum-based chemotherapy. However, most advanced-stage patients relapse within 3 years and eventually develop drug resistance to platinum-based chemotherapy. The clinical treatment methods and efficacy for platinum-resistant recurrent ovarian cancer (PROC) remain extremely limited.
Recent Phase III randomized controlled trials show that the ORR for non-platinum monotherapy chemotherapy is 4%–15.9%, with a median PFS of 3.4–3.98 months. In patients who have received 1–2 lines of prior treatment, non-platinum chemotherapy combined with bevacizumab yields an ORR of 27.3%, extending the median PFS to 6.7 months and the median OS to 16.6 months. Despite a significant extension in PFS, no notable OS benefit is observed compared to non-platinum chemotherapy[2-6].This disease represents a major unmet clinical need, underscoring the urgent demand for more effective treatment approaches.
Reference：
[1]International Agency for Research on Cancer. (2024). Cancer TODAY: GLOBOCAN 2022 (version 1.1). Retrieved April 26, 2025, from Global Cancer Observatory
[2]Pujade-Lauraine E, Fujiwara K, Ledermann JA, et al. Lancet Oncol. Jul 2021;22(7):1034-1046.
[3] Gaillard S, Oaknin A, Ray-Coquard I, et al. Gynecol Oncol. Nov 2021;163(2):237-245.
[4] Hamanishi J, Takeshima N, Katsumata N, et al. J Clin Oncol. Nov 20 2021;39(33):3671-3681.
[5] Pujade-Lauraine E, Hilpert F, Weber B, et al.
[6] Moore KN, Angelergues A, Konecny GE, et al. N Engl J Med. Dec 7 2023;389(23):2162-2174.
