On October 20, 2023 GSK plc (LSE/NYSE: GSK) and Hansoh Pharma (HKEX: 03692), a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, reported that they have entered into an exclusive license agreement for HS-20089, a B7-H4 targeted antibody-drug conjugate (ADC) currently in phase I (NCT05263479) clinical trials in China (Press release, GlaxoSmithKline, OCT 20, 2023, View Source [SID1234636177]). Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress development and commercialisation of HS-20089.

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Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: "Given early clinical data, we believe that HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours. This agreement is in line with our approach to advancing novel treatment options for patients with gynaecologic cancers."

In addition to targeting the B7-H4 surface antigen, which is overexpressed in ovarian and endometrial cancers and is often associated with poor prognosis, HS-20089 utilises clinically validated ADC technologies such as a topoisomerase inhibitor (TOPOi) payload.1 TOPOi is a validated mechanism of action in approved anti-cancer medicines and a proven standard of care in the treatment of breast and ovarian cancers.

Eliza Sun，Executive Director of Board, Hansoh Pharma, said: "In line with our commitment to deliver first- or best-in-class medicines to address unmet medical needs, Hansoh is excited to explore further development of HS-20089 to bring breakthrough medicines to cancer patients. GSK’s R&D expertise and commercial footprint in developing therapies for gynaecologic cancers make them the ideal licensee to bring HS-20089 to patients outside of China."

This agreement builds on GSK’s strategic R&D focus on tumour-cell targeting modalities as well as expertise in gynaecologic cancers including a significant medical and commercial presence. HS-20089 complements GSK’s oncology portfolio and strategic disease area focus, including potential future combinations.

GSK plans to begin phase I trials outside of China in 2024.

Terms of the agreement

Under the terms of this agreement, GSK will pay an $85 million upfront payment. In addition, Hansoh will be eligible to receive up to $1.485 billion in success-based milestones for HS-20089. Upon commercialisation of HS-20089, GSK will also pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan.

This agreement is subject to appropriate regulatory agency clearances, including under the Hart-Scott-Rodino Act in the US.

About HS-20089

HS-20089 is a novel B7-H4 directed antibody-drug conjugate (ADC) with a topoisomerase inhibitor (TOPOi) payload. B7-H4, a transmembrane glycoprotein in the B7 superfamily, has limited expression in normal tissues but is highly expressed in various cancers. HS-20089 is being developed for the treatment of gynaecologic cancers in a phase I clinical study in China.