GSK enters exclusive license agreement with Hansoh for HS-20089

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- Hansoh’s HS-20089 complements GSK’s portfolio of gynaecologic cancer therapies

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, today announced 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. 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.

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.

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.

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.

Hansoh Pharma (03692.HK), one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Founded in 1995, Hansoh Pharma has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system disorders, metabolic diseases, infectious diseases, and autoimmune diseases, among others.

GSK is committed to maximising patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumour-cell targeting therapies, and development in haematologic malignancies, gynaecologic cancers and other solid tumours.

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q2 Results for 2023 and any impacts of the COVID-19 pandemic.