GSK enters exclusive license agreement with Hansoh for HS-20093

For media and investors only

- Hansoh’s HS-20093 builds on GSK’s oncology portfolio of clinical-stage antibody-drug conjugates, following earlier agreement for Hansoh’s HS-20089 focused on gynaecologic cancers

- HS-20093 has shown promising initial clinical activity in lung cancer with potential to address unmet medical need in broader solid tumour indications

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-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093.

Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said:

B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.

This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours. HS-20093 is currently being investigated in ongoing phase I and II trials in China. Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile. 1

Eliza Sun, Executive Director of Board, Hansoh Pharma, said:

HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.

GSK plans to begin phase I trials for HS-20093 outside of China in 2024.

In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours.

Under the terms of this agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialisation of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan.

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

HS-20093 is a novel B7-H3-targeted antibody-drug conjugate composed of a fully humanised anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. HS-20093 is being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I and II clinical trials in China.

Hansoh Pharma, 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 Q3 Results for 2023.