REG - GSK PLC - GSK ADC gets orphan drug designation in the EU

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Tue 07:00

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RNS Number : 9873E  GSK PLC  28 October 2025

Issued: 28 October 2025, London UK

 

GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, receives Orphan Drug
Designation in the EU

 

·   Regulatory designation based on encouraging early clinical data showing
potential for GSK'227 in small-cell lung cancer

 

·   Patients with relapsed or refractory extensive stage small-cell lung
cancer often face a debilitating quality of life, limited therapies and poor
outcomes

 

·   Fourth designation further supports GSK plans to accelerate ADC
development in a range of solid tumours with transformational potential

GSK plc (LSE/NYSE: GSK) today announced that GSK5764227 (GSK'227), its
B7-H3-targeted antibody-drug conjugate (ADC), has received Orphan Drug
Designation (ODD) from the European Medicines Agency (EMA) for the treatment
of pulmonary neuroendocrine carcinoma (NEC), a category of cancer that
includes small-cell lung cancer (SCLC). The ODD was supported by preliminary
clinical data showing durable responses in patients with extensive stage SCLC
(ES-SCLC) who were treated with GSK'227 in the phase I ARTEMIS-001 clinical
trial. i  (#_edn1)

 

This ODD recognises the potential of GSK'227 to address a significant unmet
need for ES-SCLC, an aggressive type of NEC with poor outcomes and limited
treatment options. An estimated 250,000 patients globally are diagnosed with
SCLC each year and it is responsible for approximately 200,000 deaths
annually. ii  (#_edn2)

 

This is the fourth regulatory designation for GSK'227, exemplifying the
potential of this targeted ADC, which is being developed in a range of solid
tumour types, including in lung, prostate and colorectal cancers. Previously,
GSK'227 was granted Priority Medicines (PRIME) designation by the EMA for
relapsed or refractory ES-SCLC and Breakthrough Therapy Designations for
relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma granted
by the US FDA. iii  (#_edn3) (, iv  (#_edn4) , v  (#_edn5) )

 

About GSK'227

GSK'227 is a novel investigational B7-H3-targeted antibody-drug conjugate
composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to
a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights
(excluding China's mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma
to progress clinical development and commercialisation of GSK'227. GSK's
global phase III trial for GSK'227 in relapsed ES-SCLC began in August 2025.

 

About GSK

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.

 

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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 in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q2 Results for 2025.

 

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 i  (#_ednref1) Wang J, et al. Presented at IASLC WCLC 2024

 ii  (#_ednref2) Qian Wang, Zeynep H. Gümüş, Cristina Colarossi, Lorenzo
Memeo, Xintong Wang, Chung Yin Kong, Paolo Boffetta, SCLC: Epidemiology, Risk
Factors, Genetic Susceptibility, Molecular Pathology, Screening, and Early
Detection, Journal of Thoracic Oncology, Volume 18, Issue 1, 2023, Pages
31-46, ISSN 1556-0864, https://doi.org/10.1016/j.jtho.2022.10.002.

 iii  (#_ednref3) GSK. GSK receives US FDA Breakthrough Therapy Designation
for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.

 iv  (#_ednref4) GSK. GSK's B7-H3-targeted antibody-drug conjugate, GSK'227,
receives EMA Priority Medicines (PRIME) Designation in relapsed
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/.

 v  (#_ednref5) GSK. GSK's B7-H3-targeted antibody-drug conjugate, GSK'227,
receives US FDA Breakthrough Therapy Designation in late-line relapsed or
refractory osteosarcoma. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/.

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