EMA grants Orphan Drug Designation to GSK'227 in SCLC category

Rhea-AI Filing Summary

GSK plc reported that its B7-H3–targeted antibody-drug conjugate, GSK5764227 (GSK'227), received Orphan Drug Designation from the European Medicines Agency for treating pulmonary neuroendocrine carcinoma, a group that includes small‑cell lung cancer. The designation is based on preliminary phase I ARTEMIS-001 data showing durable responses in extensive‑stage SCLC.

This marks the fourth regulatory designation for GSK'227. The program previously secured EMA PRIME for relapsed or refractory ES‑SCLC and two US FDA Breakthrough Therapy Designations for relapsed or refractory ES‑SCLC and late‑line relapsed or refractory osteosarcoma. GSK began a global phase III trial in relapsed ES‑SCLC in August 2025.

SCLC remains a high‑need cancer, with an estimated 250,000 diagnoses and about 200,000 deaths annually worldwide. GSK holds exclusive worldwide rights to GSK'227 outside mainland China, Hong Kong, Macau, and Taiwan.

Insights

Biopharma regulatory analyst

EU Orphan Drug status adds regulatory momentum but is not approval.

The EMA’s Orphan Drug Designation for GSK'227 acknowledges early signs of activity in ES‑SCLC from phase I ARTEMIS‑001. It follows prior EMA PRIME and two US FDA Breakthrough Therapy Designations across SCLC and osteosarcoma, indicating multi‑agency interest in serious indications.

Designation does not confirm efficacy or safety; pivotal evidence will depend on the global August 2025 phase III trial in relapsed ES‑SCLC. The filing notes SCLC’s significant disease burden, underscoring the clinical need.

Actual impact hinges on phase III outcomes and regulator decisions. Subsequent filings may provide additional data readouts or regulatory interactions that clarify timelines.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of October 2025

Commission File Number 001-15170

GSK plc

(Translation of registrant's name into English)

79 New Oxford Street, London, WC1A 1DG

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F . . . .X. . . . Form 40-F . . . . . . . .

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]

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]

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],[iv],[v]

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.

Registered in England & Wales:

No. 3888792

Registered Office:

79 New Oxford Street

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WC1A 1DG

[i] Wang J, et al. Presented at IASLC WCLC 2024

[ii] 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] 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] 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] 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/.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.

GSK plc

(Registrant)

Date: October 28, 2025

By:/s/ VICTORIA WHYTE

--------------------------

Victoria Whyte

Authorised Signatory for and on

behalf of GSK plc

FAQ

What did GSK (GSK) announce about GSK'227?

GSK said GSK'227 received European Medicines Agency Orphan Drug Designation for treating pulmonary neuroendocrine carcinoma, which includes small‑cell lung cancer.

What evidence supported the EU Orphan Drug Designation for GSK'227?

The designation was supported by preliminary phase I ARTEMIS‑001 data showing durable responses in extensive‑stage SCLC.

What other regulatory designations has GSK'227 received?

GSK'227 previously received EMA PRIME for relapsed/refractory ES‑SCLC and US FDA Breakthrough Therapy Designations for ES‑SCLC and osteosarcoma.

Has GSK started late-stage trials for GSK'227?

Yes. GSK began a global phase III trial in relapsed ES‑SCLC in August 2025.

How large is the small‑cell lung cancer burden cited by GSK?

GSK cited about 250,000 diagnoses and approximately 200,000 deaths globally each year.

Who holds rights to develop and commercialize GSK'227?

GSK has exclusive worldwide rights to GSK'227, excluding mainland China, Hong Kong, Macau, and Taiwan, acquired from Hansoh Pharma.