Pharmaceutical Market Europe • October 2025 • 6-7
NEWS
GSK expands pipeline through $12bn deal with Hengrui
GSK is expanding its respiratory, immunology and inflammation (RI&I) and oncology pipeline with a $12bn deal with Hengrui Pharma.
The agreement covers up to 12 medicines, including an exclusive global licence (excluding mainland China, Hong Kong, Macau and Taiwan) for a PDE3/4 inhibitor in clinical development for chronic obstructive pulmonary disease (COPD).
Approximately 1.4 million people in the UK have been diagnosed with COPD, a chronic respiratory disease that causes progressive lung function decline and results in symptoms such as persistent cough, excessive mucus production and a shortness of breath.
Hengrui’s candidate, HRS-9821, is being evaluated as an add-on maintenance treatment for COPD, regardless of background therapy, and has already been associated with increased bronchodilation and anti-inflammatory effects in early clinical and preclinical studies.
Alongside HRS-9821, the companies will aim to generate up to 11 programmes, with Hengrui leading development up to the completion of phase 1 trials. GSK will then have the exclusive option to further develop and commercialise each programme worldwide (excluding mainland China, Hong Kong, Macau and Taiwan), as well as certain programme substitution rights.
In exchange, Hengrui will receive $500m in upfront fees and will be eligible for approximately $12bn in development, regulatory and commercial milestone payments, as well as tiered royalties on global product net sales.
BMS acquires Orbital Therapeutics in $1.5bn deal
Bristol Myers Squibb (BMS) has agreed to acquire Orbital Therapeutics in a deal valued at $1.5bn.
Robert Plenge, executive VP and chief research officer at BMS. “In vivo CAR-T represents a novel treatment approach that could redefine how we treat autoimmune diseases.
“This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system.”
Through the acquisition, BMS will gain Orbital’s lead preclinical RNA immunotherapy candidate, OTX-201, an investigational next-generation CAR-T cell therapy designed to reprogramme cells in vivo. This in vivo approach aims to reduce treatment burden and improve accessibility relative to traditional ex vivo CAR-T cell therapies.
BMS will also acquire Orbital’s proprietary RNA platform, which combines circular and linear RNA engineering with advanced lipid nanoparticle delivery and AI-enabled design to create programmable RNA therapies targeting a broad range of diseases.
Until completion, BMS and Orbital, an RNA-focused biotech company, will continue to operate as separate, independent entities.
Novartis and Matchpoint Therapeutics agree on deal worth $1bn
Novartis and Matchpoint Therapeutics have agreed on a deal worth $1bn to develop oral inhibitors for inflammatory diseases that have been historically difficult to treat.
Under the terms of the agreement, the Swiss drugmaker will pay US-based Matchpoint up to $60m in upfront payment and research funding, with Matchpoint eligible for up to $1bn in total potential payments, including option exercise fee, development and commercial milestones.
The partnership is the latest in a series of deals made by Novartis this year. Last month, the company entered into a four-year alliance with ProFound Therapeutics to discover and develop new therapeutics for cardiovascular diseases.
The collaboration, worth $750m per target, combines Novartis’ capabilities in cardiovascular drug development with ProFound’s ProFoundry Platform, which uses protein detection technologies to identify and validate novel proteins and dissect their therapeutic potential.
Novartis also said in March that it would be gaining global rights to Kyorin Pharmaceutical’s preclinical inflammatory disease drug in a deal worth over $830m, and revealed its intended $3.1bn acquisition of Anthos Therapeutics in February.
Pfizer’s Lorviqua recommended by NICE for lung cancer
Pfizer’s Lorviqua (lorlatinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment for certain types of lung cancer. The announcement follows the publication of NICE’s final guidance on the therapy, which provides a new treatment option for eligible lung cancer patients in England.
Under the new recommendation, Lorviqua is approved for use in adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.
Lorviqua is an orally administered ALK inhibitor that targets enzymes involved in cell growth and division, helping to prevent the proliferation of cancer cells.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with around 40,000 patients diagnosed in England each year. NSCLC accounts for approximately 80-85% of all lung cancer cases, and around 5% of these involve ALK-positive tumours.
NICE previously declined to recommend Lorviqua for first-line use in 2023, although the therapy was made available on the NHS in England as a second-line option. The Scottish Medicines Consortium approved Lorviqua as a first-line treatment for NHS Scotland in 2022.
Lilly’s early Alzheimer’s disease treatment gets EU approval
The European Commission (EC) has granted marketing authorisation for Eli Lilly’s Kisunla, a treatment for early symptomatic Alzheimer’s disease (AD).
AD affects nearly 7 million people in Europe and is characterised by progressive cognitive decline, including memory loss and impaired thinking. A driver of the condition is the excessive build-up of amyloid plaque in the brain.
Kisunla, administered via infusion, works by targeting and clearing this build-up, with the aim of preserving cognitive function and slowing disease progression.
The EC marketing authorisation was supported by data from a phase 3 trial that showed Kisunla significantly slowed cognitive and functional decline compared with placebo.
A subsequent phase 3b study evaluated alternative dosing regimens in relation to amyloid-related imaging abnormalities. The study reported positive results with a lower dosing schedule, consistent with the efficacy observed in a previous trial.
Following the EC marketing authorisation, Kisunla can now be prescribed across the EU for adults with mild cognitive impairment or mild dementia stages of AD, with confirmed amyloid pathology, who are apolipoprotein E heterozygotes or non-carriers.
Roche’s small cell lung cancer therapy approved by FDA
Roche has announced that the US FDA has approved Tecentriq and Tecentriq Hybreza in combination with Zepzelca to treat adults with extensive-stage small cell lung cancer (ES-SCLC).
The approval is based on positive results from the phase 3, open-label IMForte study, sponsored by Roche and co-funded by Jazz Pharmaceuticals. The trial demonstrated that, compared with Tecentriq monotherapy, the combination reduced the overall risk of death by 27% and the risk of disease progression or death by 46%. Median progression-free survival was 5.4 months with the combination vs 2.1 months with Tecentriq alone.
Following the FDA decision, Tecentriq is now available as a maintenance treatment for adults with ES-SCLC whose disease has not progressed after first-line induction therapy with either Tecentriq or carboplatin plus etoposide (CE). This marks the first and only approved combination regimen for this indication.
Tecentriq, in combination with chemotherapy, received FDA approval in 2019 as the first-line treatment for adults with ES-SCLC – the first new therapy for the disease in two decades. In the US, the Clinical Practice Guidelines in Oncology have now been updated to include the Tecentriq and Zepzelca combination as a preferred option for patients.
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