Pharmaceutical Market Europe • July/August 2025 • 6-7
NEWS
AstraZeneca and CSPC agree on AI partnership worth $5.3bn
AstraZeneca (AZ) and CSPC Pharmaceuticals Group have entered into a partnership worth up to $5.3bn to develop therapies for chronic conditions.
The research collaboration will focus on the discovery and development of pre-clinical oral candidates with the potential to treat diseases across multiple indications, including a small molecule therapy for immunological disorders.
China-based CSPC will carry out the research using its artificial intelligence (AI)-driven drug discovery platform, while AZ will have rights to exercise options for exclusive global licences to develop and commercialise candidates identified under the agreement.
In exchange, CSPC will receive $110m upfront and will also be eligible for up to $1.62bn in potential development milestone payments and $3.6bn in sales milestone payments, as well as royalties on future sales.
CSPC’s dual-engine efficient drug discovery platform uses AI to analyse the binding patterns of target proteins with existing compound molecules and conduct targeted optimisation, with the goal of identifying “highly effective” small molecules with “excellent developability”, according to AZ.
The deal is not AZ’s first with CSPC, after the Anglo-Swedish drugmaker gained rights to the biotech’s preclinical lipid-lowering therapy in October last year.
Regeneron and Hansoh announce $2bn licensing deal
Regeneron Pharmaceuticals has announced that it will be gaining rights to Hansoh Pharmaceuticals’ investigational dual GLP-1/GIP receptor agonist in a deal worth $2bn.
The in-licensing agreement will give Regeneron exclusive clinical development and commercial rights to the candidate, HS-20094, outside of Mainland China, Hong Kong and Macau.
The drug, which is administered as a weekly subcutaneous injection, is currently being evaluated by Hansoh in a phase 3 obesity trial and phase 2b diabetes study in China.
It has already successfully completed multiple phase 2 trials, and demonstrated positive efficacy and safety data, according to the companies.
“Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programmes for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits,” said Regeneron’s president and chief scientific officer, George Yancopoulos.
The deal will see Regeneron pay $80m to Hansoh upfront, with Hansoh also eligible for up to $1.93bn in development, regulatory and sales milestones, as well as royalties for global net sales outside of its designated territories.
BioNTech to acquire CureVac for $1.25bn
BioNTech has announced that it will be expanding its messenger RNA (mRNA) capabilities by acquiring CureVac for approximately $1.25bn.
The deal is aimed at strengthening BioNTech’s research, development, manufacturing and commercialisation of its investigational mRNA-based cancer immunotherapies, the company said.
mRNA is a single-stranded molecule that instructs cells to make a protein, or part of a protein, using the body’s natural machinery.
BioNTech said the acquisition “marks the next milestone” in the execution of its oncology strategy, which centres around two pan-tumour programmes, mRNA-based cancer immunotherapy candidates, and PD-L1xVEGF-A bispecific antibody candidate BNT327.
Ugur Sahin, BioNTech’s chief executive officer and co-founder, said: “We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years.”
Under the terms of the agreement, which is expected to close this year, each CureVac share will be exchanged for around $5.46 in BioNTech American depositary shares. Once complete, CureVac shareholders are expected to own between 4% and 6% of BioNTech.
Roche’s Evrysdi tablets granted EC approval for SMA
Roche’s Evrysdi (risdiplam) tablets have been approved by the European Commission (EC) to treat spinal muscular atrophy (SMA).
The new, room-temperature stable formulation of Evrysdi may offer patients greater freedom and independence compared to the currently available oral solution, according to Roche.
The 5mg tablets are suitable for use in patients aged two years and older who weigh more than 20kg and are able to swallow without the use of a feeding tube.
The original formulation will remain available for patients on other doses of the drug and for those who may prefer the oral solution.
SMA is a severe and progressive neuromuscular disease that affects approximately one in every 10,000 babies worldwide.
Given daily at home or on the go, Roche’s Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein in the central nervous system and peripheral tissues.
The label extension makes Evrysdi the first and only tablet approved in the EU for SMA and was supported by results from a bioequivalence study demonstrating that the 5mg tablet and original oral solution provided comparable exposure to the drug.
GSK’s Blenrep recommended by NICE for multiple myeloma
GSK’s Blenrep (belantamab mafodotin) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a combination treatment for multiple myeloma (MM).
The health technology assessment agency has recommended in draft guidance that the antibody-drug conjugate be used on the NHS alongside bortezomib plus dexamethasone (BVd) as a second-line MM treatment for adults who are refractory to, or intolerant of, lenalidomide.
The decision means that eligible patients will be the first in the world to access the combination.
Approximately 6,240 cases of MM, an incurable blood cancer that develops in plasma cells in the bone marrow, are diagnosed in the UK each year.
NICE’s recommendation comes two months after the Medicines and Healthcare products Regulatory Agency approved the Blenrep combination and was supported by positive results from the phase 3 DREAMM-7 study.
After one year, 71% of patients receiving the Blenrep combination were still free from disease progression, compared to 51% of those being treated with standard care. The ongoing trial also demonstrated a three-year survival rate of 74% in the Blenrep group, compared to 60% in the standard care arm.
Merck’s Keytruda approved by FDA for head and neck cancer
Merck & Co – known as MSD outside the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of adults with head and neck cancer.
The drug has been authorised for use as a single-agent neoadjuvant treatment before surgery, then continued after surgery in combination with radiotherapy (with or without cisplatin) as an adjuvant treatment, and then as a single agent.
Patients eligible for the regimen will have resectable locally advanced head and neck squamous cell carcinoma (HNSCC) and tumours expressing PD-L1 at a combined positive score of at least one, as determined by an FDA-approved test.
This is the first authorisation for HNSCC in six years and the first overall perioperative approval for locally advanced HNSCC, according to the FDA.
The regulator’s decision on the drug was supported by results from the phase 3 KEYNOTE-689 trial, in which the Keytruda perioperative regimen reduced the risk of disease recurrence, disease progression, or death by 30% compared to adjuvant standard of care in PD-L1-positive patients.
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