EU approves first pertuzumab biosimilar for HER2-positive breast cancer
The European Commission has approved Henlius and Organon’s POHERDY, making it the first approved biosimilar to Roche’s PERJETA in Europe. The pertuzumab biosimilar has been authorized for all indications of the reference product, including metastatic, neoadjuvant, and adjuvant treatment settings for certain HER2-positive breast cancers.
The approval follows POHERDY’s earlier FDA approval in the United States and is based on a comprehensive comparability package, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data showing high similarity to the reference medicine.
Henlius and Organon entered into a license and supply agreement in 2022, giving Organon exclusive commercialization rights to several Henlius biosimilars, including POHERDY, outside China. The approval expands Organon’s biosimilars portfolio and could support wider access to HER2-targeted therapy across European markets. Source
SOX2 degrader shows strong preclinical activity in resistant cancer models
Genexine has reported new preclinical data for GX-BP1, a first-in-class bioPROTAC candidate designed to selectively degrade SOX2, a transcription factor linked to tumor progression, cancer stemness, and treatment resistance. The data, presented at AACR, showed that GX-BP1 monotherapy achieved around 70 percent tumor growth inhibition across preclinical models.
The strongest effects were seen in combination settings. GX-BP1 restored sensitivity in chemotherapy-resistant models and enhanced the activity of EGFR-targeted therapy, including osimertinib, by suppressing SOX2-driven resistance mechanisms. In combination with carboplatin and paclitaxel, the therapy achieved 87–96 percent tumor growth inhibition, while pairing GX-BP1 with osimertinib prevented tumor regrowth in models where relapse occurred with osimertinib alone.
Genexine is also developing a lung-targeted lipid nanoparticle delivery system for GX-BP1 mRNA, which delivered more than 70 percent of payload to lung tissue within 24 hours in preclinical testing. The company says the candidate has generated efficacy, pharmacokinetic, biodistribution, and safety data supporting progression toward IND-enabling studies. Source
NICE backs first treatment for uncontrolled generalized myasthenia gravis
NICE has recommended rozanolixizumab as the first treatment option for some adults in England with uncontrolled generalized myasthenia gravis (gMG). The final draft guidance covers adults who test positive for AChR or MuSK antibodies and continue to have poorly controlled symptoms despite standard therapies, including steroids.
Rozanolixizumab, marketed as Rystiggo by UCB Pharma, is designed to reduce symptom severity and improve patients’ ability to manage daily activities. NICE estimates that around 800 adults in England could benefit, with the treatment available immediately through interim funding from the Innovative Medicines Fund.
The therapy is given as a short course of subcutaneous injections and may be supported through homecare, offering a more convenient alternative to hospital-based treatments such as intravenous immunoglobulin or plasma exchange. NICE said the recommendation follows an improved commercial agreement with NHS England, with final guidance expected next month. Source
Ecolab opens first Asian bioprocessing applications lab in Korea
Ecolab Life Sciences has opened a new Bioprocessing Applications Lab in Dongtan, Korea, expanding its global bioprocessing support network into Asia. The facility is designed to help biopharmaceutical manufacturers optimize purification workflows, improve process efficiency, and advance programs toward commercial readiness.
The Korea lab will support activities from early-stage testing to studies that replicate manufacturing at scale, building on Ecolab’s existing application centers in the US and UK. By locating expertise closer to customers in Asia, the company aims to reduce the need for overseas material transfers while maintaining alignment with global standards.
Ecolab says the facility will allow local teams to work directly with manufacturers under increasing pressure to scale production quickly while meeting regulatory and performance requirements. Source
WuXi Biologics gains Korean GMP certification for bispecific antibody manufacturing
WuXi Biologics has received GMP certification from South Korea’s Ministry of Food and Drug Safety for three manufacturing facilities in Wuxi, China. The certification covers drug substance manufacturing, drug product fill-finish, and packaging, enabling the company to provide end-to-end commercial manufacturing for a bispecific antibody therapy for biliary tract cancer.
The five-day inspection covered Drug Substance Facility 5, Drug Product Facility 2, and the Drug Product Packaging Center, with no critical or major findings reported. WuXi said the result supports its ability to deliver large-scale GMP manufacturing for complex biologics, including bispecific antibodies. Source
BeOne secures option on Huahui trispecific cancer antibody
BeOne Medicines, formerly known as BeiGene, has signed a licensing agreement with Huahui Health for global rights to HH160, a preclinical trispecific antibody targeting PD-1, CTLA-4, and VEGF-A. The candidate was developed using Huahui’s PolyBoost multispecific antibody platform and is designed to combine three complementary mechanisms to improve anti-tumor efficacy while reducing side effects.
Under the deal, BeOne will pay $20 million upfront, with a further $100 million option exercise fee if it activates the license. Huahui could also receive up to $374 million in development and regulatory milestones and up to $1.5 billion in sales-based milestones, alongside potential future equity investment from BeOne. Source
For this week’s cell and gene therapy news – including Intellia’s Phase 3 CRISPR milestone in hereditary angioedema, Cabaletta’s CAR-T manufacturing deal with Cellares, and advances in programmable DNA medicines, gene editing, and CAR-T performance – click here.
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