Bayer (New Zealand)

Puzolcabtagene autoleucel [®] is an autologous, humanized anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed by Chongqing Precision Biotech for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), B-cell leukemias and lymphomas, and non-Hodgkin lymphoma. CAR T-cell therapy is a personalized immunotherapy in which a patient's own T cells are genetically engineered to recognize and eliminate malignant cells through direct cytotoxicity, induction of apoptosis, and TNF ligand-mediated signaling pathways. To reduce immunogenicity, puzolcabtagene autoleucel incorporates a humanized CD19-specific single-chain variable fragment. On 4 November 2025, puzolcabtagene autoleucel received its first approval in China for the treatment of CD19+ relapsed or refractory (R/R) B-ALL in patients aged 3-21 years. This article summarizes the key developmental milestones leading to this first approval.

Rilzabrutinib (WAYRILZ™) is a small-molecule, reversible, highly specific, covalent BTK inhibitor being developed by Sanofi for the treatment of multiple immune-related and inflammatory disorders, including immune thrombocytopenia, warm autoimmune haemolytic anaemia, sickle cell disease, IgG4-related disease, asthma, chronic spontaneous urticaria, among others. As a BTK inhibitor, rilzabrutinib demonstrates multiple immunomodulatory effects, including reduced B cell activation and autoantibody production, inhibition of macrophage activity, and anti-inflammatory effects. In clinical trials, rilzabrutinib was associated with durable platelet responses in patients with previously treated immune thrombocytopenia. This article summarizes the milestones in the development of rilzabrutinib leading to its first approval for the treatment of adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to previous treatment.

Elinzanetant (Lynkuet™) is a non-hormonal, small-molecule neurokinin 1 (NK1) and 3 (NK3) antagonist being developed by Bayer for the treatment of vasomotor symptoms (VMS), which received its first approval in the UK in July 2025. As a neurokinin-targeted therapy, elinzanetant modulates the activity of hyperactive kisspeptin/neurokinin B/dynorphin neurones to reduce the frequency and severity of VMS, which was demonstrated during the OASIS clinical trials. This article summarizes the milestones in the development of elinzanetant leading to this first approval for the treatment of moderate to severe VMS associated with menopause.

Meat freshness is an important aspect of food safety. As one of the most common types of meat, accurate assessment of beef freshness helps protect consumers’ health and prevent potential health risks. To provide a convenient and accessible method for consumers to evaluate beef freshness based solely on visual information, we propose a novel deep learning framework that creatively integrates U-Net and Generative Adversarial Networks (GANs). Specifically, U-Net serves a dual purpose: as the generator within the GAN to produce realistic samples, and as a feature extractor for freshness classification. The discriminator in the GANs compels the U-Net to learn meaningful and discriminative features that improve classification performance. To validate the robustness and adaptability of our model, we executed our model on three different individual datasets, as well as the pooled dataset, to demonstrate the effectiveness and versatility of our proposed model across various imaging conditions.

Limertinib (Aoyixin) is an orally available, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which has been developed for the treatment of non-small cell lung cancer (NSCLC). In clinical trials, limertinib demonstrated efficacy in patients who are positive for the T790M gatekeeper mutation. Limertinib received its first approval for the treatment of adults with locally advanced or metastatic NSCLC with disease progression following treatment with an EGFR TKI and are positive for the EGFR T790M mutation in China in January 2025. In April 2025, limertinib was also approved in China for first-line treatment for adult patients with locally advanced or metastatic NSCLC harbouring EGFR exon 19 deletions or exon 21 L858R mutations. This article summarizes the milestones in the development of limertinib leading to this first approval.

Suzetrigine (JOURNAVX™), an oral, non-opioid analgesic that is highly selective for the voltage-gated sodium channel NaV1.8 relative to other NaV channels, is being developed by Vertex Pharmaceuticals Inc. for the management of acute and neuropathic pain. NaV1.8 is expressed in peripheral pain-sensing neurons but is not expressed in the brain. Suzetrigine prevents transmission of pain signals by blocking NaV1.8 channels located along peripheral pain-sensing neurons, inhibiting the normal action potential. On 30 January 2025, suzetrigine was approved for the treatment of moderate to severe acute pain in adults in the USA. Suzetrigine is the first NaV inhibitor to be approved in this new therapeutic class of non-opioid analgesics. This article summarizes the milestones in the development of suzetrigine leading to this first approval for the treatment of moderate to severe acute pain.

Datopotamab deruxtecan (DATROWAY®) is a trophoblast cell surface antigen2 (TROP2)-directed antibody-drug conjugate being developed by Daiichi Sankyo and AstraZeneca for the treatment of solid tumours. On 27 December 2024, datopotamab deruxtecan was approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor2 (HER2) negative unresectable or recurrent breast cancer after prior chemotherapy. The drug has since been approved on 17 January 2025 in the USA for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Datopotamab deruxtecan has also been approved in the EU for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. Regulatory review of datopotamab deruxtecan in breast cancer is underway in Canada and China. This article summarizes the milestones in the development of datopotamab deruxtecan leading to this first approval for the treatment of HR positive, HER2 negative breast cancer.

Catumaxomab (Korjuny®) is a first-in-class bispecific trifunctional rat-mouse hybrid monoclonal antibody currently under development with Lindis Biotech for malignant ascites, and bladder, gastric and ovarian cancers. It binds epithelial cell adhesion molecule (EpCAM) on tumour cells and CD3 on T cells, while its Fc domain engages Fcγ receptor-positive accessory cells, bringing immune and tumour cells into close proximity to enhance tumour cell killing through multiple immunological mechanisms. Initially approved in the EU on 20 April 2009 for malignant ascites in adults with EpCAM+ carcinomas when standard therapy was unavailable or no longer feasible, catumaxomab was marketed by Fresenius Biotech GmbH (later Neovii Biotech GmbH) before being withdrawn on 2 June 2017 for commercial reasons. Lindis Biotech later acquired the rights and pursued reapproval. On 11 February 2025, catumaxomab was approved in the EU for the intraperitoneal treatment of malignant ascites in adults with EpCAM+ carcinomas who are not eligible for further systemic anticancer therapy. This article summarizes the milestones in the development of catumaxomab leading to this new approval.

Crinecerfont (CRENESSITY™) is a corticotropin releasing factor type 1 (CRF1) receptor antagonist developed by Neurocrine Biosciences for the treatment of classic congenital adrenal hyperplasia (CAH) in adult and paediatric patients. In patients with classic CAH, circulating levels of adrenocorticotropic hormone (ACTH), androstenedione and 17-hydroxyprogesterone are elevated, which traditionally has required supraphysiologic doses of glucocorticoids to manage. As a CRF1 receptor antagonist, crinecerfont acts by reducing systemic ACTH secretion to subsequently decrease elevated levels of steroid precursors and adrenal androgens, thereby reducing the dosage of glucocorticoids required to manage androgen levels in patients. This article summarizes the milestones in the development of crinecerfont leading to this first approval as an adjunctive treatment to glucocorticoid replacement to control androgens in adults and paediatric patients aged ≥ 4years with classic CAH.