Biomed Weekly Highlights (No.27): July 19–25, 2025

July 21,Johnson & JohnsonAnnounced that the company has submitted the marketing application for Icotrokinra to the FDA.It is a globally pioneering oral peptide drug in development, which can selectively block the interleukin-23 (IL-23) receptor, for the treatment of moderate to severe plaque psoriasis (PsO) in adults and adolescents aged 12 years and above.

July 22,NeuShen TherapeuticsNeuShen Therapeutics and Livzon Pharmaceutical jointly announced that the first patient has been dosed in the Phase II clinical trial of NS-041, a highly selective small molecule KCNQ2/3 activator.

July 22,YouLing PharmaceuticalsAkeso announced that its Class 1 new drug, ACE-232 tablets, has been approved by the CDE to enter clinical trials for the potential treatment of metastatic castration-resistant prostate cancer (mCRPC).

July 23,Abbisko TherapeuticsAkeso announced that the first patient has been dosed in its self-developed, highly selective small molecule PRMT5-MTA inhibitor ABSK131.

July 23,Jingyin PharmaceuticalsAnnounced that the company's new generation of siRNA therapy, SRSD107, has been approved by the European Medicines Agency (EMA) to commence Phase II clinical trials.

July 23,Harbour BioMedAnnounced that its partner Windward Bio AG has initiated the POLARIS clinical study—a randomized, double-blind, placebo-controlled global Phase II trial aimed at evaluating the dosing regimen, safety, and efficacy of HBM9378/WIN378 in patients with asthma.

July 24,Allist PharmaceuticalsThe application for a new indication of Furmonertinib Mesylate Tablets by Allist Pharmaceuticals is intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior platinum-based chemotherapy, or are intolerant to platinum-based chemotherapy, and have been confirmed by testing to have epidermal growth factor receptor exon 20 insertion mutations (EGFR exon 20ins).

July 24,BayerBAY 2927088（sevabertinib）The marketing application was accepted by the CDE., for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations who have previously received one systemic therapy.

July 25,GenFleet TherapeuticsGenFleet Therapeutics announced that its GFH375/VS-7375 (oral KRAS G12D inhibitor) has been granted Fast Track designation by the FDA for the first-line and subsequent treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation.

Recently,AkesoAkeso, Inc. announced that its globally pioneering PD-1/VEGF bispecific antibody new drug, Eftilagimod (Eftaform), was independently developed by the company.^®) Combined chemotherapy with/without Lefalimumab (CD47 antibody) for the first-line treatment of metastatic pancreatic cancer in a pivotal/registrational Phase III study (AK112-310/HARMONi-GI2), has completed the enrollment of the first patient. Additionally, Akeso's new indication application for Eftilagimod alpha has been accepted by the CDE.

Recently,Huicun MedicalThe declared HCL001 cell injectionGranted Clinical Tacit Approval, intended for the treatment of decompensated cirrhosis.

Recently,CardioPulse Medical™Hector^®The Multibranch Stent Graft System for Thoracic Aorta Successfully Obtains EU Custom-Made Certificate. This product is used for minimally invasive interventional treatment of thoracic aortic diseases involving the three branches of the aortic arch and is the third product from Heartpulse Medical™ to obtain an EU custom-made certificate.

Recently,Minimally Invasive ElectrophysiologyIndependently Developed IceMagic^®Balloon-type cryoablation catheter receives EU MDR certification. With this, all components of the company's cryoablation system have obtained EU MDR certification, marking the official entry of the company’s cryo product series into the international market.

Recently,Shanghai Institute of Materia Medica, Chinese Academy of SciencesChen Xun's research group, in collaboration with teams from Kyoto University in Japan, Guillaume Bourque and Fumitaka Inoue from McGill University in Canada, published in the internationally renowned journalScience AdvancesPublished an article titled“A phylogenetic approach uncovers cryptic endogenous retrovirus subfamilies in the primate lineage”The research paper. This study developed a novel method for transposon annotation based on evolution, combined with phylogenetic analysis, massively parallel reporter assays (MPRAs), and multi-omics technologies, to reveal the differential evolution of endogenous retroviral sequences and functions across different species at the single-base level. In addition,Shanghai Institute of Materia Medica, Chinese Academy of SciencesZhang Jiwen's Team inJournal of Controlled ReleasePublished online under the title“Alleviation of dry eye disease with lyophilized extracellular vesicles”Research paper.