On March 3, the Drug Clinical Trial Registration and Information Publication Platform showed that Henson Pharmaceuticals initiated the first Phase III clinical trial of HS-20089 (GSK5733584). This is the first B7-H4 ADC drug to enter Phase III clinical stage. The study is a multicenter, randomized, open, positive drug-controlled clinical trial (n=468) designed to evaluate HS-20089 against investigator-selected chemotherapy (topotec...

Today, Genentech, a Roche company, announced that a detailed analysis of REGENCY, a Phase 3 clinical trial of the anti-CD20 antibody therapy Gazyva (obinutuzumab) for the treatment of patients with active lupus nephritis, has been published in the New England Journal of Medicine. The data showed that Gazyva, in combination with standard therapy, met the trial's primary endpoint, significantly improving patients' complete renal remission...

On February 6, Bristol-Myers Squibb (BMS) revealed its decision to terminate the development of Cendakimab, an IL-13 monoclonal antibody that has entered Phase III, during the release of its 2024 results.Cendakimab is no longer visible in the PPT of BMS's 2024 annual report. In response, Adam Lenkowsky, Chief Commercial Officer of BMS, explained, "Given the available data, we have decided to abandon the development of Cendakim...

On February 7, 2025, Novo Nordisk announced updated data from FRONTIER3, a Phase III clinical trial of the FIX/FX dual antibody Min8 for the treatment of childhood hemophilia A. The study was divided into two parts, with the first part receiving 26 weeks of weekly treatment and the second part, the remaining 26 weeks being switched to once-monthly or maintenance weekly treatment. For the first part, the mean annualized bleeding rate (ABR) was 0.53, with a median ABR of 0. 45...

On February 6, 2025, Merck Sharp & Dohme announced the initiation of a pivotal Phase III clinical trial of the new ROR1 ADC drug Zilovertamab Vedotin in combination with R-CHP against R-CHOP for the first-line treatment of diffuse large B-cell lymphoma (DLBCL). WaveLINE-010 is planned to enroll 1,046 patients with DLBCL, with the primary endpoint being PFS and secondary endpoints including CR rate, OS, EFS, C...

SpringWorks Therapeutics, Inc. announced yesterday that the U.S. FDA has approved the marketing of the MEK inhibitor Gomekli (mirdametinib) for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) who are no less than 2 years of age. Their tumors cannot be completely removed. The press release noted that mirdametinib is the first drug approved to...

On February 10, 2025, Boehringer Ingelheim announced that FIBRONEER-ILD, the second Phase III clinical FIBRONEER-ILD for the treatment of idiopathic pulmonary fibrosis with the PDE4B inhibitor Nerandomilast, has met its primary endpoint and will be submitted for marketing. Last September, Nerandomilast's first Phase III clinical FIBRONEER-IPF was successful. Idiopathic pulmonary fibrosis (IPF) is the most common class of progressive...

2月13日，安斯泰来宣布FDA批准Izervay(avacincaptad pegol)用于治疗年龄相关性黄斑变性(AMD)继发地图样萎缩(GA)的补充新药申请(sNDA)。经此次批准，Izervay的给药持续时间再无限制——为医生和患者管理GA提供了更大的灵活性。根据III期GATHER2研究的两…

辉瑞(Pfizer)今天公布TALAPRO-2临床3期研究的积极结果。分析显示，与活性对照药物相比，其多腺苷二磷酸核糖聚合酶(PARP)抑制剂Talzenna(talazoparib)与雄激素受体通路抑制剂(ARPI)Xtandi(恩扎卢胺，enzalutamide)组合疗法显著改善转移性去势抵抗性…