Introduction: Baili Tianhe announces clinical results of world's first EGFR×HER3 bispecific antibody ADC drug
Distribution of Clinical Trial TypesIn November 2025, according to the 【China Clinical Trials】section of the Pharma Data Enterprise Edition, the CDE disclosed a total of registered drug clinical trials.413 Clinical Trial RegistrationsAmong them, clinical trials of chemical drugs account for the majority with 298 trials, while biologics and traditional Chinese medicine have 102 and 13 trials, respectively.In terms of trial phases, the largest proportion is "Phase 1" clinical trials, reaching 33.9%, with a total of 140 trials, and the majority of these trials are new drug clinical trials for chemical drugs. Next are "Other" trials, with a total of 135 studies, followed by Phase 2 and Phase 3 trials with 93 and 72 trials respectively, while there is only 1 Phase 4 clinical trial.PS：Reply in the background of the Yaoke Data WeChat Official Account [Clinical Trial 2025], ObtainFull Report PDF Version。
DrugClinical TrialProduct AnalysisIn the top 10 list of drug clinical trial varieties registered with CDE in November 2025,"Dapagliflozin Tablets" Tops the List with 7 Registered Trials, and all are bioequivalence clinical trials. "Dapagliflozin Tablets" 7IndividualClinicalTestRespectivelyBy Jiangsu Zhongbang Pharmaceutical Co., Ltd.、Hainan Huanglong Pharmaceutical Co., Ltd.、Huayi Pharmaceutical Technology (Anhui) Co., Ltd.、Shandong Lukang Pharmaceutical Group Saite Co., Ltd.、Sichuan Luhui Pharmaceutical Co., Ltd.、Suzhou Third Pharmaceutical Factory Co., Ltd.Application, Targeting the indications for clinical trialsAll for"For adult patients with type 2 diabetes to improve blood glucose control.""Menatetrenone Soft Capsules" with 4IndividualClinicalTestRanked second, both are bioequivalence clinical trials.More detailed information,Please see the figure below for details.Or visitPharmcube Data Enterprise Edition [Clinical Trials in China]Conduct a search.DrugClinical TrialProduct AnalysisIn 2025NovemberIn the CDE drug clinical trial sponsor rankings,Qilu Pharmaceutical Co., Ltd.By 9A Clinical Registration TrialRankTop of the list，“Qilu Pharmaceutical Co., Ltd.9The item test covers7Clinical trials of different varieties,Both generic drug BE trials and new drug clinical trials are included, specifically"QL2302 Injection"、Lumateperone Tosylate Capsules、QLG1091、QLS1410 Tablets、Idebenone Tablets、Olanzapine and Samidorfan Tablets、Pembrolizumab Injection；“Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.、Jiangsu Hengrui Pharmaceuticals Co., Ltd.、Chia-TaiTianqing5A Clinical Registration TrialTied for Second。Among whichBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.AndJiangsu Hengrui Pharmaceuticals Co., Ltd.5A Clinical Registration TrialAll are new drug clinical trials, "Chia-TaiTianqing (Nanjing) Pharmaceutical Co., Ltd."5A Clinical Registration TrialThere are both generic drug BE trials and new drug clinical trials.DrugAnalysis of Clinical Trial InstitutionsIn the CDE drug clinical trial registration public announcement in November 2025,"Sun Yat-sen University Cancer Center" Ranks First by Leading 11 Clinical Trials, and all 11 clinical trials are new drug clinical trials."Peking University First Hospital and Fudan University Shanghai Cancer Center" are tied for second place, each leading 9 clinical trials, all of which are new drug clinical trials.More detailed information,Please see the figure below for details.Or visitPharmcube Data Enterprise Edition [Clinical Trials in China]Conduct a search.Distribution of Clinical Trials by ProvinceIn the CDE drug clinical trial registration public announcement in November 2025, the distribution of clinical trial provinces by region of the sponsor unit is shown in the figure below.Jiangsu Province Ranks First with 79 Clinical Trial Registrations, Shanghai and Beijing rank second and third, respectively. For more details, please see the figure below or visit the Pharma Data Enterprise Edition [China Clinical Trials] for inquiries.Key Events in Clinical TrialsIn November 2025, Baili Tianhe announced the world's first EGFR×HER3 bispecific antibody ADC drug.iza-bren, in the interim analysis of a Phase III clinical trial for recurrent/metastatic esophageal squamous cell carcinoma, both primary endpoints of progression-free survival (PFS) and overall survival (OS) were simultaneously met. This is expected to change the clinical treatment landscape and demonstrate broad potential across multiple cancer types.ADC Drug Targeting B7-H4AZD8205A global Phase III clinical trial has been initiated in China for B7-H4 positive advanced endometrial cancer patients who have failed platinum-based chemotherapy and PD-1/L1 treatment. Clinical data shows a response rate of over 30% and a disease control rate of over 80%, bringing new hope to patients with endometrial cancer.November 13-15, 2025SIBCS ForumHeld in Shanghai, focusing on new paradigms in precision diagnosis and treatment of breast cancer, introducing innovative technologies such as VR to demonstrate drug mechanisms of action and recurrence risk models.Type. Promote the identification of long-term recurrence risks in high-risk patients with HR+/HER2- early breast cancer and the popularization of adjuvant treatment strategies with new drugs such as Ribociclib.Data Source:Pharmcube Data Enterprise Edition——Global/China Clinical Trials Database, Clinical Research Analysis SystemPS：Reply in the background of the YAOZHI Data WeChat Official Account [Clinical Trial 2025], ObtainFull Report PDF Version。
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