Baili Tianheng's Innovative Biologics T-Bren and Others Granted Breakthrough Therapy Designation in China
On September 27, Baili Tianheng announced that China's NMPA granted Breakthrough Therapy Designation to three of its self-developed ADCs: T-Bren for biliary tract cancer, BL-M05D1 for gastric cancer, and iza-bren for biliary tract cancer. Separately, the NMPA approved a clinical trial for BL-M12D1, an ADC for relapsed or refractory hematologic malignancies.
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Baili Tianheng Gets China NMPA Approval for Blood Cancer ADC Trial
Baili Tianheng (688506.SH) announced on September 27 that it has received a Drug Clinical Trial Approval Notice from China's National Medical Products Administration (NMPA) for its independently developed innovative biologic, BL-M12D1 (ADC), for injection. The approval, under acceptance number CXSL2600763 and notice number 2026LP02948, authorizes the applicant—Chengdu Baili Duote Biological Pharmaceutical Co., Ltd. and Sichuan Baili Pharmaceutical Co., Ltd.—to conduct a single-agent clinical trial in patients with relapsed or refractory hematologic malignancies. The decision was based on a review under the Drug Administration Law of the People's Republic of China, concluding that the clinical trial application meets relevant drug registration requirements.
Read sourceBaili Tianheng's Innovative Biologic T-Bren Included in Breakthrough Therapy List
According to a report from People's Financial News on September 27, Baili Tianheng announced that it has received a formal 'Drug Clinical Trial Approval Notice' from China's National Medical Products Administration (NMPA). The approval is for the company's self-developed innovative biologic drug, injection BL-M12D1 (an ADC). This ADC drug is developed on the same technology platform as iza-bren and shares the same 'linker+toxin' platform as Yizekang. The approved indication is for relapsed or refractory hematologic malignancies. The news was sourced from Securities Times.
Read sourceBaili Tianheng's BL-M05D1 Gets Breakthrough Therapy Designation for Gastric Cancer
Baili Tianheng (百利天恒) announced that its self-developed innovative biologic drug, BL-M05D1 (Claudin18.2 ADC), has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. The designation is for the treatment of patients with CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who have received prior first-line standard therapy. BL-M05D1 is a novel antibody-drug conjugate targeting Claudin18.2. The company is currently conducting three clinical trials for the drug both domestically and internationally, with the Phase III clinical trial having completed enrollment of its first subject in June 2026. The company noted that drug development is subject to uncertainties due to technical, regulatory, and other factors.
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Baili Tianheng's BL-M05D1 Gets Breakthrough Therapy Designation for Gastric Cancer
Baili Tianheng (688506.SH) announced on September 27 that its self-developed innovative biologic, BL-M05D1 (Claudin18.2 ADC), has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. The designation is for the treatment of patients with CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line standard therapy. This regulatory status is intended to expedite the development and review of promising new drugs for serious conditions.
Read sourceBaili Tianheng's Innovative Biologics T-Bren and Others Granted Breakthrough Therapy Designation in China
Baili Tianheng (688506) announced on September 27 that three of its self-developed innovative biologics have been included in the National Medical Products Administration's (NMPA) Center for Drug Evaluation's Breakthrough Therapy Designation list. These include T-Bren (HER2 ADC) for HER2-expressing locally advanced or metastatic biliary tract cancer patients who failed platinum-containing chemotherapy; BL-M05D1 (Claudin18.2 ADC) for CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma patients after first-line standard therapy; and iza-bren (BL-B01D1), a first-in-class, globally first and only approved EGFR×HER3 bispecific antibody ADC, for recurrent or metastatic biliary tract cancer after platinum-containing chemotherapy. Separately, Baili Tianheng received NMPA approval for a clinical trial of BL-M12D1 (ADC), a drug sharing the same technology platform and 'linker+toxin' platform as iza-bren, for relapsed or refractory hematologic malignancies.
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