Zhejiang Huahai Pharmaceutical's subsidiary HB0025 injection has started Phase III clinical trials.
Huahai Pharmaceutical (600521.SH) announced that its subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd. (referred to as "Huatai"), recently held a meeting with the National Medical Products Administration's Drug Evaluation Center (referred to as "CDE") regarding the Phase II clinical trial of HB0025 in combination with first-line chemotherapy for the treatment of squamous and non-squamous non-small cell lung cancer. The company will officially initiate the Phase III clinical trial of HB0025 injection following the completion of the Phase II trial/ before the start of the Phase III trial.
Zhejiang Huahai Pharmaceutical (600521.SH) announced that its subsidiary Hangzhou Alltest Biotech Co., Ltd. (referred to as "Huao Tai") has officially initiated Phase III clinical trials for the HB0025 injection, following the completion of Phase II clinical trials for first-line treatment of squamous and non-squamous non-small cell lung cancer in conjunction with the China Drug Evaluation Center (CDE).
HB0025 is an innovative anti-PD-L1/VEGF bispecific fusion protein developed independently by Huao Tai, targeting both the tumor immune escape pathway PD-L1 and the tumor angiogenesis pathway VEGF. This drug design achieves high affinity binding to two targets, effectively regulating the tumor immune microenvironment and angiogenesis, with a dual anti-tumor mechanism of "immune enhancement + anti-angiogenesis". According to discussions with the CDE, the company will initiate two confirmatory Phase III clinical trials.
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