Beizray (docetaxel injection) / Zhuhai Beihai Biotech, Zydus Lifesci - LARVOL DELTA

Zydus and Beihai Biotech sign an exclusive licensing, supply and commercialization agreement for BEIZRAY (Albumin Solubilized Docetaxel Injection), a 505(B)(2) product for the US market (Zydus Press Release) - "Zydus Lifesciences Ltd...announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing, supply and commercialization agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized Docetaxel Injection), a 505(B)(2) product for the US market...Under the terms of this agreement, Beihai Biotech will be responsible for the manufacturing and supply of the product. Zydus will be responsible for commercialization of the product in the US. Beihai Biotech shall receive upfront payments, sales targets-based milestone payments and a share of BEIZRAY’s net profits earned in the US as per the terms of the agreement...BEIZRAY is indicated for the treatment of Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, and Head and Neck Cancer. "

Commercial • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Prostate Cancer

Beihai Biotech achieves a breakthrough with the first new drug (BEIZRAY) approved by the US FDA in Guangdong Province [Google translation] (Beihai Biotech Press Release) - "On October 28, 2024, Zhuhai Beihai Biotechnology Co., Ltd...announced that its independently developed new drug BH009 (trade name: BEIZRAY) has officially obtained marketing approval from the U.S. Food and Drug Administration (FDA), mainly for the treatment of breast cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, prostate cancer and gastric cancer. BEIZRAY is the first new drug in Guangdong Province to submit a new drug application (NDA) directly to the U.S. FDA and be approved for marketing in the United States. Beihai Biotechnology has completely independent intellectual property rights for BEIZRAY worldwide."

FDA approval • Breast Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck

Weekly BH009 in patients with squamous cell carcinoma of the head and neck (SCCHN) and ovarian cancer: Interim phase I results. (ASCO 2024) - P1 | "BH009 was administered at escalating doses (starting dose 40 mg/m2) as a 1-h i. v. infusion for three consecutive weeks every 28 days without dexamethasone premedication...One patient (17%, 1/6) with ovarian cancer at 50 mg/m2 dose group received a complete response to the target lesion and the non-target lesion was partially responded after 2 courses of BH009, and this patient had been previously treated with docetaxel, carboplatin, and bevacizumab... The weekly BH009 for three consecutive weeks every 28 days is a feasible schedule with a favorable toxicity profile, and the overall tolerability is better than Taxotere. BH009 has the potential to increase the dose of administration and improve the clinical efficacy. Dose escalation is ongoing."

Clinical • P1 data • Anemia • Febrile Neutropenia • Head and Neck Cancer • Immunology • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Safety analysis for BH009 vs docetaxel from a bioavailability study. (ASCO 2024) - P3 | " This multicenter, randomized, open-label, 2-way crossover study compared the pharmacokinetics and safety of BH009 and docetaxel (Winthrop docetaxel injection, an authorized generic of Taxotere). A better safety profile was observed in the study when BH009 group was compared to docetaxel group in grade 3/4 hematologic toxicity. Clinical trial information: NCT04889599."

Clinical • Anemia • Cervical Cancer • Hematological Disorders • Immunology • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

A Study of BH009 in Head and Neck Squamous Cell Carcinoma and Ovarian Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Zhuhai Beihai Biotech Co., Ltd

New P1 trial • Head and Neck Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck