The Global Phase 3 clinical trial of ® esophageal squamous cell carcinoma in Baizean, Baiji Shenzhou, obtained positive results

Today, Baiji Shenzhou announced that its phase 3 global Phase 3 clinical trial to evaluate anti-PD-1 antibody Bazean® compared to the chemotherapy chosen by the researchers for the treatment of advanced non-removable or metastatic esophageal squamous cell carcinoma that has previously underwent systemic therapy has reached the primary endpoint of total survival.
test results show that for intentional treatment population (ITT), the ® has achieved statistical and clinical significance improvement in the total lifetime.
's security ® consistent with known risks and did not appear with new security alerts.
The RATIONALE 302 clinical trial of comparative chemotherapy for late ESCC is a randomized, open, multi-center Global Phase 3 clinical trial (NCT03430843) designed to evaluate the effectiveness and safety of the chemotherapy chosen by the comparative researchers, and the use of Baizean® for the treatment of patients with late-stage non-excisive or metastasis ESCC who have previously underwent systemic therapy®.
the main endpoint of the trial was OS in the ITT population.
A total of 512 patients in 11 countries across Asia, Europe and North America were included in the trial, randomly reaching the Baizean®test arm or chemotherapy test arm in a 1:1 ratio (the drug options included yew alcohol, dositan or elixicon selected by the researchers).
about esophageal squamous cell carcinoma (ESCC) esophageal squamous cell carcinoma (ESCC) is the world's most common sub-type of esophageal cancer .
esophageal cancer is the sixth leading cancer-related cancer in the world, with more than 600,000 new cases of esophageal cancer worldwide and about 550,000 deaths worldwide by 2020.
esophageal cancer is a rapid and fatal disease, with two-thirds of patients diagnosed with advanced or metastatic diseases.
survival of esophageal cancer is about 8 to 10 months, while the five-year survival rate is less than 5%.
About Bezean ® (For Reilly Pearl Single Anti-Injection) Bezean ® (For Reilly Pearl Monoantigen Injection) is a humanized lgG4 program-resistant death subject 1 (PD-1) monoclonal antibody designed to minimize binding to Fc-oculars in macrophages.
preclinical data show that Fc gamma in macrophages binds to activate antibodies that rely on cell-mediated killer T-cells, thereby reducing the anti-tumor activity of PD-1 antibodies.
® is the first drug developed by baiji Shenzhou's bio-platform for immuno-oncology, and clinical trials of single-drug and combination therapies are under way to develop a range of broad-based adaptations to solid and blood tumors.
China's State Drug Administration (NMPA) has approved the combination of ® chemotherapy for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC).
Bzean® was also conditionally approved for the treatment of patients with relapsed or refractic classic Hodgkin's lymphoma who had underwent at least second-line system chemotherapy, as well as patients with PD-L1 highly expressed platinum-containing chemotherapy failures including localized late stage or metastatic urethroid cancer that progressed within 12 months of new assisted or assisted chemotherapy.
approval for both adaptations will depend on the results of a confirmed randomized controlled clinical trial.
In addition, the NMPA Drug Review Center (CDE) has accepted two new adaptive drug listing applications from Bezean and is in the process of reviewing them, including a combination of chemotherapy for the treatment of patients with advanced non-squamous NSCLC in the first line and one for the treatment of previously treatable patients with non-removable hepatocellular carcinoma.
currently has 15 registered clinical trials of the ® in China and around the world, including 13 Phase 3 clinical trials and 2 critical Phase 2 clinical trials.
2020, Baiji Shenzhou and Novarma reached a cooperation and licensing agreement to develop, produce and commercialize Bazean's manufacturing facilities in North America, Europe ®.
deal is expected to take effect in the first quarter of 2021, provided that the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act expires or terminates early.
has not ® approved outside China.