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Posted by Deng Yue
Jan 4
Filed in Health
#new drug
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DengyueMed Report: China's National Medical Products Administration has approved a milestone antitumor new drug—Bezean (Tislelizumab Injection)—for the treatment of various advanced solid tumors, including non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), and hepatocellular carcinoma. This breakthrough advancement marks a key step in China's independently developed innovative drugs in the field of cancer immunotherapy, providing more effective treatment options for tumor patients with PD-L1 expression positivity.
Development Background: Innovative Exploration from Laboratory to Clinic
The birth of Bezean stems from cutting-edge explorations by the BeiGene scientific team. Targeting the key role of the PD-1/PD-L1 pathway in tumor immune evasion, the research team innovatively designed a high-affinity IgG4 monoclonal antibody that specifically blocks the binding of PD-1 to PD-L1, activating T-cell immune responses and enhancing the body's killing power against tumors. Particularly noteworthy is the drug's optimized Fc segment structure, which avoids antibody-dependent cell-mediated cytotoxicity (ADCC), thereby reducing the depletion of effector T cells. In preclinical studies, it demonstrated excellent tumor suppression effects and safety, bringing new hope to patients with various solid tumors.
Clinical Data: Dual Breakthrough in Efficacy and Safety
Bezean's approval is based on outstanding data from multiple global multicenter clinical studies (such as the RATIONALE series). The studies show that in PD-L1 expression-positive advanced esophageal squamous cell carcinoma (ESCC) patients: the objective response rate (ORR) reaches over 40%, with up to 60% in first-line combination chemotherapy patients; the median progression-free survival (mPFS) is 7-10 months, extending to over 12 months in first-line treatment patients; the median overall survival (mOS) exceeds 18 months, significantly prolonging patient survival time. The efficacy in NSCLC patients is particularly outstanding, with a reduction in progression-free survival risk of over 30% in first-line combination chemotherapy, and overall safety is good, with common adverse reactions mainly being mild to moderate rash and fatigue, and the incidence of severe immune-related adverse events below 10%.
International Recognition: A Milestone for Chinese Innovative Drugs Going Global
In 2025, Bezean was approved by the European Commission for perioperative treatment of resectable NSCLC, becoming the first PD-1 inhibitor approved in the EU with a Chinese pharmaceutical company as the main entity. This achievement not only validates the global recognition of multiple international Phase III studies but also signifies China's new drug R&D transitioning from "following" to "leading." The U.S. FDA had previously approved it for esophageal squamous cell carcinoma and gastric cancer treatment and granted orphan drug designation, highlighting its global clinical value.
Patient Benefits: Ushering in a New Era of Precision Cancer Diagnosis and Treatment
The launch of Bezean has driven changes in the cancer diagnosis and treatment model. As a preferred immune drug among PD-1 inhibitors, its intravenous injection administration convenience (recommended dose of 200mg every 3 weeks) significantly improves treatment compliance. After its further inclusion in the national medical insurance catalog in 2025, the monthly treatment cost for patients has been significantly reduced, benefiting more families, especially providing accessible immunotherapy options for low-income patients.
Future Outlook: From Chinese Original Research to Global Accessibility
Bezean's success is a model of collaborative innovation among industry, academia, and research. The collaboration between BeiGene and global partners not only fills the domestic gap in high-end immunotherapy drugs but also provides a "Chinese solution" for subsequent innovative drug R&D. With the advancement of more indication studies, this drug is expected to become an important choice for global cancer immunotherapy. Enterprises like DengyueMed are using Bezean as a pivot, promoting China's pharmaceutical industry transformation from "manufacturing" to "intelligent manufacturing" through technological breakthroughs, supply chain optimization, and international cooperation. In the field of life and health, this process demonstrates how innovation rewrites disease outcomes, and the transformation of global pharmaceutical procurement will bring hope to more patients.
