STATEMENT: WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval

(Information sent by the signatory company).

STATEMENT: WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval

(Information sent by the signatory company)

CHENGDU, China, May 10, 2024/PRNewswire/ -- WestGene, a biotechnology company focused on mRNA technology, announces a historic milestone with the FDA IND approval of its therapeutic mRNA cancer vaccine, WGc. 043. This landmark achievement marks the first global approval of an EB virus-related mRNA therapeutic cancer vaccine.

Founded by renowned Dr. Yuquan Wei, an academician of the Chinese Academy of Sciences, and Dr. Xiangrong Song, WestGene has become a driving force in mRNA technology research and innovative drug development. With a relentless pursuit of scientific excellence, WestGene's latest milestone underscores its commitment to advancing the frontiers of biomedicine.

The FDA approval of WGc-043 represents a significant advance in cancer treatment and offers new hope to patients with advanced EB virus-related cancers. EB virus is highly correlated with more than 10 malignancies, including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer , breast cancer, cervical cancer and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus. These are potential indications for WGc-043.

WGc-043 shows promising efficacy, low toxicity, wide applicability, efficient scalability, and cost-effectiveness. WGc-043 has already completed investigator-initiated trials (IITs) in NPC and NKTL, demonstrating superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines. Once successfully launched, WGc-043 will provide a new treatment option for patients with advanced EB virus-positive solid tumors and hematological malignancies.

As WestGene moves forward, its strategic focus on global collaboration underscores its vision for business expansion and market penetration. With a diverse portfolio of more than 20 mRNA-based therapeutic products targeting a spectrum of diseases, WestGene is poised to reshape the biopharmaceutical landscape. WestGene has made significant advances in the three key technologies of mRNA drug development: mRNA sequence design, delivery vectors, and manufacturing. And the patent for ionizable lipids has been granted in countries and regions such as China, the United States and Europe.

The FDA's approval of WGc-043 marks a turning point in the fight against cancer and underscores WestGene's commitment to mRNA technology. As WestGene continues to push the boundaries of scientific discovery, its pioneering spirit promises to open new frontiers in cancer therapy and beyond.

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