Xinhe Bio's First-in-Class mRNA Tumor Neoantigen Vaccine XH101 Receives IND Approval in China, Marking a Milestone in RNA Oncology

Mar 07, 2023 14:15 CST Updated 14:15

On March 4, 2023, Shenzhen Xinhe Biomedical Technology Co., Ltd. submittedofChina's First mRNA Tumor Neoantigen VaccineThe Investigational New Drug (IND) application for XH101 Injection has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration [Acceptance Number: CXSL2300170].This target is a global first-in-class target., Xinhe Bio achieves a milestone in the field of RNA-based cancer therapy.

图片1.png Acceptance Information for the IND Application of XH101 Injection

XH101 Injection is a first-in-class therapeutic mRNA tumor vaccine targeting gastric cancer public neoantigens, pioneered globally by Xinhe Bio. This public neoantigen is a highly immunogenic and broadly covering tumor public neoantigen sequence that was screened, predicted, and validated from a large cohort of gastric cancer patients using Xinhe Bio’s proprietary platforms, including a tumor neoantigen prediction algorithm platform, an immunogenicity Elispot validation platform, and a cell cytotoxicity platform. Preclinical study data demonstrate that XH101 Injection can effectively elicit T-cell immune responses and induce tumor cell killing effects, highlighting its significant potential for clinical therapy.

Xinhe Biologics Vaccine Production Workshop

Gastric cancer is a malignant tumor originating from the gastric mucosal epithelium and is one of the most prevalent malignancies in China. According to statistics from the International Agency for Research on Cancer (IARC), there were approximately 1.1 million new cases of gastric cancer globally in 2020, with Chinese patients accounting for 43.9% of this total, or about 480,000 cases, ranking first worldwide. Data show that in 2020, China had 480,000 new cases of gastric cancer and over 370,000 deaths, highlighting an urgent need for innovative therapies to address this significant public health challenge.

Against this backdrop, Xinhe Biopharma has independently developed XH101, an mRNA tumor shared neoantigen vaccine injection for gastric cancer, leveraging its cutting-edge AI+RNA technology and top-tier R&D team. Compared with traditional drugs, this vaccine exhibits stronger immunogenicity and can induce the body’s natural immune response. It not only shortens the vaccine preparation cycle and reduces treatment costs for patients, but also generates durable and effective immune memory in vivo, offering the potential to prevent tumor recurrence and metastasis. Furthermore, XH101 injection can effectively inhibit advanced and metastatic tumors.

图片2.png Xinhe Bio Vaccine R&D Laboratory

In the future, Xinhe Bio aims to provide patients with more safe and effective innovative RNA therapeutics through continuous R&D, promote high-quality clinical translation and application of innovative RNA drugs, address unmet clinical needs, and bring more and better treatment options to patients at an earlier date.