Xinhé Bio's AI-Driven mRNA Personalized Neoantigen Vaccine XH001 Granted IND Approval, Pioneering a New Paradigm in Precision Oncology

NeoCura's XH001 Injection IND Approval Information

Postoperative tumor recurrence is the biggest pain point in clinical practice, with limited traditional treatment options.

Currently, with the popularization of physical examinations, an increasing number of tumors are being detected at an early stage. Many patients have gained the opportunity for surgical treatment. However, even after receiving various perioperative adjuvant therapies, postoperative recurrence and metastasis remain urgent clinical challenges. Once recurrence occurs, the tumor often cannot be treated with curative intent, meaning that the patient transitions from a previously quasi-"healthy" state to a patient with advanced cancer. There is an urgent need in clinical practice for advanced treatment methods that can effectively reduce the risk of tumor recurrence to improve overall treatment outcomes and patient survival rates. However, the biological characteristics of tumors vary significantly among different patients. Traditional one-size-fits-all treatments always result in some patients benefiting while others do not, making it difficult to achieve precise personalized interventions.

NeoCura’s Self-Developed mRNA Personalized Tumor Neoantigen Vaccine XH001 Enters Clinical Research, Signifying a “Tailored” Approach Based on Patients’ Tumor Mutation Profiles, Truly Achieving the “One Person, One Drug” Revolution in Personalized Treatment – A Prime Example of Precision Medicine. The Clinical Approval of XH001 Brings Hope for Solving the Challenge of Post-Curative Cancer Recurrence.

NeoCura Empowers Precision Targeting with AI and Disrupts Previous Pain Points with mRNA Vaccine Technology.

XH001 is the first personalized tumor neoantigen vaccine developed by NeoCura based on its AI-driven mRNA technology platform. By utilizing the self-developed and proprietary NeoCura AI ALPINE system to screen for highly immunogenic neoantigens, the vaccine integrates the unique mutation profiles of patients' tumor cells with HLA typing data to customize a personalized neoantigen vaccine that activates tumor-specific T cells, precisely eliminating residual tumor cells and reducing the risk of recurrence at the source.

In addition, compared with traditional drugs, another significant advantage of XH001 is that traditional postoperative adjuvant treatments are usually dominated by chemotherapy drugs, which inevitably have toxic side effects and are thus difficult to apply over the long term. However, the immune memory established by vaccines in the human body can persist for a long time, providing patients with prolonged protection that extends beyond the period of drug administration.

NeoCura, with its full-chain self-research and development capabilities, creates industry-leadingmRNA Technology Ecosystem. XH001, developed on this basis with the AI-driven NeoCura ALPINE system, has achieved a breakthrough lead in the global tumor immunotherapy field.

According to reports, the research and development of XH001 innovatively utilized NeoCura's self-built five major scientific platforms. These platforms delve into various aspects such as neoantigen prediction, presentation, immunogenicity validation, mRNA design and efficient delivery, and mRNA drug manufacturing processes, comprehensively enhancing the efficiency of vaccine development and treatment outcomes. Relevant data indicates that this vaccine is well-tolerated and significantly outperforms similar overseas products in key performance indicators such as tumor-specific T-cell activation and maintenance. Clinical research initiated by investigators (IIT) shows that XH001 has good safety and tolerability and can activate specific T-cell immune responses in the body, laying a solid foundation for Phase I clinical trials.

As one of the earlier companies in China to venture into mRNA innovative drug research and development, NeoCura has consistently remained at the forefront of the tumor immunotherapy field, continuously exploring new boundaries as a pioneer.This clinical approval marks a key breakthrough in the clinical transformation of NeoCura in the mRNA innovative drug field, continuously expanding its leading advantage in the industry.According to the clinical trial plan, NeoCura will collaborate with multiple Class III Grade A hospitals in China to conduct a Phase I clinical trial of XH001 injection for adjuvant treatment in patients with high-risk recurrent solid tumors after radical surgery. The trial will systematically evaluate its safety, tolerability, and preliminary efficacy, providing critical data support for subsequent clinical development.

The approval of XH001 marks that China has entered the first tier in the global race for tumor immunotherapy. We look forward to mRNA neoantigen vaccines bringing long-term survival benefits to patients as clinical trials progress, leading the tumor treatment industry into a new era with better efficacy and greater accessibility.

NeoCura is a high-tech enterprise that relies on AI technology to focus on the research and development of RNA innovative drugs. It has built a multi-omics big data collection platform and a multi-layered bio-omics database, using AI and bioinformatics technology for in-depth drug target mining and fully automated drug design for innovative RNA drug research. It has established a leading RNA drug production center in China to support pipeline research and development and clinical needs.