Transferred from: Medicilon

Recently, Yuanben (Zhuhai Hengqin) Biotechnology Co., Ltd. announced that its YB-01 for injection has been approved by the National Medical Products Administration (NMPA) of China for clinical trials after successfully obtaining clinical trial approval from the U.S. Food and Drug Administration (FDA) in December 2024. This milestone not only demonstrates the hard-core innovation strength of Yuanben Biosciences in the field of tumor immunotherapy, but also injects new hope into the development of global cancer therapy!

As a partner of Yuanben Biopharma, Shanghai Medicilon Biopharmaceutical Co., Ltd. provided pharmacodynamic research services for YB-01 with its deep R&D experience in the field of oncology drugs, accelerating its realization of dual application and approval in China and the United States.

Off-the-shelf cancer vaccines targeting MUC1

YB-01 may become a "rising star" in cancer immunotherapy

YB-01 is a off-the-shelf cancer vaccine targeting MUC1 specific epitope, which has been continuously iteratively optimized on the basis of summarizing products in the same technical track, and its unique design shows revolutionary therapeutic potential

Precise targeting, broad-spectrum anti-tumor: Combined with the characteristics of differentiated expression of MUC1 antigen in normal state and tumor tissues, and referring to the research and development ideas of neoantigen vaccines, it is designed to only target the MUC1 antigen determinants expressed in tumor cells, which can not only effectively target tumor cells, but also reduce cross-reactivity to normal cells. At the same time, because of the widespread presence of MUC1 in different tumor types, the varieties have broad-spectrum tumor resistance.

Multi-fragment tandem to break through MHC limitations: Designed as a repeat tandem of multiple MUC1 immunodominant fragments, it enables it to directly bind and activate T cells without being limited by major histocompatible complex complexes (MHCs).

Addition of CpG adjuvant to enhance immunity: The formulation is designed to directly add CpG adjuvant, which can specifically activate the Toll-like receptor signaling pathway, so that the final formulation product can be activated by multiple targets and pathways, and enhance the intensity and duration of the immune response. The success of proof-of-concept (POC) clinical trials such as off-the-shelf cancer vaccine OSE2101 with the same design concept has demonstrated the feasibility of the technology used in this vaccine.

At present, YB-01 has been granted Chinese invention patents and international PCT patent protection. The results of preclinical studies have shown that the variety has a clear pharmacodynamic effect, a precise mechanism of action, a clear immune law, no obvious safety risks, and has the potential of a variety of combination drugs, which further confirms the potential to become a "rising star" in cancer immunotherapy.

　　MEDICILON

Medicilon 440+ tumor models

Accelerate the development of innovative anti-tumor therapies

Efficient and reliable efficacy models are the key to success in oncology drug development. In this field, Medicilon has built a complete pharmacodynamic evaluation system, covering 440+ tumor efficacy evaluation models, including PDX models, allograft tumor models, xenograft tumor models, human tumor transplantation models, and tumor multi-drug resistance models, etc., which can be ADC, PROTAC, CAR-T, TCR-T, CAR-NK, Oncolytic Virus, antibodies (monoclonal antibodies/bispecific antibodies/polyclonal antibodies, etc.), siRNA, AAV and other drugs provide efficacy evaluation services to help customers make efficient decisions, shorten the R&D cycle, and improve the success rate.

Medicilon congratulates Yuanben Biotech on the successful submission and approval of YB-01, and looks forward to the smooth progress of clinical trials and providing better choices for global cancer treatment. In the future, Medicilon will continue to support more breakthrough therapies like YB-01 to the clinic and the world with tumor pharmacodynamic models and one-stop preclinical R&D services.

About Yuanben Biotech

Founded in 2021 by patriotic overseas Chinese and local top scientists, Yuanben (Zhuhai Hengqin) Biotechnology Co., Ltd. has established a complete industrialization team covering production, quality, registration, legal affairs and other functions.

The company is committed to the development of first-in-class drug therapies for complex and refractory diseases such as malignant tumors, autoimmune diseases, Alheimer's disease, Parkinson's disease, etc., and has a therapeutic protein vaccine platform with completely independent intellectual property rights.

After years of technology precipitation, the company has established a rich R&D pipeline including therapeutic cancer vaccines, therapeutic drugs for neurodegenerative diseases and a variety of targeted diagnostic products.

Medicilon (stock code: 688202.HK) Founded in 2004 and headquartered in Shanghai, SH is committed to providing a full range of preclinical new drug research services for global pharmaceutical companies, research institutions and researchers. Medicilon's one-stop comprehensive service helps customers accelerate the process of new drug development with strong project management and more efficient and cost-effective R&D services, covering the whole process of pharmaceutical preclinical new drug research, including drug discovery, pharmaceutical research and preclinical research. By the end of 2024, Medicilon has provided drug R&D services to more than 2,000 customers around the world, and has participated in the research and development of about 520 IND clinical trials of new drugs and generic drugs, growing together with high-quality customers at home and abroad. Medicilon will continue to be based on a global vision, focus on China's innovation, and contribute to human health!

(Redirected from: Medicilon).