Cell Therapy Platform - BINHUI BIOPHARM

Four

Platforms

Through the accumulation of technology, talents, and management experience gained over the last ten years in the R&D and industrialization of innovative anti-tumor drugs, Binhui Bio has developed a mature technical service platform for viral vectors, nucleic acid drugs, protein drugs, and cell therapies.

Viral Vector Platform

Binhui Bio has developed a mature viral vector platform, and its first product OH2 injection (BS001) was clinically approved by NMPA in June 2018, making it the first clinically researched HSV2-derived OV in China. OH2 injection is currently in phase II clinical trials for multiple indications in China and is set to enter phase III; meanwhile, clinical trials for the drug are also being started in the United State. Moreover, OH2 plus PD-1/PD-L1, BS006, BS008, BS032VX, and other pipeline products are also in the IND application or clinical trial stage in China and the United States. In addition to fulfilling proprietary R&D needs, Binhui Bio assist customers in accelerating their R&D processes and lowering production costs by providing R&D and production services for viral vectors such as the herpes simplex virus, adenovirus, poxvirus, lentivirus, and retrovirus through this platform.

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Nucleic Acid Platform

Binhui Bio's nucleic acid platform (BH-RACE platform) has four remarkable features: rapid, easy to be amplified, uncapped, and economical. With uncapped mRNA structure synthesis without using N1mψTP, combined with the proprietary encapsulation instrument and LNP delivery system, Binhui Bio significantly lower the cost of mRNA products, simplify production process, and shorten the production cycle. Covid-19 S protein trimer mRNA vaccine and HSV2-gD protein mRNA vaccine, which have been developed based on the BH-RACE platform, can effectively activate humoral and cellular immunity in animals. Relying on the company's BH-RACE platform, Binhui Bio provides services including plasmid preparation, mRNA in vitro transcription, mRNA/DNA purification, liposome preparation, mRNA/DNA encapsulation, filling, and product quality control. Additionally, the platform provides encapsulation instruments and some nucleic acid raw materials, which can effectively meet the demands for mRNA vaccines/drugs at research and GMP levels.

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Protein Platform

Binhui Bio's protein platform has the unique trimer domain (TD) antibody affinity purification technology for target protein that enables one-step purification of trimer protein. Since it is combined with the efficient mammalian cell and insect cell expression system, this platform can quickly meet the purification needs of COVID-19 recombinant protein vaccines and other products. After process development, efficacy evaluation and safety evaluation the COVID-19 S protein trimer vaccine will soon be submitted for an IND application. Binhui Bio's protein platform also provides expression and purification services for small polypeptide and large proteins, as well as protein interaction research.

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Cell Therapy Platform

Binhui Bio's cell therapy platform includes OV-activated immune cell therapy (VAK) and BsAb-activated immune cell therapy (Bat-T). At present, VAK cell therapy is in the IIT stage, and Bat-T cell therapy is in the preclinical research stage. Based on this platform, Binhui Bio provides the whole process design of preclinical and clinical research for T cell, NK cell, DC cell, and other cell therapies, covering preclinical pharmacodynamics, safety evaluation, production SOPs, quality inspection SOPs, design, and development of clinical research protocols, etc. Meanwhile, this platform also provides consultation and design services for pilot-scale cell therapy GMP compliant workshops.

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