On October 8, 2022, the foundation laying ceremony of the tumor immunotherapy drug industrial base of Wuhan Binhui Biotechnology Co., Ltd. (hereinafter referred to as Binhui Biotechnology), an invested enterprise of Denuo Capital, was held in Wuhan Optics Valley Biological City Medical Park.
On October 8, 2022, the foundation laying ceremony of Binhui Biological Tumor Immunotherapy Drug Industry Base was held in Wuhan East Lake High tech Zone Optical Valley Biological City Medical Park. The leaders of Hubei Provincial Department of Human Resources and Social Security, Wuhan National Bio industry Base Construction Service Center, Hubei Provincial Party Committee Organization Department Talent Office, Hubei Provincial Talent Development Center Professional and Technical Talent Service Office, Hubei University of Technology leaders and shareholder representatives such as DeNuo Capital, Shared Investment and Jiuzhoutong jointly laid the foundation for the project.
The construction area of Binhui Biological Tumor Immunotherapy Drug Industry Base Project is 45000 square meters. It is planned to build a GMP compliant office and research and development platform, storage and related supporting facilities for pilot and production rooms. It is expected to be completed and put into use by the end of 2024. The established tumor immunotherapy drug industry base is mainly used for the production of recombinant oncolytic type I herpes simplex virus 0H2 injection and the development and production of other candidate new drugs. At the same time, it can fully meet the CMC and CDMO business development, drive the upstream and downstream industrial chains, promote employment, and boost regional economic construction and development.
At the end of September 2022, the key dish phase clinical trial of Binhui Biological's first oncolytic virus candidate drug, 0H2 injection, to treat Yansu tumor completed the ethical process in Peking University Cancer Hospital. 0H2 injection was approved by NMPA in 2018, becoming the first oncolytic virus in the world to enter clinical research with herpes simplex virus type A as the carrier; In August 2021 and July 2022, 0H2 injection was approved by the US FDA for clinical trials and orphan drug identification respectively, becoming the first oncolytic virus candidate drug independently developed by China and certified by the US FDA for orphan drugs.
From the first candidate drug of oncolytic virus to oncolytic virus expressing bispecific antibody, to oncolytic virus COCKTAIL therapy, Binhui Biological has formed a rich product pipeline; From viral vector platform to recombinant protein drug platform, to differential nucleic acid drug platform, 1+1>2 platform synergy is emerging; From the combination of drugs, expansion of indications and frontline treatment to promoting clinical research, to the submission of IND application to FDA, overseas layout has become a more sensible strategy; From single drug discovery to CMC and CDMO, the whole industrial chain has been deeply connected from innovative research, clinical trials to product production.
Following the approval of 0H2 injection to carry out clinical trials in the United States, BS006 injection, the second oncolytic virus candidate drug of Binhui Biology, has submitted an IND application to FDA; The combined use of several oncolytic viruses (COCKTAIL therapy) has been patented in the United States. At the same time, Binhui Biology has built a platform for protein medicine and nucleic acid medicine with distinctive characteristics. The COVID-19 3 protein trimer vaccine produced by the protein drug platform with the molecular clip purification technology with independent intellectual property rights has been proved to have a strong cross protection effect on a variety of virus strains by experiments; The LNP delivery carrier developed by the nucleic acid drug platform has obtained patent authorization, and innovatively designed a non capped structure without using pseudouridine( ψ ) Replacing the molecular structure of uridine not only improves the production efficiency, but also greatly reduces the cost.
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