On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd ("Yuansong Biotechnology") announced that its self-developed lysosomal virus Class I new drug "Recombinant L-IFN Adenovirus Injection (YSCH-01)" has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors.

The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the treatment of multiple in-situ or metastatic tumors in the lungs.
Dr. Kangjian Zhang, Co-founder and General Manager of YuanSong Bio, said, "The approval of CDE is a leap from the early stage of research and development to the clinical trial of the strategy of "Cancer Targeted Gene-Viral Therapy (CTGVT)", which marks another solid and firm step towards the market for YSCH-01, and opens up a new mileage in the research and development of innovative drugs. This also fully proves that YSCH-01 is the first innovative drug to be developed in China. This also fully proves the excellent ability of the frontline team of YSCH-01 from drug discovery to clinical development in China and the U.S. It is believed that the YSCH-01 team will continue to apply what they have learned and make progress in the future, so as to provide more choices for the treatment of cancer patients.
Product Characteristics

"Recombinant L-IFN Adenovirus Injection (YSCH-01) is an oncolytic viral product based on the strategy of "Cancer Targeted Gene-Virus Therapy (CTGVT)", which is developed independently by the R&D team of Yuansong Bio. YSCH-01 is developed by the R&D team of Yuansong Biotechnology and possesses completely independent intellectual property rights. The preclinical study of YSCH-01 has confirmed that it has the characteristics of dual regulation, high safety and broad-spectrum anti-cancer. The results of existing studies show that YSCH-01 has a very innovative multiple anti-cancer mechanism, with a wide range of indications, significant effect in at least 7 solid tumor categories, significant direct tumor lysis effect, and also has a significant distant anti-cancer effect; relies on long-lasting immune-memory NK cells to fight against cancer, and at the same time induces the tumor cells' own antigen to be significantly raised, which greatly weakens the immune escape ability of the tumor; reverses the immune brake protein PD-L1-negative, which is a key factor in the development of the tumor cells. brake protein PD-L1-negative tumors into a strong positive, providing a theoretical basis for the combined immune test point monoclonal antibody sequential combination of drugs. In an investigator-initiated clinical trial (IIT), YSCH-01 has also demonstrated excellent safety and anti-cancer efficacy, making it a theoretically more effective CTGVT product that combines tumor targeting and safety.

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