On February 27, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd. ("Eucure Biopharma"), has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences ("Chipscreen NewWay"), a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan) (Press release, Biocytogen, FEB 27, 2023, View Source [SID1234627780]). Eucure Biopharma retains YH008’s global rights to develop and commercialize YH008 outside Greater China. Under the agreement, Chipscreen NewWay will pay Eucure Biopharma an upfront payment of 40 million RMB, a potential development milestone payment of up to 360 million RMB, a potential sales milestone payment of up to 196 million RMB, as well as tiered royalties on net sales.
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YH008 is Biocytogen’s independently developed proprietary bispecific antibody for tumor immunotherapy. The IND application for a phase I study of YH008 was cleared by the US FDA and accepted by the Chinese NMPA.
"Chipscreen Biosciences and Chipscreen NewWay have extensive experience in clinical drug development and commercialization," said Dr. Yuelei Shen, President and CEO of Biocytogen. "With this agreement in place, we will work together to accelerate YH008’s entry into the market to benefit patients."
"Biocytogen’s YH008 has unique mechanisms and outstanding preclinical results," said Dr. Xianping Lu, CEO and President of Chipscreen Biosciences. "This licensing agreement will expand Chipscreen NewWay’s pipeline in the field of antibody drugs and immuno-oncology. I look forward to these fruitful collaborations."
"The unique mechanism of action of YH008 bring together the synergies of immune activation and immunosuppressive blockade, and can reduce toxic side effects and increase safety," said Dr. Bin Liu, Head of the Center of Antibody Early R&D at Chipscreen NewWay. "The clinical potential of YH008 is worth looking forward to and it is a good addition to the products under development of Chipscreen NewWay. Chipscreen NewWay will rapidly advance the clinical stage research and development of YH008."
About YH008
YH008 is a bispecific antibody that exerts antagonistic and agonistic activities. In vitro and in vivo studies indicate that YH008 can conditionally activate the immune pathway in the tumor microenvironment where certain tumor specific T cells are enriched to avoid systemic non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity when compared to parental monoclonal antibodies (mAbs) or combination therapy in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark mAbs.