BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) today announced 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). 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.
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.”
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.
About Eucure Biopharma
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with two products in launched phase II multi-regional clinical trials (MRCT) and two in phase I. For details, please visit https://www.eucure.com/en/index.
Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM/RenLiteTM/RenNanoTM mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum. As of June 30, 2022, this project has resulted in 28 drug co-development agreements and 16 RenMiceTM licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. For more information, please visit http://en.biocytogen.com.cn.
In 2001, Chipscreen Biosciences was founded in Shenzhen, specializing in the research and development of original small molecule drugs. With the self-created "integrated drug discovery and early evaluation platform based on chemical genetics" as its core competitiveness, Chipscreen Biosciences has now become one of China's leading innovative drug enterprises, forming a modern biomedicine group company in Shenzhen, as its headquarters / research and development center / GMP production base, Chengdu, as a regional headquarter / research and development center / GMP production base, Beijing clinical research center and Shanghai commercial center. At present, the company has developed a number of original new drug product lines for tumors, diabetes, and endocrine and autoimmune diseases. In December 2014, the original anti-tumor new drug Chidamide was approved by the China Food and Drug Administration for marketing. Shenzhen Chipscreen Biosciences Co., Ltd. (Stock symbol: 688321.SH) has been listed on the SSE STAR Market on August 12, 2019.
About Chipscreen NewWay Biosciences
Chipscreen NewWay, affiliated with Chipscreen, is an innovative and R&D-driven biotech company dedicated to developing large molecules and other novel therapeutic modalities, including antibodies/ADC-centered large molecules, and nucleic acid drugs.
It develops innovative drugs that meet clinical needs and novel mechanisms of action in multiple therapeutic areas such as oncology and autoimmunity while providing patients with innovative mechanisms and globally leading-based new therapeutic approaches and options.
Chipscreen NewWay has built a large molecular R&D center of over 1,800 square meters in Chengdu Hi-Tech Zone and has established an experienced antibody and ADC R&D team from the discovery to the early process development, with a number of in-house and cooperation projects in continuous and rapid advancements.