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Biocytogen’s YH008 Greater China Licensee Chipscreen NewWay Announces First-Patient-In for Bispecific Antibody NWY001, a Next-Gen Tumor Immunotherapy

Beijing, China, January 5, 2024 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) partner Chipscreen NewWay Biosciences (“Chipscreen NewWay”) achieved first-patient-in for a phase I clinical trial evaluating a PD-1 x CD40 bispecific antibody, NWY001 (originally YH008), at Sun Yat-Sen University Cancer Center in China, the trial-leading institution. The trial is a multi-center, non-randomized, open-label, multi-dose phase I clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.

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NWY001 is world’s first PD-1 x CD40 bispecific antibody (bsAb) entering clinical study. Mechanistically, the bsAb targets two targets synergistically and can activate the CD40 pathway in a PD-1 dependent manner, reducing the potential toxicity commonly associated with CD40 agonism. It is expected that this bsAb can transform “cold” tumors into “hot” tumors, thereby increasing cancer patients’ sensitivity to PD-(L)1 immune checkpoint inhibitors, especially PD-(L)1 antibody resistant cancer patients. Previously, Biocytogen’s wholly owned subsidiary, Eucure Biopharma, reached an exclusive licensing agreement with Chipscreen NewWay for the clinical development and commercialization of YH008 in Greater China.

Dr. Bin Liu, Scientific Director of Chipscreen NewWay, said, “First-patient-in is an exciting milestone for the clinical development of NWY001. Its unique mechanism is expected to circumvent the ineffectiveness or toxicity caused by PD-(L)1 immune checkpoint inhibitor monotherapy, CD40 agonists, or their combination therapy, therefore benefiting more cancer patients. We thank the experts at Sun Yat-Sen University Cancer Center for their support, the clinical and related teams at Chipscreen NewWay for their efforts, and the patients and their families enrolled in this NWY001 clinical trial.”

Dr. Yuelei Shen, Biocytogen’s President and CEO, said, “Congratulations to Chipscreen NewWay for completing the first-patient-in for NWY001. Our bispecific antibody, which was designed with a conditional activation concept in mind, demonstrated impressive preclinical in vivo efficacy. We look forward to seeing this antibody validated in the clinic, bringing new treatment solutions to patients.”

About Chipscreen NewWay

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 3,000 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.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMabTM/RenLite®/RenNano®/RenTCR-mimicTM) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMiceTM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit

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