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バイオサイトジェンのビジョン
バイオサイトジェンは、創造的かつ規模化された抗体医薬品開発プラットフォーム「RenMice HiTS Platform」を基に革新的な抗体医薬品開発を続けていきます。
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研究領域
新薬研究開発の全過程をプラットフォーム化して、バイオサイトジェンは免疫療法, 自己免疫疾患, 代謝疾患および感染病などの疾病領域について様々な研究開発を行っています。様々な疾患に対して高い効果と安全性を持つ抗体医薬品を開発·普及することに力を注いでいます。
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CTLA-4
OX40
CD40
4-1BB
抗感染
バイオサイトジェンの技術
バイオサイトジェンが独自開発したRenMiceプラットフォームを基に、弊社はGPCR創薬研究開発プラットフォーム、TCR技術プラットフォーム、二重特異性抗体技術プラットフォームなど、抗体医薬品ディスカバリープラットフォームを持続的に構築し、規模化された抗体医薬品の開発を加速しています。
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研究提携
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Beijing, China, December 8, 2021 – Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient dosing for a phase II clinical trial of YH003 (anti-CD40 monoclonal antibody, mAb) (No. YH003004) in Australia. The open-label, multi-regional clinical trial (MRCT) will evaluate the efficacy and safety of YH003 in combination with Toripalimab (anti-PD-1 mAb) for the treatment of patients with PD-(L)1 resistant unresectable/metastatic melanoma or pancreatic ductal adenocarcinoma (PDAC). The trial will be conducted in Australia, the United States, China and other countries or regions. Each subject will receive 0.3 mg/kg YH003 and 240 mg Toripalimab every-three-week to evaluate the antitumor efficiacy and safety in three parallel cohorts. The first two cohorts will consist of subjects with unresectable/metastatic melanoma that failed PD-1/PD-L1 treatment, or subjects with unresectable/metastatic PDAC who failed first-line treatment, respectively. The third cohort will evaluate YH003/Toripalimab plus standard chemotherapy (Nab palitaxel + Gemcitabine) as first-line treatment in subjects with unresectable/metastatic PDAC. The study adopts Simon’s two-stage optimization design. The evaluation will be made when each cohort has recruited 18 subjects. The study marks the first phase II clinical trial for Biocytogen. Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the company will continue making rapid progress to develop safe and effective innovative medicines to benefit patients worldwide. About YH003 YH003 is a humanized IgG2 agonistic CD40 antibody. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Phase I dose-escalation data indicates a desirable safety profile of YH003/Toripalimab. About Eucure Biopharma Eucure Biopharma develops innovative antibody drugs for Biocytogen’s R&D pipelines in oncology and other indications. Relying on a strong team with extensive clinical development experience, the company‘s pipeline includes more than 10 targets. At present, four products have received clinical trial approvals in the US and China including two products that have obtained phase II clinical approvals from both the FDA and NMPA, two products that have entered phase I clinical trials in China, and four in phase I clinical trials in Australia. About Biocytogen Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. Using RenMabTM and RenLiteTM mice for fully human antibody production, Biocytogen has integrated its monoclonal and bispecific antibody development platforms, in vivo drug efficacy screening platforms and strong clinical development ability to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs in collaboration with global partners for more than 1000 druggable targets, known as the RenMiceTM HiTS Platform. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, and Boston, USA.
2021.12.08
BEIJING, December 7, 2021 - Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the completion of first patient dosing for phase I clinical trial of YH004 (anti-4-1BB monoclonal antibody, mAb) (No. YH004002) in Australia. The study is an open-label, multi-center and classical dose-escalation phase I study of YH004 alone or in combination with anti-PD-1 mAb. Subjects are patients with advanced solid tumor or relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The objective of the study is to evaluate the safety, tolerability and efficacy of YH004 alone or in combination with anti-PD-1 mAb in patients with advanced solid tumor or R/R NHL. Pharmacokinetics and immunogenicity of YH004 will also be evaluated. Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that happy to see the completion of first patient dosing for phase I clinical trial of YH004 in Australia. We will continue making rapid progress in clinical studies of YH004 so that patients around the world may be able to access the innovative, safe and effective therapy as soon as possible. About YH004 YH004 is a humanized IgG1 agonistic monoclonal antibody (mAb) targeting 4-1BB with high affinity and specificity. YH004 can enhance the immune response against tumor through multiple mechanisms. Antibody mediated activation of 4-1BB can enhance the co-activation of T cells, enhance NK cell cytotoxicity, promote the maturation of antigen presenting cells (APCs) and inhibit regulatory T cells (Tregs). Both in vitro and in vivo data showed YH004 alone or in combination with anti-PD-1 antibody having significant anti-tumor activities with good safety and tolerability. About Eucure Biopharma As a wholly-owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen R&D pipelines. Relying on a strong clinical development team and rich clinical development experience, Eucure Biopharma develops innovative drugs to meet clinical needs for patients in China and around the world. Biocytogen focuses on antibody drug therapy of tumor and non-tumor. The company has established a product pipeline for more than 10 targets. At present, four products have received clinical trial approvals in the US and China including that two products have obtained the phase II clinical approvals from both FDA and NMPA, two products have entered the phase I clinical trials in China, and four at phase I clinical trials in Australia. About Biocytogen Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to patients around the world. Based on the fully human antibody RenMabTM and RenLiteTM mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in monoclonal and bi-specific antibody development platforms, in vivo drug efficacy screening platforms and strong clinical development ability to streamline the entire drug development process. Biocytogen is developing antibody drugs in large-scale for more than 1000 druggable targets known as Project Integrum. With the implementation of the Project, Biocytogen will collaborate with global partners to constantly produce many first-in-class and/or best-in-class antibody drugs to benefit patients. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai and Boston US.
2021.12.07
ニュース & ウェビナー
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08
Dec , 2021
Biocytogen/Eucure Biopharma Announce the Completion of First Patient Dosing for Phase II Clinical Trial of YH003 in Australia
Beijing, China, December 8, 2021 – Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient dosing for a phase II clinical trial of YH003 (anti-CD40 monoclonal antibody, mAb) (No. YH003004) in Australia. The open-label, multi-regional clinical trial (MRCT) will evaluate the efficacy and safety of YH003 in combination with Toripalimab (anti-PD-1 mAb) for the treatment of patients with PD-(L)1 resistant unresectable/metastatic melanoma or pancreatic ductal adenocarcinoma (PDAC). The trial will be conducted in Australia, the United States, China and other countries or regions. Each subject will receive 0.3 mg/kg YH003 and 240 mg Toripalimab every-three-week to evaluate the antitumor efficiacy and safety in three parallel cohorts. The first two cohorts will consist of subjects with unresectable/metastatic melanoma that failed PD-1/PD-L1 treatment, or subjects with unresectable/metastatic PDAC who failed first-line treatment, respectively. The third cohort will evaluate YH003/Toripalimab plus standard chemotherapy (Nab palitaxel + Gemcitabine) as first-line treatment in subjects with unresectable/metastatic PDAC. The study adopts Simon’s two-stage optimization design. The evaluation will be made when each cohort has recruited 18 subjects. The study marks the first phase II clinical trial for Biocytogen. Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the company will continue making rapid progress to develop safe and effective innovative medicines to benefit patients worldwide. About YH003 YH003 is a humanized IgG2 agonistic CD40 antibody. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Phase I dose-escalation data indicates a desirable safety profile of YH003/Toripalimab. About Eucure Biopharma Eucure Biopharma develops innovative antibody drugs for Biocytogen’s R&D pipelines in oncology and other indications. Relying on a strong team with extensive clinical development experience, the company‘s pipeline includes more than 10 targets. At present, four products have received clinical trial approvals in the US and China including two products that have obtained phase II clinical approvals from both the FDA and NMPA, two products that have entered phase I clinical trials in China, and four in phase I clinical trials in Australia. About Biocytogen Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. Using RenMabTM and RenLiteTM mice for fully human antibody production, Biocytogen has integrated its monoclonal and bispecific antibody development platforms, in vivo drug efficacy screening platforms and strong clinical development ability to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs in collaboration with global partners for more than 1000 druggable targets, known as the RenMiceTM HiTS Platform. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, and Boston, USA.
30
Nov , 2020
Biocytogen Teams With Ina Research To Boost Presence In Japan
Beijing, China and Nagano, Japan; November 30, 2020-Beijing Biocytogen Co., Ltd. (hereinafter “Biocytogen”) announced today that it has entered into a commercial agency agreement with Ina Research Co., Ltd. (hereinafter “INA”) to expand its business in Japan market. As one of the world’s largest pharmaceutical markets, Japan has an established reputation for innovative drug research and development. The partnership will help introduce Biocytogen’s innovative animal models and its world-class antibody drug research capabilities to Japanese customers in various therapeutic fields including but not limited to immuno-oncology and auto-immune diseases. Under the agreement, INA represents Biocytogen as a sales agent and distributor to promote Biocytogen’s animal models and research services and capabilities in Japan. “As both INA and Biocytogen having a strong focus on supporting pharmaceutical partner’s development on novel therapeutics, each has strength at different drug development stages. Therefore, the partnership would be a perfect match and create added value. By working as a team, we can provide a streamlined drug discovery and development platform to our business in Japan.” said Yuelei Shen, Ph.D., president and CEO of Biocytogen. “We feel the thriving demand in Japan for animal models and non-clinical in vivo drug efficacy evaluation services, especially in the field of immunotherapy. Biocytogen‘s animal models and research capabilities have been recognized by  world-wide customers including top MNCs in US, Europe and China for years and we would love to introduce them into Japan to support our customers and more importantly, to help accelerate drug innovation here in Japan.” said Kenshi Nakagawa, president and CEO of INA. The partnership gives Biocytogen immediate access to INA’s well-established Japanese customer network including top pharmas, biotechs and institutes in the country. To fulfill the agreement, INA has already hosted a webinar in early October and will launch more events and campaigns to raise awareness of the models and services provided by its newly forged partner, Biocytogen. Company Profile About Beijing Biocytogen Co., Ltd. Biocytogen is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to the patients around the world as its mission. Biocytogen has established a highly integrated antibody drug discovery platform based on a series of genetically-modified animal models. Biocytogen has developed the RenMab™ mouse model for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity. Biocytogen has launched a pioneering antibody drug development plan (KO target library: https://biocytogen.com/renmab-mouse/project-integrum/) to tackle difficult targets based on the immunization of RenMab™ knockout mice. Nearly 1,500 targets knockout mouse strains will be generated within 2 years for antibody discovery. Moreover, with the knockout immunization strategy, antibody hits cross-reacting with different species shall be more likely to be generated for better translational efficacy and toxicity evaluation. With the world-class expertise in genetically-engineered animal development and maintenance with large-scale animal breeding capacity, antibody discovery, and preclinical pharmacology services, the company provides seamless integrated antibody discovery services to the biomedical community for a true one-stop solution from target to IND application and has built its collaboration with more than 2,000 partners worldwide, including over 70% of top 20 MNCs. About Ina Research Co., Ltd. Founded in 1974, Ina Research’s headquarters is in the city of Ina, located in the Nagano prefecture, and it operates offices in Tokyo. The firm’s shares are traded publicly on the JASDAQ exchange. Ina’s scientists primarily conduct analysis and safety and efficacy studies for customers in the pharmaceutical industry, though the organization also works with companies that produce agricultural chemicals and medical equipment. Research specialties including drug dependence studies, efficacy studies for central nervous system therapies, cancer studies, reproductive and developmental toxicity studies, and animal models. Ina has established a research center on Ina’s campus under the collaboration with academic institute to conduct non-clinical safety studies for CAR-T therapy, funded by the Japan Agency for Medical Research and Development.
01
Feb , 2021
Biocytogen and LiberoThera Enter into Strategic Collaboration Agreement
Beijing, China and Tokyo, Japan, February 1st, 2021 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”) and LiberoThera Co.,Ltd (“LiberoThera”) announced today that they have entered into an agreement for strategic collaboration on fully human therapeutic GPCR antibody development incorporating Biocytogen’s world-class antibody discovery expertise based on its fully human antibody RenMab™ mouse platform with LiberoThera’s state-of-the-art antigen preparation capabilities. The collaboration is expected to yield fully human GPCR antibodies for therapeutic use. Under the terms of the agreement, the companies will jointly work on the discovery research targeting an oncology-related GPCR until completion of in vivo evaluation studies as a first step. LiberoThera will provide antigens and assistance on in vitro screening while Biocytogen commits to use its RenMabTM mouse platform for the GPCR antibody generation and lead the in vitro and in vivo evaluation. ”GPCR monoclonal antibodies have great potential in various therapeutic areas. However, development of GPCR antibodies remains challenging due to the lack of understanding of the targets their biology and structure plus the technical hurdles in antigen design, preparation, modification, etc. With LiberoThera’s unique GPCR antigen preparation platform and its in-depth understanding of the target structure, we believe this strategic collaboration can break bottlenecks through leveraging the strengths of both ends to propel therapeutic GPCR antibody development forward.” said Yuelei Shen, Ph.D., president and CEO of Biocytogen. “We are excited about this strategic collaboration as we see a great potential and synergy of Biocytogen’s innovative humanized models and streamlined antibody development platform together with LiberoThera’s membrane protein technologies.” said Toru Kanke, Ph.D., CEO of LiberoThera. “The fully human antibody RenMabTM Mouse developed by Biocytogen together with the target knock-out strategy and single-cell screening platform will increase the fully human antibody repertoire against the targets. In combination with our structural antigen, discovery of antibodies with functional properties are highly expected. In addition, it is more likely to discover antibodies cross-reacting to orthologs of other species for convenient downstream evaluation in animal models. With its established in vivo testing capabilities, altogether, Biocytogen’s platform allows for a streamlined solution to improve the productivity of GPCR therapeutic antibody drug development. Collaboration between LiberoThera and Biocytogen would be a good match on confronting the challenges in the field.” About Biocytogen Pharmaceuticals (Beijing) Co., Ltd. Biocytogen is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to the patients around the world as its mission. Based on the fully human antibody RenMab™, RenLite™ and RenNano™ mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in single-cell antibody discovery, gene editing, large-scale animal model supply, and screening to form a new approach to streamline the entire drug development process. Biocytogen has launched a pioneering antibody drug development plan (Project Integrum https://renmab.com/ko-library/) to tackle difficult targets based on the immunization of RenMabTM knockout mice. More than 1,000 targets knockout mouse strains will be generated within 2 years for antibody discovery. Moreover, with the knockout immunization strategy, antibody hits cross-reacting with different species shall be more likely to be generated for better translational efficacy and toxicity evaluation. Biocytogen collaborates with global partners to accelerate new drug discovery and development. For more information, please visit https://biocytogen.com/. About LiberoThera Co., Ltd. LiberoThera is an early-stage drug discovery company targeting GPCRs (https://www.liberothera.com/). The company was established in 2018 aiming to contribute to medical care through innovative drug discovery utilizing the novel membrane protein technologies invented at RIKEN. Based on its unique cell-free membrane protein synthesis and non-canonical amino acid incorporation technologies, membrane proteins with complexed multiple membrane spanning structures, such as GPCRs, can be prepared in natural forms with structural and functional integrity. LiberoThera has established antibody generation and characterization platform with best use of the membrane protein technologies and is tackling to develop novel therapeutic candidates targeting physiologically important GPCRs in collaboration with multiple biotech companies.