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바이오사이토젠의 비전
바이오사이토젠은 새롭고 창조적인 기술 플랫폼을 바탕으로 신약 개발에 앞장서는 바이오텍입니다. 규모화된 항체 신약 개발 플랫폼 'RenMice HiTS Platform'을 바탕으로, 지속적인 항체의약품 개발을 추진하여, 환자들의 수요를 충족시킬 수 있도록 하겠습니다.
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연구개발 영역
신약 연구개발의 전 과정을 플랫폼화하여, 저희 바이오사이토젠은 면역항암, 자가면역질환, 대사질환 및 감염병 등의 질병 영역에 대하여 다양한 연구개발중인 파이프라인을 보유하고 있습니다. 여러 질환들에 대하여 높은 효과와 안전성을 갖고 있는 항체의약품을 개발하여 보급하는데 주력하고 있습니다.
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CTLA-4
OX40
CD40
4-1BB
RSV
바이오사이토젠의 플랫폼
바이오사이토젠이 독자 개발한, RenMice플랫폼을 바탕으로, 저희는 GPCR플랫폼, TCR플랫폼, 이중특이성항체 플랫폼 등 항체의약품 디스커버리 플랫폼들을 추가적으로 구축하여, 규모화된 항체 신약의 개발을 지속적으로 추진하고 있습니다.
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파트너쉽
바이오사이토젠은 전세계의 제약사 & 바이오텍과 다양한 파트너쉽을 체결하고 있습니다.
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
뉴스 & Webinar
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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.
05
Dec , 2019
KTR(한국화학융합시험연구원)과 바이오사이토젠, 전략합작협의 체결
2019년 12월 5일, 바이오사이토젠의 한국 대리사인 KNTSC의 송영종, 양단씨의 안내하에  KTR(한국화학융합시험연구원)의 박명규 팀장과 김상호 선임연구원이 바이오사이토젠의 베이징 본사에 방문하여, 항암신약 후보물질 전임상시험에 대한 교육을 받았으며 동시에 쌍방간의 전략합작협의를 체결하여 추가적인 교류를 이어 나가기로 결정하였습니다. KTR은 1969년 한국에서 설립되었으며, 50여년의 발전을 거쳐 국제적인 인증 기관들과 어깨를 나란히 하며 한국을 대표하는 시험 인증 기업이 되었습니다. 1000여명의 직원들이 의료기구의 합격성 검증, GLP 독성 시험, 동물 대체 임상시험 등 의료, 생물, 보건위생영역 에서 전문적인 시험과 평가 서비스를 제공하고 있으며, 매년 한국 기업에게 약 30만건의 평 가 보고서를 제공하고 있습니다. 이와 동시에 KTR은 30여개 국가에서 140여개 기구들과 파트너 관계를 맺고 있어, 전세계 시장에서 두각을 나타내고 있습니다. 이번 KTR의 참관 과정에서는 바이오사이토젠 베이징 본사의 약리약효 서비스 플랫폼 및 동물시설들을 주로 살펴보았으며, 바이오사이토젠 특유의 신약 타겟부터 IND 신청에  이르는 전 과정의 원스톱식 신약 연구개발 서비스 플랫폼, 인간화 마우스와 질병 모델에 대하여서도 확인하였습니다. 또한 양측은, '전임상연구과 신약개발시,어떻게 적절한 유전자 편집 마우스를 선택할 수 있는지'에 대한 주제로 깊은 논의를 가졌으며, 전임상 체내 약효 분석 및 PK/PD, 독성연구 시험법 및 QC, 전임상연구에서의 인간화 마우스의 중요성, ex vivo 약효 시험에서의 데이 터 신뢰성 확보 방법등의 주제로 교류를 이어나갔습니다.  바이오사이토젠은 전세계의 고객에게 전문적인 서비스와 동물 모델을 제공하기 위해 최 선을 다하고 있으며, 이번 KTR의 참관 및 협의 체결은 바이오사이토젠이 아시아태평양 시장에서 업무를 전개하는데 있어서 많은 도움이 될 것이며, 앞으로 지역 내에서 더욱 많은 합작 협의 체결에 대한 기대감을 더하게 하고 있습니다. (중국어 기사 원문 확인) https://zhuanlan.zhihu.com/p/98126502
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