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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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CD40 mAb-YH003
CTLA-4 mAb - YH001
PD-1 x CD40 BsAbs-YH008
CTLA-4 x OX40 BsAbs-YH006
HER2 x TROP2 BsADCs- YH012
RSV- YH009
바이오사이토젠의 플랫폼
Based on our proprietary RenMice(RenMab, RenLite and RenNano)platform, we have established a system of antibody drug discovery platforms including fully human monoclonal, bispecific antibody,nanobody development,bispecific ADC,GPCR antibody, TCR-like antibody platforms. These platforms can efficiently accelerate large scale innovative antibody drug development process.
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파트너쉽
BEIJING, China, and Shanghai, China, January 3, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", SEHK : 02315) a clinical-stage biotechnology company with a focus on the antibody discovery and development based on its proprietary RenMiceTM Platforms and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”, SEHK: 3692),  a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases and autoimmune diseases, today announced an antibody collaboration, assignment and exclusive license agreement. Biocytogen will provide a license to Hansoh Pharma for their selected fully human antibody molecules against the designated target for the development, manufacturing and commercialization globally. Under the agreement, Biocytogen will receive an upfront payment and will be eligible to receive development and commercial milestones of up to tens of millions of Chinese yuan, as well as single-digit tiered royalties on net sales. “We are very excited to partner with Hansoh Pharma, one of the largest pharmaceutical companies in China. The licensed antibodies were selected from Biocytogen’s Project Integrum programs and generated from our proprietary fully human antibody RenMiceTM target-knockout mice. The antibodies possess highest possible diversity to improve the success rate of antibody discovery,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “Thanks to Hansoh Pharma’s recognition of our RenMiceTM platforms and Project Integrum. We believe Hansoh Pharma’s strong R&D, manufacturing and commercialization capabilities will accelerate the development of RenMiceTM-derived antibody molecules and bring the benefits to patients worldwide.” About Project Integrum Project Integrum is a large-scale antibody drug development project for 1000+ potential drug targets using RenMiceTM (RenMabTM, RenLite® and RenNano®) target knockout mice. Different from the traditional mechanism of action (MOA)-based drug development strategy, Project Integrum uses large-scale in vivo drug efficacy screening methods to discover innovative drugs with excellent safety and efficacy. So far, we have completed making RenMiceTM KO for 1000+ targets. In addition, we have developed a large variety of preclinical antibody assets including 10 fully human bispecific antibodies, 20+ bispecific ADCs, 10+ TCR-mimic antibodies, 30+ monoclonal antibodies against novel targets, and 600+ antibody hits. Antibody molecules generated by Project Integrum have high specificity, high affinity and good druggability, which have attracted many top biopharmaceutical companys to obtain a license or reach a drug co-development agreement with us, including Merck KGaA, ADC Therapeutics, Remgen, NJCTTQ, etc. About Biocytogen: 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/RenLite®/RenNano® 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. 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. Biocytogen’s Contacts: Antibody assets and platforms: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
2023.01.03
Beijing, China, December 30, 2022 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) today officially launched its fully human heavy chain antibody platform, RenNanoTM. RenNanoTM is the third member of the RenMiceTM family, joining RenMabTM and RenLite®. Together, Biocytogen’s three RenMiceTM platforms allow for the streamlined discovery and development of fully human monoclonal antibodies, bispecific/multispecific antibodies and single-domain antibodies (sdAbs, or nanobodies) (Figure 1). Figure 1. Biocytogen’s RenMiceTM family consists of RenMabTM, RenLite® and RenNanoTM. While humans and mice generate antibodies that require heavy and light chain pairing to be functional, camels and sharks generate heavy-chain-only antibodies (HCAb), meaning their variable domains (VHH or sdAb) can function without pairing with the light chain. Owing to their nanometer-level size and small molecular weight, sdAbs have superior permeability, thus can cross the blood-brain barrier and infiltrate solid tumor tissues. In addition, the longer CDR3 region enables sdAbs to detect the otherwise hidden epitopes of GPCRs and other challenging targets. Since sdAbs have a simple structure, they are ideal building blocks for assembling bispecific/multispecific antibodies and CAR cell therapies. While nanobodies have its unique advantages, animals that naturally produce HCAbs, such as camels, are difficult to be widely used for the preparation of monoclonal antibodies because they are large, having a long breeding cycle and few offspring. Meanwhile, humanization is required to develop camelid antibody sequences into drugs, which further increases the complexity and time of drug development. Therefore, Biocytogen developed RenNanoTM mouse that was engineered to produce HCAbs by modifying the constant region of the fully human RenMabTM model. Compared with other existing HCAb platforms, the in situ replacement of the mouse genes with the complete human heavy chain variable genes makes the RenNanoTM mouse one of the most comprehensive fully human antibody platforms in the world. SdAb sequences generated from RenNanoTM mice have the highest possible diversity, and do not require antibody humanization, which saves time and cost, and reduces risk of failure during later stages of drug development. Additionally, compared with camelids or other natural HCAb-producing species, mice are easier to breed and immunize. Our in-house studies show that immunization of RenNanoTM mice can generate HCAbs with diverse CDR3 sequences that recognize a variety of epitopes. These HCAbs can recognize antigens with nM-level affinity independent of light chains. Moreover, antibodies derived from RenNanoTM mice are capable of exerting biological functions both in vitro and in vivo. They are highly hydrophilic and have favorable developability characteristics. The successful development of the RenNanoTM platform expands Biocytogen’s capabilities of antibody discovery and broadens the applications of our antibody library. We welcome global parthers to realize the full potential of our RenMiceTM platforms and derived antibodies and bring benefit to the patients. About RenMice RenMiceTM, i.e., RenMabTM, RenLite® and RenNanoTM mice, which have proprietary intellectual property rights, were developed by Biocytogen over the course of 5 years using size-unlimited, precise chromosome engineering technology (SUPCE). RenMiceTM is one of the top 3 fully human antibody mice made by in situ replacement technology globally. All RenMiceTM members contain full human heavy chain VDJ loci replaced in situ. Regarding antibody κ light chains, RenMabTM mouse contains full human VJ loci replaced in situ and RenLite® mouse contains a single human VJ locus replaced in situ. RenNanoTM mouse has modified heavy chain constant regions to generate functional heavy-chain-only antibodies (HCAbs). RenMiceTM can generate robust immune response and produce fully human antibodies with great diversity, specificity, affinity and druggability. Using RenMiceTM, Biocytogen has built 6 fully human antibody discovery platforms, covering various types of targets and modalities such as monoclonal antibody (RenMabTM), bispecific antibody and bispecific ADC (RenLite®), nanobody (RenNanoTM), TCR-mimic antibody for intracellular targets (HLA/RenMice, i.e., MHC humanized RenMiceTM), and antibody platform against GPCR and other challenging targets (RenMiceTM knockouts). RenMiceTM has been recognized by top biopharmaceutical companies around the world, including Merck KGaA, Xencor, BeiGene, Innovent, etc. About Biocytogen: 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/RenLite®/RenNanoTM mice platforms for fully human monoclonal antibody, 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. 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. Biocytogen’s Contacts Antibody platforms and antibody assets: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
2022.12.30
뉴스 & Webinar
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20
Dec , 2022
Biocytogen BDL Team to Participate in the 41st Annual JPM Healthcare Conference, the Biotech Showcase and BIO Partnering at JPM
Biocytogen (HKEX: 02315) will attend the upcoming 41st J.P. Morgan (JPM) Healthcare Conference week, and participate in several satellite conferences, including the Biotech Showcase and BIO Partnering at JPM, which are all to be held in San Francisco from January 9-12, 2023. The team will also present in the BFC conference and ACCESS CHINA before and after JPM week. Dr. Chaoshe Guo, VP of Biocytogen, and the antibody drug Business Development & Licensing (BDL) team will be in attendance to discuss Biocytogen’s innovative antibody technology platforms and antibody drug assets to explore partnerships with other pharmaceutical and biotech companies in attendance. The team’s full itinerary during JPM week is as follows: Jan. 8, The 6th BFC Annual Global Healthcare Business Development and Investment Conference (Presentation) Jan. 9-12, 41st Annual J.P. Morgan Healthcare Conference Jan. 9-11, Biotech Showcase (Presentation) Jan. 9-12, BIO Partnering at JPM Jan. 16-20, ACCESS CHINA Biotech Forum @ JPM 2023 (Presentation) Dr. Vivian Tian, Senior Director of the BDL team, will give a presentation at the Biotech Showcase, where she will introduce Biocytogen’s 6 therapeutic antibody discovery platforms for various targets and modalities, the company’s large-scale in vivo evidence-based drug efficacy screening platform, and the antibody-based drug assets generated by these platforms, including preclinical mAb/BsAb/BsADC assets and clinical assets. Details are summarized as follows: 1) 6 innovative fully human antibody discovery platforms for various targets and modalities: mAb platform: RenMab-based monoclonal antibody discovery with high affinity and great diversity; BsAb platform: RenLite-based common light chain bispecific antibody discovery with high pairing success rate and good druggability; Bispecific ADC platform: High-throughput RenLite-based bispecific ADC discovery for 200+ TAA targets with good tumor specificity, anti-tumor activity, and CMC efficiency; GPCR platform: Target knockout RenMice-based antibody discovery for multi-species cross-regonition of GPCR and other challenging targets; TCRm antibody platform: HLA-transgenic RenMice-based TCRmimic (TCRm) antibody divscovery for intracellular targets with superior affinity and specificity; Nanobody platform: RenNano-based single-domain antibody (nanobody) discovery with great blood-brain-barrier permeability and tumor infiltrating ability, suitable for the assembly of bispecific, multi-specific antibodies, CAR-T therapies, etc. 2) Preclinical mAb/BsAb/BsADC assets: In the past two years, Biocytogen has been continuously generating competitive antibody candidates or hits through Project Integrum, which can be further developed into various drug modalities, including mAb, BsAb, BsADC, TCR-mimic antibody and nanobody drugs. Our leading candidates to be discussed are as follows: 10 fully human BsAbs: YH006, a fully human CTLA-4×OX40 BsAb generated by the RenLite platform; 20+ bispecific ADCs: YH012, a HER2 x TROP2 BsADC and YH013, an EGFR x cMET BsADC, both with expected IND submissions in 2023; 10+ TCRm antibodies: Targeting intracellular TAAs including WT-1, KRAS, P53, AFP, GP100、NY-ESO-1, etc; 30+ mAbs for novel targets: targeting B7H3, TNFR2, CCR8, AMHR2 and other novel TAAs, co-stimulatory/co-inhibitory molecules, tumor microenvironment molecules, GPCRs, etc; 600+ antibody hits: targeting B7H4, DLL3, MUC1, GPRC5D, PSMA, LRRC15 and other therapeutic targets for oncology, inflammatory and autoimmune diseases, infectious diseases, and neurodegenerative disease applications. 3) Clinical-stage assets Five assets from Biocytogen’s pipeline have entered clinical trials. All of them were obtained from our high-throughput in vivo efficacy-based screening platform and demonstrated good efficacy and safety. YH003: CD40 mAb in phase II MCRTs; YH001: CTLA-4 mAb in an ongoing phase I clinical trial for the treatment of sarcoma in partnership with TRACON; YH008: PD-1×CD40 bsAb, which received FDA IND clearance in December 2022; YH002: OX40 mAb in phase I clinical trials in Australia and China; YH004: 4-1BB mAb in phase I clinical trials in Australia and China. With our innovative antibody technology platforms and drug assets developed by these unique platforms, Biocytogen has established collaborations with many biopharmaceutical and biotech companies, including Merck KGaA, ADC therapeutics, Xencor, Tracon, BeiGene, Remegen, etc. We are excited to continue expanding our global partnerships to accelerate new drug development. Contact us at BD-Licensing@biocytogen.com to set up a meeting. We look forward to discussing licensing and co-development opportunities with you!
30
Dec , 2022
Biocytogen Launches RenNano Mouse, a Fully Human Heavy Chain Antibody Platform to Accelerate Nanobody Drug Discovery
Beijing, China, December 30, 2022 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) today officially launched its fully human heavy chain antibody platform, RenNanoTM. RenNanoTM is the third member of the RenMiceTM family, joining RenMabTM and RenLite®. Together, Biocytogen’s three RenMiceTM platforms allow for the streamlined discovery and development of fully human monoclonal antibodies, bispecific/multispecific antibodies and single-domain antibodies (sdAbs, or nanobodies) (Figure 1). Figure 1. Biocytogen’s RenMiceTM family consists of RenMabTM, RenLite® and RenNanoTM. While humans and mice generate antibodies that require heavy and light chain pairing to be functional, camels and sharks generate heavy-chain-only antibodies (HCAb), meaning their variable domains (VHH or sdAb) can function without pairing with the light chain. Owing to their nanometer-level size and small molecular weight, sdAbs have superior permeability, thus can cross the blood-brain barrier and infiltrate solid tumor tissues. In addition, the longer CDR3 region enables sdAbs to detect the otherwise hidden epitopes of GPCRs and other challenging targets. Since sdAbs have a simple structure, they are ideal building blocks for assembling bispecific/multispecific antibodies and CAR cell therapies. While nanobodies have its unique advantages, animals that naturally produce HCAbs, such as camels, are difficult to be widely used for the preparation of monoclonal antibodies because they are large, having a long breeding cycle and few offspring. Meanwhile, humanization is required to develop camelid antibody sequences into drugs, which further increases the complexity and time of drug development. Therefore, Biocytogen developed RenNanoTM mouse that was engineered to produce HCAbs by modifying the constant region of the fully human RenMabTM model. Compared with other existing HCAb platforms, the in situ replacement of the mouse genes with the complete human heavy chain variable genes makes the RenNanoTM mouse one of the most comprehensive fully human antibody platforms in the world. SdAb sequences generated from RenNanoTM mice have the highest possible diversity, and do not require antibody humanization, which saves time and cost, and reduces risk of failure during later stages of drug development. Additionally, compared with camelids or other natural HCAb-producing species, mice are easier to breed and immunize. Our in-house studies show that immunization of RenNanoTM mice can generate HCAbs with diverse CDR3 sequences that recognize a variety of epitopes. These HCAbs can recognize antigens with nM-level affinity independent of light chains. Moreover, antibodies derived from RenNanoTM mice are capable of exerting biological functions both in vitro and in vivo. They are highly hydrophilic and have favorable developability characteristics. The successful development of the RenNanoTM platform expands Biocytogen’s capabilities of antibody discovery and broadens the applications of our antibody library. We welcome global parthers to realize the full potential of our RenMiceTM platforms and derived antibodies and bring benefit to the patients. About RenMice RenMiceTM, i.e., RenMabTM, RenLite® and RenNanoTM mice, which have proprietary intellectual property rights, were developed by Biocytogen over the course of 5 years using size-unlimited, precise chromosome engineering technology (SUPCE). RenMiceTM is one of the top 3 fully human antibody mice made by in situ replacement technology globally. All RenMiceTM members contain full human heavy chain VDJ loci replaced in situ. Regarding antibody κ light chains, RenMabTM mouse contains full human VJ loci replaced in situ and RenLite® mouse contains a single human VJ locus replaced in situ. RenNanoTM mouse has modified heavy chain constant regions to generate functional heavy-chain-only antibodies (HCAbs). RenMiceTM can generate robust immune response and produce fully human antibodies with great diversity, specificity, affinity and druggability. Using RenMiceTM, Biocytogen has built 6 fully human antibody discovery platforms, covering various types of targets and modalities such as monoclonal antibody (RenMabTM), bispecific antibody and bispecific ADC (RenLite®), nanobody (RenNanoTM), TCR-mimic antibody for intracellular targets (HLA/RenMice, i.e., MHC humanized RenMiceTM), and antibody platform against GPCR and other challenging targets (RenMiceTM knockouts). RenMiceTM has been recognized by top biopharmaceutical companies around the world, including Merck KGaA, Xencor, BeiGene, Innovent, etc. About Biocytogen: 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/RenLite®/RenNanoTM mice platforms for fully human monoclonal antibody, 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. 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. Biocytogen’s Contacts Antibody platforms and antibody assets: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
03
Jan , 2023
Biocytogen and Hansoh Pharma Announce an Antibody License Agreement
BEIJING, China, and Shanghai, China, January 3, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", SEHK : 02315) a clinical-stage biotechnology company with a focus on the antibody discovery and development based on its proprietary RenMiceTM Platforms and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”, SEHK: 3692),  a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases and autoimmune diseases, today announced an antibody collaboration, assignment and exclusive license agreement. Biocytogen will provide a license to Hansoh Pharma for their selected fully human antibody molecules against the designated target for the development, manufacturing and commercialization globally. Under the agreement, Biocytogen will receive an upfront payment and will be eligible to receive development and commercial milestones of up to tens of millions of Chinese yuan, as well as single-digit tiered royalties on net sales. “We are very excited to partner with Hansoh Pharma, one of the largest pharmaceutical companies in China. The licensed antibodies were selected from Biocytogen’s Project Integrum programs and generated from our proprietary fully human antibody RenMiceTM target-knockout mice. The antibodies possess highest possible diversity to improve the success rate of antibody discovery,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “Thanks to Hansoh Pharma’s recognition of our RenMiceTM platforms and Project Integrum. We believe Hansoh Pharma’s strong R&D, manufacturing and commercialization capabilities will accelerate the development of RenMiceTM-derived antibody molecules and bring the benefits to patients worldwide.” About Project Integrum Project Integrum is a large-scale antibody drug development project for 1000+ potential drug targets using RenMiceTM (RenMabTM, RenLite® and RenNano®) target knockout mice. Different from the traditional mechanism of action (MOA)-based drug development strategy, Project Integrum uses large-scale in vivo drug efficacy screening methods to discover innovative drugs with excellent safety and efficacy. So far, we have completed making RenMiceTM KO for 1000+ targets. In addition, we have developed a large variety of preclinical antibody assets including 10 fully human bispecific antibodies, 20+ bispecific ADCs, 10+ TCR-mimic antibodies, 30+ monoclonal antibodies against novel targets, and 600+ antibody hits. Antibody molecules generated by Project Integrum have high specificity, high affinity and good druggability, which have attracted many top biopharmaceutical companys to obtain a license or reach a drug co-development agreement with us, including Merck KGaA, ADC Therapeutics, Remgen, NJCTTQ, etc. About Biocytogen: 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/RenLite®/RenNano® 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. 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. Biocytogen’s Contacts: Antibody assets and platforms: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
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