BIOCYTOGEN-PHARMA
19.12.2022 14:56:41 CET | Business Wire | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) today announced that the US FDA has approved the Investigational New Drug (IND) application for a phase I study of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (bsAb). The IND application was completed by Biocytogen’s wholly owned subsidiary Eucure Biopharma.
The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH008 monotherapy in patients with PD-(L)1-resistant advanced solid tumors or hematological malignancies.
YH008 exerts antagonistic and agonistic activities on PD-1 and CD40, respectively. In vitro and in vivo studies indicate that activation of the CD40 signaling pathway is dependent on PD-1 expression. Therefore, YH008 can conditionally activate the CD40 pathway in the tumor microenvironment where tumor specific PD-1+ T cells are enriched, without systemic CD40 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 than parental monoclonal antibodies (mAbs) or combination therapy in vivo. Moreover, the anti-tumor activity of YH008 was also superior to benchmark PD-1 mAbs and PD-L1 x CD40 bsAbs 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 CD40 mAbs.
“The CD40 agonistic activity of YH008 is PD-1-dependent, which allows for more targeted immune cell activation and synergies,” said Dr. Yi Yang, Chief Scientific Officer (CSO) of Biocytogen. “These characteristics prevent occurrence of liver toxicity, even at high doses, while enhancing anti-tumor activity, giving YH008 high clinical potential.”
“YH008 is a first-in-class bispecific antibody discovered through large-scale in vivo efficacy screening, where it demonstrated excellent anti-tumor activity, even in cold tumors,” said Dr. Rong Chen, CEO and CMO of Eucure Biopharma, VP of Biocytogen. “With this IND clearance for YH008, the company will have more products with diversified modalities entering the clinic to benefit patients.”
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.
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 RenMab™ /RenLite® mice platforms for fully human monoclonal and bispecific antibody 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 antibody drugs for more than 1000 targets, known as Project Integrum. This project has resulted in 28 drug co-development agreements and 16 RenMice™ licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221219005464/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom