A bispecific antibody molecule jointly developed by Buchang Pharmaceutical and REMD Biotherapeutics, partners of GenScript ProBio, received IND clearance from NMPA for clinical trial

NANJING,China,Nov. 29,2022 -- Buchang Biopharmaceutical and REMD Biotherapeutics,partners of GenScript ProBio,recently received IND approval of BC008-1A from China NMPA for Phase 1 clinical trial. BC008-1A (NMPAIND number: CXSL2200315),a bispecific antibodydrug co-targeting the immune checkpoints PD-1 and TIGIT,for treatment of patients with advanced solid tumors. GenScript ProBio extends congratulations on this.

Buchang Biopharmaceutical will be responsible for the Phase 1 trial in China for BC008-1A. During the development of BC008-1A bispecific antibody,by using the screening and evaluation system of GenScript ProBio's SMABody® (Single-Domain Antibody fused to Monoclonal Ab) platform,Buchang Biopharmaceutical collaborated with REMD Biotherapeutics developed and optimized the CMC process and completed several batches of clinical samples. The approval of BC008-1A for clinical development has demonstrated the feasibility and manufacturability of SMABody® bispecific antibody platform.

BC008-1A is a bispecific antibody moleculespecifically targeting PD-1 and TIGIT,which can relieve the inhibition of T lymphocytes and Natural Killer cells by directly blocking the corresponding inhibitory signaling pathways,thereby "releasing the brakes" on immune system. Due to the bispecific nature of BC008-1A,there are potential synergistic effect of simultaneously blocking of PD-1 and TIGIT on enhancing the anti-tumor response. At present,there is no similar PD-1 and TIGIT targeted bispecific drug approved for marketing in the United States nor China.

Different from other bispecific antibody platforms,the bispecific antibody derived from SMABody® platform is composed of single-domain antibody fused directly with monoclonal antibody with minimum sequence manipulation and molecular engineering,resembling native monoclonal antibody in structural configuration and have bivalent binding to each of the target. Those attributes resulted in bispecific molecules with low immunogenicity risk,good developability and simple process for large-scale manufacturing,among others. It will only take about 12 to 15 months from the discovery to IND enabling CMC. Moreover,the flexibility of single-domain antibodies in the SMABody® allows the bispecific antibody to bind to "hidden" epitopes such as enzymes and ion channels. Bispecific antibody derived from SMABody® can also be adaptable to "plug and play" approach to construct multivalent molecules,which greatly maximize their therapeutic applications.

"Over the years,in the field of antibody drug discovery contract services,we have cooperated extensively with GenScript ProBio and created a series of innovative antibody-based molecules. The SMABody® platform has its technical uniqueness,and the IND approval of BC008-1A has proven the bispecific antibody created by SMABody® has a robust CMC developability. We hope the BC008-1 clinical development will benefit the patients with various advanced solid tumors in the future." Dr. Hai Yan,co-founder and CEO of REMD Bio,said.

"In past decades,Buchang Biopharmaceutical has been focusing on the biological drugs such as antibodies and fusion proteins,and currently has a number of First-in-Class clinical candidate under development. SMABody®'s unique platform technology provides a fast and high-quality services for the early screening of candidate molecules. It is our hope that the platform will generate additional innovative and high-quality new biological drugs in the future." Dr.Chun Yang,CEO of Buchang Biopharmaceutical, said.

"We warmly congratulate our partners received IND approval of BC008-1A,an innovative bispecific antibody,from China NMPA. The approval of this program fully demonstrated that the SMABody®Platform has excellent developability and simple process manufacturing processes." Dr. Brian Min,CEO of GenScript ProBio, said,"In the future,we will continue to support the innovative companies,such as REMD Bio and Buchang Biopharmaceutical,to bring new and improved treatment options to patients worldwide."

About Buchang Pharmaceutical

Found in 2014,as a wholly-owned subsidiary of Shandong Buchang Pharmaceutical Co.,Ltd.,Buchang Pharmaceuticalis an innovation-driven biopharmaceutical enterprise covering the entire industry chain of biopharmaceutical R&D and manufacturing. Focusing on the fields of tumors,autoimmunity,metabolism,cardiovascular and cerebrovascular diseases,Buchang Pharmaceuticalhas deployed a number of projects including fusion proteins,polypeptides,monoclonal antibodies,diabodies,etc.,forming a complete echelon of biological drug research and development pipelines.

At present,the company has a number of biological drugs under development,of which 6 are in the clinical trial stage,and 3 are in the phase 3 clinical trial stage. The main representative products include: PTH (recombinant human parathyroid hormone 1-84 for injection),BC001 (full human anti-vascular endothelial growth factor receptor 2 monoclonal antibody for injection),long-acting EPO (Recombinant human erythropoietin Fc fusion protein for injection) and so on. Buchang Pharmaceuticalfocuses on major diseases,adheres to innovation-driven,and is committed to the discovery,development,manufacturing and commercialization of new biological drugs with significant clinical value,providing Chinese patients with effective,accessible and affordable biological drugs and high-quality treatment solutions.

About REMD Biotherapeutics Inc

REMD Biotherapeutics Inc is a privately held clinical-stage biopharmaceutical company with R&D operations located in the US and China. The company was founded in Camarillo,CA in 2011 by two seasoned former Amgen research scientists and has R&D operations in Camarillo and Beijing.

Since its establishment,the company has established several unique antibody research and development platforms including G protein-coupled receptors (GPCRs) antibody platform,a SynerMab bispecific antibody platform,and a Tumor Activating Interferon (TAI) bifunctional antibody interferon fusion platform and produced a series of innovative drug candidate molecules in the fields of metabolic disorders and cancer treatment with global intellectual property rights. REMD Biotherapeutics's most advanced program is Volagidemab (REMD-477),a fully human antibody antagonizing human glucagon receptor that has completed Phase 2 clinical studies in Type 1 and Type 2 Diabetes and is in preparation for initiating global multi-center clinical Phase 3 studies in Type 1 Diabetes.

About GenScript ProBio

GenScript ProBio,a subsidiary of GenScript Biotech Corporation,offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies,professional solutions and efficient processes in CGT,vaccine,biologics discovery and antibody protein drug,aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States,the Netherlands,South Korea,and China (Hong Kong,Shanghai,and Nanjing) and other regions to serve global customers,and has helped customers in the United States,Europe,Asia Pacific and other regions obtain more than 40 IND approvals since October 2017.

GenScript ProBio's total CGT solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. GenScript ProBio's innovative solutions for biologics discovery and development include therapeutic antibody discovery,antibody engineering and antibody characterization. In the biologics CDMO service,GenScript ProBio has built a DNA to GMP material platform,including stable cell line development,host cell commercial license,process development,analytical development to clinical and commercial manufacturing,and offer fed-batch and perfusion processes to meet the growing needs for antibody and protein drugs. GenScript ProBio has established GMP capacity that meets regulatory requirements of the US Food and Drug Administration (FDA),European Medicines Agency (EMA) and National Medical Products Administration (NMPA).

Toward the mission of "Innovation through Collaboration",GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization,significantly lowering R&D costs and shaping a healthier future.

https://www.genscriptprobio.com/