Hualan Genetic Engineering Co., Ltd.

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, March 28, 2024 /PRNewswire/ -- Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, released annual financial results of full year 2023. "We made progress in two significant undertakings in 2023, the third financial year since listing on the Main Board of the Stock Exchange of Hong Kong: preparing Harbour Therapeutics to operate as a faster, more focused clinical-stage next-generation therapeutics company and initiating Nona Biosciences to leverage our unique global patent-protected technology platforms to empower global therapeutic innovation. We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "We are navigating a fiercely competitive world that is going through rapid changes, facing human being's fundamental quest for longevity and quality of life, and having a greater demand for biotechnological breakthroughs and innovative therapeutics. We've been well-positioned in the new era to achieve results that will propel the Company to new heights and create robust business value." FULL YEAR 2023 FINANCIAL HIGHLIGHTS Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023. This is the first time that the Company has recorded a net profit on its annual financial statements. Other financial highlights include: Revenue: The revenue for the full year 2023 is US$89.5 million, which increased significantly by US$48.8 million, or 119.9%, compared with US$40.7 million for the year ended 31 December 2022. Our revenue primarily consists of molecule license fee, research service fee and technology license fee. The increase is primarily attributed to license out and collaboration agreement with Pfizer, Cullinan Oncology and Kelun-Biotech. Research and development costs: The research and development expenses decreased by 66.6%, from US$135.1 million in 2022 to US$45.1 million in 2023. This decrease was primarily attributable to the combined impact of (i) optimized investments in our clinical programs and our molecule assets in discovery and pre-clinical stages; and (ii) the efficient implementation of cost control measures. Administrative expenses: The administrative expenses decreased by 28.6%, from US$27.3 million in 2022 to US$19.5 million in 2023. ROBUST PORTFOLIO AND DIFFERENTIATED PIPELINE Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is individually responsible for the development of the Company's product pipeline. Focused on oncology and immunology, Harbour Therapeutics has a robust and diversified pipeline of more than ten potentially differentiated drug candidates, four of which are in clinical development stage. Batoclimab (HBM9161), porustobart (HBM4003), HBM7008 and HBM1020 are the main products. Batoclimab, as the clinically most advanced FcRn inhibitor being developed in Greater China, has the potential to be a breakthrough treatment for a wide spectrum of autoimmune diseases in Greater China. Harbour Therapeutics completed the treatment of patients in early 2023 and announced the positive topline results of the phase III clinical trial of batoclimab for the treatment of generalized myasthenia gravis (gMG) in March, which is also the first positive pivotal trial outcome for batoclimab worldwide. This marks a major milestone as it is the Company's first product to complete phase III clinical trial and be poised for commercialization to benefit the gMG patients. The Company also initiated open-label extension clinical trial in 2022 and completed enrolment in March 2023. As the cut-off of open-label extension clinical trial for gMG in November 2023, the data showed sustainable efficacy and safety of batoclimab in long-term disease management. Porustobart (HBM4003) is the next-generation, fully human heavy chain only anti-CTLA-4 antibody generated from the HCAb platform. It is also the first fully human heavy chain only antibody which has entered into clinical development around the world. In 2023, Harbour Therapeutics conducted the global clinical development program of porustobart for multiple types of solid tumors, and positive data of efficacy and safety profile have been read out in the ongoing trials of neuroendocrine neoplasms and hepatocellular carcinoma. Another example demonstrating Harbour Therapeutics' strong research capabilities is the discovery of HBM7008, a novel product targeting B7H4 and 4-1BB. Developed from the immune cell engager platform HBICE®, HBM7008 is the only bispecific antibody against these two targets globally. Leveraging and integrating the expertise in biology and antibody engineering and the unique characteristics of HBICE® platform, HBM7008 showed exciting performance both in efficacy and safety profile at pre-clinical stage. In 2022, the Company conducted the phase I trials in the U.S. and Australia. In February 2023, to maintain a leading position in the development of this first-in-class asset, the Company entered into a co-development collaboration with Cullinan Oncology, to expand its study process in the U.S., Europe and Australia. HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which potentially plays a more important role for tumor cells to escape immune surveillance. HBM1020 is the first product against B7H7 in clinical stage globally. With its excellent product design and target features, HBM1020 presents great potential to address huge unmet medical needs on solid tumors. Driven by the Company's leading drug innovation and discovery engine, new assets are continually being developed, of which HBM1020, HBM1022, HBM1007 and HBM9033 obtained the IND clearance from the U.S. FDA to initiate clinical study in the U.S. in 2023, and HBM9027 obtained the IND clearance from U.S. FDA in the first quarter of 2024. In addition, we have a number of pre-clinical stage products in the pipeline, including HBM7004, HBM1047 and HBM9014, which have shown great potential for development. PLATFORM-VALUE-MAXIMIZED BUSINESS COLLABORATIONS In 2023, the Company continued to expand its business collaborations with leading academic institutions and select industrial partners focusing on innovation and efficiency across the world. The business collaboration model is not only limited to out-licensing, but also to engage with academic institutions or other leading innovative pioneers in the industry for co-development and incubation of joint ventures on next-generation innovative therapy. With flexible business models built around proprietary technologies and platforms, the Company can and will maximize its platform value to address global unmet medical needs. Assets Collaboration of Harbour Therapeutics Harbour Therapeutics has entered into several external collaborations in terms of pipeline licensing and collaborations. In 2023, Harbour Therapeutics has granted the regional out-licensing of HBM7008 in the U.S. to Cullinan Oncology, and HBM7022/AZD5863, which was licensed to AstraZeneca in 2022, has entered into clinical stage. Meanwhile, the three assets which have been licensed the Greater China Rights to Hualan Genetic obtained IND approvals from NMPA to initiate clinical study in China. In addition, HBM9378, which was developed in collaboration with Kelun-Biotech, completed its phase I clinical trial. With these multiple collaborations based on the assets generated from HBICE®, Harbour Therapeutics has shown its strength and unique advantages in building a comprehensive portfolio in immune cell engagers. And the co-development and collaboration of the pipeline is not only the recognition of the industry partners for the Company's products and technology platforms, but will also help the Company to improve the efficiency of portfolio advancement, spread the costs and risks, and make the development of the Company more robust. Multiple Collaborations of Nona Biosciences In addition to collaboration through the molecules and pipeline generated from the platforms, the Company is also focusing the vision on more original and innovative collaborations on early stages. By integrating the industry leading Harbour Mice® and HCAb PlusTM platforms with an experienced therapeutic antibody discovery team, Nona Biosciences provides a one-stop solution for therapeutic antibody discovery, engineering and development from I to ITM (Idea to IND) with flexible business models. From the end of 2022, Nona Biosciences achieved big success in its launch as it has landed several international collaborations in multiple innovative formats. It is worth mentioning that Nona Biosciences has granted the global out-licensing of HBM9033, a potential best-in-class MSLN-targeted ADC, to Pfizer. Until now, Harbour Mice® platforms have been validated by over 50 industry and academic partners. Nona Biosciences has established four leading technology units based on HCAb, including protein engineering, conjugation technology, delivery technology and cell therapy to empower the next-generation therapies. With the multiple collaborations based on the assets generated from HCAb PlusTM, Nona Biosciences has demonstrated its robust capabilities in antibody discovery and development, exploring a new path to expand the collaboration network and maximize the value of the platforms. Incubation on Cutting-Edge Collaborations To give full play to the value of the unique platform technologies, the Company has continued to explore the expandability of platform technology application scenarios which generate impactful values and bring us new value growth points with minimal marginal investment. Representative projects include HBM Alpha Therapeutics, in partnership with Boston Children's Hospital, and Shanghai NK Cell Technology Limited. 2024 OUTLOOK: EXTENSIVE GLOBALIZATION AND BREAKTHROUGH INNOVATION Looking to the future, Harbour BioMed will keep driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences. The former will advance multiple clinical trials of the internal pipeline to fully advance the global clinical development project, and the latter will keep providing integrated discovery solutions for biotechnology and pharmaceutical companies and ultimately create an innovation ecosystem to promote biological advancement. A range of products based on the technology platform and generated from the concept of T-cell engager and NK cell engager, will be pushed forward to clinical stage in the following years. With a combination of in-house development and business collaborations, the Company will continuously form a portfolio of products with a differentiated competitive advantage in immuno-oncology. The platform-valued-maximized business collaborations, driven by Nona Biosciences, will further walk the Company down the path of global development. Positive outcomes have been attained through platform-based collaborations with top institutions around the world and more extensive global collaborations are expected in 2024 as our preclinical products become increasingly mature. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to . SOURCE Harbour BioMed

DUBLIN, Oct. 19, 2023 /PRNewswire/ -- The "Antibody Discovery Market: Focus on Services and Platforms - Distribution by Type of Service Offered, Antibody Discovery Method, Type of Antibody Generated, Nature of Antibody Generated, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering. The global antibody discovery services and platforms market is poised for significant growth, with a projected value of over $1.6 billion in 2023 and a forecasted Compound Annual Growth Rate (CAGR) of 12.0% during the coming years. The market is driven by pharmaceutical companies' increasing reliance on outsourcing antibody discovery processes and the growing demand for targeted therapies. Streamlining Drug Development with Outsourcing The traditional drug development process is lengthy, spanning 10-15 years and involving investments of over $2 billion. Despite these efforts and investments, more than 90% of drug candidates fail in clinical trials. To streamline drug development, reduce timelines, and mitigate financial risks associated with failed trials, pharmaceutical companies are increasingly outsourcing their discovery-stage operations to specialized contract research organizations (CROs). Outsourcing allows companies to optimize resource utilization, save costs, and tap into a global network of scientific talent, ultimately enhancing the efficiency and success rate of bringing novel antibody-based therapeutics to market. Evolution of Monoclonal Antibodies Since the approval of the first monoclonal antibody-based therapy, Orthoclone OKT3, in 1986, monoclonal antibodies have become a versatile class of biopharmaceuticals. These antibodies have seen significant advancements in engineering, format diversification, and discovery methods. Over 160 monoclonal antibodies have been approved worldwide for the treatment of diseases such as cancer, chronic inflammatory diseases, infectious diseases, and cardiovascular diseases. Recent approvals include ELREXFIOT, TALVEYT, Rystiggo, COLUMVI, and EPKINLYT. Due to the complexities associated with discovering such antibodies, many firms are licensing and utilizing specialized antibody discovery platforms and technologies, driving the growth of the antibody discovery services and platforms market. Market Drivers: Biotech Advancements and Increasing Demand Key drivers of the global antibody discovery services and platforms market include recent advancements in biotechnology, a growing demand for targeted therapies, rising prevalence of chronic diseases, increased R&D expenditure in the pharmaceutical industry, and a growing trend of outsourcing antibody discovery. Collaborations between academic institutions and antibody discovery companies further contribute to market growth. Market Size and Segments The global market size for antibody discovery services and platforms is projected to grow at an annualized CAGR of 11.0% during the forecast period. The hit generation segment holds the largest market share, driven by its significance in R&D expenditure. In terms of the antibody discovery method, the hybridoma method is dominant, thanks to its capability to create immortalized cell lines for continuous antibody manufacturing. Regional Analysis: North America Leads North America currently captures nearly 40% of the market, driven by a rising interest in advanced antibody discovery platforms and increased outsourcing in the pharmaceutical industry. North America is anticipated to grow at a CAGR of 12% during the forecast period. Key Players and Recent Developments Key players in the antibody discovery services and platforms market include Ablexis, Antibody Solutions, ChemPartner, GenScript, Genmab, Harbour BioMed, ImmunoPrecise, Mabsilico, and more. Recent developments in the field include the launch of transgenic mouse-based antibody discovery platforms and initiatives to support the discovery of bispecific antibody formats. Recent Developments: In June 2023, AbTherx announced the launch of its transgenic mouse-based antibody discovery platform, AtlasT Mice. In June 2023, Sanyou Biopharmaceuticals, a China-based company, launched its Sanyou Super Trillion Common Light Chain Antibody Discovery Platform, which supports the discovery of bispecific antibody formats. In January 2023, IASO Biotherapeutics raised USD 75 million in a venture series C round, highlighting the increasing funding activity in the antibody drug discovery service and platform domain. In March 2023, Twist Bioscience announced the launch of its antibody discovery services under the Twist Biopharma Solutions subsidiary after acquiring Abveris, an antibody discovery CRO, in 2022. Key Topics Covered: 1. PREFACE 2. RESEARCH METHODOLOGY 3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS 4. EXECUTIVE SUMMARY 5. INTRODUCTION 6. ANTIBODY DISCOVERY: PROCESS AND METHODS 7. ANTIBODY DISCOVERY SERVICE PROVIDERS: MARKET LANDSCAPE 8. COMPANY COMPETITIVENESS ANALYSIS 9. COMPANY PROFILES: ANTIBODY DISCOVERY SERVICE PROVIDERS 10. ANTIBODY DISCOVERY TECHNOLOGIES: MARKET LANDSCAPE 11. TECHNOLOGY COMPETITIVENESS ANALYSIS 12. COMPANY PROFILES: ANTIBODY DISCOVERY PLATFORM PROVIDERS 13. PARTNERSHIPS AND COLLABORATIONS 14. FUNDING AND INVESTMENT ANALYSIS 15. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES 16. GLOBAL ANTIBODY DISCOVERY SERVICES MARKET 17. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF SERVICE OFFERED 18. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF ANTIBODY DISCOVERY METHOD 19. ANTIBODY DISCOVERY SERVICES MARKET, BY NATURE OF ANTIBODY DISCOVERED 20. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF THERAPEUTIC AREAS 21. ANTIBODY DISCOVERY SERVICES MARKET, BY KEY GEOGRAPHIES 22. GLOBAL ANTIBODY DISCOVERY TECHNOLOGIES MARKET 23. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY TYPE OF ANTIBODY DISCOVERED 24. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY KEY GEOGRAPHIES 25. LICENSING DEAL STRUCTURE 26. SWOT ANALYSIS: ANTIBODY HUMANIZATION SERVICE PROVIDERS 27. CASE IN POINT: DRUG DISCOVERY PROCESSES OF TOP SELLING ANTIBODIES 28. FUTURE GROWTH OPPORTUNITIES IN ANTIBODY DISCOVERY 29. CONCLUSION 30. EXECUTIVE INSIGHTS 31. APPENDIX 1: TABULATED DATA 32. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION Companies Mentioned 2BScientific 3SBio AAT Bioquest Ab Initio Biotherapeutics Ab Studio ABBA Therapeutics AbBioSci Abbiotec AbbVie Abcalis Abcam AbCellera Abcentra (formerly CardioVax) Abcepta AbCheck Abclonal Abcore ABDYS Abeome Abexxa Biologics ABGENEX AbGenics Life Sciences Abilita Bio ABL Bio Ablexis Ablynx Abnova Abpro AbSano Absci Absea Biotechnology Absolute Antibody Abterra Biosciences AbTherx AbTis Abveris (Acquired by Twist Bioscience) AbVision Abwiz Bio Abzena Abzyme Therapeutics AC Immune Acceleron Pharma Accurus Biosciences AceMab Achaogen Aclys Bio ACROBiosystems ACYTE Biotech Adagene Adaptate Biotherapeutics ADC Therapeutics Adcentrx Therapeutics Adimab AdipoGen Life Sciences Administration for Strategic Preparedness and Response (ASPR) Aduro Biotech AffinityImmuno AFSBio Aganitha Agency for Science, Technology and Research Agenus Agro-Bio AIMM Therapeutics Aimmune Therapeutics Akeagen Akeso Akeso Biopharma Alacrita Alamar Biosciences Aldevron Alector Alexion AlivaMab Discovery Services Alligator Bioscience Allogene Therapeutics Alloy Therapeutics Almirall AlpalifeBio ALSA Ventures Alvaxa Biosciences (Acquired by Sensei Biotherapeutics) ALX Oncology Alytas Therapeutics Amerigo Scientific Amgen AMSBIO Analytics Engine AnaptysBio Angios Annoron Biotechnology Antengene Antibodies Incorporated Antibodies-online Antibody Analytics Antibody Design Labs Antibody Production Services (A division of Life Science Group) Antibody Solutions Antiverse AP Biosciences Apexigen APITBIO Applied Biological Materials Applied StemCell AprilBio Aptevo Therapeutics Aragen Life Sciences Aravive Arctoris Arcus Biosciences argenx Aridis Pharmaceuticals aRNAy Sciences Aro Biotherapeutics Aronora Arsanis Artizan Biosciences Arvinas ARVYS Proteins AskGene Pharma Astellas AstraZeneca aTen Therapeutics Atlantis Bioscience Atlas Venture Atreca ATUM Aureka Aurigene Pharmaceutical Services Autolus Therapeutics Automated Lab Solutions AvantGen Aviva Systems Biology AxioMx Axxora Bayer BBI Group BBI Solutions Beckman Coulter BeiGene BenevolentAI Berkeley Lights Betta Pharmaceuticals Bhami's Research Laboratories Bhat Bio-tech India Big Cypress Acquisition BigHat Biosciences Bill & Melinda Gates Foundation Bill & Melinda Gates Medical Research Institute Bio Bench BioArctic BioAtla BioBench Solutions Biochem Pharma BioClue (Acquired by ImmunoPrecise Antibodies) Bio-Connect Biocure Technology Biocytogen BioD BioDuro-Sundia Biogen BioHub International Trade Bioinborn Scientific Biointron BioInvent BioKey (Acquired by ImmunoPrecise Antibodies) Biologics International Biomolecular Discovery Services BioNTech Bioqube Ventures Bio-Rad Laboratories Biosion BioStrand (Acquired by ImmunoPrecise Antibodies) Biosynth Biotalys Bio-Techne Biotecnol BIOTEM BioTeZ Biotheus BioTickle BioVision BioXpress Therapeutics Bird Rock Bio Blue Sky BioServices (Acquired by LakePharma) BlueBird Bio Bluejay Therapeutics Boan Biotech Boehringer Ingelheim Bolt Biotherapeutics Boster Biological Technology Bristol Myers Squibb Broteio Pharma CALIXAR Cambridge Research Biochemicals CANbridge Pharmaceuticals Cancer Research UK Cantargia Capra Science Capralogics Caris Life Sciences Carterra CASI Pharmaceuticals Catalent Biologics Cayman Chemical CD ComputaBio CDI Laboratories Celexion Celgene Cell Signaling Technology Celltrion Celros Biotech Celsius Therapeutics Centre for Applied Medical Research Centers for Disease Control and Prevention Charles River ChemBio Discovery Solutions ChemPartner Cherry Biolabs Chia Tai Tianqing Pharmaceutical Chiome Bioscience Chipscreen Biosciences ChromoTek Chugai Pharmabody Research Chugai Pharmaceutical Cidara Therapeutics Cilag Citryll City of Hope Cizzle Biotechnology Clayton Biotechnologies Click Chemistry Tools Clinica Universidad de Navarra CliniSciences Columbia University Irving Medical Center Compass Therapeutics Context Therapeutics Coronavirus Immunotherapy Consortium Corvidia Therapeutics Cosmo Bio CP Qingdao Creative Bioarray Creative Biolabs Creative Biostructure Creative Diagnostics Crescendo Biologics Crystal Bioscience CSL Behring Cstone Pharmaceuticals CureVac Curia CUSABIO Cyclogenix Cygnus Technologies DAAN Biotherapeutics Daiichi Sankyo Dako Dana-Farber Cancer Institute Danaher DaTaMabs DBA Italia Deerfield Discovery and Development Denali Therapeutics DetaiBio Diagnostic BioSystems Diatheva Digital Proteomics Dingkang Biology discoveric bio Distributed Bio DJS Antibodies Dragonfly Therapeutics E2DG Eisai Elabscience Eli Lilly and Company Elpis Biopharmaceuticals Emergent BioSolutions Empirico e-nnovation Life Sciences ENPICOM Enthera Entos Pharmaceuticals Envigo EpimAb Biotherapeutics EQRx Erasmus MC Ethris Eureka Therapeutics Eurofins Discovery Everest Medicines Evitria Evotec EVQLV Exelixis ExeVir Bio Exiris exonbio Exscientia Faculta (Acquired by Prosci) FairJourney Biologics Faron Pharmaceuticals Ferring Pharmaceuticals FibroGen Five Prime Therapeutics Fluoroprobes Forty Seven Foundery Innovations Fred Hutchinson Cancer Center Frederick National Laboratory for Cancer Research French Institute of Health and Medical Research Frugi Biotechnology Funakoshi Fusion Antibodies Fusion Pharmaceuticals G&P Biosciences G.CLIPS BIOTECH Gator Bio Genagon Therapeutics Gene Techno Science GeneBeyond Genedata GeneFrontier GENEWIZ (Acquired by Azenta Life Sciences) GeneX India Bioscience Genmab Genome Institute of Singapore Genor Biopharma GenoSafe Genovac GenScript Genuv Gen-Y Biologics GigaGen Gilead Sciences Gladstone Institutes Glenmark Pharmaceuticals Glythera Gmax Biopharm Government of British Columbia Government of Canada Green Mountain Antibodies Grenoble Hospital GSK Gustave Roussy GV20 Therapeutics HaemaLogiX Hangzhou Qiantang River Electric Harbour Antibodies Harbour BioMed Harpoon Therapeutics HD Biosciences Helix BioPharma Jiangsu Hengrui Pharmaceuticals Henlix Biotech Heptares Therapeutics HI-Bio HiFiBiO Therapeutics Himalaya Therapeutics H-Immune Therapeutics (Acquired by HiFiBiO Therapeutics) HJB Holzel Diagnostika Handels Horizon Discovery Hualan Genetic Engineering Hubrecht Institute Humanigen Hummingbird Bioscience I&L Biosystems i2 Pharmaceuticals IAMA France IASO Biotherapeutics Ibex Biosciences iBio Icagen Icosagen IGEM Therapeutics IgGenix IGM Biosciences I-Mab Biopharma iMetabolic Biopharma Immatics Biotechnologies Immorna Immune Biosolutions Immune Pharmaceuticals Immunitas Therapeutics immunitoAI Immunochem ImmunoChina Pharmaceuticals ImmunoGenes Immunome Immunomic Therapeutics ImmunoPrecise Antibodies ImmunoQure Immusmol Immutep In-Cell-Art Incyte Indivumed InflaRx Inhibrx Innate Pharma InnoBation Bio Innovagen Innovative Targeting Solutions Innovent Inotiv InstaDeep Institute for Research in Biomedicine Intarcia Therapeutics (Acquired by i2o Therapeutics) Integral Molecular Integrated DNA Technologies International Livestock Research Institute Invenra Invetx IONTAS IRBM Isogenica Italian National Institute of Health ITBMed iTeos Therapeutics Janssen Jazz Pharmaceuticals Johnson & Johnson Innovation Jotbody Jounce Therapeutics Juno Therapeutics Junshi Biosciences Just Biotherapeutics JW Pharmaceuticals Kadmon Kairos Therapeutics KAKEN PHARMACEUTICAL Kanwhish Biotechnology KareBay Biochem Karolinska University Hospital Kemp Proteins KGbio Kite Pharma KMD Bioscience Kodiak Sciences KYinno Kymab Kyoritsuseiyaku Kyowa Kirin La Jolla Institute for Immunology LabGenius Labtoo LakePharma LamKap Bio LAMPIRE Biological Labs Lanier Biotherapeutics Lava Therapeutics Leadgene Biomedical Leading Biology Leads Biolabs LegoChem Biosciences Leica Microsystems LEO Pharma LG Chem LifeArc LifeTein Ligand Pharmaceuticals Light Chain Bioscience Lineage Cell Therapeutics Lonza Loxo Oncology Lunaphore Lundbeck Luye Pharma MAB Discovery MabGenesis Mablytics Mabpharm MAbSilico mAbsolve MabSpace Biosciences Mabtech MabVax Mabworks MacroGenics Magenta Therapeutics Maine Biotechnology Services Maravai LifeSciences Masaachusetts General Hospital Mass Biologics Maverick Therapeutics Beijing Mede Taikang Biotechnology MedAbome MedGenome Medicilon MedImmune Medix Biochemica MEDx MEMO Therapeutics Memorial Sloan Kettering Cancer Center Merck Merus Mila MI-mAbs Mithra Pharmaceuticals Mitsubishi Tanabe Pharma Corporation Moderna ModeX Therapeutics ModiQuest Molcure Molecular Devices Molecular Templates MolMed Mologic Moradec MorphoSys Mount Sinai MSD MSM Protein Technologies Mycenax Biotech Myrio Therapeutics Mythic Therapeutics Nanjing Chia-Tai Tianqing Pharmaceutical Company Nanocarry Therapeutics NanoCellect Biomedical NanoString Technologies National Cancer Institute National Research Council of Canada's Human Health Therapeutics Research Centre National, Heart, Lung, and Blood Institute NaturalAntibody Nautilus Systems NB Health Laboratory NBE Therapeutics Nelum NeoBiotechnologies NeoClone Neon Therapeutics neoX Biotech Neurimmune Nexum Nidus MB Technologies Nidus BioSciences Nkarta Nona BioSciences Nordic Society of Gynaecological Oncology Normunity North Dakota State University Northway Biotech NovaRock Biotherapeutics Novartis Novo Holdings Novo Nordisk Numab Therapeutics NYU Langone Health Oak BioSciences Oblique Therapeutics Olympic Protein Technologies OmniAb OncoC4 OncoOne OncoResponse Oncothyreon Onena Medicines Ono Pharmaceuticals Open Monoclonal Technology Optimeos Life Sciences OREGA Biotech OriCell OriGene Technologies OriMAbs Orion OSE Immunotherapeutics Ossianix Oxford Biomedica OXGENE Pandion Therapeutics Panoply Bio Paragon Therapeutics Pascal Biosciences Pediatric Brain Tumor Consortium Penn Medicine PerkinElmer Perseus Proteomics Pfizer pH Pharma Phanes Therapeutics PharmAbcine PharmAbs PharmaEssentia Innovation Research Center PharmaLegacy Pharmsynthez Pierre Fabre Pinteon Therapeutics Pioneering Medicines Pionyr Immunotherapeutics Potenza Therapeutics Precision Antibody Prellis Biologics ProMab Biotechnologies Prometheus Authors Prosci Protein Alternatives Proteogenix ProteoNic ProtTech Purdue Pharma Pure Biologics PX'Therapeutics QIMR Berghofer Medical Research Institute QoolAbs Quadira Biosciences Queen's University Rallybio Rapid Novor RayBiotech RD Biotech ReCentrics Biotechnology Regeneron Pharmaceuticals Resonant Therapeutics Retrogenix RevMab Biosciences Revolve Biotechnologies Rezolute Roche Rockland Immunochemicals RubrYc Therapeutics Rx Biosciences RxBiologics SAb Biotherapeutics Saccharo Salipro Biotech San Diego Biomedical Research Institute Sanders Tri-Institutional Therapeutics Discovery Institute Sanofi Sanyou Biopharmaceuticals Sartorius SBH Sciences Scandion Oncology Scotia Biologics Sea Lane Biotechnologies Selecxine Sema4 Sensei Biotherapeutics Serum Institute of India Servier Severance Hospital Sevion Therapeutics Shanghai Henlius Biotech Shanghai KangaBio Shanghai Pidu Biotechnology Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry RAS Shire Sichuan Kelun-Biotech Biopharmaceutical Siegfried Holding Simcere Simon Fraser University Single Cell Technology Sino Biological Sinobioway Sinopharm SmartPharm Therapeutics Sorrento Therapeutics SOTIO SouthernBiotech Specialised Therapeutics Specifica Sphere Fluidics Stanford University Straterx Summit Therapeutics Sunshine Guojian Surface Oncology Surrozen Sutro Biopharma Suzhou Bright Scistar Biotechnology Company Syd Labs Symphogen Synaffix Synbio Technologies Syngene Synthelis Tachyon Therapeutics Takeda Tanabe Research Laboratories Tasgen Biotech (Acquried by I-Mab Biopharma) Tasly Biopharmaceuticals Taurus Biosciences TC BioPharm Technical University of Denmark Telesis Bio Telix Pharmaceuticals Tempus Labs TeneoBio TESARO Tetra Partner Network Tetragenetics Teva Pharmaceuticals TG Therapeutics The Antibody Company The Wistar Institute Theraclone Sciences Theranyx ThermoFisher Scientific Third Venture Biopharma ThromboGenics Tizona Therapeutics Tmunity Therapeutics Torch Biosciences TRACON Pharmaceuticals TRANSCENTA Transgene TRIANNI Tsinghua University Tubulis Twist Bioscience U.S. Naval Medical Research Unit No. 3 UCLA Technology Development Group Universiti Sains Malaysia University College London University of Manchester University of Oxford University of Pennsylvania University of Southampton University of Surrey University of Texas MD Anderson Cancer Center University of Tokyo University of Zurich U-Protein (Acquired by ImmunoPrecise Antibodies) Utrecht University Vaccinex ValenzaBio (Acquired by ACELYRIN) Vall d'Hebron Institute of Oncology Valneva VBI Vaccines VectorB2B venBio Partners VERAXA Biotech Vir Biotechnology ViralClear Pharmaceuticals Visterra Viva Biotech Voyager Therapeutics Washington University Washington University School of Medicine Westlake Pharmaceuticals Services Westlake Therapeutics Wisconsin Alumni Research Foundation Worg Pharmaceuticals WuXi AppTec WuXi Biologics WuXi STA Wyss Institute XBiotech xCella Biosciences X-Chem Xencor XOMA Y- Biologics Yale Cancer Center Yangyang YenZym Antibodies Yinuoke Ymmunobio YUMAB Yurogen Biosystems Zai Lab Zebra Biologics Zhejiang Doer Biologics Zhejiang Teruisi Biopharmaceuticals Zoetis ZoonBio Biotechnology Zumutor Biologics Zydus Zymeworks For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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Product Development Breakthroughs Continue to Unlock Value of Integrated Antibody Discovery Platform CAMBRIDGE, Mass.and SUZHOU, China and ROTTERDAM, Netherlands, Aug. 31, 2021 /PRNewswire/ -- Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported its interim results for the six months ended June 30, 2021, and provided key business updates. Corporate Highlights Critical milestones of core clinical assets have been achieved: Batoclimab HBM9161 proceeds into full clinical stage development across the first group of indications with positive trial results reported, preparations being made for the second group of indications. Phase III trial of Tanfanercept HBM9036 are advancing at full speed. Significant progress has been made in HBM4003's global development plan, and data readout of the clinical trial results will be released at ESMO (the European Society of Medical Oncology) in September 2021 . . Multiple research programs are developing at an accelerated pace, including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1029 and HBM1007. Scientific team has put forth a strong R&D contribution: within reporting period, the Company has applied for 28 patents with 4 patents issued including 1US and 3HK applications, while presenting research results at multiple medical and academic conferences. Strengthened global partnerships continuously unlock value of HBM's integrated antibody discovery platforms through entering into research cooperation agreement with the Dana-Farber Cancer Institute, Affiliated Hospital of Harvard Medical School ; reaching a strategic collaboration agreement with BioMap, an AI driven research and development platform focusing on precision medicine; and further advancing academic cooperation with the Icahn School of Medicine at Mount Sinai. Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "Harbour BioMed remains committed to developing innovative therapeutics for patients worldwide, becoming the leader in next generation antibody therapeutics with a strategic focus on immunology and oncology. In the first half of 2021, we further accelerated our product pipeline, advancing multiple clinical trials of the core products: Batoclimab and Tanfanercept are in preparation of expected commercial launches. We will continue to invest in HBM4003, and other numerous candidates generated from our discovery engine, while exploring innovative molecules with new targets as well as known targets. The remarkable business progress and growth momentum achieved in the first half of 2021 give us full confidence in securing the Company's future. As such, the Company will continue to successfully navigate the complex market environment and provide innovative treatments for patients around the world." Core clinical assets are advancing, further developing HBM's product portfolio and pipeline Since 2021, China's healthcare reform has been further deepened, and reform of the pharmaceutical industry has gradually matured amidst policy and market changes. Adjustments made to the medical insurance catalog, price negotiation of medical insurance and a new round of volume procurement bring continuous challenges to drug pricing, especially pricing of products with weak differentiators. At the same time, the exploration of medical insurance reform has pushed the industry to pay more attention to drug pricing. The Company is committed to bringing benefits and value to patients, and value-based healthcare approach is adopted in its unique and differentiated portfolio planning as well as the clinical assets' development. Batoclimab HBM9161 A fully human monoclonal antibodies that can selectively bind to and inhibit the neonatal crystal fragment receptor (FcRn) and have the potential to treat a variety of autoimmune diseases. During the reporting period, the Company announced the positive results of its phase II clinical trial for Chinese patients with generalized myasthenia gravis (gMG), which is also the first clinical evidence of anti-FcRn therapy in Chinese patients. Batoclimab has entered full clinical stage development in: Myasthenia Gravis (MG) Obtained Breakthrough Therapy Designation (BTD) for MG treatment from China Center for Drug Evaluation (CDE) in January 2021 . . Announced positive topline results from phase II clinical trial for MG in July 2021 , as the first clinical evidence of anti-FcRn therapies among Chinese patients, which showed a statistically and clinically meaningful efficacy of Batoclimab over placebo, as well as a favorable safety and tolerability profile. , as the first clinical evidence of anti-FcRn therapies among Chinese patients, which showed a statistically and clinically meaningful efficacy of Batoclimab over placebo, as well as a favorable safety and tolerability profile. Held a "Phase II Ending" meeting with Center for Drug Evaluation, People's Republic of China's National Medical Products Administration (NMPA) and obtained their full support on proceeding to the phase III clinical trial. National Medical Products Administration (NMPA) and obtained their full support on proceeding to the phase III clinical trial. The phase III study of MG will be initiated in the second half of 2021 and submission of a BLA application is expected to occur in 2022. Neuromyelitis Optica Spectrum Disorder (NMOSD) Completed the patient enrollment of NMOSD phase Ib/IIa clinical trials in July 2021 . . Data analysis of phase Ib/IIa clinical trials is expected in the second half of 2021, and regulatory communication for key trials is anticipated at the end of 2021. Expects to submit a BLA application in 2022. Immune Thrombocytopenia (ITP) Completed phase II clinical trials in the first half of 2021 and plans to conduct data analysis in the second half of 2021. Obtained the NMPA's approval for the new dosage regimen for ITP patients in February 2021 . . Expects to submit a BLA application in 2023. Graves Ophthalmopathy (GO) Expects to initiate GO phase II/III registration trials in the second half of 2021 and submit a BLA application in 2023. Other Indications Submitted an IND application for chronic inflammatory demyelinating polyneuropathy (CIDP) indication to NMPA in May 2021 . . Submitted an IND application for pemphigus vulgaris (PV) indication to NMPA in August 2021 . Tanfanercept HBM9036 Tanfanercept is the Company's lead candidate product for the treatment of moderate to severe dry eye disease (DED), which is expected to meet the huge clinical needs of the Chinese patients. Completed the first patient dosing in ongoing phase III clinical trial in China in March 2021 . in . Expects to submit a BLA application in 2022. HBM4003 HBM4003 is a next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from HBM's HCAb platform. It is also the world's first fully human heavy chain only antibody to enter clinical development. In 2021, we have implemented the global development plan of multiple types of solid tumors utilizing HBM4003. Obtained IND approvals of combination therapy with PD-1/chemotherapy for advanced non-small cell lung cancer (NSCLC) and other advanced solid tumors from NMPA in February 2021 . . Achieved the first data readout of a phase I clinical trial of monotherapy in Australia with positive results. The abstract has been accepted by the ESMO and will be published at its annual conference in September 2021 . with positive results. The abstract has been accepted by the ESMO and will be published at its annual conference in . Accomplished the first dosing of part 2/dose expansion cohort of the phase I monotherapy clinical trial in May 2021 . . Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1 for advanced melanoma and other advanced solid tumors in China in March 2021 . in . Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1/chemotherapy for advanced NSCLC and other advanced solid tumors in China in June 2021 . in . Submitted 2 IND applications for new indications, hepatocellular carcinoma (HCC) and neuroendocrine neoplasm (NEN), with PD-1 combination therapy in June 2021 . We anticipate the approvals in the second half of 2021, and the Company plans to start patient dosing in early 2022. Multiple potential preclinical assets approach clinical stage In addition to the above-mentioned clinical assets, multiple potential products are also in full-speed preclinical development including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1007, HBM1029, etc. – which are all approaching clinical stages. In the near future, the Company will continuously submit more IND applications through its efficient drug discovery engine. HBM7008 HBM7008 is a bispecific antibody targeting Tumor Associated Antigen (B7H4)x4-1BB. It is discovered from Company's heavy-chain antibody immune cell engager HBICE® and is currently the only bispecific antibody against these two targets worldwide. It is expected to file a CTA/IRB submission in the second half of 2021. HBM9378 HBM9378 is a fully human monoclonal antibody generated from HBM's H2L2 platform, which has less immunogenicity risk and better bioavailability comparing to the other TSLP target competitors. The long half-life optimization and outstanding biophysical properties support its favorable dosing and formulation advantages. It is expected that an IND application will be submitted in the second half of 2021. HBM1022 HBM1022 is a CCR8 antibody developed by HBM, which cross-reacts with the CCR8 target of cynomolgus monkeys, and has demonstrated its significant tumor growth inhibitory effect in mouse tumor models. As an innovative target, CCR8-targeted drugs have not yet entered the clinical development stage globally. It is expected that an IND application will be submitted in 2022. HBM1020 HBM1020 is a fully human monoclonal antibody generated from HBM's H2L2 platform. The antibody is directed against a brand-new target in the B7 family and can enhance the anti-tumor immunity by blocking the immune checkpoint target. Preclinical data has demonstrated its immune activation and anti-tumor functional activities. It is expected to file an IND in 2022. HBM1007 HBM1007 is a fully human monoclonal antibody against CD73 generated from HBM's H2L2 platform. It is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. HBM1007 is being studied in preclinical setting and an IND application is expected to be submitted in 2022. HBM7020, HBM1029 and HBM7015 HBM7020 is a BCMAxCD3 bispecific antibody equipped with HBM's HBICE® technology. HBM1029 is a fully human monoclonal antibody developed from the Company's H2L2 platform with higher CLDN18.2 binding affinity and stronger ADCC and CDC anti-tumor activities. HBM7015 is a bifunctional fusion protein generated from the H2L2 platform that demonstrated better PD-L1 binding activity than competitor drugs. In 2020, the Company licensed-out the Greater China rights and interests of three preclinical products (HBM7020, HBM1029 and HBM7015) developed from its own technology platform to Hualan Genetic, a Chinese biopharmaceutical corporation. After completing the technology transfer, the two companies have jointly worked on the development of these three innovative products. It is expected that IND applications for these products will be submitted in 2022. Build a global innovation hub with strong R&D capabilities and expertise HBM focuses on a new generation of innovative therapies in the field of immunology and oncology. The drug discovery and preclinical research team has conducted drug discovery, formulation development, process development and preclinical research on new drug candidates. At the same time, the Company has a professional team of scientists to optimize, upgrade and re-develop our technology platform. During the reporting period, the Company's main progress in drug discovery, technology platform and patents are as follows: Applied for 28 patents, 4 patents got issued including 1 US and 3 HK applications. These patent applications have further strengthened the intellectual property protection of the Company's core products and technology platforms. Developed and presented a newly discovered fully human anti-B7H7 monoclonal antibody HBM1020 at the American Association for Cancer Research (AACR) Annual Meeting in April 2021 . . Developed and presented a novel bispecific antibody HBM7022 (CLDN18.2xCD3) at the Antibody Engineering and Therapeutics (AET) Conference in June 2021 . HBM has established a robust antibody discovery platform and GPCR drug development platform. Based on these technology platforms, the Company is expected to move towards more novel and challenging drug targets worldwide. Strengthened R&D collaborations worldwide During the reporting period, HBM continued to expand collaborations with leading global academic institutions and selected industry partners focused on innovation and efficiency. HBM's flexible business models built around our proprietary technologies and our strong internal discovery capabilities can and will maximize our platform value by leveraging complementary advantages from the Company and our collaborators. In May 2021 , it reached a strategic cooperation agreement with BioMap, committed to the scientific research, development and transformation of new antibodies products, and integrated BioMap's artificial intelligence technology advantages into the Harbour Mice ® platform. , it reached a strategic cooperation agreement with BioMap, committed to the scientific research, development and transformation of new antibodies products, and integrated BioMap's artificial intelligence technology advantages into the Harbour Mice platform. In June 2021 , it entered into a multi-year and multifaceted research cooperation agreement with Dana-Farber Cancer Institute ("Dana-Farber"), an affiliated hospital of Harvard Medical School , to jointly develop new biological therapies in cancer treatment. Company scientists and Dana-Farber researchers will jointly develop novel biotherapies in cancer treatment, including bispecific antibodies, CAR-T cell products, etc. , it entered into a multi-year and multifaceted research cooperation agreement with Dana-Farber Cancer Institute ("Dana-Farber"), an affiliated hospital of , to jointly develop new biological therapies in cancer treatment. Company scientists and Dana-Farber researchers will jointly develop novel biotherapies in cancer treatment, including bispecific antibodies, CAR-T cell products, etc. Further advanced academic cooperation with Icahn School of Medicine at Mount Sinai ("Mount Sinai") in connection with an exclusive license agreement between Mount Sinai and a third party over a collection of antibodies having SARS-CoV-2 (COVID-19) neutralizing assets generated from Harbour Mice® platform. Build internal manufacturing and commercialization capability to support clinical development and product launches With the maturity of our pre-clinical products, we planned to build internal manufacturing and commercialization capability in due course. In 2021, the Company initiated the clinical supply manufacturing facility project to support the clinical development of its pipeline products. The pilot facility is located in Suzhou, Jiangsu Province . The facility's floor area is of around 8,500 square meters and the designed production capability scales up to 4000 liters. With the initiation and rapid formation of the Company's CMC team, it is expected that the facility will be ready for manufacturing in 2022. . The facility's floor area is of around 8,500 square meters and the designed production capability scales up to 4000 liters. With the initiation and rapid formation of the Company's CMC team, it is expected that the facility will be ready for manufacturing in 2022. The Company has begun to build a commercial team with in-depth knowledge, experience and expertise in sales, marketing, and market access strategies, who will be involved in launches across several therapeutic areas. During the reporting period, the commercial team has initiated preparation for the launch of leading products, future academic promotion and pipeline expansion. Financial Summary of First Half of 2021 For the half-year ended June 30, 2021, the Company recorded a revenue of US$2.2 million, mainly from molecule license fee. For the half-year ended June 30, 2021, the Company's other income and gains were US$2.7 million, mainly attributable to the increase of bank deposit interest, as well as increase of government subsidy and grants. For the half-year ended June 30, 2021, the Company's R&D expenses were US$41.2 million, increased investment in key clinical programs, discovery and pre-clinical programs; increased employee costs, mainly research scientists and development clinician headcounts, as well as share-based compensation expenses. About HBM4003 HBM4003 is the next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice®. It is the first molecule generated through our in-house efforts and has entered clinical trial since first being discovered as a drug candidate only 3 years ago. HBM4003 is the world's first fully human heavy chain only anti CTLA-4 antibody entered into clinical development. It shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug. About Tanfanercept (HBM9036) Tanfanercept (HBM9036) is at the forefront of the Company's R&D pipeline, it is a modified 19 kDa TNF receptor 1 fragment and is for the treatment of moderate to severe Dry Eye Disease. Tanfanercept has the potential to seize a majority market share in a fast-growing DED drug market. About Batoclimab (HBM9161) Batoclimab (HBM9161) is a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). As the first in class FcRn inhibitor being developed in Greater China, it is expected to become a breakthrough therapy to patients with autoimmune disease conditions. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions. The Company's proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies. 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