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DURHAM, N.C., April 23, 2025 /PRNewswire/ -- Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER® platform —the first point-of-care heparin monitoring assay. Designed for patients receiving unfractionated or low molecular weight heparin, the test provides results in under 15 minutes from just 50 µL of whole blood. This designation recognizes the test's potential to bring heparin monitoring closer to the patient, enabling faster and more effective dose management in critical care settings. Continue Reading Baebies FINDER Anti-Factor Xa | Cartridge Protocol | FDA Breakthrough Device FINDER Multifunctional Testing - One Platform, Multiple Types of Tests, Delivering Rapid Results for Near-Patient Use FINDER in Action: Simple 4-Step Workflow "This designation provides priority FDA review and dedicated regulatory guidance, accelerating our efforts to bring the test to market," said Richard West, Founder and CEO of Baebies. "It positions FINDER® to expand rapidly into the multi-billion-dollar coagulation testing space." Heparin dosing requires tight control to prevent both bleeding and clotting complications. In high-risk settings such as extracorporeal membrane oxygenation (ECMO), mortality rates are often around 50%, and bleeding occurs in over a third of patients. Anti-Factor Xa tests—the preferred method for guiding therapy—are confined to central labs and often take over an hour, delaying time-sensitive dosing. "It is rewarding to see our long-standing, NIH-funded collaboration with Baebies achieve FDA breakthrough," said Dr. Sitaram Emani, Associate Professor of Surgery at Harvard Medical School. "I look forward to the test supporting timely anticoagulation decisions and advancing heparin management." Unlike existing tests, the FINDER Anti-Factor Xa Test requires no centrifugation and can be run directly at the point of care or in a central lab, delivering results in minutes. It addresses a life-threatening condition, offers significant advantages over existing methods, introduces breakthrough technology where no cleared alternatives exist, and serves the best interest of patients—meeting the FDA Breakthrough Device criteria. "We're growing beyond our pediatric roots to serve broader populations by bringing multifunctional diagnostics to patients of all ages, wherever care is delivered," said Vamsee Pamula, PhD, Founder and President of Baebies . Baebies is a diagnostics company headquartered in Research Triangle Park, North Carolina. With over 22 million tests delivered globally, Baebies is a technology leader that pioneered digital microfluidics (DMF). Its multifunctional FINDER® platform supports chemistry, immunoassay, molecular, and coagulation testing from small-volume samples. Baebies was awarded the ADLM Disruptive Technology Award. Driven by its mission—Any Test, Anywhere, Everyone™—Baebies is shaping a future where diagnostic testing is accessible everywhere, delivering better healthcare for everyone—across every age and setting. Media Contact: Baebies Communications Team [email protected] 919-328-8389 SOURCE Baebies Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HEMLIBRA has strong market potential due to its unique, subcutaneous prophylactic treatment for Hemophilia A, including patients with and without factor VIII inhibitors. With increasing global diagnosis rates and expanding access in emerging markets, HEMLIBRA is poised for continued growth. LAS VEGAS, April 21, 2025 /PRNewswire/ -- DelveInsight's " HEMLIBRA Market Size, Forecast, and Market Insight Report" highlights the details around HEMLIBRA, a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of HEMLIBRA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Chugai/Genentech/Roche's HEMLIBRA (emicizumab) Overview HEMLIBRA is a bispecific antibody that targets both factor IXa and factor X, two key proteins in the body's natural blood clotting process. Bridging these proteins it helps restore clotting function in individuals with hemophilia A. HEMLIBRA is used as a preventive treatment and is administered as a ready-to-use subcutaneous injection. It can be given once a week, every two weeks, or every four weeks—following an initial four-week period of weekly doses. Developed by Chugai Pharmaceutical Co., Ltd., HEMLIBRA is co-developed internationally by Chugai, Roche, and Genentech. In the U.S., Genentech markets the drug under the name HEMLIBRA (emicizumab-kxwh), with "kxwh" assigned per FDA guidance on naming biological products. HEMLIBRA can be prescribed in various dosage regimens. The initial loading dose is 3 mg/kg administered via subcutaneous injection once weekly for the first four weeks. This is followed by one of the following maintenance dosing options: 1.5 mg/kg once every week, 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks The choice of maintenance dose should be guided by the healthcare provider's judgment, taking into account the potential for improved patient adherence with certain regimens. The prophylactic use of bypassing agents should be stopped the day before initiating HEMLIBRA prophylaxis. Factor VIII (FVIII) prophylaxis may be continued during the first week of HEMLIBRA treatment. Learn more about HEMLIBRA projected market size for hemophilia A @ HEMLIBRA Market Potential Hemophilia A is marked by bleeding episodes, though in mild and moderate cases, these initial episodes are often less intense, which can lead to delays in diagnosis as patients may not seek medical attention promptly. Moreover, early detection is frequently hindered by the lack of access to adequate diagnostic facilities. In 2023, the number of treated prevalent Hemophilia A cases across the 7MM was estimated at around 45,000, with projections indicating growth throughout the forecast period, according to DelveInsight. Among hemophilia A patients—whether or not they have inhibitors—those without inhibitors represent a larger portion of the population. The standard treatment approach focuses on replacing the missing clotting factor, FVIII, to support normal clot formation and minimize or prevent bleeding episodes. Initially, FVIII replacement was sourced from whole blood and plasma, but advances in biotechnology led to the development of recombinant FVIII (rFVIII) therapies, significantly enhancing disease management by offering more precise and efficient options. More recently, innovative therapies using novel mechanisms to prevent bleeding are expanding the treatment arsenal. Several approved therapies for hemophilia A include ALTUVIIIO (Sanofi/Sobi), ROCTAVIAN (BioMarin), OBIZUR (Takeda), ALHEMO (Novo Nordisk), HEMLIBRA (Chugai/Genentech/Roche), ESPEROCT (Novo Nordisk), JIVI (Bayer), WILATE (Octapharma), and ADYNOVATE (Takeda), among others. Notably, ROCTAVIAN, a gene therapy developed by BioMarin, represents a major advancement—it offers a one-time treatment by introducing functional FVIII genes into the patient's cells, potentially restoring normal clotting ability and reducing the need for regular injections. With a wholesale acquisition cost of USD 2.9 million, BioMarin has already facilitated reimbursement in Europe and administered treatment to a patient in Germany in Q2 2023 at a discounted price of approximately USD 900,000. Looking ahead, the hemophilia A treatment landscape is expected to evolve significantly from 2024 to 2034, fueled by the introduction of new therapies currently in development. According to DelveInsight, the hemophilia A market across the 7MM is projected to grow from USD 11.1 billion in 2023 at a robust CAGR through 2034. Nonetheless, factors like delayed diagnosis, limited awareness, and high treatment costs may pose barriers to market growth. Discover more about the hemophilia A market in detail @ Hemophilia A Market Report Emerging Competitors of HEMLIBRA Emerging therapies such as SPK-8011 (Roche [Spark Therapeutics]), fitusiran (Sanofi), marstacimab (Pfizer), Mim8 (Novo Nordisk), and others are being developed to provide safe and effective treatment options. Companies like GeneVentiv Therapeutics are also working on advancements like Adeno-associated Virus (AAV)-based universal gene therapy for hemophilia (GENV-HEM [AAV8.Fva]). Fitusiran is a subcutaneously administered small interfering RNA (siRNA) therapy under development for the prophylactic treatment of hemophilia A and B, regardless of the presence of inhibitors. Its mechanism involves reducing levels of antithrombin—a protein that inhibits clot formation—to enhance thrombin generation, restore hemostatic balance, and prevent bleeding episodes. In January 2018, Sanofi and Alnylam Pharmaceuticals restructured their RNAi therapeutics collaboration to better align and accelerate the development and commercialization of select treatments for rare genetic diseases. Through this revised agreement, Sanofi obtained global rights to develop and commercialize fitusiran. Marstacimab (PF-06741086) is a monoclonal IgG1 antibody that targets the Kunitz 2 domain of the Tissue Factor Pathway Inhibitor (TFPI). It is being developed to prevent or reduce bleeding events in patients with severe hemophilia A or B (defined as <1% activity of Factor VIII or IX), whether or not they have inhibitors. The FDA granted Fast Track Designation to marstacimab in September 2019 for its potential use in patients with inhibitors. In December 2023, Pfizer announced that the FDA had accepted its Biologics License Application (BLA) for marstacimab, supported by data from the Phase III BASIS study involving patients without FVIII or FIX inhibitors. BBM-H803 is Belief BioMed's first gene therapy candidate for hemophilia A and its second product to gain Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA). In December 2022, the U.S. FDA granted Orphan Drug Designation to BBM-H803. To know more about the number of competing drugs in development, visit @ HEMLIBRA Market Positioning Compared to Other Drugs Key Milestones of HEMLIBRA In June 2022, Chugai received approval in Japan for acquired Hemophilia A based on a domestic Phase III AGEHA study. In October 2018, HEMLIBRA was approved by the US FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors (FVIII). However, this therapy, which was co-developed by Genentech, Chugai, and Roche, was already FDA-approved in 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with FVIII inhibitors In April 2018, the US FDA granted breakthrough therapy designation to Genentech's HEMLIBRA for people with hemophilia A without factor VIII inhibitors. In October 2014, the US FDA granted orphan drug designation to HEMLIBRA for the treatment of Hemophilia A. Discover how HEMLIBRA is shaping the hemophilia A treatment landscape @ HEMLIBRA Cost HEMLIBRA Market Dynamics HEMLIBRA developed by Roche/Genentech, has significantly reshaped the hemophilia A treatment landscape since its approval. Designed as a bispecific monoclonal antibody, HEMLIBRA mimics the function of factor VIII by bridging activated factor IX and factor X, offering prophylactic treatment for patients with hemophilia A with or without factor VIII inhibitors. Its subcutaneous administration and less frequent dosing schedule (weekly, biweekly, or monthly) offer considerable convenience compared to traditional intravenous factor replacement therapies, making it a preferred option for both patients and caregivers. The market dynamics for HEMLIBRA have been largely influenced by its clinical efficacy, improved patient compliance, and strong safety profile. Since its launch, it has rapidly gained market share, especially among inhibitor patients where treatment options were limited and complex. In non-inhibitor patients as well, the shift away from frequent IV infusions has led to strong adoption rates, allowing HEMLIBRA to cannibalize traditional recombinant factor VIII therapies. Furthermore, its entry has pressured pricing and market share dynamics across the hemophilia therapeutic space, triggering strategic shifts by legacy players like Takeda, Sanofi, and Bayer. However, HEMLIBRA's market leadership is being challenged by the evolving competitive landscape. The emergence of gene therapies, which offer the potential for long-term or even curative outcomes, introduces a new dimension to treatment decisions. While some gene therapies are still in early stages of adoption and face challenges related to durability, safety, and patient eligibility, they represent a looming threat to the long-term dominance of HEMLIBRA, particularly in younger, eligible patient populations. Going forward, the market trajectory for HEMLIBRA will depend on several factors: expanding label indications (such as pediatric use), long-term safety and efficacy data, continued pricing negotiations with payers, and how effectively Roche can defend its position against next-generation therapies. Additionally, with increasing emphasis on patient-centric outcomes and value-based care, HEMLIBRA's ability to demonstrate long-term cost-effectiveness versus both traditional and novel competitors will be key to sustaining its market share. Dive deeper to get more insight into HEMLIBRA's strengths & weaknesses relative to competitors @ HEMLIBRA Market Drug Report Table of Contents Related Reports Hemophilia A Market Hemophilia A Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hemophilia A companies, including BioMarin Pharmaceutical, Roche (Spark Therapeutics), ApcinteX, Novo Nordisk, Sanofi (Genzyme), Alnylam Pharmaceuticals, Pfizer, Sangamo Therapeutics, Bayer, Ultragenyx Pharmaceutical, among others. Hemophilia A Pipeline Hemophilia A Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hemophilia B companies, including UniQure Biopharma B.V., CSL Behring, Pfizer, Spark Therapeutics, Genzyme, a Sanofi Company, Alnylam Pharmaceuticals, Novo Nordisk, ApcinteX Ltd, Freeline Therapeutics, Sangamo Therapeutics, among others. Hemophilia B Market Hemophilia B Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key hemophilia B companies such as Gem Pharmaceuticals, Lytix Biopharma, Incyte Corporation, Daiichi Sankyo, NantPharma, Iovance Biotherapeutics, Agenus, Eli Lilly and Company, Adaptimmune, Aadi, AVEO Pharmaceuticals, Amgen, among others. Hemophilia B Pipeline Hemophilia B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hemophilia B companies, including Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

None\n Bispecific antibodies (BsAbs) have emerged as a transformative class of biologics, offering dual-targeting mechanisms that enhance therapeutic efficacy across oncology, autoimmune disorders, and rare diseases. According to Research and Markets, the bispecific antibody market is experiencing rapid growth, projected to rise from $12 billion in 2024 to $50 billion by 2030, driven by over 600 ongoing clinical trials.With the increasing demand for fast-tracked drug development, researchers and biopharmaceutical companies require high-quality bispecific antibodies delivered at high speed and scale. Biointron’s bispecific antibody production service addresses this need, providing customized, scalable solutions with a 2–3 week turnaround time.The Rise of Bispecific Antibodies: A New Era in Targeted TherapiesTraditional monoclonal antibodies (mAbs), primarily immunoglobulin G (IgG), are monospecific, recognizing and binding a single antigen. In contrast, bispecific antibodies are engineered to engage two distinct targets, enabling enhanced therapeutic mechanisms such as dual inhibition, immune cell redirection, and payload delivery. These properties make BsAbs highly effective in oncology, autoimmune diseases, and infectious disease therapies.Market Expansion and Clinical AdvancementsThe bispecific antibody sector has witnessed exponential growth, with 19 bispecific antibodies approved globally and total sales surpassing $35 billion as of March 2025. The expansion is fueled by breakthrough therapies such as:Hemlibra (emicizumab, Roche) – Approved in 2018, Emicizumab is a humanized, asymmetric bispecific IgG4 antibody that binds to blood clotting factor IXa and factor X. Emicizumab is used for the treatment of patients with hemophilia A, a hereditary bleeding disorder resulting from a deficiency of blood clotting factor VIII. This BsAb replicates the function of coagulation factor VIII by promoting the formation of the prothrombinase complex and subsequent clot formation.Vabysmo (faricimab, Roche) – Approved in 2022, Faricimab is a humanized bispecific immunoglobulin G1 (IgG1) antibody that inhibits both Ang-2 and vascular endothelial growth factor A (VEGF-A). Through VEGF-A inhibition, Faricimab reduces endothelial cell proliferation, neovascularization, and vascular permeability. It was first approved to treat neovascular age-related macular degeneration, diabetic macular edema.One example of an emerging candidate under review is Regeneron’s Linvoseltamab, an investigational, fully human, BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.The US Leads in R&D and InnovationThe United States remains the global leader in bispecific antibody R&D and commercialization, with key players such as Roche, Amgen, Pfizer, and Johnson & Johnson having strong pipelines. Since 2015, the number of bispecific antibody clinical trials has surged from fewer than 100 to over 650 in 2025, highlighting the growing significance of BsAbs in modern medicine.Speed, Scale, and Success: Why Rapid Bispecific Antibody Development MattersThe Need for Speed in Drug DevelopmentWith bispecific antibody innovation accelerating, speed has become a critical factor in drug development. Pharmaceutical companies are under pressure to advance novel therapeutics through preclinical and clinical stages before competitors. Rapid antibody production allows researchers to:Optimize lead candidates efficiently through high-throughput screening.Accelerate preclinical studies to secure early-stage funding and partnerships.Meet IND application requirements with high-purity, functionally validated BsAbs.The Role of CROs in Expediting Bispecific Antibody DevelopmentAs bispecific antibody pipelines expand, biotech and pharmaceutical companies are increasingly outsourcing development to specialized contract research organizations (CROs). CRO partnerships provide:Rapid turnaround times that internal teams may struggle to achieve.Scalable production capabilities for large-scale research programs.Access to advanced antibody engineering technologies without in-house infrastructure constraints.Biointron’s Fast-Track Bispecific Antibody Production: A Game Changer2–3 Week Turnaround: Enabling Rapid Drug DiscoveryBiointron’s streamlined bispecific antibody production service provides high-quality BsAbs in just 2–3 weeks, significantly reducing preclinical development timelines. The optimized workflow includes:Gene Synthesis & Plasmid Preparation (1 week)Codon optimization for enhanced expression.Subcloning into proprietary high-expression vectors.Plasmid amplification and purification.Transient Expression & Purification (1–2 weeks)Mammalian cell-based expression for high-yield production.Affinity purification with stringent QC (SDS-PAGE purity >95%, endotoxin <1 EU/mg).Size-exclusion chromatography (SEC-HPLC) to confirm antibody integrity.Scalability and Customization for Any Research NeedsTo support the growing demand for bispecific antibodies, Biointron offers scalable solutions tailored to diverse research needs, including:Support for all bispecific formats – IgG-like, BiTE, DVD-Ig, and more.Automated production platforms for high-throughput antibody expression.Multiple purification methods ensuring consistent quality and reproducibility.Conclusion: The Future of Bispecific Therapies Requires Speed and ScaleBiointron’s fast-track bispecific antibody production service enables researchers to accelerate preclinical research, optimize therapeutic candidates, and bring life-changing therapies to market faster. Biointron has delivered over 10,000 bispecific antibodies to global biotech and pharmaceutical companies, offering industry-leading expertise in bispecific antibody engineering, consistent, high-purity production with rapid turnaround, and end-to-end support for researchers and drug developers.Would you like to find out more about antibody production?Visit Biointron’s Learning Center or contact our expert team at info@biointron.com or +1 (732) 790 - 8340.