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SUZHOU, China, Oct. 10, 2024 /PRNewswire/ -- On 8 October, Xi'an Jiaotong-Liverpool University (XJTLU) welcomed Nobel laureate Professor Michael Levitt for an engaging science talk. He delivered the talk, A Wonderful Life in Science, both onsite and to a worldwide online audience.  XJTLU Master Forum | “A Wonderful Life in Science” by Professor Michael Levitt Professor Levitt, a computational biologist, is the Robert W. and Vivian K. Cahill Professor of Cancer Research at Stanford University. His pioneering work in developing computer algorithms to model and analyse biological molecules has substantially impacted biology, with important implications for human health. In 2013, he was awarded the Nobel Prize in Chemistry for his work, along with two other co-winners. Michael Levitt (centre) in a discussion after the talk "I want young people to appreciate the glorious nature of science both basic and applied," Professor Levitt said, ahead of his talk. "They should see that research is done by normal people often mentored and inspired by others." Professor Levitt is a member of the National Academy of Sciences in the USA, the American Academy of Arts and Sciences, and the Royal Society of London. He was one of the first scientists to develop computer simulations that help researchers understand and predict the motion of atoms and molecules in complex biological systems. His research led to a new understanding of protein structures and their characteristics. During his talk, Professor Levitt reflected on significant milestones in modern biology, including the discovery of DNA's structure and advances in protein folding, which laid the foundation for computational structural biology. He emphasised the importance of integrating physics, chemistry, and biology to uncover the secrets of life. Professor Levitt has witnessed the dramatic changes AI can bring to computational biology. These include Google DeepMind's AI system, AlphaFold, which can reliably predict a protein's 3D structure from its amino acids without time-consuming and costly experiments. A significant portion of Levitt's talk focused on the transformative impact of artificial intelligence. He explained how he utilises ChatGPT as a smart assistant to understand new concepts, write code, and even provide advice. He said, "The future of everything is AI." In closing, he also gave some valuable advice to the students. He said: "Be creative, be persistent, be passionate, and be kind and good." You can watch the full video of the talk here.
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Oct. 10, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, today announced the online publication of the results from its phase I clinical trial of porustobart (HBM4003), the Company's first-in-class fully human heavy chain antibody targeting CTLA-4. The trial evaluated porustobart in combination with the anti-PD-1 antibody toripalimab for the treatment of advanced solid tumors, with a particular focus on melanoma. These results were published in the Journal for ImmunoTherapy of Cancer (IF=10.3, 2023). This multicenter, open-label phase I trial was led by Dr. Jun Guo, Chief Physician of the Department of Melanoma and Soft Tissue Sarcoma at Beijing Cancer Hospital. The data demonstrated that the combination of porustobart and toripalimab had a manageable safety profile with no new safety signals in the treatment of solid tumors. Initial results also indicated promising antitumor activity, particularly in PD-1 treatment-naïve mucosal melanoma. Dual immunotherapy combining anti-CTLA-4 and anti-PD-1 antibodies is currently approved as a frontline treatment for several solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer. However, the high toxicity associated with anti-CTLA-4 antibodies has limited their broader use. Porustobart, a next-generation fully human anti-CTLA-4 antibody developed using the HCAb Harbour Mice® platform, is the first of its kind to enter clinical development globally. Its unique properties offer the potential to overcome the efficacy and toxicity challenges of conventional anti-CTLA-4 therapies, making it a promising candidate in the field of cancer immunotherapy. The phase I trial was conducted in two stages: a dose-escalation phase (Part 1) and a dose-expansion phase (Part 2). A total of 40 patients received treatment aimed at evaluating the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of the combination therapy for the treatment of solid tumors, with a particular focus on melanoma. Safety Results Among the 40 patients who received study treatment, 10 (25.0%) patients reported grade ≥3 treatment-related adverse events (TRAEs). The commonly reported TRAEs were rash (30.0%), abnormal liver function (30.0%), leukopenia (25.0%), and fever (20.0%). Additionally, 5 (12.5%) patients experienced immune-related adverse events (irAEs) with maximum severity of Grade 3. No Grade 4 or 5 irAEs occurred. Efficacy Results Efficacy was evaluated in 32 melanoma patients treated with the recommended phase II dose (RP2D) of porustobart 0.3 mg/kg combined with toripalimab 240 mg every three weeks (Q3W), and who had available post-baseline imaging data. The objective response rate (ORR) was 33.3% in the anti-PD-1/PD-L1 treatment-naïve subgroup. For patients with mucosal melanoma, the ORR in this anti-PD-1/PD-L1 treatment-naïve subgroup was 40.0%. A high baseline Treg/CD4+ ratio in the tumor was identified as an independent predictive factor for immunotherapy efficacy. In summary, the combination of porustobart 0.3 mg/kg with toripalimab 240 mg Q3W demonstrated promising antitumor activity and manageable safety in patients with advanced melanoma, including the difficult-to-treat mucosal subtypes. Further studies are needed to confirm these findings, particularly in patients with mucosal melanoma. "We are encouraged by the positive results from our phase I study of porustobart in combination with an anti-PD-1 antibody, which has shown a favorable safety profile and early signs of clinical activity," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "Porustobart is the first internally developed molecule generated from our HCAb Harbour Mice® platform. We look forward to moving forward with further studies to fully explore the potential of this combination in addressing unmet medical needs and ultimately making a meaningful difference in patients' lives." About Porustobart Porustobart (HBM4003) is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice®. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, porustobart has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect present 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 in monotherapy and combination therapy. 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 www.harbourbiomed.com.
ADELAIDE, South Australia, Oct. 9, 2024 /PRNewswire/ -- BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organization (CDMO), announced a new partnership with Centivax, Inc., for a project involving cell line development, cell banking and plasmid DNA manufacture. Centivax is developing Cent-Flu, a universal influenza vaccine, consisting of a proprietary multivalent mixture of 22 unique mRNA transcripts delivered as a lipid nanoparticle (LNP) encapsulated mRNA vaccine. In vivo, the vaccine has been demonstrated to convey protection against current, past, and future influenza strains. BioCina will provide proven expertise in the selection of optimal plasmid manufacturing cell lines, Master Cell Bank (MCB) and plasmid manufacturing, to support Centivax's progression to First-in-Human clinical trials. Centivax Selects Global CDMO BioCina to Initiate cGMP Manufacturing of Revolutionary Universal Influenza Vaccine. BioCina's Chief Executive Officer, Mark W. Womack stated, "We're privileged to support Centivax's breakthrough approach to sustained flu prevention and we couldn't be more excited to be their partner of choice to initiate cGMP manufacturing, thus advancing the journey to bring such an important vaccine to market. This is a tremendous opportunity for the BioCina Team to leverage our world-class capabilities in cell line development, cell banking, and cGMP plasmid production." Centivax's Chief Executive Officer, Jacob Glanville, said, "We are thrilled to announce BioCina as our Master Cell Bank manufacturing partner for the first phase of manufacturing our universal influenza vaccine. BioCina's exemplary expertise and track record in mRNA/LNP MCB, combined with their state-of-the-art facilities, aligns perfectly with Centivax's commitment to innovation and quality. This partnership enables us to leverage BioCina's expertise to ensure the highest standards of vaccine production. Together, we're taking a significant step forward in bringing our universal influenza vaccine to market, with the goal of providing broad, lasting protection against the disease on a global scale." About BioCinaBioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), offering highest-quality, cost-effective cell line, process, analytical and formulation development, and cGMP clinical & commercial manufacturing for the microbial, pDNA and mRNA modalities. BioCina's first facility in Adelaide, South Australia has a rich history of developing and manufacturing both clinical and commercial drug substance, backed by most critical SME's having an average tenure of 15+ years at the site. BioCina boasts an elite quality record having successfully passed regulatory inspections by the US FDA, EMA, TGA and Health Canada. Through a partnership with NovaCina, BioCina offers clients a highest-quality fill-and-finish solution. BioCina is proud to have clients globally, including the U.S., Europe, and the Asia Pacific. Australia offers one of the most attractive tax incentives globally (up to 48.5% cash refund), and one of the world's premier trial networks, making it an ideal destination for biologics companies looking to invest in scaling-up and manufacturing products. Visit https://biocina.com. About CentivaxCentivax is a universal vaccine platform technology company founded and led by experts in vaccinology, vaccine regulatory affairs, immunology, and computational bioengineering. The universal vaccine platform intellectual property has demonstrated unprecedented breadth of protection against influenza and coronaviruses. The platform delivers ultra-broad neutralizing titers, HAI titers and in-vivo protection in ferrets, pigs, rats, mice and human immune organoids. Development of the Centivax platform has been financially supported by the Global Health Investment Corporation (GHIC) BARDA venture arm, NFX, BLUE KNIGHT™ J&J/BARDA program, the Bill and Melinda Gates Foundation, the National Institute of Health (NIH), the Naval Medical Research Center, the Walter Reed Army Institute of Research, the Medical Technology Enterprise Consortium, the Department of Defense, and the National Institute for Innovation in Manufacturing Biopharmaceuticals. Centivax is on a mission to accelerate the world's transition to a post-pathogen humanity. Media Contactmedia@biocina.com
SEATTLE, Oct. 9, 2024 /PRNewswire/ -- Arbele, a leading innovator in biopharmaceutical & biotechnology focused on targeting cadherin-17 (CDH17), is pleased to announce strategic collaborations in precision oncology using artificial intelligence (AI) to advance targeted immunotherapeutics of bispecific T-cell engagers (TCEs) and antibody-drug conjugates (ADCs). These partnerships, aimed at advancing the quantification and prognostic prediction of CDH17 expression in tumor tissue and the surrounding tumor immune microenvironment, are expected to accelerate the development of precise companion diagnostics and effective clinical trials for the treatment of advanced cancer patients. Collaboration with BioAI: Development of IHC-Based Quantification Algorithm Arbele enters a strategic alliance with BioAI Health to develop a prototype of an immunohistochemistry (IHC)-based quantification algorithm. Leveraging the PredictX platform to develop AI-based models using Arbele's clinical trial data on colorectal cancer (CRC) biomarker screening, we join force to establish a gold standard companion diagnostic test for anti-CDH17 therapies for patient selection and prediction of clinical outcomes. "By partnering with Arbele, we are excited to apply our novel AI platform and expertise to accelerate the development of innovative treatment options for gastrointestinal cancers," said Thomas Colarusso, CEO of BioAI. "This partnership underscores our commitment to revolutionizing personalized medicine through cutting-edge machine learning." "BioAI's machine learning capabilities offer a transformative approach to biomarker identification and patient stratification through predicting CDH17 expression and its spatial interaction with immune cells in tumor microenvironment," said Dr John Luk, CEO of Arbele. "This collaboration is a critical step in guiding us the uses of the right treatment modalities and/or therapeutic regimens, thereby improving outcomes for patients with high mortality cancers." Collaboration with Chime Biologics: Accelerated CMC Process Development of novel ADC and TCE Arbele has entered a strategic alliance with Chime Biologics to accelerate chemistry, manufacturing and control (CMC) process development of the novel designs of ADCs and TCEs. The partnership supports multiple pipelines of about 10 first-in-class and best-in-class immunotherapeutics, including monoclonal, bispecific/biparatopic and TriAx antibodies within the coming 3 years. The collaboration will ensure Arbele continues to have at least 1-2 new molecular entities (NMEs) successfully filing for investigational new drug (IND) application and entering clinical studies in the next 5 years without any technical and supply-chain interruptions. The first deliverable will be anti-CDH17 ADC (ARB102A), for IND submission in early 2025. "Chime Biologics has partnered Arbele for several years, with our advanced biologics development supporting key milestones such as previous IND filings for multinational clinical trials," said Dr. Jimmy Wei, President of Chime Biologics. "We adopt the Quality-by-Design (QbD) strategy for process development to yield optimal outcomes cost-effectively, delivering innovative immunotherapeutics to enhance the global accessibility of these treatments." About Arbele Arbele founded by accomplished scientists and pharmaceutical executives in 2016 researching on cadherin-17 (CDH17) to develop innovative diagnostic platforms and breakthrough immunotherapeutic solutions; to provide early intervention and treatment for patients with advanced CRC, cholangiocarcinoma, pancreatic adenocarcinoma and subtype of ovarian cancers, for which effective treatment options are scanty with high mortality rates. For more information on ARBELE, please visit http://www.arbelebio.com/ About BioAI BioAI is a leading provider of multimodal AI in precision medicine, offering world-leading machine learning technology to develop H&E-based predictive models and digital biomarkers. BioAI works with leading pharmaceutical, biotechnology, clinical laboratories, and academic cancer centers around the world. The company's proprietary PredictX platform enables the generation of advanced AI models using multimodal data. BioAI aims to revolutionize personalized medicine by developing novel AI-based biomarkers to more effectively guide patients to targeted therapies. For more information about BioAI and its innovative machine learning technologies, please visit bioaihealth.com. About the Chime Biologics & Chime Innovation Center Chime Biologics is a global leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Built in state-of-the-art technology at Shanghai Innovation Center and Wuhan manufacturing plant, Chime Biologics provides a one-stop CMC solution for biopharmaceutical customers around the world, making biomedicines affordable and accessible to all patients and fulfilling its commitment to human health. For more information, please visit: www.chimebiologics.com. For Press Contact: Dr Diana Hay, diana.hay@arbelebio.com For Corporate Inquires: Ms. Khim Poon, info@arbelebio.com
OSAKA, Japan, Oct. 9, 2024 /PRNewswire/ -- Alpha Fusion, Inc. (CEO: Sunao Fujioka, headquartered in Kita-ku, Osaka), has raised a total of ¥1.02 billion through a Series B funding round. The round was led by SBI Investment Co., Ltd. and OSAKA University Venture Capital, with participation from several new investors. This funding will enable Alpha Fusion to accelerate its research and development efforts, enhance its supply chain, and deliver Japan's cutting-edge cancer therapies to the global market as quickly as possible. Alpha Fusion Leading the World in Astatine-based Drug Discovery Alpha Fusion is a pioneering startup dedicated to bringing "Targeted Alpha Therapy (TAT) using Astatine (At-211)" to cancer patients worldwide. As a leader in the clinical development of Astatine-based therapeutics, Alpha Fusion is advancing its pipeline and building a highly efficient supply chain using cyclotrons in collaboration with partners across the globe. TAT is highly anticipated to become a foundational drug discovery platform in oncology, offering the potential to create numerous novel treatments. In the past year, several major pharmaceutical companies in Europe and the U.S. have acquired startups developing Actinium (Ac-225) -based radiopharmaceuticals, signaling a surge of interest in this field. Astatine (At-211) is garnering attention for its short half-life, which anticipates clinical safety, its halogen properties that allow it to be directly labeled into low-mid sized-molecule ligands, its ease of sourcing raw material, and the simplicity of its production using cyclotrons. Business Progress and the Impact of Series B Funding Since our Series A funding round in May 2023, Alpha Fusion has made significant strides, as detailed below: 1.1st Pipeline (Thyroid Cancer, Phase 1 ongoing): Progress in high-dose administration, approaching the determination of recommended dosages. 2. 2nd Pipeline (Prostate Cancer, Phase 1 ongoing): Successful completion of the world's first administration of [211At]PSMA-5 to a patient in June. 3. Additional Pipelines: Multiple pipeline developments underway through both in-house R&D and collaborations. July 2023: Initiated joint research with QST Chiba for tumor-specific targeting. August 2023: Began joint research with QST Takasaki/Niigata University on novel Astatine-labeling platform technologies. 4. Supply Chain: Progress in manufacturing preparations for clinical trial drugs both domestically and internationally, shaping the future of our supply chain. First half of 2024: Completion of Osaka University's TAT Cyclotron building to enable efficient Astatine production. First half of 2024: Set up GMP facilities for clinical trial drug production in Japan and advanced collaboration with overseas CDMOs. 5. Intellectual Property: Received patent approvals covering manufacturing methods, materials, and applications related to our pipeline. 6. Research Centers: Expanded domestic research operations, including a new center in Tsukuba (SakuLab-Tsukuba), in addition to Osaka University's research hub. 7. Team Expansion: Strengthened the advisory board and enhanced functional capabilities critical to pharmaceutical development (e.g., supply chain, CMC, quality assurance, clinical development, regulatory affairs). With this funding, we will accelerate our R&D efforts and prepare for company-sponsored clinical trials, enhance our supply chain for GMP-grade clinical trial drug production domestically and internationally, and further expand our team. We are committed to demonstrating the unique advantages of Astatine-based drug discovery with tangible business results and clinical evidence. Investors in Series B Round (in no particular order): New Investors: SBI Investment Co., Ltd. Mitsui Mining & Smelting Co., Ltd. Kobe University Capital Joyo Capital Partners Existing Investors (Follow-on Investment): OSAKA University Venture Capital D3 LLC JGC Corporation Comments from Alpha Fusion CEO, Sunao Fujioka "In the past year, Alpha Fusion has made great progress. We are strategically advancing pipeline R&D and supply chain construction by leveraging the unique characteristics of Astatine: its short half-life, the potential for pipeline expansion due to its halogen properties, and the stable supply enabled by cyclotron production. The market is moving rapidly, with ongoing M&A and large-scale funding in the TAT sector globally. As we continue developing TAT pipelines, this funding round serves as a critical step toward company-sponsored clinical trials and GMP-grade Astatine drug production. We will push forward, engaging more stakeholders to realize our mission of advancing cancer treatment." About Alpha Fusion Alpha Fusion, Inc. was established to commercialize Astatine (At-211) drug discovery, based on research outcomes from Osaka University and the Japan Science and Technology Agency (JST) OPERA QiSS program. The company is dedicated to unleashing the therapeutic potential of Alpha (Astatine) therapy in the fast-emerging field of Targeted Alpha Therapy. Through world-class R&D and business development, Alpha Fusion aims to bring this innovative modality to the forefront of cancer treatment. Contact Information For further inquiries, please contact: Email: info@alpha-fusion.com
NANJING, China, Oct. 9, 2024 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") announced that Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by Leads Biolabs with global intellectual property rights, for the treatment of the patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) who have progressed after receiving two or more lines of chemotherapy. The Breakthrough Therapy Designation awarded to LBL-024 stems from its remarkable clinical efficacy and safety profile in patients with advanced EP-NEC who failed in second-line and above chemotherapy. The current clinical data demonstrate that LBL-024 monotherapy has more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments for this disease. Breakthrough Therapy refers to innovative or improved drugs that treat life-threatening conditions or significantly impact quality of life, where no effective treatment exist, or there is sufficient evidence that the therapy offers clear advantages over existing treatment options. In July 2012, the U.S. Food and Drug Administration (FDA) pioneered the "Breakthrough Therapy" review process, complementing fast track, accelerated approval, and priority review mechanisms. By accelerating the approval process and fostering closer collaboration, Breakthrough Therapy Designation facilitates faster development and market access for drugs with significant clinical potential. Historically, FDA data suggests that Breakthrough Therapy Designation can reduce time-to-market by approximately 2.5 years on average. In July 2020, CDE officially introduced the Breakthrough Therapy Designation concept in China. Products granted Breakthrough Therapy Designation status will receive closer guidance and various forms of support to ensure that patients are provided with new treatment options as soon as possible. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "According to historical data from the China Drug Review Annual Report, only a few products are eligible for Breakthrough Therapy Designation, and even fewer have been approved. The designation for LBL-024 is another proof of the robust R&D capabilities of Leads Biolabs, and it is also a major victory for Leads Biolabs' insistence on focusing on the first-in-class product R&D strategy for the global market. Leads Biolabs will vigorously pursue the global clinical development of LBL-024, with the anticipation of offering more effective treatment options for patients with EP-NEC at the earliest opportunity." Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said "The Breakthrough Therapy granted by the CDE prioritizes candidates that demonstrate exceptional clinical data, differentiated targets, and therapies with a high degree of efficacy certainty. This Designation represents the highest threshold and most prestigious qualification within China's pharmaceutical regulatory system, functioning as a crucial benchmark for uncovering valuable new drug projects. Leads Biolabs has consistently embraced differentiated innovation, and we eagerly anticipate the timely market introduction of LBL-024 as a novel immunotherapy, following the groundbreaking successes of anti-PD-1/PD-L1, CTLA-4, and LAG-3." About LBL-024 LBL-024 is a tetravalent bispecific antibody that simultaneously targets PD-L1 and 4-1BB, serving dual functions: blocking the immunosuppressive PD-1/PD-L1 pathway, and selectively co-stimulating 4-1BB in the tumor microenvironment to enhance immune responses. The dual functions of LBL-024—lifting PD-1/PD-L1 immune inhibition and intensifying 4-1BB modulated T cell activation—synergistically enhance the anti-tumor immune response. About EP-NEC Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NENs), which originate in the diffuse neuroendocrine cell system and can occur in many different sites. NEC can be categorized into pulmonary NEC and EP-NEC. EP-NEC exhibits similar highly aggressive and metastatic characteristics to small cell lung cancer (SCLC). Most patients are diagnosed at a later stage or already have distant metastases, resulting in rapid disease progression and a poor prognosis. Currently, the primary first-line treatment for advanced EP-NEC involves platinum-based chemotherapy, achieving an overall response rate (ORR) of approximately 30% to 50%, with a median overall survival (mOS) of only approximately one year. Treatment options for advanced EP-NEC are limited, and there are no standard treatment strategies for patients who progress beyond second-line chemotherapy. These underscore the urgency to develop novel therapeutic approaches. About Leads Biolabs Nanjing Leads Biolabs Co., Ltd is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally. Backboned by our proprietary technology platforms and robust drug development capabilities, we have curated a rationally designed and differentiated pipeline of 12 innovative drug candidates, six have successfully progressed into the clinical stage. Leads Biolabs is committed to providing safe, effective, accessible and affordable new drugs to address the unmet needs of patients around the world.
Biotechnology
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