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马萨诸塞州沃本2025年3月14日 /美通社/ -- Azurity Pharmaceuticals （以下简称"Azurity" ）今日宣布成功完成从现有投资者手中收购Covis Group S.à r.l. （以下简称"Covis" ）的交易。 通过此次收购， Covis现在是Azurity的全资子公司。 此次战略收购巩固了Azurity在品牌药品领域的领导地位，利用两家公司在多种复杂剂型和治疗领域的互补优势。 通过结合专业知识和资源， Azurity加强了其在全球范围内为被忽视的患者提供药物的能力。 收购的战略效益： 扩大的治疗产品组合 – Covis产品组合和产品线的整合增强了Azurity在十种复杂剂型和九个关键治疗领域的产品，包括心血管、呼吸、中枢神经系统、内分泌、胃肠道、血液学、免疫学、抗感染和肿瘤学。 全球足迹 –此次收购加强了Azurity的全球足迹，将其商业存在扩展到50多个国家，并使患者能够更好地获得改变生活的治疗方法。 Azurity及其子公司将在北美、欧洲和亚洲雇用800多名员工。 首选关键生物制药合作伙伴– 合并后的公司将成为全球生命科学公司的重要合作伙伴，这些公司希望开发和商业化其产品，为合作伙伴提供深入开发能力和全球商业基础设施。 加速创新 –通过结合专业知识和资源， Azurity定位于推进创新的治疗方法，进一步推进Azurity的使命，通过独特且加速的发展过程为被忽视的患者提供服务–实现规模和速度。 下一代商业模式– 整合后的公司投资组合将受益于Azurity高效、有效的商业模式，结合数据、分析和人工智能驱动的数字功能，使用优化的全渠道营销方法推动利益相关者的参与。 "我们很高兴欢迎Covis Pharma加入Azurity。" Azurity首席执行官Ronald Scarboro 表示。 "两家公司的同事的努力，他们对被忽视的患者的奉献精神，以及我们的执行文化，使我们共同建立了这家独特的、高度差异化的制药公司。 我期待着我们在全球发展过程中取得的一切成就，并在我们的目标驱动下迎接新的机遇。" Covis董事会主席Rajiv De Silva 表示： "我很高兴Azurity认可了Covis的成就和潜力，并感谢Covis同事为支持从公司产品中受益的患者所做的不懈努力。" "我相信，两家公司将能够利用彼此高度互补的能力，加速为服务不足的患者开发和商业化必要的药物。" "QHP Capital很自豪能够在此次收购中为Azurity提供支持，这符合我们对投资生命科学和医疗保健创新的承诺，" Azurity的大股东QHP Capital合伙人 Jeff Edwards表示。 "我们很荣幸能够为Azurity提供支持，使其从2018年投资之初的小型、有限产品、仅限美国的公司，发展成为如今的全球性、大型、多元化投资组合、高增长的公司。 我们致力于进一步实现Azurity的显著增长，其团队已做好充分准备。" 高盛担任财务顾问， Eversheds Sutherland和White & Case担任Azurity的法律顾问。 古根海姆证券担任Covis的财务顾问， Reed Smith和A&O Shearman担任Covis的法律顾问。 关于Azurity Pharmaceuticals ： Azurity Pharmaceuticals是一家私营公司，致力于为被忽视的患者提供创新的高质量药物。 Azurity的全球足迹遍布50多个国家，拥有30多个营销品牌的多元化组合，涵盖10种剂型和9个关键治疗领域。 在其下一代商业模式的支持下， Azurity利用数据、分析和人工智能驱动的数字工具来增强市场影响力和利益相关者的参与度。 如需了解更多信息，请访问 www.azurity.com 。 关于QHP Capital ： QHP Capital是生命科学、医疗技术和医疗保健领域的技术和服务公司的投资者。 QHP已经建立了一个投资平台，与强大的管理团队合作，提供战略资本和行业专业知识。 投资团队由经验丰富的投资和运营专业人员组成，他们拥有丰富的投资体验和深厚的生命科学、医疗技术和医疗保健专业知识。 QHP受益于广泛的行业专家网络，这些专家协助识别、分析和发展QHP的投资组合公司。 如需了解更多信息，请访问 www.qhpcapital.com 。 披露通知： Azurity和QHP不承担因新信息、未来事件或不断变化的情况而更新或修改本新闻稿中包含的任何前瞻性叙述的义务。
WOBURN, Mass., March 14, 2025 /PRNewswire/ -- Azurity Pharmaceuticals ("Azurity") announced today the successful completion of its acquisition of Covis Group S.à r.l. ("Covis") from existing investors. With this acquisition, Covis is now a wholly-owned subsidiary of Azurity. This strategic acquisition reinforces Azurity's leadership in branded pharmaceuticals, harnessing the complementary strengths of both companies across multiple complex dosage forms and therapeutic areas. By combining expertise and resources, Azurity strengthens its ability to deliver medicines to overlooked patients on a global scale. Strategic Benefits of the Acquisition: Expanded Therapeutic Portfolio – The integration of Covis' product portfolio and pipeline enhances Azurity's offerings across ten complex dosage forms and nine key therapeutic areas, including cardiovascular, respiratory, central nervous system, endocrinology, gastrointestinal, hematology, immunology, anti-infectives, and oncology. Global Footprint – The acquisition strengthens Azurity's global footprint, expanding its commercial presence to over 50 countries and enabling greater patient accessibility to life-changing treatments. Azurity and its subsidiaries will employ more than 800 colleagues across North America, Europe and Asia. Key Biopharma Partner of Choice – The combined company is positioned to be a key partner for global life sciences companies looking to develop and commercialize their products, providing partners access to its deep development capabilities and global commercial infrastructure. Accelerated Innovation – By combining expertise and resources, Azurity is positioned to advance innovative treatments furthering Azurity's mission to serve overlooked patients using a unique and accelerated development process – enabling scale and velocity. Next-Gen Commercial Model – The integrated company portfolio will benefit from Azurity's highly efficient and effective commercial model, combining data, analytics, and AI-driven digital capabilities to drive stakeholder engagement using an optimized omnichannel marketing approach. "We are excited to welcome Covis Pharma to Azurity," said Ronald Scarboro, CEO of Azurity. "The efforts of colleagues at both companies, their devotion to overlooked patients, and our culture of execution have brought us together to build this unique, highly differentiated pharmaceutical company. I look forward to all that we will accomplish as we grow globally and embrace new opportunities, driven by our purpose." "I am delighted that Azurity recognized the accomplishments and potential of Covis, and am thankful for the tireless efforts of Covis colleagues in support of patients that benefit from the company's products," said Rajiv De Silva, Chairman of the Board of Covis. "I am confident that the two companies will be able to untap each other's highly complementary capabilities to accelerate development and commercialization of necessary medicines to underserved patients." "QHP Capital is proud to support Azurity in this acquisition, which aligns with our commitment to investing in life sciences and healthcare innovations," said Jeff Edwards, Partner at QHP Capital, the majority owner of Azurity. "It has been our privilege to support and enable Azurity from a small, limited product, US-only company at the start of our investment in 2018 to the global, large, diversified portfolio, high-growth company it is today. We are committed to further enabling Azurity for the significant growth its team is well positioned to execute." Goldman Sachs served as financial advisor and Eversheds Sutherland and White & Case served as legal advisors to Azurity. Guggenheim Securities served as financial advisor to Covis and Reed Smith and A&O Shearman served as legal advisors to Covis. About Azurity Pharmaceuticals:Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity's global footprint is over 50 countries, with a diversified portfolio of 30+ marketed brands spanning ten dosage forms and nine key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. For more information, visit www.azurity.com. About QHP Capital: QHP Capital is an investor in technology and services companies in the life sciences, medical technology, and healthcare sectors. QHP has built an investment platform to provide strategic capital and industry expertise in partnership with strong management teams. The investment team consists of seasoned investment and operational professionals with significant investment experience and deep life science, medical technology, and healthcare expertise. QHP benefits from an extensive network of industry experts that assist in identifying, analyzing, and growing QHP's portfolio companies. For more information, please visit www.qhpcapital.com. Disclosure notice: Azurity and QHP undertake no obligation to update or revise any forward-looking statements contained in this release as a result of new information, future events, or evolving circumstances.
BEIJING and BRIDGEWATER, N.J., March 10, 2025 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the first participant has been successfully dosed in a Phase 2 clinical trial of bofanglutide (research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee, in the US participants with overweight or obesity. Notably, bofanglutide is the first GLP-1 receptor mono-agonist to undergo a head-to-head comparison with tirzepatide for evaluating the efficacy in body weight management globally. This Phase 2 clinical trial (ClinicalTrials.gov registration number: NCT06737042) was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity. The study plans to enroll 285 subjects, who will be randomized to receive either 24 mg, 36 mg, or 48 mg of bofanglutide bi-weekly, 15 mg of tirzepatide once-weekly, or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment. Previously, a Phase 1 study (NCT06548997) of bofanglutide injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential[1]. The initiation of head-to-head clinical study for bofanglutide versus tirzepatide, marking a new phase in Gan & Lee's GLP-1 innovation. This milestone underscores the company's ambition to challenge the leading GLP-1 therapy in the global market for weight management, aiming to provide a better treatment option for patients with overweight or obesity worldwide. Reference: [1].Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 Mar 3. doi: 10.1111/dom.16285. Epub ahead of print. PMID: 40028667. About Bofanglutide (GZR18) Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly GLP-1 receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly GLP-1 RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of GLP-1 RAs, and significant reductions in both blood glucose levels and body weight. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin), fast-acting lispro injection (Prandilin®™), fast-acting aspart injection (Rapilin), mixed protamine zinc lispro injection (25R) (Prandilin®™25), aspart 30 injection (Rapilin30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine)®. In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets®. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.
HANGZHOU, China, March 3, 2025 /PRNewswire/ -- METiS Pharmaceuticals, a clinical-stage, AI-driven biotechnology company specializing in innovative drug delivery technologies, today announced the appointment of Mark Herbert as Chief Business Officer (CBO), effective January 22, 2025. In this role, Mr. Herbert will lead global business development, build key partnerships, and explore new opportunities to support METiS' growth and advance the commercialization of its drug delivery technologies. METiS Pharmaceuticals Appoints Mark Herbert as Chief Business Officer With over 20 years of experience in the biotechnology and pharmaceutical industries, Mr. Herbert has a proven track record in business development, commercialization, and strategic partnerships. Prior to joining METiS, he served as President of Arcturus Therapeutics, where he led strategic collaborations with Takeda Pharmaceutical and CureVac on platform and mRNA pipeline collaborations, generating over $2 billion in partnership value. He has also held key roles as Vice President of Business Development at Varda Space Industries, Chief Business Officer at Scientist.com, and served on the boards of multiple biotech companies. His extensive industry experience will be instrumental in METiS' next phase of growth. "We are excited to welcome Mark Herbert to METiS," said Dr. Chris Lai, Co-founder & CEO of METiS Pharmaceuticals. "Mark is a highly experienced executive with a proven track record in driving business development and commercialization in the biotech space. His leadership will be instrumental in strengthening our partnerships and unlocking new growth opportunities as we enter this crucial phase." "Mark's deep industry knowledge and global perspective will be invaluable as METiS accelerates its growth," said Dr. Hongmin Chen, Co-founder & CRDO of METiS Pharmaceuticals. "His leadership will help enhance our business development efforts and foster partnerships that will bring our transformative drug delivery technologies to patients around the world." "Joining the talented team at METiS Pharmaceuticals is a tremendous honor," said Mark Herbert. "I look forward to working closely with the team to advance our cutting-edge nucleic acid and drug delivery technologies, drive innovation, and expand our global partnerships. METiS is at the forefront of using AI to revolutionize drug delivery, and I'm thrilled to be part of this exciting journey." Over the years, METiS Pharmaceuticals has made significant progress in developing AI-driven LNP (lipid nanoparticle) delivery systems, achieving breakthroughs in targeted nano delivery for organs such as the liver, lungs, spleen, muscles, and central nervous system. These advancements demonstrate up to 20 times greater efficacy in liver cancer and lung tumors compared to industry standards. The company has also established strategic collaborations with over 20 leading global pharmaceutical and biotech companies. With Mark Herbert's appointment, METiS is entering an exciting new chapter. Moving forward, it is committed to delivering transformative therapies to patients worldwide through its innovative delivery technologies. About METiS Pharmaceuticals Founded in 2020, METiS Pharmaceuticals is an AI-driven biotechnology company focused on drug delivery. Utilizing cutting-edge AI, machine learning, and quantitative modeling, METiS is redefining the drug delivery and drug development. The company is also pioneering programmable nucleic acid therapeutics and next-generation RNA delivery to address unmet medical needs, ultimately delivering transformative treatments to patients worldwide. Media Relations Contact:pr@metispharma.com
REYKJAVIK, Iceland, Feb. 24, 2025 /PRNewswire/ -- 3Z Pharmaceuticals, a CNS-focused therapeutic development specialist, today announced the publication of a groundbreaking study in The Journal of Pharmacology and Experimental Therapeutics, unveiling novel insights into the metabolic mechanisms of ADHD treatments. This research, utilizing untargeted metabolomic and lipidomic profiling, addresses a critical knowledge gap in ADHD treatment. It reveals a convergence of molecular pathways among stimulant and non-stimulant ADHD medications and supports 3Z's earlier announced discovery of amlodipine as an L-type calcium channel blocker candidate. ADHD is a highly prevalent neurodevelopmental disorder with complex underlying mechanisms and limited treatment options. While both stimulant and non-stimulant medications are widely used, their precise metabolic effects on the brain remain poorly understood. "This study represents a major leap forward in our understanding of ADHD therapeutics," commented Dr. Karl Karlsson, CEO of 3Z Pharmaceuticals, emphasizing the study's significance, "By leveraging advanced metabolomics and lipidomics, we have uncovered a shared metabolic signature across treatments—highlighting the potential of L-type calcium channel modulation as the foundation for a new non-stimulant ADHD therapy. These findings not only validate our drug discovery platform but also pave the way for much-needed new treatment options." To bridge this gap, 3Z Pharmaceuticals employed an advanced systems biology approach, integrating cross-species analysis using the zebrafish adgrl3.1 ADHD model with targeted metabolomic profiling to explore common metabolic pathways underlying ADHD therapeutics. Key Findings from the Study: Metabolic Pathway Convergence: The study demonstrated that existing ADHD treatments—methylphenidate, guanfacine, and atomoxetine—as well as the novel candidate amlodipine, modulate share metabolic pathways related to amino acid and lipid metabolism. These include glycine, serine, threonine, lysophosphatidylcholine, and sphingomyelin metabolism. Systemic impact: Rather than acting through distinct, isolated mechanisms, ADHD medications appear to exert a broader, systemic impact on neurotransmitter precursors, oxidative stress markers, and energy metabolism. Amlodipine's Overlapping Effects with ADHD Medications: The metabolic profile of amlodipine significantly overlapped with that of established ADHD treatments, supporting L-type calcium channel engagement as a potential therapeutic pathway for ADHD. Full Study: https://www.sciencedirect.com/science/article/pii/S0022356525396163 Building on these findings, 3Z Pharmaceuticals is advancing its metabolomics-driven approach to CNS drug discovery, focusing on refining therapeutic targets and optimizing treatment strategies for future clinical development. About 3Z Pharmaceuticals 3Z Pharmaceuticals, based in Reykjavik, Iceland, identifies and advances next-generation therapies for CNS disorders through both novel discovery and strategic repurposing. The company is pioneering a state-of-the-art drug development platform that integrates high-throughput screening, multi-omics, and AI analytics. With a strong focus on translational validation, 3Z de-risks CNS drug development by combining multi-species assessment with human Mendelian randomization, polygenic risk scoring, and genetic studies to enhance clinical predictability. Contact For more information or media inquiries, please contact: Karl KarlssonCEO, 3Z PharmaceuticalsKarlsson@3z.isDD: +354 825 66467 This information was brought to you by Cision http://news.cision.com https://news.cision.com/3z-ehf/r/3z-pharmaceuticals-publishes-breakthrough-study-on-shared-metabolic-pathways-in-adhd-therapeutics,c4110316
TAIPEI, Feb. 17, 2025 /PRNewswire/ -- TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first Apixaban oral dissolving film (ODF). The study confirmed that TAH3311 is bioequivalent to U.S. and European reference Apixaban tablets (Eliquis®) under fasting conditions, with Cmax and AUC values falling within the regulatory acceptance range (80-125%). The study enrolled 60 healthy volunteers with 48 completing the trial. These results meet the criteria previously discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a basis for filing a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively, marking a significant milestone in the regulatory development. Globally, 15 million people suffer from strokes each year. Nearly half of hospitalized stroke patients experience swallowing difficulties, and approximately 13% develop long-term dysphagia. Conventional anticoagulants often require crushing tablets and mixing with liquids for patients with swallowing difficulties, which can lead to dosing inaccuracies and significant patient inconvenience. TAH3311 dissolves rapidly in the mouth without water, providing a more convenient alternative to tablets. Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, stated, "This pivotal study underscores our commitment to patient-centric innovation. TAH3311 is especially valuable for stroke patients, the elderly, children or others who have swallowing difficulties and require anticoagulant therapy twice daily. We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by choking when swallowing medication with water." U.S. Apixaban sales reached $26.1 billion in 2024*, and the global anticoagulant market continues to expand. Given these trends, TAH3311 is well positioned as a safer and more accessible treatment option. TAHO Pharmaceuticals plans to file regulatory submissions in both the United States and Europe in Q3 2025. At the same time, the company is actively pursuing strategic collaboration opportunities with international partners to accelerate TAH3311's global launch.*Source: IQVIA 2024 About ApixabanApixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis after hip/knee replacement, and the treatment and prevention of deep vein thrombosis or pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC). About TAHO Pharmaceuticals Ltd.Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan. Media Contact:TAHO PharmaceuticalsWebsite: https://www.tahopharma.com/en/+886-2-2659-8515ir@tahopharma.com
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