China Pharmaceutical University

Dr. Julie Clark, SVP Clinical Development; Dr. Fang Li, SVP Regulatory Affairs, to join February 1st Experienced executives bring extensive track record in products for retinal and ophthalmology diseases MELBOURNE, Australia, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced the appointment of Julie Clark, MD, MS, as Senior Vice President (SVP), Clinical Development, and Fang Li, Ph.D. RAC, as SVP, Regulatory Affairs, effective February 1, 2024. Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team. “It is my great pleasure to welcome two ophthalmology experts, Dr. Clark and Dr. Li, to the Company as we prepare for the next stage in our growth and work towards advancing the development of sozinibercept (OPT-302),” said Dr. Guerard. “Their past contributions to the development and registration of ophthalmology therapies such as IZERVAY™, BEOVU®, and EYLEA®, will be instrumental to the potential success of our lead program investigating sozinibercept, currently in two Phase 3 pivotal trials.” Dr. Clark shared, “I am thrilled to join Opthea as we prepare to complete patient enrollment in the pivotal Phase 3 clinical program for sozinibercept in the first half of 2024. The majority of my career has been dedicated to the clinical development of novel therapies for retinal diseases. Sozinibercept could be the first new drug for wet age-related macular degeneration (AMD) in more than 15 years, with the potential to deliver superior visual gains when administered in combination with standard of care therapy. I look forward to contributing to bringing this novel product candidate to patients with serious retinal disease.” Dr. Li commented, “As we work towards the potential release of topline results for our Phase 3 program in mid-2025, I am excited to apply my expertise to support the development and execution of our regulatory strategy and potential filings for sozinibercept in the U.S. and other markets. I look forward to the opportunity to bring Opthea’s innovative potential medicine through the regulatory process for the benefit of patients with retinal diseases.” Julie Clark, MD, MS With more than 15 years of experience in ophthalmology medical and clinical development, Dr. Clark brings expertise in both early and late-stage programs, regulatory submissions, and approvals. Her contributions include substantial support for the approval and launches of retinal therapies such as EYLEA®, JETREA® and BEOVU®. In Dr. Clark’s most recent position as Vice President Clinical Development at IVERIC bio, Inc., An Astellas Company, she oversaw the development program leading to the August 2023 U.S. Food and Drug Administration (FDA) approval of IZERVAY™, a complement inhibitor approved for the treatment of geographic atrophy secondary to age-related macular degeneration. Dr. Clark previously served as Chief Medical Officer at Adverum Biotechnologies Inc, where she played a crucial role in developing intravitreal delivered gene therapy for retinal diseases. Dr. Clark is a graduate of Wake Forest University and Wake Forest University School of Medicine in Winston-Salem, NC, U.S. Fang Li, PhD, RAC Dr. Li brings over 30 years of expertise in drug development and more than 20 years in regulatory affairs experience. Her experience spans various domains including small molecules, biologics, gene therapy, over-the-counter products, in-vitro diagnostic products and medical devices, with a specific focus on ophthalmology. She has held key roles at prominent ophthalmology companies such as Novartis AG, Alcon Inc., and Bausch + Lomb Corporation. Dr. Li's extensive background includes significant involvement in health authority interactions, U.S. FDA advisory committee meeting preparation and the establishment and leadership of regulatory teams. She has a proven track record of success in obtaining product approvals in the U.S. and other regions. Throughout her career, Dr. Li has played a pivotal role in leading numerous FDA drug approvals, specifically contributing to the approval of ophthalmology products like JETREA®, LOTEMAX® Ointment, SYSTANE® COMPLETE. She has also contributed to the development and registration of other ophthalmology drug products such as BEOVU®, PAZEO®, LOTEMAX® GEL, BESIVANCE®, and VYZULTA®. Fang holds a PhD in Medicinal Chemistry from China Pharmaceutical University, China. About Opthea Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including neovascular (wet) age-related macular degeneration (wet AMD). Opthea’s lead product candidate sozinibercept is being evaluated in two pivotal Phase 3 clinical trials (ShORe, NCT04757610, and COAST, NCT04757636) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care. To learn more, visit and follow us on X and LinkedIn. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe,” “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding expectations on the outcomes of Opthea’s Phase 3 clinical trials of sozinibercept, the potential for sozinibercept as a combination therapy to be the first therapy to achieve superior visual outcomes over anti-VEGF-A monotherapy and improve vision outcomes for patients with wet AMD, the expected timing for completion of enrollment for the Phase 3 studies and topline data, the market opportunity for sozinibercept, and the future performance of Opthea. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of Phase 3 clinical trial patient enrollment and clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023 and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Frederic Guerard, CEO Company & Media Enquiries: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333 Investor Enquiries PJ Kelleher LifeSci Advisors Email: pkelleher@lifesciadvisors.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web:

NANJING, China, Jan. 4, 2024 /PRNewswire/ -- On December 28, 2023, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) successfully submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vicagrel capsule, which is indicated to treat a range of thrombotic cardiovascular and cerebrovascular diseases, including acute coronary syndrome, ischaemic stroke, and peripheral arterial disease. This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline. This NDA filing builds on continuous dialogues with the FDA and is supported by robust nonclinical data and clinical studies conducted in both China and US. Vicagrel, a novel oral P2Y12 receptor antagonist, represents Jiangsu Vcare's commitment to addressing unmet clinical needs with innovative approaches. Its mechanism of action involves the same active metabolite as clopidogrel that effectively inhibits platelet activation and aggregation, while addressing the issue of "clopidogrel resistance". This NDA filing reflects more than ten years of persistent innovation and dedication by Jiangsu Vcare. Once approved, Vicagrel promises to offer a new treatment option for the estimated 27.6 million US patients with coronary heart disease and stroke. About Vicagrel Vicagrel, a product of the collaboration between Jiangsu Vcare and China Pharmaceutical University, is under the exclusive ownership of Jiangsu Vcare. The early R&D breakthroughs were published in prestigious journals including the American Chemical Society's Journal of Medicinal Chemistry (2012) and Nature-affiliated SciBX (2012). Vicagrel stands out among antithrombotic treatments, offering key advantages in both pharmacogenomics and pharmacokinetics over clopidogrel due to its unique structural design. Recent Pharmacokinetics/Pharmacodynamics data positions vicagrel as a superior version of clopidogrel, eliminating the Black Box Warning associated with clopidogrel use and reducing drug interaction concerns, all achievable at a much lower daily dose. About Jiangsu Vcare Founded in 2010, Jiangsu Vcare PharmaTech Co., Ltd. is a high-tech enterprise specializing in innovative drug development, with over 700 employees, mostly technical staff, and operates a major R&D center in Nanjing Biomedical Valley. The company's research portfolio encompasses a range of clinical assets and preclinical projects, targeting key areas such as cardiovascular and cerebrovascular diseases, oncology, and autoimmune disorders. The company features a start-of-art drug discovery platform and partners with China Pharmaceutical University for postdoctoral and graduate research in Nanjing. Having raised nearly 1 billion yuan through three financing rounds between 2021 and 2023, the company aims to leverage its decade-long experience to develop innovative drugs addressing unmet medical needs. Jiangsu Vcare is seeking worldwide commercialization partner(s) for Vicagrel, and welcomes interested parties to contact us. Contact person: Eric Zhang, PhD AmberSight LLC Rockville, MD 20850 Cell: 01-301-518-5028 Yongheng.zhang@amber-sight.com Disclaimer: This news release was compiled and provided by Jiangsu Vcare, and any Commercial use is prohibited without permission. In any case, it is for non-commercial communication and reference purposes only and does not indicate any intention for cooperation or express any opinions. Please independently assess whether to use the content and information in this article at your own risk, Jiangsu Vcare does not assume any legal responsibility. While the company and the team strive for accuracy, they do not guarantee the full accuracy of the contents. If you have any questions about this information, please contact us. This statement will be governed by and interpreted under the laws of the People's Republic of China (PRC). As an essential component of this article, the above statement must be read and confirmed. Your use of this article implies your acceptance of this statement. View original content to download multimedia: SOURCE Jiangsu Vcare

NANJING, China--(BUSINESS WIRE)-- On April 22, Neuboron Medical Group (NMG), a leading global Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) total solution provider, and Xiamen Humanity Hospital (XHH) collaborated to co-host the Xiamen BNCT Technology Forum 2023 at the BNCT center in XHH. The event agenda underscored various topics, including BNCT clinical research, molecular imaging, nuclear medicine, and the development of next-generation boron drugs. A group of distinguished speakers from renowned research institutions, such as Peking Union Medical College Hospital, Taipei Veterans General Hospital, West China Hospital of Sichuan University, Nanjing University, China Pharmaceutical University, Dalian University of Technology, Tamkang University, and Changhua University of Education, gathered in person to present their latest research findings. The conference was a hybrid event bringing together around 5,000 physical and virtual attendees to discuss the outlooking of BNCT's new drug and clinical development. The first patient with recurrent head and neck chondrosarcoma at the forum shared his transformative experience with BNCT treatment. In addition, Prof. Dr. Yuan-Hao Liu of NMG presented the latest clinical research findings from the Xiamen BNCT center. To date, the Neuborons’ NeuPex AB-BNCT System, along with the use of boronophenylalanine (BPA) NBB-001, has demonstrated promising treatment efficacy and tolerable toxicity levels in 14 patients with 18 irradiations, particularly in controlling local tumors for head and neck (HN) patients, as well as demonstrating remarkable safety and efficacy for glioblastoma (GBM) patients. As of now, there have been a few cases where individuals have reached a complete response (CR). The expansion of clinical indications for BNCT relies heavily on the development of new NCT drugs. Multiple research teams presented their latest findings on potential new compounds during the conference. These groups also carried out preclinical efficacy evaluation experiments on the Xiamen BNCT platform, which included cell and animal studies, in addition to fundamental pharmaceutical research. Their findings provided essential data for future clinical applications. As a highly multidisciplinary advanced radiation modality, the forum marked an ideal platform for researchers to exchange their insightful perspectives on BNCT research. The Xiamen BNCT center strives to promote open innovation within the global BNCT community to accelerate the clinical application of BNCT research and novel drug development from bench to market in the short future. Please note that the Neuborons' NeuPex AB-BNCT System and boron drugs are currently in development and are not available for commercial use. About BNCT Boron Neutron Capture Therapy (BNCT) is a targeted radiation oncology therapy in that neutron beams destroy only boron compound-bearing tumors without destroying neighboring healthy tissue. BNCT has significant advantages of delivering highly effective and very cell-centralized radiation therapy in treating patients with recurrent, invasive, and local-regional metastases refractory tumors with a relatively low impact on the patient’s quality of life. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide. About Xiamen Humanity Hospital XHH is a Class III non-profit comprehensive hospital funded by Xiamen Ren’ai Medical Foundation (a non-public charitable medical foundation launched by Xiamen C&D Corporation Limited, the state-owned enterprise under Xiamen City), which is a modern hospital integrated with medical, first aid, prevention, healthcare, rehabilitation, teaching and R&D and with rich talent advantages and appropriate medical supporting equipment and facilities. About Neuboron Medical Group Neuboron Medical Group (NMG) was founded in 2014 in Nanjing and then expanded to Xiamen, China. NMG is China’s first and only company focused on providing Boron Neutron Capture Therapy (BNCT) total solutions to hospital users, including hardware, software, and boron drugs. Neuboron is a research and development-oriented enterprise that has built integrative and comprehensive know-how and capability over the whole BNCT technology. Neuboron has deployed China’s first in-hospital compact AB-BNCT medical system (aka. NeuPex) since August 2021 and has undergone the first-in-human study at Xiamen Humanity Hospital (XHH) BNCT Center in 2022. View source version on businesswire.com: Contacts Business Collaboration Qing-You Luo Neuboron Medical Group sales@neuboron.com Public Relations Chris Yu Neuboron Medical Group yuchenxiao@neuboron.com Source: Neuboron Medical Group View this news release online at: