Fexolazan hydrochloride

The first Korean developed medical device for spine implantation Expecte to receive faster approval in the U.S. by priority support from the FDA NOVOSIS PUTTY, combining bone-forming proteins and ceramic scaffolds, induces rapid bone formation SEOUL, South Korea, Jan. 2, 2024 /PRNewswire/ -- CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY", has been granted 'Breakthrough Device Designation' (BDD) by the U.S. Food and Drug Administration (FDA). This material incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2). On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA, 510(k), and De Novo, consistent with the Agency's mission to protect and promote public health. The FDA considers all of these factors to determine whether a device is 'reasonably expected to provide more effective treatment or diagnosis,'" according to the guidance. NOVOSIS PUTTY's designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY's efficacy and innovative aspects are recognized internationally. Devices with 'Breakthrough Device Designation' benefit from prioritized FDA support during the approval process. This support includes continuous communication with the FDA, assignment of a specialized review team, and prioritized review of everything from clinical trial design to approval. This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices. According to SmartTrak, the market for growth factor bone substitutes in North America is expected to grow from USD 0.66 billion in 2022 to USD 0.78 billion in 2029, with an average annual growth rate of 4.7%. NOVOSIS PUTTY, a second-generation product, features a ceramic-based synthetic scaffold with superior moldability and osteoconductive properties, and incorporates advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho. A key ingredient in NOVOSIS PUTTY is rhBMP-2, mass-producedx by Daewoong Pharmaceutical Co., Ltd., a leader in the South Korean pharmaceutical industry. This protein plays a crucial role in bone regeneration, transforming stem cells into bone cells in cases of bone defect. Known internationally as 'Nebotermin' and recognized by organizations including the WHO, Daewoong's rhBMP-2 has earned global acclaim for its impact on health. Hydroxyapatite (HA) ceramic material, bone graft substitute that acts as a scaffold of rhBMP-2 at the same time, allows for controlled release of rhBMP-2, reducing the risk of unwanted bone growth and surrounding soft tissue swelling, unlike collagen sponge-based scaffolds. It enables high-density bone formation with lower rhBMP-2 doses. Its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, also allows customizable shaping. CGBio has completed preclinical studies for U.S. confirmatory clinical trials of NOVOSIS PUTTY and is conducting clinical trials to determine the optimal dosage, with plans to apply for U.S. confirmatory clinical trials in the first half of 2024. Hyun Seung Yu, CEO of CGBio, commented, "The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio's technological prowess, innovation, and potential. With the designation's emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY." Jumi Han, head of CGBio's U.S. Development Center, stated, "The 'Breakthrough Device Designation' for NOVOSIS PUTTY confirms that regulatory authorities are prioritizing support for our product development. We are accelerating U.S. clinical trials to demonstrate its efficacy and safety." About CGBio CGBio began with the mission of 'Pursuing the Improvement of Quality of Life,' specializing in the production and sale of therapeutic materials for reconstructing musculoskeletal tissues damaged by diseases. Expanding its scope, the company now also provides materials for the beauty and plastic surgery sectors. Building on biomaterial-based technology, CGBio collaborates with clinical experts to supply essential products for clinical use and products that are convenient for use in clinical settings. More detailed information can be found at (). About Daewoong Pharmaceutical Daewoong Pharmaceutical, a leading global pharmaceutical company based in South Korea, is dedicated to improving consumer quality of life through its innovative products. Its self-developed NABOTA, a botulinum toxin type-A, is Asia's first FDA-approved botulinum toxin, and Daewoong has also developed novel drugs for GERD, using the active ingredient Fexuprazan, and for diabetes with Enavogliflozin for two consecutive years. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]. SOURCE CGBio

ROCKVILLE, Md., Dec. 20, 2023 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS), Daewoong Pharmaceutical (KRX: 069620.KS), and NurrOn Pharmaceuticals announced their participation in the 7th Annual Sachs Associates Neuroscience Innovation Forum. The event is scheduled to take place on January 7th, 2024, at the historic Marines' Memorial Club in San Francisco, California. The forum immediately precedes the JP Morgan Healthcare Conference, beginning January 8th. The collaborative efforts of HanAll, Daewoong, and NurrOn will be featured in a dedicated presentation highlighting the progress and potential of their ongoing Nurr1-focused Parkinson's Disease Program, currently in Phase I. The forum, renowned for bringing together thought leaders, researchers, and industry experts in the field of neuroscience, provides an ideal platform for HanAll and Nurron to share insights, innovations, and future directions. "We are excited to discuss our joint efforts with Daewoong and NurrOn at the Sachs Neuroscience Innovation Forum, a premier event in the neuroscience community. This collaboration represents a significant step forward in our commitment to advancing therapies with the potential to treat Parkinson's disease as well as to contribute to the evolution of neuroscience research," said Dr. Almira Chabi, Chief Medical Officer and Chief Development Officer at HanAll, who is presenting and also participating as a panelist at the forum. "We eagerly anticipate engaging with thought leaders and industry experts, sharing insights into the clinical development of ATH-399A, our innovative Nurr1 activator that may have the potential to capture both acute beneficial effects and long-term disease modification in Parkinson's disease," said Deog Joong Kim, Ph.D., CEO of NurrOn Pharmaceuticals. In addition to participating at the Neuroscience Innovation Forum, HanAll will also be attending the 42nd Annual J.P. Morgan Healthcare Conference from January 8th to 11th, 2024. About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presences in Korea, the USA, Japan, and Indonesia with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the areas of endocrine, circulatory, and urologic diseases for 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). About Daewoong Pharmaceutical Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. Daewoong is dedicated to completing the Phase 2 clinical study of this drug by 2025. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at naraesong@daewoong.co.kr. About NurrOn Pharmaceuticals NurrOn Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of Parkinson's disease (PD) and other Nurr1-related incurable human disorders. Through targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance, we aim to develop a paradigm changing PD treatment to improve patients' quality of life. While currently there are only symptomatic treatment options for patients with PD, there have not been any successful therapies to slow or prevent the progression of the disease. We believe that disease-modifying therapies will be achieved through targeting Nurr1, which has generated supportive data as a new druggable PD target. NurrOn was awarded a substantial grant from Michael J. Fox Foundation in support of the Phase 1 clinical trial of ATH-399A/HL192, that initiated in the second half of 2023. For further information on NurrOn Pharmaceuticals, please visit our official website or contact info@nurronpharma.com. Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2023 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma