Fexolazan hydrochloride

Recorded FY'23 unconsolidated revenue of KRW 1.22 trillion and FY'23 operating profit of KRW 133.4 billion SEOUL, South Korea, Feb. 6, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (KRX: 069620.KS), a global pharmaceutical company located in Seoul, announced its marvelous financial results for 2023. Demonstrating a consistent growth trajectory, the company reported stand-alone sales of KRW 1.22 trillion and a commendable operating profit of KRW 133.4 billion. Chang-jae Lee, CEO of Daewoong Pharmaceutical, emphasized the company's global reach and innovative edge, stating, "Our role as a global healthcare solutions provider is mirrored in the impressive global performance of our novel drugs and our strategic expansion initiatives. Our strong financial results, characterized by record revenues and profits, affirm our unwavering commitment to innovation and to expanding our global market presence." Key Highlights (Unconsolidated) (unit: KRW billion) Revenues reached KRW 1,222 billion in 2023, marking a 60.7% increase from the previous year. Operating profit was KRW 134 billion in 2023, reflecting a 25.9% increase from the previous year. The annual net income was KRW 111.5 billion, an increase of 129.6% compared to the previous year. Product Developments: Fexuclue (Fexuprazan): A P-CAB drug for GERD, Fexuclue, has shown strong sales since its launch, amassing KRW 55 billion. It quickly became a blockbuster, accumulating a cumulative revenue of KRW 71.7 billion, attributable to its fast positioning in both local and global markets. Within just 17 months of its release, Fexuclue climbed to the 2nd rank in the domestic GERD treatment market. Additionally, it is gaining international traction, with NDA submissions in 18 countries and approvals from 5, including key Latin American markets such as Ecuador, Chile, and Mexico. Envlo (Enavogliflozin): An SGLT-2 inhibitor, Envlo, has rapidly expanded globally, submitting NDAs in 11 countries, including Indonesia and the Philippines, within just six months of its domestic launch. The global expansion of Envlo is regarded as a meaningful step, considering it is the only SGLT-2 inhibitor originally made by South Korea. NABOTA (Botulinumtoxin Type A): Recognized as Asia's first FDA-approved botulinum toxin, NABOTA has recorded sales of KRW 147 billion. It is expanding its international footprint through Evolus, launching as Nuceiva in several European countries and strengthening its position in North America and Europe. Additionally, Daewoong's US clinical trial partner, AEON Biopharma, secured a U.S. patent for migraine treatment last September. Pipeline Developments: DWP213388, targeting both BTK and ITK for immune cell activation, has received approval for U.S. Phase 1 Clinical Trials. The FDA endorsed its IND application in August 2023, highlighting its potential in treating autoimmune diseases such as RA. Bersiporocin, focusing on the PARS1 enzyme essential for collagen synthesis, is progressing through Phase 2 trials in the US and Korea. With its potential anti-fibrotic benefits, Daewoong remains dedicated to ensuring its safe use. The drug has achieved the FDA's Orphan Drug and Fast Track Designations for IPF. Additionally, it has received Orphan Drug and Fast Track Designations for IPF in Europe. DWRX2008, a novel drug candidate from Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical Group, aims to revolutionize the treatment of diabetic retinopathy by transitioning Envlo from oral administration to an innovative ocular pathway. As a first-in-class development, DWRX2008 has secured approval from South Korean's Ministry of Food and Drug Safety (MFDS) to commence Phase 1 clinical trials for its innovative candidate targeting diabetic eye diseases. DWP306001, which incorporates Envlo, is in development as a potential treatment for obesity. The combination of Envlo with an appetite suppressant is set to enter Phase 2 clinical trials later this year. Forward-Looking Statements: This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials. 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. SOURCE Daewoong Pharmaceutical Co., Ltd.

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