Bersiporocin 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 The global expansion of Envlo is regarded as a meaningful step, considering it is the only SGLT-2 inhibitor originally made by South Korea.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.

SEOUL, South Korea, Jan. 29, 2024 /PRNewswire/ -- Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug Designation (ODD)' from the European Medicines Agency (EMA), adding to its earlier designation by the U.S. FDA for both IPF and systemic sclerosis. Continue Reading Daewoong Pharmaceutical's Bersiporocin Receives ‘Orphan Drug Designation’ in Europe to Treat Idiopathic Pulmonary Fibrosis The EMA's recognition highlights Bersiporocin's potential to meet critical needs in rare diseases, targeting conditions affecting fewer than 5 in 10,000 individuals in the EU. The designation offers several benefits, including guidance on clinical trials, reduced authorization fees, and 10-year market exclusivity upon approval. IPF is characterized by abnormal collagen accumulation in the lungs, reducing lung function. With a global incidence rate of about 13 cases per 100,000 people and a 5-year survival rate of only 40%, there's a pressing need for more effective and safer treatments. Bersiporocin's mechanism involves inhibiting PRS (Prolyl-tRNA Synthetase), thus targeting the excess collagen production that leads to fibrosis. The drug's efficacy was demonstrated in a study published by the European Molecular Biology Organization (EMBO). In addition to orphan drug designations, Bersiporocin has been granted fast track designation by the FDA. It also has been recognized in the 'Clinical Development Support' program by the Korea Drug Development Fund (KDDF). Bersiporocin has successfully completed phase 1 clinical trials in Korea and Australia, establishing its safety and pharmacokinetic properties in 162 healthy subjects. Multinational phase 2 clinical trials are currently in progress in Korea and the U.S. Seng-ho Jeon, CEO of Daewoong Pharmaceutical, stated, "With Bersiporocin's global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease." 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. Photo - Logo -