RTA-404

SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that China’s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. The application was submitted by partner Hansoh Pharmaceutical Group Company Limited (3692.HK), one of the leading biopharmaceutical companies in China, and is based on positive results from Phase 3 studies in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. In February 2021, SCYNEXIS entered into an agreement for the development and commercialization rights for oral ibrexafungerp in the greater China region with Hansoh Pharma. Under the terms of the agreement, Hansoh is responsible for the development, regulatory approval and commercialization of ibrexafungerp in Greater China. Ibrexafungerp, once approved, is expected to become a new, first in class anti-fungal treatment for Chinese patients with vulvovaginal candidiasis (VVC). “We are delighted by the progress of our partner and the opportunity to make our novel antifungal agent available to patients worldwide,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We are excited to be contributing to the global fight in the treatment of fungal infections.” Ms. Sun Yuan, Executive Director of the Board of Hansoh Pharma, added, “The successful NDA filing of Ibrexafungerp in China marks a significant step in our efforts to combat antifungal resistance, a pressing global health threat. We appreciate the exceptional work carried out by our team and strong support from our partner throughout the regular filing process and the initial assessment conducted by the NMPA. The acceptance of the NDA brings us one more step closer to making this novel and differentiated antifungal available to patients in Greater China.” About Ibrexafungerp Ibrexafungerp is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent provides, for the first time, the opportunity for oral antifungal treatment with the well-established activity of glucan synthase inhibitors. Ibrexafungerp is in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral and IV formulations of ibrexafungerp for the indications of invasive candidiasis (IC), including candidemia, and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. The European Medicines Agency (EMA) has granted ibrexafungerp Orphan Medicinal Product designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078. About Hansoh Pharma Hansoh Pharma（03692.HK) is a leading innovation-driven pharmaceutical company in Greater China. It focuses on major disease treatment areas including oncology, anti-infectives, CNS diseases and metabolic diseases as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. As of now, the company has marketed seven innovative drugs, and has more than 30 innovative drug programs in different clinical stages with over 40 clinical trials in progress, forming a competitive pipeline. The company was listed on the Hong Kong Stock Exchange in June 2019. For more information, please visit www.hspharm.com. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing its proprietary class of enfumafungin-derived antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. The U.S. Food and Drug Administration (FDA) approved the first representative of this antifungal class, BREXAFEMME® (ibrexafungerp tablets), in June 2021 for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022 for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections is ongoing. Additional assets in the novel “fungerp” class of antifungals are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com. The content above comes from the network. if any infringement, please contact us to modify.

DUBLIN--( BUSINESS WIRE )--The "Invasive Aspergillosis - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Invasive Aspergillosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The assessment part of the report embraces, in depth Invasive Aspergillosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Invasive Aspergillosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Invasive Aspergillosis Emerging Drugs Chapters This segment of the Invasive Aspergillosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Invasive Aspergillosis Emerging Drugs Olorofim: F2G Olorofim (formerly F901318) is F2G's leading candidate from this class and has fungicidal activity against a broad range of mould infections including a variety of rare and resistant moulds that cause life-threatening infections for which current therapies have limitations or are ineffective. Olorofim has received orphan drug status from the European Medicines Agency and orphan drug status, Qualified Infectious Disease Product (QIDP) designation and Breakthrough Therapy designation from FDA. Ibrexafungerp: SCYNEXIS Ibrexafungerp (formerly SCY-078) is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. It has shown activity against Aspergillus and Candida, including against multidrug-resistant (MDR) species Candida auris as well as Pneumocystis. Ibrexafungerp combines the well-established activity of glucan synthase inhibitors with the flexibility of oral and IV formulations, offering a broad use across different settings (in-patient and out-patient). Invasive Aspergillosis: Therapeutic Assessment This segment of the report provides insights about the different Invasive Aspergillosis drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Invasive Aspergillosis There are approx. 3+ key companies which are developing the therapies for Invasive Aspergillosis. The companies which have their Invasive Aspergillosis drug candidates in the most advanced stage, i.e. phase III include, F2G. Report Highlights A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Invasive Aspergillosis. In the coming years, the Invasive Aspergillosis market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. The companies and academics that are working to assess challenges and seek opportunities that could influence Invasive Aspergillosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition. A detailed portfolio of major pharma players who are involved in fueling the Invasive Aspergillosis treatment market. Several potential therapies for Invasive Aspergillosis are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Invasive Aspergillosis market size in the coming years. The in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Invasive Aspergillosis) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities. Phases The report covers around 3+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Inhalation Inhalation/Intravenous/Oral Intranasal Intravenous Intravenous/ Subcutaneous NA Oral Oral/intranasal/subcutaneous Parenteral Subcutaneous Molecule Type Products have been categorized under various Molecule types such as Antibody Antisense oligonucleotides Immunotherapy Monoclonal antibody Peptides Protein Recombinant protein Small molecule Stem Cell Vaccine Product Type Invasive Aspergillosis Report Insights Invasive Aspergillosis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Invasive Aspergillosis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players F2G SCYNEXIS Pulmocide Ltd TFF Pharmaceuticals Key Products Olorofim Ibrexafungerp PC945 Voriconazole dry powder inhalation For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/7wjzpt