TTY Biopharm Co. Ltd.

Lipid nanoparticles (LNPs) have become a powerful tool for delivering drugs and genes. This technology has been instrumental in the development of various cancer treatments and vaccines, including those for COVID-19. LNPs are also being explored for use in vaccines against other infectious diseases, demonstrating their broad potential in improving human health. Lipid nanoparticles (LNPs) are being investigated as a game-changer in drug delivery for a wide range of pharmaceuticals, from tiny molecules to complex biologicals. The key advantage lies in their ability to overcome challenges faced by traditional drug delivery methods. This makes some of us ask this question - what are Lipid nanoparticles? What are Lipid nanoparticles? Lipid nanoparticles (LNPs) are microscopic spheres of fatty molecules (lipids). They act as Trojan horses, carrying drugs or genetic material like messenger RNA (mRNA) inside them. LNPs are a promising tool in medicine because they can address some of the challenges medications face when entering the body. LNPs are typically between 10 and 1000 nanometers in diameter. A nanometer is one-billionth of a meter. LNPs are made of various lipids, including cholesterol, phospholipids, and ionizable lipids. These lipids help to stabilize the LNP and allow it to fuse with cells. What are the different types of the lipid nanoparticles market Liquid Lipid-Core LNP, Solid Lipid-Core LNP (Solid Lipid Nanoparticle), Nanostructured Lipid Carrier (NLC), Hollow LNPs are types of the lipid nanoparticles. There are also other emerging LNP types, such as liposomes (early versions of LNPs) and some hybrid variations. These may be used for specific applications or offer unique properties. This is the largest segment and focuses on LNPs used to deliver drugs for various diseases like cancer, infectious diseases, and others. Explore the Demo Study @ 1.Liquid Lipid-Core LNP Liquid Lipid-Core LNPs have a core composed of liquid lipids. This liquid can be arranged in various structures, including liquid crystalline phases. The shape and structure of lipid nanoparticles (LNPs) depend on the ingredients used and how they're made. Traditionally, scientists create LNPs by mixing water and oil solutions with a helper molecule (surfactant) using machines like high-pressure homogenizers or sound waves (ultrasonication). Alternatively, they can use solvents to separate and then combine the components 2. Solid Lipid-Core LNP These LNPs have a solid lipid core that can encapsulate both hydrophilic (water-loving) and hydrophobic (water-fearing) drugs. They offer good stability and controlled release properties but may have limitations in drug loading capacity. 3.Nanostructured Lipid Carrier (NLC) NLCs have a core matrix made from a blend of solid and liquid lipids, rather than just solid lipids like in SLNs. This unique structure offers some advantages. NLCs potentially hold more medication compared to SLNs due to the presence of liquid lipids. Additionally, the ability to control the ratio of solid and liquid lipids allows researchers to tailor NLCs for controlled drug release or targeting specific tissues. Read our related market research report’s key insights: Lipid Nanoparticles (LNPs) CDMO Market Lipid Nanoparticle Raw Materials Market Lipid-Nanoparticle Based Genomic Medicines Market Liposomal and Lipid Nanoparticle Drug Delivery Systems Market Nanoparticle Formulation Market mRNA Treatment Market So, what are the market dynamics of the lipid nanoparticles industry? Key Market Driving Factors: Advancements in Drug Delivery Technology Growing Demand for Innovative Therapeutics Rising Investment in R&D Success of LNP-based Therapies Focus on Addressing Challenges COVID-19 Vaccine Development Increasing Prevalence of Chronic Diseases Biocompatibility and Safety Patent Expirations and Generic Drugs Rising Healthcare Expenditure Market Restraints: High Production Costs Complex Formulation Process Limited Expertise and Technical Knowledge Stability and Shelf-life Concerns Competition from Alternative Technologies Trends: Expansion of mRNA-Based Therapeutics Gene Editing and Gene Therapy Targeted Drug Delivery Biodegradable and Sustainable LNPs The lipid nanoparticles sector is highly specialized, competitive and rapidly growing. Johnson & Johnson, Sun Pharmaceutical, CSPC, Teva, Fudan-Zhangjiang, Zydus Cadila, TTY Biopharma, Pacira, Luye Pharma, Echelon Biosciences, BroadPharm, Biopharma PEG Scientific Inc., NOF AMERICA CORPORATION, CordenPharma, International, Merck KGaA, Avanti Polar Lipids, Tebubio, Creative Biolabs are some of the prominent players in the industry. This can be attributed to the effectiveness of lipid nanoparticles in cancer treatment and the commercial success of recently developed screening tool for evaluating mRNA enclosed in lipid nanoparticle. In February 2024, University of Pennsylvania researchers in the United States have developed a unique high-throughput screening tool designed for evaluating mRNA enclosed in lipid nanoparticles. With the help of this cutting-edge platform, large libraries of LNPs intended for brain targeting may be quickly screened. Its application accelerates the development of gene editing treatments by assessing and fine-tuning LNPs meant for brain delivery. Similarly, in July 2023, a formulation technique from Cytiva has been made available to enable the seamless production of lipid nanoparticle medications at both the clinical and commercial stages. By streamlining the procedure, this method makes it possible to produce lipid nanoparticle-based drugs effectively and completely, from development to commercialization. Call: North America +1 551 226 6109 Email: diana.dsouza@insightaceanalytics.com

SHANGHAI, Sept. 27, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved the New Drug Application (NDA) for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). "The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections and other life-threatening infections to more patients in Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Following the successful commercial launch of XERAVA® in mainland China and Singapore, we will accelerate patient access to this product in more markets including Hong Kong and Taiwan." XERAVA® was approved by the National Medical Products Administration ("NMPA") of China in March 2023 and commercially launched in July. It has also been approved and commercialized in Singapore. XERAVA® has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. Everest entered into an exclusive partnership agreement with TTY Biopharm (TTY) in 2022 for commercialization of XERAVA® in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin). About XERAVA® (eravacycline) XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines

Taiwan FDA accepts New Drug Application for Xerava for treatment of cIAI Everest enters into strategic partnership with TTY Biopharm for the commercialization of Xerava in Taiwan SHANGHAI, Aug. 10, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin). "The acceptance of our New Drug Application for Xerava and our agreement with TTY are key steps towards bringing this important and novel therapy to Taiwan," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "With a robust organization that includes expert functions in regulatory, medical, marketing and sales, and a successful record of commercializing other important anti-infective products in the region, TTY was a clear partner of choice as we continue our work to expand the regional reach and access of this critical therapy for patients with complicated intra-abdominal infections and other potentially life-threatening infections." "TTY Biopharm has been dedicated in the fields of cancer and critical care for many years. It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing. Through this partnership, TTY may provide more options and better solutions to both patients and medical professionals in the near future," said Sara Hou, Chief Executive Officer of TTY Biopharm. Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan. Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region. About Xerava™ (eravacycline) Xerava™ (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore and the medicine is currently under review for cIAI in Greater China. Everest is also developing Xerava for the treatment of community-acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit . About Complicated Intra-Abdominal Infections Complicated intra-abdominal infections (cIAI) is a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at . About TTY Biopharm Established in 1960, TTY Biopharm Company Limited, a publicly listed pharmaceutical company, has transformed in the last sixty years from a production- and sales-oriented generic manufacturing factory into a development- and marketing-focused company of branded generics. With unending self-renovation and transformation, TTY is utilizing the experience, technology, and relationship network accumulated over the decades to redefine itself as a biotech company focusing on developing special formulations and novel drugs. Its mission is to improve the quality of human life with scientific innovation. Additional information can be found at . Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines