Calliditas Therapeutics AB

TOKYO & NOVI, Mich. & DÜSSELDORF, Germany--( BUSINESS WIRE )-- Asahi Kasei Pharma has taken another step in its transformation into a global specialty pharmaceuticals company through a new licensing agreement with Chiome Bioscience for its humanized anti-CX3CR1 antibody. The partnership exemplifies Asahi Kasei Pharma’s Open Innovation platform, which addresses unmet medical needs through strategic collaboration and cutting-edge science. The anti-CX3CR1 antibody, currently in preclinical development, works by inhibiting CX3CR1, a receptor involved in immune cell migration to inflammatory sites. By accelerating its development, Asahi Kasei Pharma aims to bring an innovative therapy to market that could significantly improve patient outcomes. “ By establishing an effective co-creation framework with Chiome, we successfully brought this initiative to fruition,” said Dr. Kazunobu Konishi, Senior General Manager of Pharmaceuticals Research Center at Asahi Kasei Pharma. “ We hope that this partnership will expedite the development of the anti-CX3CR1 antibody. Furthermore, we are committed to intensifying our open innovation activities to continuously secure global rights to early-stage projects, thereby enhancing our presence on the global stage.” The licensing agreement complements the “One AK Pharma” initiative, which unifies Asahi Kasei’s pharmaceutical operations in Japan and the U.S. to optimize resources and drive healthcare expertise. Earlier this year, Asahi Kasei acquired Calliditas Therapeutics , a Swedish firm recognized for developing TARPEYO™, a therapy for immunoglobulin A (IgA) nephropathy, a rare kidney disease. “ We’ve integrated our pharmaceutical businesses worldwide to better achieve our mid- and long-term goals,” said Yoshikazu Aoki, President of Asahi Kasei Pharma. “ This effort includes consolidating our Business Development functions in the U.S., where we plan to further accelerate activities that drive growth and innovation. Additionally, the acquisition of Calliditas strengthens our business foundation, enabling us to expand the scale of our pharmaceutical operations in the U.S. and enhance our market presence. These initiatives are key to Asahi Kasei’s goal of reaching $3 billion in annual pharmaceutical sales by 2030 through specializing in immunology, transplantation, and related diseases.” Through partnerships like the licensing agreement with Chiome, and a commitment to research-driven innovation, Asahi Kasei Pharma is well-positioned to address pressing global health challenges and deliver meaningful solutions that enhance quality of life. Learn more about Asahi Kasei Pharma’s Open Innovation platform . About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. For more information, visit www.asahi-kasei.com . Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/ .

Shanghai, China – November 28, 2024 – Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that NEFECON® has been included in the National Reimbursement Drug List ("NRDL"). The 2024 NRDL will take effect starting from January 1st, 2025. “NEFECON®’s inclusion in the NRDL acknowledges its significant clinical value in improving patient care.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, “With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. We believe that with NEFECON®'s inclusion in the NRDL, more patients with IgAN in China will have access to this innovative treatment and benefit from it. Moving forward, we will proactively collaborate with the government departments for the implementation of medical insurance policies, to benefit more Chinese IgAN patients and their families.” "I am excited to see NEFECON®’s inclusion in the NRDL. IgAN is highly prevalent in China and is one of the main causes of kidney failure in young adults. Compared to European and American populations, Chinese IgAN patients experience faster disease progression, poorer prognosis, and impose a heavy burden on patients and society.” Said Professor Chen Nan, Director of the Department of Nephrology at Ruijin Hospital-Shanghai Jiao Tong University School of Medicine, Level II Professor and Doctoral Supervisor at Shanghai Jiao Tong University, Tenure Professor at Ruijin Hospital-Shanghai Jiao Tong University School of Medicine, Director of the Clinical Nephrology Committee of the Chinese Medicine Education Association, “As the first and only approved etiological treatment for IgAN in China, NEFECON® has been providing benefits to IgAN patients since its approval. Under the medical insurance policies, we expect more patients with IgAN can benefit from early etiological treatment to help with disease management and embrace a better life." Results from Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. With its innovative mechanism of action and clinical benefit, NEFECON® has been recommended by multiple domestic and international treatment guidelines, further established its first-line cornerstone position in IgAN treatment. NEFECON® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong, Taiwan, China, South Korea and in Singapore under the trade name Nefegan®. NEFECON® was first approved in December 2021 by the United States FDA under the trade name TARPEYO® and was in 2022 approved by the European Commission and in 2023 by the MHRA, United Kingdom under the trade name Kinpeygo®. The product is marketed in the US by Calliditas Therapeutics AB and in Europe by Calliditas’ commercial partner, STADA Arzneimittel AG. About NEFECON® NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, 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 www.everestmedicines.com. 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.

According to DelveInsight's analysis, the market for Down syndrome is anticipated to increase during the forecast period (2024–2034), owing to the launch of emerging therapies such as AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, and others and healthcare spending globally. LAS VEGAS, Nov. 26, 2024 /PRNewswire/ -- DelveInsight's Down's Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Down's syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Down's Syndrome Market Report According to DelveInsight's analysis, the market size for Down's syndrome was found to be USD 241 million in the US in 2023. In 2023, the United States accounted for nearly 220K prevalent cases of Down's syndrome. The types of Down's syndrome include Trisomy 21, Robertsonian translocation, and Mosaicism. In 2023, among all types, Trisomy 21 accounted for the highest number of prevalent cases in the 7MM. Leading Down's syndrome companies such as AELIS FARMA, AC IMMUNE, PERHA PHARMACEUTICALS, ANNOVIS BIO, APHIOS THERAPEUTICS, and others are developing novel Down's syndrome drugs that can be available in the Down's syndrome market in the coming years. The promising Down's syndrome therapies in the pipeline include AEF0217, ACI-24.060, LEUCETTINIB-21, BUNTANETAP, APH-1104, and others. Discover which therapies are expected to grab the major Down's syndrome market share @ Down's Syndrome Market Report Down's Syndrome Overview Down's syndrome, also known as trisomy 21, is a genetic disorder caused by the presence of an extra copy of chromosome 21. This chromosomal anomaly disrupts normal development, resulting in a range of physical and cognitive differences. The condition is primarily caused by random genetic mutations during the formation of reproductive cells or early embryonic development, though advanced maternal age increases the likelihood of having a child with Down's syndrome. People with Down's syndrome typically exhibit distinct facial features, such as a flattened face, almond-shaped eyes that slant upward, and a small nose. Other common symptoms include developmental delays, intellectual disabilities, and a variety of health issues like heart defects, respiratory and hearing problems, and a higher susceptibility to infections. Despite these challenges, many individuals with Down's syndrome lead fulfilling lives with appropriate support. Diagnosis of Down's syndrome can occur prenatally through screening and diagnostic tests, such as blood tests and ultrasounds in the first and second trimesters, or through more definitive tests like chorionic villus sampling (CVS) and amniocentesis. Postnatal diagnosis is typically confirmed by a physical examination and a karyotype analysis to identify the extra chromosome. Early diagnosis and intervention can help address developmental needs and improve the quality of life for individuals with Down's syndrome. Down's Syndrome Epidemiology Segmentation The Down's syndrome epidemiology section provides insights into the historical and current Down's syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Down's syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Down's Syndrome Gender-specific Diagnosed Prevalent Cases of Down's Syndrome Type-specific Diagnosed Prevalent Cases of Down's Syndrome Age-specific Diagnosed Prevalent Cases of Down's Syndrome Diagnosed Cases of Down's Syndrome by Clinical Manifestations Down's Syndrome Treatment Market There is no single treatment for Down's syndrome; instead, care plans are customized to address each person's unique physical and intellectual needs, emphasizing their strengths and accommodating their limitations. For some individuals, immediate surgery may be needed after birth to correct heart defects or long-term dietary modifications may be required for digestive concerns. Common interventions include assistive devices such as hearing aids, mobility aids, and adaptive technology to support learning and daily tasks. People with Down's syndrome often face an earlier and more pronounced cognitive decline than the general population. Treatments for Down syndrome-associated dementia (DSAD) may include medications like rivastigmine, galantamine, memantine, and donepezil, which inhibit acetylcholine breakdown, providing notable benefits. Seizure management for those with Down syndrome may involve anticonvulsants like carbamazepine and phenytoin, although these can exacerbate other Down syndrome-related issues. Respiratory problems are also common due to immune deficiencies and respiratory tract abnormalities, often requiring antibiotics or inhaled bronchodilators for effective management. Along with pharmacological treatments, non-pharmacological therapies such as physical, speech, occupational, and behavioral therapies play a vital role in the early development of children with Down syndrome, promoting independence and productivity. Physical therapy aims to improve motor skills, build muscle strength, and enhance posture and balance, laying the groundwork for key abilities. Speech-language therapy focuses on boosting communication skills and addressing physical challenges like low muscle tone to avoid long-term complications. Occupational therapy adapts daily tasks to suit the individual's abilities, teaching crucial skills such as eating, dressing, writing, and using a computer. Emotional and behavioral therapies tackle challenges like frustration from communication barriers, compulsive behaviors, and ADHD by identifying triggers and creating strategies to foster positive behaviors and reduce undesirable ones. To know more about Down's syndrome treatment guidelines, visit @ Down's Syndrome Management Down's Syndrome Pipeline Therapies and Key Companies AEF0217: AELIS FARMA ACI-24.060: AC IMMUNE LEUCETTINIB-21: PERHA PHARMACEUTICALS BUNTANETAP: ANNOVIS BIO APH-1104: APHIOS THERAPEUTICS Discover more about Down's syndrome drugs in development @ Down's Syndrome Clinical Trials Down's Syndrome Market Dynamics The Down's syndrome market dynamics are expected to change in the coming years. The prevalence of Down syndrome has increased with the rise in lifespan over the past three decades. This, along with the combination of several neurological features in Down syndrome patients—such as language impairment, cognition, learning, and memory—has sparked intense neurodevelopmental research. Studies in this area hold promise for improving clinical care and quality of life for individuals with Down syndrome and their families, as well as for assessing ways to enhance communication between parents and children. A thorough understanding of the factors affecting pharmacotherapy in Down syndrome could significantly contribute to better clinical outcomes for these individuals. Furthermore, potential therapies are being investigated for the treatment of Down's syndrome, and it is safe to predict that the treatment space will significantly impact the Down's syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Down's syndrome market in the 7MM. However, several factors may impede the growth of the Down's syndrome market. Down syndrome presents unique challenges in clinical treatment, as there is currently no medical cure or approved products available in the market, complicating the treatment process. This complexity is compounded by the lack of appropriate, validated scales to measure progress or side effects in participants with learning disabilities, making it difficult to gauge treatment impact effectively. Furthermore, recruiting participants and their families is challenging, adding to the difficulties in conducting research. Down syndrome is also associated with numerous health problems and high healthcare costs, and individuals may require more intensive monitoring for adverse effects, adherence, and treatment efficacy when managing medications. Conducting clinical studies on the efficacy of psychotropic medications in individuals with Down syndrome is particularly challenging due to the unique language and communication characteristics of this population. Moreover, Down's syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, Down's syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact Down's syndrome market growth. Scope of the Down's Syndrome Market Report Therapeutic Assessment: Down's Syndrome current marketed and emerging therapies Down's Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Down's Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Down's Syndrome Market Access and Reimbursement Download the report to understand which factors are driving Down's syndrome market trends @ Down's Syndrome Market Trends Table of Contents Related Reports Down's Syndrome Epidemiology Forecast Down's Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Down's syndrome epidemiology trends. Down's Syndrome Pipeline Down's Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Down's syndrome companies, including Alzheon, Inc, Connecta Therapeutics, among others. Alport Syndrome Market Alport Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alport syndrome companies, including Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec , among others. Alport Syndrome Pipeline Alport Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alport syndrome companies, including Eloxx Pharmaceuticals, Inc., Chinook Therapeutic/Novartis, River 3 Renal Corp., Travere Therapeutics, Inc., Reata Pharmaceuticals, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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