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Bagsværd, Denmark, 22 August 2022 – Novo Nordisk today announced headline results from a phase 2 clinical trial with CagriSema, a once-weekly subcutaneous combination of semaglutide and a novel amylin analogue, cagrilintide. The trial investigated the efficacy and safety of a fixed dose combination of CagriSema (2.4 mg semaglutide and 2.4 mg cagrilintide) compared to the individual components semaglutide 2.4 mg and cagrilintide 2.4 mg, all administered once weekly, in 92 people with type 2 diabetes and overweight. People were equally randomised among the three treatment arms. In the trial, the mean baseline HbA1c was 8.4% and the mean baseline body weight was 106 kg. After 32 weeks of treatment, people treated with CagriSema achieved a numerically higher HbA1c reduction of 2.18%-points compared to a reduction of 1.79%-points for people treated with semaglutide and 0.93%-points with cagrilintide alone. People treated with CagriSema achieved a numerically higher body weight reduction of 15.6% compared to a reduction of 5.1% for people treated with semaglutide and 8.1% with cagrilintide alone1. In the trial, CagriSema appeared to have a safe and well-tolerated profile. “We are encouraged by the impressive phase 2 results for CagriSema in people with type 2 diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “The results indicate that CagriSema reduces blood sugar more than semaglutide alone and the weight loss seen in the trial confirms the substantial weight lowering potential of CagriSema”. Based on the results, Novo Nordisk is now planning to initiate a phase 3 development programme for CagriSema in people with type 2 diabetes in 2023. The CagriSema (2.4 mg semaglutide and 2.4 mg cagrilintide) phase 3 programme in people with overweight and obesity, REDEFINE, is expected to begin in the fourth quarter of 2022. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

HANGZHOU, China and SAN FRANCISCO, Aug. 2, 2022 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, today announced positive results from a 20-week Phase 2 clinical trial of XW003 (Ecnoglutide) in Chinese adults with type 2 diabetes (T2D). The results demonstrated that weekly subcutaneous administration of XW003 for up to 20 weeks was safe and well tolerated and achieved robust reductions in HbA1c, meeting the study's primary endpoints. The Phase 2 study is a multi-center, randomized, placebo-controlled clinical trial conducted in China with the participation of over 20 hospital-based certified study centers. A total of 145 adult patients with T2D, whose disease was inadequately controlled through lifestyle management or oral anti-diabetic therapy prior to entering the study, were randomized into four cohorts to receive once-weekly subcutaneous injections of 0.4 mg, 0.8 mg, or 1.2 mg XW003 or placebo for 20 weeks. At baseline, participants had a mean HbA1c of 8.55%. At week 20, participants receiving 0.4 mg, 0.8 mg, and 1.2 mg XW003 had statistically significant HbA1c reductions from baseline of 1.8%, 1.9% and 2.4%, respectively, compared to 0.5% in participants receiving placebo (P < 0.0001). At the end of the treatment, 88% of participants in the 1.2 mg XW003 cohort achieved HbA1c ≤ 7.0%, the target recommended by the American Diabetes Association for people with diabetes, compared to 21% in the placebo group. HbA1c ≤ 6.5% was achieved for 72% of participants in the 1.2 mg XW003 cohort, compared to 9% in the placebo group. Despite the participants' relatively low mean body weight at baseline, XW003 significantly reduced participants' body weight in a dose-dependent fashion. XW003 also led to improvements in additional cardiometabolic parameters, including fasting and post-meal serum glucose, waist circumference, blood pressure, and liver transaminases, showing the potential to provide patients with an overall treatment benefit. XW003 was generally safe and well tolerated with a similar incidence of adverse events (AEs) across treatment groups. There were no treatment-related serious adverse events (SAEs) or occurrence of serious hypoglycemia. Treatment-related AEs were all mild to moderate, with gastrointestinal side effects, such as diarrhea, nausea, constipation, and loss of appetite, being the most commonly reported AEs. The discontinuation rate due to AEs was less than 1% in participants receiving XW003. "Type 2 diabetes is a debilitating disease with the incidence rate steadily growing in China. It is often accompanied with cardiometabolic comorbidities such as obesity, high blood pressure, dyslipidemia, and fatty liver disease, seriously impacting patients' lives. More efficacious and better tolerated therapies are still urgently needed to address this great need," said Dalong Zhu, MD, Professor of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School and Principal Investigator of the study. "I am very pleased to see the highly positive results from this Phase 2 clinical trial, particularly the strong effect of XW003 in reducing HbA1c indicating a best-in-class potential among this class of drugs. We look forward to continuing this collaborative effort with the clinical investigators, patients, and Sciwind team to further develop this promising drug candidate to help patients in need of new therapies." "We are very excited to receive the positive topline results from this Phase 2 trial, which reenforce that XW003 has strong potential to address significant unmet needs for patients with T2D and other metabolic conditions," said Hai Pan, PhD, founder and CEO of Sciwind. "We plan to discuss these results with the Chinese regulatory authorities soon and prepare to initiate, pending the outcome of such discussions, the pivotal Phase 3 clinical trial in China in the near future." XW003 is also currently being investigated in clinical trials for obesity in China and Australia. Data readouts from these studies are expected later in the year. About XW003 Glucagon-like peptide-1 (GLP-1) analogs are effective tools in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. XW003 is a novel, biased long-lasting GLP-1 peptide analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. XW003 has been shown to be safe and well tolerated in a Phase 1 clinical study. Phase 2 studies are evaluating XW003 as a potential treatment for type 2 diabetes and obesity. About Sciwind Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates. Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutics delivery platforms and identified several drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.

SAN FRANCISCO, July 4, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Hemoglobin A1C (HbA1C) Testing - Global Market Trajectory & Analytics". The report presents fresh perspectives on opportunities and challenges in a significantly transformed post COVID-19 marketplace. FACTS AT A GLANCE What's New for 2022? A $1.7 Billion Global Opportunity for Hemoglobin A1C (HbA1C) Testing by 2026 - New Research from StrategyR Global competitiveness and key competitor percentage market shares Market presence across multiple geographies - Strong/Active/Niche/Trivial Online interactive peer-to-peer collaborative bespoke updates Access to our digital archives and MarketGlass Research Platform Complimentary updates for one year Edition: 17; Released: June 2022 Executive Pool: 5872 Companies: 110 - Players covered include A.Menarini Diagnostics Ltd.; Abbott Laboratories; Alere Inc.; ARKRAY Inc.; Beckman Coulter Inc.; Bio-Rad Laboratories Inc.; Diazyme Laboratories Inc.; EKF Diagnostics Holdings Plc; HemoCue® AB; OSANG Healthcare Co., Ltd; PTS Diagnostics; Roche Diagnostics; Siemens Healthineers; Tosoh Bioscience Inc.; Trinity Biotech plc and Others. Coverage: All major geographies and key segments Segments: Technology (Ion-Exchange High Performance Liquid Chromatography (HPLC), Immunoassays, Boronate Affinity Chromatography, Direct Enzymatic Assays, Other Technologies); End-Use (Hospitals & Clinics, Diagnostic Laboratories, Other End-Uses) Geographies: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa. Complimentary Project Preview - This is an ongoing global program. Preview our research program before you make a purchase decision. We are offering a complimentary access to qualified executives driving strategy, business development, sales & marketing, and product management roles at featured companies. Previews provide deep insider access to business trends; competitive brands; domain expert profiles; and market data templates and much more. You may also build your own bespoke report using our MarketGlass™ Platform which offers thousands of data bytes without an obligation to purchase our report. Preview Registry ABSTRACT- Amid the COVID-19 crisis, the global market for Hemoglobin A1C (HbA1C) Testing estimated at US$1.2 Billion in the year 2022, is projected to reach a revised size of US$1.7 Billion by 2026, growing at a CAGR of 8.4% over the analysis period. Ion-Exchange High Performance Liquid Chromatography (HPLC), one of the segments analyzed in the report, is projected to record a 7.5% CAGR, while growth in the Immunoassays segment is readjusted to a revised 8.1% CAGR. With diabetes reaching epidemic levels, there is strong potential for diabetes diagnostic and monitoring devices or tools including Hemoglobin A1c blood test. The adoption of HbA1c has gained momentum over the last decade as an essential assay for diabetes testing and monitoring. By measuring HbA1c levels in red blood cells, physicians gain access to information on patient's average concentration of glucose (sugar) level in the blood for the preceding 8-12 weeks. Given that red blood cells have a lifespan of 3 months (120 days) and HbA1c levels vary as new red blood cells are made, measuring HbA1c levels in a person's blood effectively gives an indication into the average blood glucose levels over the past two-to-three month period. Hemoglobin A1c test is attracting the attention of the healthcare industry and patients alike by virtue of its numerous advantages. For example, HbA1c tests can be performed at any given time in a day and do not necessitate overnight fasting prior to the collection of blood sample, which is an essential requirement in case of traditional oral glucose tolerance test. Moreover, HbA1c testing needs to be performed on a quarterly-basis. Also, HbA1c test results provide physicians with information needed to develop intervention strategies and treatment plans to prevent diabetes-related complications. Healthcare professionals are increasingly choosing to prescribe HbA1c test for patients for tracking their blood glucose levels, as against blood glucose tests owing to the former's better reliability, thereby enhancing the overall test volume. Since A1c test determines the glucose levels in a patient over the prior 2-3 month period, it is considered to be an ideal and reliable option for tracking diabetes than the conventional blood glucose tests. North America holds a commanding stake within the global hemoglobin A1c testing market and is predicted to retain its strong position over the coming years. The regional market is bolstered by increasing adoption of direct enzyme assay methods and technological advances related to the HPLC technology. The North American market is slated to gain from increasing acceptance of advanced chromatographic devices across hospitals, clinical settings and diagnostic laboratories. Led by Germany, Europe represents the second-leading market for hemoglobin A1c testing and is estimated to register a decent growth in the coming years. On the other hand, Asia-Pacific is forecast to post impressive gains and increase its market share due to rising incident of diabetes and the need for effective diagnostic techniques. By technology type, global HbA1c testing devices market is categorized into ion-exchange HPLC, affinity binding chromatography, enzymatic assay, and turbidimetric inhibition immunoassay, among others. All types of techniques are utilized for estimating blood hemoglobin levels or for checking HbA1c concentrations in diabetic individuals. Affinity binding chromatography emerged as the largest technology segment, with segment growth fueled by the sustained increase in investments being made by medical device manufacturers in this technology. In boron affinity chromatography technique, HbA1c is known to bind with boronate affinity resin, thus separating from the non-HbA1c component. HbA1c gets released from boronic acid sites on the resin, following further elution with sorbitol, and the proportion of HbA1c release is measured using photometric absorbance techniques. Antigen molecule (HbA1c) interacts with specific antibody-coated latex beads (HbA1c specific) for enabling detection of concentrations of HbA1 and total hemoglobin in whole blood, a method that is termed as immunoassay or latex-enhanced immunoassay method. The interaction between HbA1c and Hba1c specific causes inhibition of agglutination. Due to inhibited agglutination, the light scattering reduces, thus leading to a reduction in absorbance. The calibrated curve of absorbance and related HbA1c concentration leads to showing of HbA1c percentages from absorbance readings. Other techniques used include capillary electrophoresis, proteomic analysis by mass spectrometry and direct enzymatic assay. Capillary electrophoresis technique is used for separating hemoglobin derivatives and hemoglobin variants. Mass spectrometry is utilized for detecting masses in globin chain in order to identify hemoglobin variant, HbA1c and total hemoglobin levels. The ion-exchange high performance liquid chromatography (HPLC) segment claims the majority stake in the global hemoglobin A1c testing market and is projected to maintain its dominance in the coming years. The segment is estimated to exhibit a considerable growth rate due to several benefits of the technique over other options. Ion-exchange HPLC is fast, enhances ionic strength of the buffer, and identifies variants. The direct enzymatic assays segment is forecast to increase its market share due to continuous influx of new products. Enzymatic hemoglobin A1c testing is known for high reliability as enzymatic HbA1c assays remain unaffected by genetically- or chemically-modified hemoglobin variants. These benefits are anticipated to significantly drive global adoption of these assays. High performance liquid chromatography (HPLC) testing for HbA1c has been perceived as the gold standard to monitor glucose control among diabetics since the separation of hemoglobin A1c from other types of hemoglobin using the chromatographic column in 1958. Despite the development and availability of alternative techniques over the following years, HPLC testing has successfully retained its value and is offering unique, significant advantages to hospitals, laboratories, medical professionals and patients. While the traditional format of HPLC was known for its time- and labor-intensive nature, continuing advances have addressed these issues and allowed seamless integration of HPLC testing for hemoglobin A1c on automated hematology platforms. These developments have enabled laboratories to offer the testing in an affordable manner. In the recent years, the hematology domain has witnessed the emergence of multi-discipline EDTA automation options. These approaches allow majority of tests on an EDTA tube by leveraging integration of standard hematology testing with specialized testing like HPLC for hemoglobin A1c testing. Though there are other approaches to determine HbA1c, there are concerns associated with chemical and genetic variants that lead to false negatives and false positives. However, the use of HPLC eliminates these concerns and allows reliable testing. There are different forms of HPLC including boronate affinity and ion-exchange methods that are commonly used for measuring HbA1c. In addition, the ion-exchange HPLC approach is capable of identifying different variants like C, D, E and S in the heterozygous state along with fetal Hb, LA1c and CHb. More MarketGlass™ Platform Our MarketGlass™ Platform is a free full-stack knowledge center that is custom configurable to today`s busy business executive`s intelligence needs! This influencer driven interactive research platform is at the core of our primary research engagements and draws from unique perspectives of participating executives worldwide. Features include - enterprise-wide peer-to-peer collaborations; research program previews relevant to your company; 3.4 million domain expert profiles; competitive company profiles; interactive research modules; bespoke report generation; monitor market trends; competitive brands; create & publish blogs & podcasts using our primary and secondary content; track domain events worldwide; and much more. Client companies will have complete insider access to the project data stacks. Currently in use by 67,000+ domain experts worldwide. Our platform is free for qualified executives and is accessible from our website or via our just released mobile application on iOS or Android About Global Industry Analysts, Inc. & StrategyR™ Global Industry Analysts, Inc., () is a renowned market research publisher the world`s only influencer driven market research company. Proudly serving more than 42,000 clients from 36 countries, GIA is recognized for accurate forecasting of markets and industries for over 33 years. CONTACTS: Zak Ali Director, Corporate Communications Global Industry Analysts, Inc. Phone: 1-408-528-9966 Email: [email protected] LINKS Join Our Expert Panel Connect With Us on LinkedIn Follow Us on Twitter Journalists & Media [email protected] SOURCE Global Industry Analysts, Inc.