TIDES Weekly | Global Peptide and Oligonucleotide Therapeutics Highlights (July 22–31)
ANKEBIO
Biopharmaceutical R&D and Manufacturer
Rona Therapeutics
Nucleic Acid Drug Developer
July 18, 2024According to the official announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the Investigational New Drug (IND) application for AFN0328 Injection, a Class 1 new drug jointly developed by Hefei Afana Biotechnology Co., Ltd. ("Afana Bio") and Anhui Anke Biotechnology (Group) Co., Ltd. ("ANKEBIO"), has been approved. This makes it the second HPV-related tumor mRNA therapeutic vaccine in China to be approved for clinical trials.
AFN0328 Injection is an mRNA drug for cancer treatment, jointly developed by Afana Biotechnology and ANKEBIO teams. It also benefits from the long-term cooperation between Afana Biotechnology and the University of Science and Technology of China, Hefei Comprehensive National Science Center, Key Laboratory of Immune Therapy and Immune Response, and the Key Laboratory of Natural Immunity and Chronic Diseases of the Chinese Academy of Sciences.Thick Accumulation.
AFN0328 adopts an adjuvant system with independent intellectual property rights, demonstrating significant advantages over existing systems on the market. In addition, this injectable utilizes an innovative antigen design that effectively presents antigens in primates. After process upgrades and further formulation innovations, it has solved the challenges of cold chain transportation and long-term storage. Notably, the sequence design of AFN0328 employs the MiQro RNA drug design platform jointly released by Hefei Afana Biotechnology Co., Ltd. and its collaborators.
July 18, 2024Novartis announced its financial results for the first half of 2024. Net sales in the first half of the year reached $24.3 billion, representing an 11% increase year-over-year at constant exchange rates; net profit was $5.9 billion, up 43% year-over-year. Sales in China amounted to $2.1 billion, marking a 29% year-over-year increase.
In the first half of 2024, Novartis' sales in its four key therapeutic areas—Cardiovascular-Renal-Metabolic, Immunology, Neuroscience, and Oncology—reached $4.111 billion (+37%), $4.403 billion (+21%), $2.234 billion (+39%), and $6.984 billion (+14%), respectively.
Novartis TOP20 Best-Selling Drugs in the First Half of 2024
About Novartis
Novartis is committed to reimagining medicine to improve people's quality of life and extend human lifespan. By leveraging our technological leadership in research and development and innovative accessibility initiatives, we deliver high-value medicines that alleviate the greatest disease burdens on society. In the pursuit of new drugs, we persistently innovate, with our R&D investment consistently ranking among the top in the global pharmaceutical industry. Novartis has approximately 106,000 employees from over 140 countries and regions worldwide, and nearly 800 million patients globally have benefited from Novartis products.
July 19, 2024, LargeRona Therapeutics (Shanghai) Co., Ltd. ("Rona Therapeutics"), a clinical-stage platform company that continues to lead in the field of nucleic acid drug research and development, today officially announced the successful completion of a US$35 million Series A+ financing round. This round of financing was led by LongRiver Jiangyuan Investment, with participating investors including Zhaode Investment, Boyuan Capital, Zhongqi Capital, and Lilly Asia Ventures, among others.
About Rona Therapeutics
Rona Therapeutics is a globally leading nucleic acid innovative drug platform company, focusing on the treatment of metabolic diseases and central nervous system degenerative diseases. Rona Therapeutics is committed to developing best-in-class siRNA drugs, demonstrating unique differentiation and innovation in liver-targeted metabolic-related pipeline products for cardiovascular diseases, non-alcoholic fatty liver disease, obesity, and kidney diseases. In addition, Rona Therapeutics also focuses on the field of central nervous system degenerative diseases, deeply exploring the potential of extrahepatic nucleic acid delivery, successfully establishing its proprietary extrahepatic delivery platform, aiming to treat a series of complex diseases such as amyotrophic lateral sclerosis and Alzheimer's disease, which are difficult to address with traditional drug therapies.
On July 19, 2024, the NMPA website announced that Eli Lilly's glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist Mounjaro (Tirzepatide) has been approved for a new indication in China. It is indicated for long-term weight management in adult patients with obesity or overweight with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
Tirzepatide is a once-weekly GIPR and GLP-1R agonist. In May 2022, Tirzepatide was first approved by the FDA for the treatment of type 2 diabetes. This year, Tirzepatide has been approved for marketing in China for the treatment of type 2 diabetes.
In February 2023, Eli Lilly announced that the China Phase III SURMOUNT-CN study of Tirzepatide for obese or overweight adult patients achieved positive results, meeting the primary endpoint and all key secondary endpoints, with no new safety signals observed.
About Eli Lilly and Company
Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, production, and sale of medicines, committed to improving human health through innovation. Eli Lilly was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876, with the founder dedicated to producing high-quality medicines to meet genuine medical needs.
July 22, 2024Day,Ionis Pharmaceuticals Announces Positive Six-Month Results from Phase 1/2a Clinical Trial of Its Antisense Oligonucleotide (ASO) Therapy ION582 in Patients with Angelman Syndrome, Plans to Initiate Phase 3 Trial in the First Half of 2025
About ION582
ION582It is an ASO drug designed to inhibit the expression of the UBE3A antisense transcript (UBE3A-ATS) and increase the production of UBE3A protein for the potential treatment of Angelman syndrome. In 2022, the U.S. Food and Drug Administration (FDA) granted ION582 Orphan Drug Designation and Rare Pediatric Disease Designation.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been a leader in the field of RNA-targeted therapeutics, pioneering new markets and transforming treatment standards. Ionis currently has four approved drugs on the market and a promising late-stage pipeline, with a focus on cardiovascular and neurological franchises. Our scientific innovation began with and will continue because we know that patients rely on us, driving our vision to become a leader in genetic medicine by utilizing a multi-platform approach to discover, develop, and deliver life-changing therapies.
July 22, 2024Day,Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, production, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, cardiovascular conditions, and ophthalmology, announced today that its dual agonist of glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), mazdutide (research code: IBI362), has achieved the primary endpoint and all key secondary endpoints in the Phase III clinical trial (DREAMS-1) conducted among Chinese patients with type 2 diabetes. The results demonstrated comprehensive benefits in glycemic control, weight loss, and cardio-renal metabolic indicators. Previously, the head-to-head Phase III clinical trial DREAMS-2 comparing mazdutide with dulaglutide for the treatment of type 2 diabetes also met its study endpoints. Mazdutide showed significantly superior glycemic control efficacy compared to dulaglutide and exhibited greater overall benefits in weight reduction and cardiovascular metabolic parameters. Innovent Biologics plans to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for mazdutide as a treatment for type 2 diabetes in the near future. Its first weight-loss indication was accepted in early 2024.
About Masidepeptide
Mashidu Peptide (IBI362) is a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist jointly advanced by Innovent Biologics and Eli Lilly and Company. As a mammalian oxyntomodulin (OXM) analog, Mashidu Peptide not only promotes insulin secretion, lowers blood sugar, and reduces weight by activating GLP-1R, but also enhances weight loss efficacy by increasing energy expenditure through GCGR activation, while improving liver fat metabolism.
About Innovent Biologics
"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is Innovent Biologics' mission and goal. Founded in 2011, Innovent Biologics is committed to the development, production, and commercialization of innovative drugs in major disease areas such as oncology, metabolic disorders, cardiovascular diseases, autoimmune conditions, and ophthalmology. The company has received approval for 10 products to be marketed, with 4 additional products currently under review by the NMPA. Four new drug molecules have entered Phase III or pivotal clinical trials, and another 18 new drug candidates have entered clinical studies. The company accelerates drug innovation through in-depth collaborations with pharmaceutical enterprises both domestically and internationally. Innovent Biologics has established over 30 strategic partnerships with international collaborators including Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center.
July 23, 2024Day,Cellectar Biosciences Announces Positive Results from the Pivotal CLOVER WaM Study of Iopofosine I-131, a First-in-Class Radiotherapeutic, for the Treatment of Waldenstrom’s Macroglobulinemia (WM). The study evaluated the efficacy of iopofosine I-131 in WM patients who had previously received at least two prior lines of therapy, including BTKi. Cellectar Biosciences plans to submit a New Drug Application in the fourth quarter of 2024 and apply for Priority Review.
July 24, 2024DayViking Therapeutics released its Q2 earnings report, updated pipeline progress, and subsequent development plans. The GLP-1R/GIPR dual-target agonist VK2735 will advance to Phase III clinical trials for weight loss, with an EOP2 meeting planned for the second half of the year. The oral version of VK2735 will initiate Phase II clinical trials in Q4. The THR-β agonist VK2809 for the treatment of NASH will also hold an EOP2 meeting in Q4 this year. The amylin receptor agonist project is planned to file an IND in 2025.
About VK2735
VK2735 is a dual agonist targeting glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, currently under development for the treatment of metabolic disorders such as obesity. Based on the results of these Phase 1 trials, the company plans to initiate a Phase 2 clinical trial of an oral formulation of VK2735 for the treatment of obesity later this year.
About Viking Therapeutics
Viking Therapeutics was founded in 2012, with its headquarters located in California, USA, and went public on NASDAQ in 2015. It is a clinical-stage biopharmaceutical company focused on developing first-in-class/best-in-class therapies in the field of metabolic/endocrine diseases.
July 25, 2024Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, agreeing to update the label of its once-weekly subcutaneous weight management therapy Wegovy (2.4 mg semaglutide) to reflect data from the SELECT cardiovascular outcomes trial. The trial demonstrated that in adults with established cardiovascular disease who are overweight or obese (initial body mass index [BMI] ≥27 kg/m²) and do not have diabetes, Wegovy reduces the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke.
SELECT is a randomized, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of 2.4 mg Wegovy compared to placebo as an adjunct to standard care in preventing MACE. The trial enrolled approximately 17,000 participants.Adult patients aged 45 years or older, diagnosed with cardiovascular disease and without a history of diabetes, who are overweight or obese.
About Semaglutide
Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, reduces appetite, and decreases food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (Brand Name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (brand name: Wegovy), and it is the first new drug approved by the US FDA for controlling common obesity or overweight since 2014. The drug was later approved by the EU for the treatment of obesity indications in the same year.
AboutNovo Nordisk
Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes, obesity, rare blood diseases, endocrine disorders, and other serious chronic conditions. To achieve this, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, delivering products and services to more than 168 countries and regions globally.