This is a randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial designed to evaluate the efficacy and safety of mazdutide in improving fatty pancreas in patients with overweight or obesity. The study plans to enroll 194 participants with overweight or obesity, who will be randomly assigned in a 1:1 ratio to either the mazdutide plus standardized lifestyle intervention group or the placebo plus standardized lifestyle intervention group, for a treatment duration of 48 weeks. The primary efficacy endpoint is the change from baseline in pancreatic proton density fat fraction (PDFF) measured by MRI at week 48. Secondary efficacy endpoints include changes in body weight, body mass index (BMI), waist circumference, glycemic and lipid metabolic parameters, visceral fat, and hepatic fat content. This study aims to provide preliminary evidence-based data supporting the application of mazdutide in the treatment of fatty pancreas associated with metabolic dysfunction.

Start Date15 Nov 2026

Sponsor / Collaborator-

NCT07781150

/ Not yet recruitingPhase 2IIT

Mazdutide Plus Levonorgestrel-Releasing Intrauterine System for Fertility-Sparing Treatment in Overweight or Obese Patients With Atypical Endometrial Hyperplasia or Early Endometrioid Endometrial Cancer

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of mazdutide combined with a levonorgestrel-releasing intrauterine system (LNG-IUS) for fertility-sparing treatment in overweight or obese patients with atypical endometrial hyperplasia (AEH) or early-stage endometrioid endometrial cancer. Eligible participants will be randomized in a 1:1 ratio to receive LNG-IUS plus mazdutide or LNG-IUS plus matching placebo. The primary outcome is the complete response rate of endometrial lesions at 24 weeks after randomization.

Start Date01 Nov 2026

Sponsor / Collaborator

Huazhong University of Science Tongji Hospital, Tongji Medical College

[+1]

NCT07767552

/ Not yet recruitingNot ApplicableIIT

Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial

The purpose of this study is to investigate and efficacy of Mastitide for diabetes remission in Chinese type 2 diabetic subjects with poor glycemic control on diet or exercise therapy alone or metformin/sodium-glucose cotransporter (SGLT2) inhibitor monotherapy.

Start Date30 Sep 2026

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Mazdutide

100 Translational Medicine associated with Mazdutide

100 Patents (Medical) associated with Mazdutide

Literatures (Medical) associated with Mazdutide

04 Aug 2026·Journal of the American Heart Association

Cardiovascular Effects of Glucagon Receptor Signaling Alone and Combined With Glucagon‐Like Peptide‐1 Receptor Signaling in Multiagonists: A Narrative Review With a Translational Focus

Review

Author: Kushner, Pamela R. ; Michos, Erin D.

Cardio–kidney–metabolic diseases including obesity, metabolic dysfunction–associated liver disease, and type 2 diabetes have reached pandemic prevalence, fueling the search for new treatments for these conditions, given their associated complications, notably cardiovascular disease. Dual agonists of the glucagon and glucagon‐like peptide (GLP‐1) receptors are promising. Certain GLP‐1 receptor monoagonists are indicated for treatment of type 2 diabetes, obesity, and metabolic dysfunction–associated steatotic liver disease; and for reducing cardiovascular events in type 2 diabetes or obesity and cardiorenal events in people with type 2 diabetes and chronic kidney disease. GCGR (glucagon receptor)/GLP‐1 receptor dual agonists may have additional efficacy, given emerging evidence that glucagon regulates energy balance and lipid metabolism as well as glucose homeostasis. However, putative cardiac effects of glucagon highlight cardiovascular safety considerations for dual agonists. Although unequivocal evidence that the GCGR is expressed in the human heart is lacking, high‐dose exogenous glucagon has acute chronotropic, inotropic, and hypertensive effects. Clinical studies of GCGR/GLP‐1 receptor dual agonists (eg, mazdutide, survodutide) have generally found that they increased heart rate to a similar extent as GLP‐1 receptor monoagonists (which are cardioprotective despite such chronotropic effects). Mazdutide and survodutide also reduced blood pressure and hyperglycemia. However, at least 1 other dual agonist was discontinued, partly due to unacceptably large increases in heart rate and prolongation of the corrected QT interval. These between‐compound differences may reflect different potencies for activating the GCGR and GLP‐1 receptors. Cardiovascular effects of GCGR signaling by dual agonists should be clarified per compound by ongoing clinical trials, notably the cardiovascular outcomes trial SYNCHRONIZE‐CVOT (A Study to Test the Effect of Survodutide [BI 456906] on Cardiovascular Safety in People With Overweight or Obesity) and thorough corrected QT study of survodutide.

04 Aug 2026·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity

Article

Author: Zhao, Yuzhu ; Han, Jie ; Qian, Lei ; Tian, Junhang ; Lv, Lingchun ; Cai, Hanqing ; Ji, Linong ; Zheng, Xuqin ; Ma, Qingyang ; Chen, Lei ; Gao, Leili ; Lu, Xiaohua ; Lian, Qiufang ; Li, Li ; Gu, Xuejiang ; Pang, Shuguang ; Meng, Haiyan ; Wang, Long ; Li, Hua ; Qin, Xihu ; Wang, Yanqi ; Bi, Yan ; Qiu, Wei ; Shi, Bimin ; Huang, Chongbing ; Han-Zhang, Han ; Deng, Huan ; He, Yuquan ; Jiang, Hongwei ; Yang, Tao ; Zhang, Suhe ; Han, Junfeng ; Zhang, Yawei ; Zhang, Tie

Importance:

Obesity is a worldwide problem and a major public health issue in China.

Objective:

To evaluate the efficacy and safety of mazdutide (a once-weekly glucagon and glucagon-like peptide-1 receptor dual agonist) in Chinese adults with obesity (defined as a body mass index of ≥30).

Design, Setting, and Participants:

A double-blind, placebo-controlled, phase 3, randomized clinical trial including Chinese adults with or without type 2 diabetes that was conducted at 27 hospitals from December 2023 to November 2025.

Interventions:

Participants were randomized in a 2:1 ratio to receive a once weekly, 9-mg dose of mazdutide administered subcutaneously (n = 308) or placebo (n = 154) as an adjunct to a reduced calorie diet and increased physical activity for 60 weeks.

Main Outcomes and Measures:

The coprimary outcomes were the percentage change in body weight from baseline and a weight reduction of at least 5% at week 60. The efficacy and safety analyses were performed in participants who received at least 1 dose of the study treatment.

Results:

A total of 461 participants (295 [64.0%] female; 16.1% with type 2 diabetes; mean age, 33.9 [SD, 8.4] years; body weight, 94.0 [SD, 13.8] kg; BMI, 34.3 [SD, 3.2]) received the study treatment (307 in the mazdutide group and 154 in the placebo group) and were included in the analyses. At week 60, the mean percentage change in body weight from baseline was –16.65% (95% CI, –18.19% to –15.12%) in the mazdutide group compared with –1.50% (95% CI, –3.43% to 0.43%) in the placebo group (between-group difference, −15.15% [95% CI, −17.22% to −13.09%]; P &lt; .001). At week 60, 84.3% of participants in the mazdutide group had a body weight reduction of 5% or greater compared with 33.1% in the placebo group (between-group difference, 51.6% [95% CI, 43.0% to 60.1%]; P &lt; .001). Adverse events leading to study treatment discontinuation were reported in 2.9% of participants in the mazdutide group compared with 0% in the placebo group. The most common adverse events were vomiting (53.1% in the mazdutide group vs 1.3% in the placebo group), nausea (46.9% vs 3.2%, respectively), and diarrhea (39.4% vs 6.5%); most of the adverse events were mild to moderate in severity.

Conclusions and Relevance:

Mazdutide provided clinically meaningful weight reduction in Chinese adults with moderate to severe obesity compared with placebo, but participants receiving the drug experienced gastrointestinal adverse reactions compared with those receiving placebo.

Trial Registration:

ClinicalTrials.gov Identifier: NCT06164873

04 May 2026·EXPERT OPINION ON THERAPEUTIC PATENTS

Patent landscape and therapeutic evolution of mazdutide: a dual GLP-1/Glucagon receptor agonist for obesity and type 2 diabetes

Review

Author: Abdul Fasi, Mohammed

INTRODUCTION:

Mazdutide is a dual glucagon-like peptide-1 receptor (GLP-1 R) and glucagon receptor (GCGR) agonist representing a new generation of incretin-based therapeutics for obesity and type 2 diabetes. While its clinical efficacy is increasingly recognized, the intellectual property framework that underpins its development and long-term positioning has not been systematically examined.

AREAS COVERED:

This review presents a comprehensive patent landscape analysis of mazdutide and related oxyntomodulin analogs. Patent documents were identified using the Patentscope database, covering filings between 2015 and 2025. Twelve patent families were analyzed, encompassing composition-of-matter, process chemistry, formulation technologies, dosing regimens, and therapeutic applications. The analysis traces the evolution of innovation from early peptide design by Eli Lilly to later formulation, clinical, and indication-expansion strategies led by Innovent Biologics, including obesity, type 2 diabetes, hyperuricemia, and adolescent obesity.

EXPERT OPINION:

Mazdutide illustrates how layered patent strategies integrating molecular design, manufacturability, formulation stability, and clinical use claims can secure durable exclusivity. This approach provides a strategic model for future dual and multi-receptor peptide therapeutics.

News (Medical) associated with Mazdutide

02 Sep 2026

·www.genohopebio.com

FDA’s Concerns With Unapproved GLP-1 Drugs Used For Weight Loss

Sep 02, 2026 View: 106 Leave a message FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA's review for safety, effectiveness and quality before they are marketed. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy. Visit FDA's BeSafeRx campaign for resources to safely buy prescription medicines online. Talk to your doctor if you have questions about your medicines. Contact the compounder who made the drug or the telehealth platform where you purchased the drug if you have any questions about instruction for use or information on the label. Look for these warning signs, including if a company: makes claims such as the compounded drug is the same as an FDA-approved drug offers medicine at deep discounts or prices that seem too good to be true sends medicine that looks different than what you've previously received at your local pharmacy or was pictured on their website, or arrives in packaging that is broken or damaged or lacks instructions for use does not require a screening and prescription by a licensed doctor before providing medicine does not have a licensed doctor available to answer questions after you receive your medication makes spelling errors on the label or provides incorrect addresses of the pharmacy includes a pharmacy name on the label that you think might be fraudulent A compounded drug might be appropriate if a patient's medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed. The agency has identified some areas of concern for compounded GLP-1 drugs. FDA is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns. Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition. The agency has warned: Telehealth companies for marketing unapproved drugs such as retatrutide, including instances of direct marketing to consumers. Active pharmaceutical ingredient distributors for selling retatrutide and other GLP-1 drugs to compounders. Outsourcing facilities for repackaging retatrutide. FDA is aware that compounded GLP-1 medications may be dispensed in vials containing multiple doses of medication for a patient to self-administer. Generally, FDA recommends that vials containing multiple doses of sterile medications be used within 28 days after the first use because there is an increased risk of contamination after 28 days. However, in some instances, a consumer may not finish using all the medication within 28 days of the first use, meaning some medication may remain in the vial 28 days after the first use. In these instances, FDA recommends consumers: Discard the vial within 28 days after the first use, even if medication remains in the vial. Do not continue using medication from the vial after 28 days, even if instructions from the compounder say the medication can be used for longer than 28 days. Always use a new, sterile needle and syringe for each dose. Reusing needles or syringes can result in contamination of the medication. Injectable GLP-1 drugs require refrigeration as indicated in their package inserts. FDA has received complaints that certain compounded GLP-1 drugs have arrived warm or with inadequate ice packs to keep the drug at recommended storage temperatures. The agency recommends patients not use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration, as this can affect the drug's quality. The agency has established a green list import alert (66-80) to help stop GLP-1 active pharmaceutical ingredients (APIs) that have potential quality concerns from entering the U.S. supply chain. This import alert does not apply to GLP-1 API from manufacturers that, based on an FDA inspection or other FDA evaluation, appear to be in compliance with FDA's rigorous standards for manufacturing practices. This action will help protect consumers from receiving poor-quality compounded drugs containing foreign-made APIs (which are also called bulk drug substances) that may be manufactured without appropriate controls to assure quality. This action does not stop the legal importation into the U.S. market of GLP-1 APIs from compliant API manufacturers, nor does it create any new limits on the legal compounding of GLP-1 drugs. FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In some cases, the compounding pharmacies identified on the labels of the products do not exist. In other cases, the labels of the fraudulent compounded medicine contain the name of a licensed pharmacy that, based on information FDA has gathered, did not compound these products. FDA is aware of one reported adverse event associated with a product labeled as compounded tirzepatide from a pharmacy that did not actually compound the product. The adverse event report included symptoms such as redness, site swelling, pain, and a red lump at the injection site. FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug. Additionally, the agency has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what is in the FDA-approved drug label. This could mean using more product in a single dose, taking doses more frequently or increasing the amount more quickly (titration schedule). Some of the adverse events are serious and some patients reported seeking medical attention for their symptoms, including nausea, vomiting, diarrhea, abdominal pain and constipation. Health care providers should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients. The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide. The agency is aware that some semaglutide products sold by compounders may be the salt forms. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding. FDA has received reports of adverse events related to compounded versions of semaglutide and tirzepatide. However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported. Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products. As of May 31, 2026, the FDA has received: 990 reports of adverse events associated with compounded semaglutide. more than 730 reports of adverse events associated with compounded tirzepatide. It is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events. FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients, and are illegal. The agency investigates reports of suspected counterfeit drugs to determine the public health risks and the appropriate regulatory response. FDA remains vigilant in protecting the U.S. drug supply from these threats. FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. These illegally marketed drugs: may be counterfeit could contain the wrong ingredients or harmful ingredients could contain too little, too much or no active ingredient at all The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies. FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labeled "for research purposes" or "not for human consumption." These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health. GenoHope Biotech Ltd. A leading manufacturer of GLP-1 API Approal by FDA Welcome any Inquiry WhatsApp/Tel:+8613833133635 Email:info@genohopebio.com Send Inquiry

25 Aug 2026

·www.prnewswire.com

Innovent Announces 2026 Interim Results and Business Updates

Transforming from Regional Leader to Global Premier: A Clear Strategic Path for Growth and Globalization SAN FRANCISCO and SUZHOU, China, Aug. 25, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announces its 2026 interim results and 2030 strategic vision. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "Looking back over the past fifteen years, Innovent has completed two key transformations: from 2016 to 2020, we transformed from an R&D-driven biotech company into a biopharmaceutical company with full-value-chain capabilities spanning R&D, manufacturing, and commercialization; from 2021 to 2025, we progressed from a long-term investment phase into a biopharmaceutical company that achieved revenue over RMB 10 billion and full-scale profitability. 2026 marks Innovent's best strategic window to date, and it is against this backdrop that we have set forth our new strategic goals for 2030. We have both the resolve and the confidence to drive our third critical transformation: evolving from a regional leading biopharmaceutical company into a global premier biopharma with global business operational capabilities. In the first half of 2026, Innovent delivered strong growth in both revenue and profit, further reinforcing our leading position in China's biopharmaceutical industry and highlighting our scarce value in both certainty and growth potential. At the same time, over the past ten months, we have reached multiple strategic collaborations with global multinational pharmaceutical leaders including Takeda, Eli Lilly, and Pfizer, while also partnering with biotechs such as Ollin and Spero to advance the global development of our differentiated pipeline. Our partnered pipeline now spans more than 20 assets, including 5 co-development and co-commercialization ("Co-Co") programs, with an aggregate deal value reaching USD 34 billion, representing more than 30% of the total out-licensing value among Chinese pharmaceutical companies over the same period1. Innovent stands at the most favorable strategic window in its development. We will continue to pursue high-quality growth in revenue and profit, guided by clear strategy and disciplined execution — strengthening and amplifying our 'dual-engine' advantage across oncology and general biomedicine, accelerating our global expansion, and advancing toward our 2030 strategic goals, so as to continue creating long-term value for our shareholders and society." A Visible Growth Path: Scale and Profitability Advancing in Parallel In the first half of 2026, Innovent reached RMB 8.6 billion in total revenue, representing 45% year-over-year growth, while product revenue reached RMB 8.2 billion, up 57% year over year. Building on the RMB 10 billion-plus revenue scale, Innovent maintained strong growth momentum, with its dual-engine strategy of oncology and general biomedicine continuing to deliver. Rapid revenue growth, coupled with continued improvements in operational efficiency, further drove improvements in profitability. IFRS net profit for the first half of the year was approximately RMB 1.3 billion, representing approximately 50% year-over-year growth, while Non-IFRS net profit reached RMB 1.7 billion, up 41% year over year. Innovent has entered a new stage characterized by simultaneous expansion in scale and improvement in earnings quality, setting a new paradigm for high-quality growth among biopharmaceutical companies. As of July 31, 2026, Innovent held RMB 30.2 billion in cash reserves, equivalent to approximately US$4.5 billion. In addition, we continued to generate positive cash flow, providing a strong financial foundation for long-term growth. Vision 2030: From China Leader to Global Premier Biopharma Building on high-quality growth and systematic portfolio development, the Company has underpinned its 2030 development goals. Revenue Scale: By 2030, we target to achieve total revenue of RMB 35–40 billion, largely driven by organic expansion from the existing business and pipeline. Sustainable Profitability: By 2030, we aim to benchmark our profit margin to top-tier pharmaceutical companies, through continued revenue expansion and efficiency improvements. Global Innovation: By 2030, we aim to advance at least five molecules into global MRCT Phase 3 development, achieve product launches in key markets, i.e. U.S. and Europe with international revenue emerging. Globalization: building global infrastructure and business operating capabilities, truly transforming into a global premier biopharmaceutical company. From "Product-led Growth" to "Portfolio-Driven Growth," with Dual Growth Engines Unleashing New Momentum China's Leading Oncology Franchise: Strengthening Core Oncology Leadership While Expanding Strategically into Key Growth Areas In oncology, Innovent has established a strong product portfolio and brand presence across core indications including lung cancer, gastrointestinal cancers and hematological malignancies. Focusing on the next-generation "IO + ADC" innovation strategy, the Company is advancing next-generation assets including IBI363 (PD-1/IL-2α-biased), IBI343 (CLDN18.2 ADC), and IBI3003 (GPRC5D/BCMA/CD3) into late-stage clinical development, establishing long-term growth drivers and competitive advantages across multiple strategic areas. Meanwhile, through its collaboration with Lilly on Verzenio® (abemaciclib) in breast cancer, we have strategically gained an important entry point into this major high-incidence tumor type. This asset lays the foundation for upcoming in-house pipeline programs such as IBI354(HER2 ADC) and IBI3014(PD-L1/TROP2 ADC), and paves the way for a more systematic presence in breast cancer. General Biomedicine Franchise Emerged as a New Growth Engine In general biomedicine, Innovent has established a clear framework across four major chronic disease areas—metabolic, cardiovascular, ophthalmology and autoimmune—and this franchise has become another core pillar of Innovent. SYCUME® (Teprotumumab, IGF-1R antibody), China's first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world's first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO® (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE® (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025. At the same time, our next‑generation metabolic and obesity pipeline – including IBI3032 (once‑daily oral GLP‑1), IBI3042 (once‑weekly oral GLP‑1), IBI3040 (Amylin), IBI3046 (INHBE siRNA) and IBI3030 (monthly PCSK9‑GGG) – provides deep, long‑term growth reserves in global obesity and metabolic disease. In cardiovascular & metabolism, autoimmune and ophthalmology, we are following a "flagship products life cycle management + next‑generation innovation" strategy to build focused product clusters and durable competitive positions in each area. Three Late-Stage Global Assets Unlocking More Than US$60 Billion Total Addressable Market (TAM), and 20+ Partnered Programs Accelerating Global Innovation Innovent is advancing global development of its core assets through multiple collaboration models. Three key assets have entered, or are about to enter, global multi-regional Phase 3 trials, with a combined addressable market estimated at over US$60 billion, and are expected to be major value drivers in the coming years: IBI363 (PD-1/IL-2α-biased, Takeda R&D Code: TAK-928): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications, global co-development with Takeda A global multi-regional Phase 3 study (MarsLight-11) in IO-resistant squamous non-small cell lung cancer (NSCLC) is ongoing, and with expansion into IO-resistant non-squamous NSCLC in preparation. A pivotal Phase 2 study of IBI363 in melanoma in China is expected to read out in the second half of 2026, potentially supporting the first NDA submission for IBI363. IBI363 has demonstrated preliminary positive PoC results in first-line NSCLC. PoC studies in first-line NSCLC and first-line colorectal cancer are ongoing, with additional PoC studies being advanced across other tumor types, further supporting its potential as a next-generation IO backbone therapy. Arcotatug Tavetecan (CLDN18.2 ADC, Innovent/Takeda R&D Code: IBI343/TAK-921): Globally First NDA stage Next-Generation Fc-Silenced CLDN18.2 ADC, potential TAM over US$8 billion The China-Japan multicenter Phase 3 study completed its first interim analysis and achieved primary endpoint. The NDA submission has been accepted by NMPA for the treatment of CLDN18.2-positive advanced gastric cancer in later-line settings. A Phase 3 study in first-line pancreatic cancer is planned to initiate in China. International multicenter Phase 1 and PoC studies in first-line pancreatic cancer and first-line gastric cancer are ongoing. IBI324 (VEGF/ANG2, Ollin R&D Code: OLN324): Potential best-in-disease retinal therapy, potential TAM US$15 billion Our partner Ollin Biosciences reported positive results from the Phase 1b JADE head-to-head study against faricimab in nAMD and DME patients in the U.S. Ollin plans to initiate global multi-regional Phase 3 studies in DME and nAMD in the second half of 2026, and through collaboration with Innovent, to conduct patient enrollment in China and South Korea. Diversified Partnerships to Accelerate Global Innovation Over the past 10 months, Innovent has entered into strategic multi-product collaborations with global multi-national pharmaceutical companies including Takeda, Lilly and Pfizer, while partnering with biotech companies such as Ollin and Spero to rapidly validate differentiated pipeline programs in selected disease areas. The aggregate deal value reaching US$34 billion, covering more than 20 pipeline programs, among which five are "Co-Co" assets. Leveraging diversified partnership models, the Company will progressively build overseas R&D and commercialization capabilities and evolve into a truly world-class biopharmaceutical company with global business operating capabilities. High-Quality Manufacturing Standards Innovent operates advanced manufacturing facilities built to international standards and our Suzhou manufacturing site has recently undergone and successfully passed a Good Manufacturing Practice (GMP) inspection conducted by the European Medicines Agency (EMA), and has obtained the corresponding GMP certificate. Total operational capacity of 140,000 liters, accounting for 20% of China's total biologic manufacturing capacity. Suzhou site houses 60,000 liters of antibody capacity and ADC commercial lines; Hangzhou site has 80,000 liters of antibody capacity, supporting global supply and CDMO services. Sustainable Development and ESG Commitment 9,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou. Over 3,000 new cancer patients initiate Innovent therapies daily; more than 10 million patients have benefited to date. Maintained MSCI ESG AAA rating, leading China's biopharmaceutical industry. First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status). Launched community health initiatives including the MV 'Weight Management Made Easy' and documentary 'Down in Weight, Up in Life' to promote science-based healthy weight management. Published patient education materials on thyroid eye disease and weight management to enhance public health awareness. Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 4 billion. Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise". Created over 2,700 jobs for new graduates. Cumulative taxes and contributions exceeding RMB 9 billion. Note: Data source: Next Pharma database. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset in NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Takeda, Pfizer, Roche, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo), Pirtobrutinib (Jaypirca) and abemaciclib (Verzenios) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements of Innovent Biologics This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 1Clinical ResultPhase 3Drug ApprovalPhase 2

13 Aug 2026

·www.globenewswire.com

OPKO Health Expands Strategic Relationship with HealthCare Royalty Through $125 Million Notes Issuance Secured by Mazdutide Royalty Interests

Transaction provides additional non-dilutive capital and enhanced financial flexibility while preserving meaningful long-term royalty upsideMIAMI, Fla., Aug. 13, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced the expansion of its financing relationship with HealthCare Royalty, a business of KKR (HCRx), through the issuance of an additional $125 million aggregate principal amount of senior secured notes. The newly issued notes are secured by OPKO’s royalty interests arising under its mazdutide license agreement with Eli Lilly and Company and mature in 2044, consistent with the maturity of OPKO’s existing HCRx notes issued under the original financing arrangement. The transaction provides OPKO with additional non-dilutive capital while preserving significant long-term participation in the value of the mazdutide franchise. Total payments under the expanded financing structure are capped at 1.5 times the amount funded, after which OPKO retains future royalty economics associated with the financed stream. The structure is intended to unlock immediate value from an emerging royalty stream while maintaining OPKO’s participation in long-term royalty growth. "This transaction with HCRx further demonstrates our ability to leverage high-quality royalty assets to create non-dilutive financing alternatives for our shareholders," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "Mazdutide represents a promising opportunity in China within our partnered product portfolio. By financing a portion of these future royalty interests on attractive terms, we strengthen our balance sheet while retaining meaningful long-term upside." The product is being commercialized in China by Innovent Biologics, and OPKO receives royalties on commercial sales pursuant to its licensing arrangement with Eli Lilly and Company. OPKO recorded its initial mazdutide royalty revenue during 2025 following commercial launch activities in China. "We are pleased to further expand our partnership with OPKO," said Clarke Futch, Chairman and CEO of HealthCare Royalty. "OPKO has assembled a unique portfolio of royalty-generating assets, and mazdutide represents an attractive opportunity to invest in a high growth segment in China. We believe this transaction provides a compelling outcome for both organizations and further demonstrates the strength of our relationship." About HealthCare Royalty HealthCare Royalty ("HCRx") is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR). Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products. With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties. For more information, visit https://www.hcrx.com . HEALTHCARE ROYALTY®, HEALTHCARE ROYALTY PARTNERS® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and novel and proprietary technologies. For more information, please visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of mazdutide, including whether royalty economics will remain favorable, the growth potential of the market in China, whether the relationship with our commercial and strategic partners will be successful, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:Alliance Advisors IRVivian Cervantes, 973-873-7724vcervantes@allianceadvisors.com

License out/in

100 Deals associated with Mazdutide

External Link

KEGG	Wiki	ATC	Drug Bank
D12225	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Innovent Biologics (Suzhou) Co. Ltd.	16 Sep 2025
Obesity	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Jun 2025
Overweight	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Jun 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	20 Mar 2026
Sleep Apnea, Obstructive	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	13 May 2025
Metabolic dysfunction-associated steatotic liver disease	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Apr 2025
Early-onset type II diabetes	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	29 Feb 2024
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	20 Jun 2025
Heart failure with mid range ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Heart failure with normal ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Heart failure with reduced ejection fraction	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Apr 2025
Hyperuricemia	Preclinical	China	Innovent Biologics (Suzhou) Co. Ltd.	12 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06164873 (Pubmed \| JAMA)	Phase 3	Obesity	461	9-mg Mazdutide	crmfzxfaat(hehsudrtec) = uslpycsiod lskliotdnj (dlfxwzgpij ) View more	Positive	04 Aug 2026
				Placebo	crmfzxfaat(hehsudrtec) = ykccxrkogx lskliotdnj (dlfxwzgpij ) View more
NCT06164873 (GLORY-2, ADA2026)	Phase 3	Obesity	462	Mazdutide 9 mg	xifaffbajn(ypwskddvve) = ptdvbaoekt enkocyztoi (absgpmrsfd ) View more	Positive	20 Jun 2026
				Placebo	xifaffbajn(ypwskddvve) = luxhnhmovk enkocyztoi (absgpmrsfd ) View more
NCT04904913 (Pubmed \| Med)	Phase 2	Obesity	80	Mazdutide 9 mg	nnebirqjje(vkwxjqponj) = vptzkwymsf drjpcmnrzb (dooskhlawd ) View more	Positive	01 May 2026
				Placebo	nnebirqjje(vkwxjqponj) = sweezjesvs drjpcmnrzb (dooskhlawd )
NCT06124807 (CTgov)	Phase 2	Overweight \| Obesity	179	Placebo (Placebo)	fadxnegexh(opnnsinsfo) = cvxzfgxoty iejhdysnvl (vzqollpurx, 0.787) View more	-	21 Apr 2026
				Mazdutide (10 mg Mazdutide)	fadxnegexh(opnnsinsfo) = gumgmollao iejhdysnvl (vzqollpurx, 0.744) View more
NCT05628311 (DREAMS-1, Nature \| Pubmed \| PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	320	Mazdutide 4 mg	pbdwpfjlvo(qdlovphnji) = oghuxkkfkx ykyueyttxw (prksebwnxr ) Met View more	Positive	17 Dec 2025
				Mazdutide 6 mg	pbdwpfjlvo(qdlovphnji) = ecbdlyuwid ykyueyttxw (prksebwnxr ) Met View more
NCT05606913 (DREAMS-2, Nature \| Pubmed \| PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	731	Mazdutide 4 mg	xidbdzbqdy(dqujaarohf) = ykmgjfgsck ifuaxnojxw (okwosevmsn ) Met View more	Superior	17 Dec 2025
				Mazdutide 6 mg	xidbdzbqdy(dqujaarohf) = cpikbpkypk ifuaxnojxw (okwosevmsn ) Met View more
NCT05606913 (Pubmed \| Nature)	Phase 3	Diabetes Mellitus, Type 2	731	Mazdutide 4 mg	omdwqsjcbe(ssihazyguo) = The most common treatment-emergent adverse events were diarrhoea, nausea and vomiting. rhhmmxevad (oyvkddajbq )	Positive	17 Dec 2025
				Mazdutide 6 mg
PRNewswire Manual	Phase 1	Obesity	36	mazdutide 4 mg	nxrvojzwak(sztrwskosp) = oaqhhhclck toidkpkllh (byqvckyxgl ) Met View more	Positive	11 Dec 2025
				mazdutide 6 mg	nxrvojzwak(sztrwskosp) = kmuuzzukvy toidkpkllh (byqvckyxgl ) Met View more
NCT06164873 (GLORY-2, Company_Website) Manual	Phase 3	Obesity	462	Mazdutide 9 mg	dxugnqypdu(cdpdzwbsfb) = peapcjucul uhmhkbzmqf (buwpbnlusj ) Met View more	Positive	20 Nov 2025
				Placebo	dxugnqypdu(cdpdzwbsfb) = zpqqnegyks uhmhkbzmqf (buwpbnlusj ) Met View more
NCT05623839 (Pubmed \| Diabetes Obes Metab)	Phase 1	Overweight \| Obesity	32	Mazdutide (Cohort 1)	ejgsqqxpxy(gokstrpgqe) = the most common AEs were mild or moderate gastrointestinal disorders. oaeswnyobm (xngyofrjjo )	Positive	01 Nov 2025
				Mazdutide (Cohort 2)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis