Latest news with #Innovent
Malaysian Reserve
30-06-2025
- Business
- Malaysian Reserve
Innovent Biologics Showcases "Dual Innovations" at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms
SAN FRANCISCO and SUZHOU, China, June 30, 2025 /PRNewswire/ — Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, held its Oncology R&D Day, unveiling its forward-looking strategy centered on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. This strategic focus aims to redefine the standards of cancer treatment and propel Innovent toward becoming a global, premier biopharmaceutical leader. The event drew over 500 participants, including leading oncology key opinion leaders (KOLs), principal investigators, analysts, and global investors, signaling strong engagement with Innovent's transformative vision for the future of oncology. 'Over the past decade, Innovent has been at the forefront of China's biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China's leading oncology brand, with over 3 million cancer patients treated with our therapies,' said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent. 'We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innovation of next-generation IO and next-generation ADC. Our recent presence at the 2025 ASCO with eight oral presentations highlights the strength and global competitiveness of our R&D. But this is only the beginning. With a clear vision to advance at least five pipeline assets into MRCT Phase 3 by 2030, we are committed to delivering innovative, high-quality, and accessible cancer treatments to patients worldwide.' Dual Innovation to Unlock the Future of Oncology: Next-gen IO + Next-gen ADC At the core of Innovent's oncology strategy lies the dual engines of next-generation immunotherapy (IO) and next-generation antibody-drug conjugates (ADC), supported by deep insights in cancer biology and differentiated technology platforms. 'We are harnessing deep cancer biology insights, advanced antibody and protein engineering, and differentiated ADC linker-payload technologies to develop broader-spectrum, more potent, and less toxic therapies aimed at transforming the oncology treatment paradigm,' said Dr. Zhou Hui, SVP of Innovent Oncology R&D. 'Our strategy is designed to target some of the toughest challenges in cancer care, including drug resistance, cold tumors, and improve the efficacy of current IO treatment, while bringing new hope to patients worldwide.' Global R&D Roadmap: a Clear, Stepwise Development Strategy Innovent's pipeline is guided by a rational, phased IO+ADC combination strategy designed to address tumor heterogeneity and immune escape, evolving through three stages: Next-gen IO + Chemotherapy: to redefine the IO cornerstone Next-gen IO + mAb-ADC / bispecific ADC: to cover expansive tumor types and treatment lines Next-gen IO + Dual-Payload ADC (dpADC): to unlock full potential of IO+ ADC synergy, and reshape cancer treatment Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the U.S., EU, and Asia. The company also continues to invest in global R&D infrastructure, supported by R&D hubs in Shanghai and San Francisco and antibody and ADC manufacturing capacity exceeding 140,000L. Innovent is rapidly expanding its global innovation footprint, with a 2030 goal to advance at least five pipeline assets into global MRCT Phase 3 trials. Key potential candidates includes: IBI343: innovative CLDN18.2 ADC with site-specific conjugation and a TOPO1 inhibitor payload, demonstrating significant survival benefits in both GC and PDAC IBI363: PD-1/IL-2α-bias fusion protein as next-gen IO to redefine cancer treatment and expand the boundaries of IO responsiveness IBI3009: DLL3 ADC in collaboration with Roche IBI3003: tri-specific T-cell engager targeting BCMA/GPRC5D/CD3 for multiple myeloma IBI3001: EGFR/B7H3 ADC with two synergetic targets covering multiple potential indications IBI3020: CEACAM5 dual-payload ADC as globally the first to enter clinical phase IBI363: Next-Gen IO Redefining Cancer Immunotherapy IBI363 is a global first-in-class PD-1/IL-2α-bias fusion protein, featuring a differentiated molecular design and a dual immune activation mechanism. Emerging clinical data strongly support its mechanism of action in reinvigorating and expanding tumor-specific T cells (TSTs). At ASCO 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits: Immune-resistant NSCLC (squamous & Adeno): boosted response rate and extended PFS reflects strong immune activation; median overall survival (mOS) up to 17.5 months in 1.5 mg dose cohorts, 12-month OS rate exceeding 70% for 3 mg dose cohorts, and benefit observed even in PD-L1 low expressers Later-line CRC (3L+): mOS of 16.1 months in monotherapy and only 17.8% OS events occurred in combination with bevacizumab with 9.4 months follow-up, outperforming historical benchmarks Immune-resistant melanoma (mucosal/acral subtypes): confirmed overall response rate (cORR) 23%, median duration of response (mDoR) 14 months, and median OS 14.7 months, showing unprecedented positive response and a long-lasting immunologic tailing effect With two Breakthrough Therapy Designations from the NMPA CDE, two Fast Track Designations from the FDA, IBI363 is advancing rapidly toward registrational development. The first head-to-head trial vs. pembrolizumab in mucosal and acral melanoma was initiated. Meanwhile, IBI363 is in preparation for registrational trails in IO-treated squamous NSCLC, and third-line MSS colorectal cancer. Additional trails for first-line and other solid tumors also under exploration in ongoing PoC studies. High-Potency, Low-toxicity ADC Platforms Synergizing with IO for Broad Indication Coverage Innovent is rapidly advancing its next-gen ADC pipeline, including: IBI343 (CLDN18.2 ADC): first in PDAC to demonstrate long-term survival benefits (mOS 12.1 months in 2L) IBI3001 (EGFR/B7H3 ADC): dual-targeted ADC with broad potential in solid tumors IBI3020 (CEACAM5 dual payload ADC): designed for high efficacy and low toxicity in treatment-resistant tumors These programs leverage proprietary payloads and linkers, optimized for lower toxicity and high potency, and are poised to synergize with Innovent's IO agents to address broader and deeper indications. Innovent Academy: R&D Engine to Drive Global Innovation Innovent Academy is the company's discovery engine for driving global innovation. The Academy continues to expand its platforms in IO, ADC, T-cell engagers, and cytokines, firmly establishing its leadership in next-gen oncology discovery and translational science to generate 6–8 novel molecules per year. Specifically, for next-gen IO and next-gen ADC dual upgradation, Innovent Academy focuses on: diversified antitumor mechanisms to integrate TME modulation and optimize IO efficacy; dual targeting approaches to overcome tumor heterogeneity and drug resistance. This framework allows Innovent to systematically escalate efficacy and broaden tumor applicability, laying the foundation for first-in-class and best-in-class combination regimens for cancer treatments. Catalyzing China's Role in Global Oncology Innovation Leading oncology KOLs and principal investigators (PIs) delivered keynote speeches, reflecting on a pivotal moment for China's biotech industry. They emphasized that China's innovation, which is driven by rising translational capabilities, expanding global talent pools, and patient-centric trial execution, has entered a 'Deepseek' moment, one where Chinese-discovered drugs can lead global standards, not just follow them. 'What we're witnessing is a profound shift,' said one keynote speaker. 'Innovent's next-generation IO programs like IBI363, with a clear global-first design, and ADC platforms targeting previously untreatable populations, show that Chinese biotech is poised to influence—not just participate in—the next global oncology paradigm.' The enthusiastic response from investors and KOLs underscores growing confidence in China-originated oncology innovation and reaffirms Innovent's position as it enters a new era of global innovation with a vision to become a global premier biopharmaceutical leader. About Innovent 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 16 products in the market. It has 2 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statements 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. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
Yahoo
30-06-2025
- Business
- Yahoo
Innovent Biologics Showcases "Dual Innovations" at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms
SAN FRANCISCO and SUZHOU, China, June 30, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, held its Oncology R&D Day, unveiling its forward-looking strategy centered on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies. This strategic focus aims to redefine the standards of cancer treatment and propel Innovent toward becoming a global, premier biopharmaceutical leader. The event drew over 500 participants, including leading oncology key opinion leaders (KOLs), principal investigators, analysts, and global investors, signaling strong engagement with Innovent's transformative vision for the future of oncology. "Over the past decade, Innovent has been at the forefront of China's biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China's leading oncology brand, with over 3 million cancer patients treated with our therapies," said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent. "We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innovation of next-generation IO and next-generation ADC. Our recent presence at the 2025 ASCO with eight oral presentations highlights the strength and global competitiveness of our R&D. But this is only the beginning. With a clear vision to advance at least five pipeline assets into MRCT Phase 3 by 2030, we are committed to delivering innovative, high-quality, and accessible cancer treatments to patients worldwide." Dual Innovation to Unlock the Future of Oncology: Next-gen IO + Next-gen ADC At the core of Innovent's oncology strategy lies the dual engines of next-generation immunotherapy (IO) and next-generation antibody-drug conjugates (ADC), supported by deep insights in cancer biology and differentiated technology platforms. "We are harnessing deep cancer biology insights, advanced antibody and protein engineering, and differentiated ADC linker-payload technologies to develop broader-spectrum, more potent, and less toxic therapies aimed at transforming the oncology treatment paradigm," said Dr. Zhou Hui, SVP of Innovent Oncology R&D. "Our strategy is designed to target some of the toughest challenges in cancer care, including drug resistance, cold tumors, and improve the efficacy of current IO treatment, while bringing new hope to patients worldwide." Global R&D Roadmap: a Clear, Stepwise Development Strategy Innovent's pipeline is guided by a rational, phased IO+ADC combination strategy designed to address tumor heterogeneity and immune escape, evolving through three stages: Next-gen IO + Chemotherapy: to redefine the IO cornerstone Next-gen IO + mAb-ADC / bispecific ADC: to cover expansive tumor types and treatment lines Next-gen IO + Dual-Payload ADC (dpADC): to unlock full potential of IO+ ADC synergy, and reshape cancer treatment Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the U.S., EU, and Asia. The company also continues to invest in global R&D infrastructure, supported by R&D hubs in Shanghai and San Francisco and antibody and ADC manufacturing capacity exceeding 140,000L. Innovent is rapidly expanding its global innovation footprint, with a 2030 goal to advance at least five pipeline assets into global MRCT Phase 3 trials. Key potential candidates includes: IBI343: innovative CLDN18.2 ADC with site-specific conjugation and a TOPO1 inhibitor payload, demonstrating significant survival benefits in both GC and PDAC IBI363: PD-1/IL-2α-bias fusion protein as next-gen IO to redefine cancer treatment and expand the boundaries of IO responsiveness IBI3009: DLL3 ADC in collaboration with Roche IBI3003: tri-specific T-cell engager targeting BCMA/GPRC5D/CD3 for multiple myeloma IBI3001: EGFR/B7H3 ADC with two synergetic targets covering multiple potential indications IBI3020: CEACAM5 dual-payload ADC as globally the first to enter clinical phase IBI363: Next-Gen IO Redefining Cancer Immunotherapy IBI363 is a global first-in-class PD-1/IL-2α-bias fusion protein, featuring a differentiated molecular design and a dual immune activation mechanism. Emerging clinical data strongly support its mechanism of action in reinvigorating and expanding tumor-specific T cells (TSTs). At ASCO 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits: Immune-resistant NSCLC (squamous & Adeno): boosted response rate and extended PFS reflects strong immune activation; median overall survival (mOS) up to 17.5 months in 1.5 mg dose cohorts, 12-month OS rate exceeding 70% for 3 mg dose cohorts, and benefit observed even in PD-L1 low expressers Later-line CRC (3L+): mOS of 16.1 months in monotherapy and only 17.8% OS events occurred in combination with bevacizumab with 9.4 months follow-up, outperforming historical benchmarks Immune-resistant melanoma (mucosal/acral subtypes): confirmed overall response rate (cORR) 23%, median duration of response (mDoR) 14 months, and median OS 14.7 months, showing unprecedented positive response and a long-lasting immunologic tailing effect With two Breakthrough Therapy Designations from the NMPA CDE, two Fast Track Designations from the FDA, IBI363 is advancing rapidly toward registrational development. The first head-to-head trial vs. pembrolizumab in mucosal and acral melanoma was initiated. Meanwhile, IBI363 is in preparation for registrational trails in IO-treated squamous NSCLC, and third-line MSS colorectal cancer. Additional trails for first-line and other solid tumors also under exploration in ongoing PoC studies. High-Potency, Low-toxicity ADC Platforms Synergizing with IO for Broad Indication Coverage Innovent is rapidly advancing its next-gen ADC pipeline, including: IBI343 (CLDN18.2 ADC): first in PDAC to demonstrate long-term survival benefits (mOS 12.1 months in 2L) IBI3001 (EGFR/B7H3 ADC): dual-targeted ADC with broad potential in solid tumors IBI3020 (CEACAM5 dual payload ADC): designed for high efficacy and low toxicity in treatment-resistant tumors These programs leverage proprietary payloads and linkers, optimized for lower toxicity and high potency, and are poised to synergize with Innovent's IO agents to address broader and deeper indications. Innovent Academy: R&D Engine to Drive Global Innovation Innovent Academy is the company's discovery engine for driving global innovation. The Academy continues to expand its platforms in IO, ADC, T-cell engagers, and cytokines, firmly establishing its leadership in next-gen oncology discovery and translational science to generate 6–8 novel molecules per year. Specifically, for next-gen IO and next-gen ADC dual upgradation, Innovent Academy focuses on: diversified antitumor mechanisms to integrate TME modulation and optimize IO efficacy; dual targeting approaches to overcome tumor heterogeneity and drug resistance. This framework allows Innovent to systematically escalate efficacy and broaden tumor applicability, laying the foundation for first-in-class and best-in-class combination regimens for cancer treatments. Catalyzing China's Role in Global Oncology Innovation Leading oncology KOLs and principal investigators (PIs) delivered keynote speeches, reflecting on a pivotal moment for China's biotech industry. They emphasized that China's innovation, which is driven by rising translational capabilities, expanding global talent pools, and patient-centric trial execution, has entered a "Deepseek" moment, one where Chinese-discovered drugs can lead global standards, not just follow them. "What we're witnessing is a profound shift," said one keynote speaker. "Innovent's next-generation IO programs like IBI363, with a clear global-first design, and ADC platforms targeting previously untreatable populations, show that Chinese biotech is poised to influence—not just participate in—the next global oncology paradigm." The enthusiastic response from investors and KOLs underscores growing confidence in China-originated oncology innovation and reaffirms Innovent's position as it enters a new era of global innovation with a vision to become a global premier biopharmaceutical leader. About Innovent 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 16 products in the market. It has 2 new drug applications (NDA) under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statements 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. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. View original content to download multimedia: SOURCE Innovent Biologics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-06-2025
- Business
- Yahoo
Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval from China's NMPA for Chronic Weight Management
SAN FRANCISCO and SUZHOU, China, June 27, 2025 /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 that China's National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight management in Chinese adults with overweight or obesity. Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for weight loss, offering a unique mechanism that enhances weight-loss efficacy while reducing visceral fat and delivering comprehensive metabolic benefits, named by Fierce Pharma as one of the top ten most anticipated drugs globally in 2025. The increasing prevalence of overweight and obesity in China poses an urgent public health challenge requiring immediate intervention. In April 2025, the National Health Commission officially included "Healthy Weight Management Action" in the "Healthy China 2030" initiative. Under the updated plan, the national health authorities aim to build supportive environments for effective weight management, raise public awareness and behavior skills, and promote healthy lifestyles to curb rising rates of overweight and obesity. Aligned with these national priorities and the 2025 weight management campaign, the approval of mazdutide represents a timely and important milestone. Aiming to be an innovative leader in the cardiovascular and metabolic (CVM) disease area, Innovent is committed to accelerating the delivery of this drug to benefit a broad population in China. Scientific and effective treatment options for weight loss are urgently needed in China Overweight and obesity are chronic metabolic diseases characterized by excessive fat accumulation in the body. The pathogenesis of overweight and obesity includes genetic, metabolic, environmental, and behavioral factors. Obesity can significantly increase the risk of various diseases, such as cardiovascular and cerebrovascular, endocrine, specific tumors, respiratory, reproductive, and skeletal diseases, and can seriously affect quality of life[1]. In China, over 500 million adults live with overweight (BMI ≥ 24 kg/m2 and ˂ 28 kg/m2) or obesity (BMI ≥ 28 kg/m2). Nearly 90% of obese adults have comorbidities, including metabolic dysfunction-associated fatty liver disease, which affects around 50% of adults with overweight and over 80% of adults with obesity. The World Obesity Federation (WOF) estimates that obesity costs China around US$283.3 billion in GDP loss in 2020[2]. With such heavy societal burdens, obesity and related chronic diseases have become major public health concerns in China and around the world. In response to the escalating obesity problem, several national policies and clinical guidelines have underscored the need for structured outpatient weight management and earlier pharmacological intervention. The National Health Commission's "Notice on Effective Outpatient Settings and Management of Weight Management" encourages the development of optimized outpatient care models. Additionally, "Guidelines for the Diagnosis and Treatment of Obesity (2024 Edition)" recommended pharmacotherapy when lifestyle interventions fail to meet weight loss goals. The "Guidelines for Long-term Weight Management and Clinical Application of Drugs for Obese Patients (2024 Edition)" issued by the Chinese Society of Endocrinology further advocates for initiating drug treatment early in patients with obesity-related comorbidities. Mazdutide is supported by robust clinical data published in multiple high-impact journals, including Nature, the Lancet sub-journals, and the New England Journal of Medicine. As the first marketed dual GCG/GLP-1 receptor agonist , mazdutide has been recommended by multiple clinical guidelines in China[3],[4],[5],[6] and expert consensus on obesity management on account of its innovative mechanism and solid evidence base. Multiple metabolic benefits of mazdutide in supporting weight management GCG receptors are mainly expressed in the liver, and GCG receptor agonism can inhibit hepatic fat synthesis and promote hepatic lipolysis. As a dual GCG/GLP-1 receptor agonist weight loss drug, mazdutide can deliver significant weight loss efficacy and metabolic benefits such as waist circumstance and liver fat content reductions to adults with overweight or obesity. The approval of mazdutide was mainly based on data from GLORY-1, a Phase 3 pivotal clinical study conducted in Chinese adults with overweight or obesity. The primary endpoint and all key secondary endpoints of the study were successfully achieved in 2024. Results showed that at weeks 32 and 48, the percentage of body weight reduction from baseline and the proportions of participants with a body weight reduction of ≥5%，≥10% and ≥15% in the mazdutide 4 mg group and mazdutide 6 mg group were superior to those of the placebo group. Based on the efficacy estimand, at week 48, the mean percentage changes in body weight relative to baseline in the mazdutide 4 mg, mazdutide 6 mg, and placebo groups were −12.0%, −14.8%, and −0.5%, respectively; The proportion of participants with a body weight reduction ≥ 5% relative to baseline were 73.5%, 82.8%, and 11.5%, respectively; the proportion of participants with a body weight reduction ≥ 15% relative to baseline were 37.0%, 50.6%, and 2.1%, respectively; The mean changes in waist circumference relative to baseline were −9.5 cm, −11.0 cm, and −1.5 cm, respectively. In addition, mazdutide reduced liver fat content in adults with overweight or obesity. Among participants with baseline liver fat content ≥ 10%, the mean percent change from baseline in liver fat content to week 48 were −65.85%, −80.24%, and −5.27% in the mazdutide 4 mg, 6 mg, and placebo groups, respectively. The results of GLORY-1 study have been presented at the American Diabetes Association (ADA) Annual Meeting and published in the New England Journal of Medicine, which have received widespread attention from industry experts and scholars. Mazdutide addresses a critical unmet need in China by offering effective treatment for weight reduction while also improving cardiometabolic indicators in adults with overweight or obesity. Its use may help reduce the long-term societal and economic burdens associated with obesity-related diseases. Professor Linong Ji, the Leading Principal Investigator of GLORY-1, Peking University People's Hospital, stated, "Obesity is a chronic disease that demands a coordinated societal response. With China facing a high prevalence of overweight and obesity, the associated cardiometabolic disease burdens continue to rise. There is an urgent need for weight-loss therapies that are both effective and safe, with proven cardiovascular and metabolic benefits. As the principal investigator of this novel dual GCG/GLP-1 receptor agonist with a unique mechanism of action, I'm proud to see our clinical results recognized by China's national regulatory authority and anticipate its subsequent approval for market launch. My fellow researchers and I hope mazdutide will become a valuable therapeutic option for Chinese adults with overweight or obesity." Dr. Lei Qian from Innovent Biologics, stated, "Mazdutide represents the next-generation dual GCG/GLP-1 receptor agonist. Its clinical development has been made possible by pooling the collective expertise of leading endocrinology experts across China, and its successful approval reflects the NMPA's high recognition of its clinical value and safety. This milestone marks another breakthrough for Innovent in the cardiovascular and metabolic fields. We hope mazdutide will provide another therapeutic option for Chinese adults with overweight or obesity, improve their quality of life, and alleviate societal burdens. Centered on patient needs and innovation, Innovent has established and will continue to expand its rich CVM pipeline with mazdutide as a cornerstone product, aiming to continuously address the public's growing demand for health and quality of life and to serve more patients." About Obesity/Overweight Obesity is a chronic metabolic disease with complex causes, and it serves as a major risk factor for a range of diseases including diabetes, fatty liver disease, cardiovascular and cerebrovascular diseases, kidney disease, joint disorders, sleep-disordered breathing, and cancer. China has the world's largest population of individuals with overweight or obesity, a trend that is likely to rise[7]. Obesity is associated with multiple comorbidities and is a major contributor to reduced life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths from chronic non-communicable diseases in China, nearly doubling from 5.7% in 1990[8]. Despite the chronic nature of obesity and its need for long-term management, treatment options remain limited. While lifestyle interventions remain the cornerstone of treatment, many patients struggle to achieve or maintain meaningful weight reduction. This underscores the urgent need for safe, effective, and sustainable pharmacological interventions. About Mazdutide Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG /GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity. Mazdutide is approved by NMPA for chronic weight management in adults with overweight or obesity*; and mazdutide currently has another NDA accepted for review by NMPA, for glycemia control in adults with type 2 diabetes. Mazdutide has currently conducted seven Phase 3 clinical studies, including: GLORY-1: A Phase 3 clinical study conducted in Chinese adults with overweight of obesity; GLORY-2: A Phase 3 clinical study conducted in Chinese adults with moderately to severely obesity; GLORY-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with overweight of obesity accompanied metabolic-associated fatty liver disease (MAFLD); GLORY-OSA: A Phase 3 trial in Chinese participants with obstructive sleep apnea (OSA) and obesity; DREAMS-1: A Phase 3 clinical study conducted in Chinese adults with untreated type 2 diabetes; DREAMS-2: A Phase 3 clinical study comparing mazdutide versus dulaglutide in Chinese adults with type 2 diabetes who have poor glycemia control with oral medication; DREAMS-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity; Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing. In addition, several new clinical studies of mazdutide are initiated or planned, including: A Phase 3 trial in adolescents with obesity; New studies in patients with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). *Mazdutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of: BMI ≥ 28 kg/m² (obesity); or BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome and etc.). 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 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement 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. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. REFERENCES [1] Multidisciplinary Clinical Consensus on Diagnosis and Treatment of Obesity (2021 edition), Chinese Journal of Endocrinology and Metabolism. 2021;37(11):959-972. [2] Qin X, Pan J. The Medical Cost Attributable to Obesity and Overweight in China: Estimation Based on Longitudinal Surveys. Health Econ. 2016;25(10):1291-1311. doi:10.1002/hec.3217 [3] Guideline for Chronic Weight Management and Clinical Practice of Anti-obesity Medications (2024 version). Chinese Journal of Endocrinology and Metabolism. 2024,40(7): 545-564 [4] Expert Consensus on Weight Management for Type 2 Diabetes Mellitus. International Journal of Endocrinology and Metabolism.2024,44(5):359-370 [5] Expert Consensus on Glucagon-like Peptide-1 Receptor Agonist Analogs Combined with Lifestyle Intervention for Weight Loss (2024 Edition). Chinese Journal of Diabetes, 2024 [6] Interpretation of National Health Commission of the People's Republic of China. National Clinical Practice Guideline on Obesity Management (2024 Edition). Chinese Medical Journal, 2025, *105*(18): 1387-1391. [7] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373-92 [8] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. 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Bloomberg
27-06-2025
- Health
- Bloomberg
Innovent Wins China Nod For Obesity Drug Rivaling Novo, Lilly
China approved Innovent Biologics Inc.'s closely watched weight loss drug Friday, unleashing a potent homegrown competitor against foreign giants Novo Nordisk A/S and Eli Lilly & Co. The drug, mazdutide, is approved for weight management among people who are either obese or overweight with at least one weight-related condition such as high blood sugar or high blood pressure, according to a statement from the National Medical Products Administration. Suzhou-based Innovent first licensed Greater China rights to mazdutide in 2019 from Eli Lilly, which is testing the drug outside of China.
Associated Press
22-06-2025
- Business
- Associated Press
Multiple Research Results from Innovent's General Biomedicine Pipeline to be Showcased at the ADA 85th Scientific Sessions
SAN FRANCISCO and SUZHOU, China, June 21, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced that multiple exploratory mechanism-of-action (MoA) analyses of mazdutide (investigator-initiated trials) as well as a preclinical study of IBI3030 (PCSK9-GGG antibody-peptide-conjugate) will be showcased at the American Diabetes Association's (ADA) 85th Scientific Sessions. Details are listed below： Title: A novel antibody-peptide conjugate targeting PCSK9, GLP-1R, GCGR, GIPR improves cardiovascular risk markers in preclinical study Abstract Number：1886-LB Presentation Form: Poster Presentation Time: Sunday, June 22, 2025. 12:30 P.M. - 1:30 P.M. CDT Location: Poster Hall (Hall F1) Author: Dr. Decheng Ren, Innovent Biologics IBI3030 is a novel anti-PCSK9 antibody conjugated with peptides targeting GLP-1R, GCGR, and GIPR. Through multi-target synergistic effects, it significantly improves cardiovascular metabolic risk indicators. Mechanistically, the anti-PCSK9 antibody component inhibits LDL receptor degradation, thereby lowering reduce plasma LDL-c levels. Simultaneously, the triple-target agonist peptide activates GLP-1R/GCGR/GIPR receptors, enhancing hepatic fatty acid oxidation capacity, with demonstrates superior efficacy compared to the control. Preclinical studies demonstrate that in multiple models (mice, rats, and non-human primates), IBI3030 significantly reduces LDL-c (p<0.01 vs. baseline) and Lp(a), improves oral glucose tolerance (OGTT) (effective even in GLP-1R knockout mice), reduces body weight, and preserves insulin sensitivity. Additionally, it exhibits excellent safety in non-human primates, with a maximum tolerated dose reaching 50 mg/kg. Furthermore, mazdutide, the fastest-developing dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist globally, has ignited significant research interest in the scientific community due to its comprehensive metabolic benefits. This year's ADA Annual Meeting featured multiple MoA studies on mazdutide's effects in reducing liver fat, improving fibrosis, and lowering serum uric acid. The following are investigator-initiated studies: Topic: The Dual Glucagon and Glucagon-Like Peptide 1 Receptor Agonist Mazdutide Outbalanced Glucagon-Like Peptide 1 Receptor Agonist Semaglutide Monotherapy in Improving Mice Liver Fat Accumulation Abstract Number: 777-P Presentation Form: Poster Presentation Time: Sunday, June 22, 2025. 12:30 P.M. - 1:30 P.M. CDT Location: Poster Hall (Hall F1) Author: Tianpei Hong, Peking University Third Hospital Liver RNA-sequencing and KEGG enrichment analysis showed that compared with Semaglutide treatment, Mazdutide treatment predominantly activated oxidative phosphorylation and fatty acid degradation pathways. Meanwhile, lipid metabolism-related genes were upregulated in Mazdutide group compared to Semaglutide group. We further screened differentially expressed transcription factors (TF) through the TRRUST database and found that activating transcription factor 3 (Atf3) upregulated in the Mazdutide treatment group might be the functional TF regulating lipid degradation in the liver. The dual GCGR/GLP-1R agonist mazdutide exhibited a better efficacy in weight loss and liver fat accumulation alleviation compared with the GLP-1R agonist semaglutide monotherapy potentially due to its promotion of fatty acid oxidation via transcription factor ATF3. Topic: Mazdutide，a GCG/GLP-1R dual-agonist, alleviates MASH and hepatic fibrosis Abstract Number: 1616-P Presentation Form：Poster Presentation Time: Sunday, June 22, 2025. 12:30 P.M. - 1:30 P.M. CDT Location: Poster Hall (Hall F1) Author: Ling Li, Zhongda Hospital, School of Medicine, Southeast University, With the mice presented NASH and fibrosis phenotypes, Mazdutide decreased body weight, liver weight and hepatic triglyceride levels. Notably, Mazdutide also mitigated hepatic fat accumulation, inflammation, and hepatic fibrosis, compared with a single GLP1R or GCGR agonist. Therefore, Mazdutide alleviates hepatic fibrosis in MASH mice and regulates lipid metabolism as well as the gut microbiota, which may contribute to providing a novel therapeutic method and therapeutic target for MASH Topic: Mazdutide, a Dual GLP-1R/GCGR Agonist, Alleviates Hyperuricemia by Modulating Hepatic Energy and Lipid Metabolism and Inhibiting Purine Pathways Abstract Number: 775-P Presentation Form: Poster Presentation Time: Sunday, June 22, 2025. 12:30 P.M.- 1:30 P.M. CDT Location: Poster Hall (Hall F1) Author: Hongwei Jiang, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology Mazdutide significantly lowers serum uric acid levels in hyperuricemic rats, primarily by enhancing fatty acid oxidation and regulating cellular energy metabolism within hepatocytes. This process suppresses the expression of genes associated with glucose and purine metabolism in the liver, leading to a reduction in the generation and utilization of purine precursors. SnRNA-Seq analysis indicates that mazdutide increases the expression of GCGR in hepatocytes, whereas semaglutide slightly inhibits it. In hyperuricemic rats, the expression of key genes involved in fatty acid oxidation, such as Cpt1a, Fabp1, Apoa1, Acox1, and Acaa1a is significantly reduced. However following Mazdutide treatment, the expression of these genes markedly increases, promoting fatty acid oxidation and improving overall energy metabolism. In contrast, genes associated with fatty acid synthesis, such as Acaca and Fasn, show a significant reduction in expression. Furthermore, after Mazdutide intervention, the expression of genes related to glucose metabolism and purine metabolism, including Pklr, G6pc1, Glul, Gckr, Gk, Nt5e, and Ppat, also experience significant decreases. This shift may reflect a change in cellular metabolism towards more efficient fatty acid oxidation, resulting in reduced the generation and utilization of purine precursors. Compared to Semaglutide, Mazdutide offers more substantial benefits in lowering uric acid levels. Dr. Lei Qian from Innovent Biologics, stated, 'We are delighted to see mazdutide's mechanism exploration studies featured extensively at the ADA conference. The growing body of scientific evidence will further validate mazdutide's differentiated profile as a next-generation GCG/GLP-1 dual receptor agonist, particularly in liver fat and serum urine reduction. Moreover, in the field of cardiovascular and metabolic diseases, Innovent is dedicated to developing next-generation innovative therapies. This includes IBI3030 (PCSK9-GGG), a novel modality with a unique MoA that embodies an innovative 'one-drug, multiple-effects' therapeutic strategy. IBI3030 has the potential to deliver comprehensive therapeutic benefits and meaningfully improve outcomes for more patients worldwide.' *Poster 2-4 are results from investigator-initiated trials (IITs) About Mazdutide (IBI362) Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Currently, Mazdutide has two NDAs accepted for review by NMPA, including for: Mazdutide is currently being evaluated in seven Phase 3 clinical studies, including: Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing. In addition, several new clinical studies of mazdutide are initiated or planned, including: About Innovent 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 [15/16] products in the market. It has [3/2] new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, 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: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement 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 Biologics ('Innovent'), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. View original content: SOURCE Innovent Biologics
