Accessibility StatementSkip Navigation SAN FRANCISCO and SUZHOU, China, Nov. 25, 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, and ophthalmologic diseases, announces that the supplementary application for the 9 mg dosage of mazdutide, an innovative glucagon (GCG)/ glucagon-like peptide-1 (GLP-1) du ...

Core Insights - Innovent Biologics announced that the Phase 3 clinical trial of mazdutide met its primary and key secondary endpoints, indicating its efficacy for weight management in Chinese adults with obesity [1][2][3] Clinical Trial Details - The GLORY-2 study involved 462 participants with a mean baseline weight of 94.0 kg and a mean BMI of 34.3 kg/m², randomized to receive either mazdutide 9 mg or placebo over a 60-week period [2] - Participants in the mazdutide group experienced a mean weight reduction of 18.55% at Week 60, compared to 3.02% in the placebo group, with 44.0% achieving a weight reduction of 20% or more [3][4] Secondary Endpoints and Safety - All key secondary endpoints were met, including improvements in waist circumference, blood pressure, and lipid levels, demonstrating the drug's superiority over placebo [4][5] - The treatment showed favorable tolerability, with a low discontinuation rate due to adverse events (2.9% in the mazdutide group) [6] Expert Commentary - Experts highlighted the significance of mazdutide in addressing obesity, particularly in a country with a high prevalence of obesity and related cardiometabolic diseases [7] - The drug is positioned as a viable alternative to metabolic surgery, with evidence supporting its effectiveness in weight management [7][8] Future Plans and Recognition - Innovent plans to submit a new drug application for mazdutide to the NMPA and is exploring further therapeutic potentials for the drug [8][10] - Mazdutide has received recognition in top-tier journals and was listed among the "Top 10 Most Anticipated Drug Launches of 2025" [8][9] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases and has launched 16 products to date [17]

Summary of China Obesity KOL Event Industry Overview - The focus is on the **China obesity market**, which is currently **under-penetrated** with significant potential for growth [2][3][6] Key Insights 1. **Market Potential**: The obesity market in China has substantial growth potential due to its current under-penetration [2][3] 2. **GLP-1 Therapies**: The brand value of currently approved **GLP-1 therapies** in China is considered modest, primarily due to their short market presence and high costs, which significantly influence patient adoption [2][3][6] 3. **Patient Demographics**: GLP-1 therapies are mainly utilized by the younger generation (under 40 years old) for cosmetic weight loss rather than for health-related obesity treatment, unless severe comorbidities are present [3][6] 4. **Tirzepatide Uptake**: **Tirzepatide** has shown strong market uptake due to its effective weight loss results and manageable safety profile, with fewer gastrointestinal adverse events reported compared to competitor GLP-1s [2][3][7] 5. **Cost Considerations**: The current price range for GLP-1 therapies is between **RMB 4,000 to RMB 4,500** (approximately **$560 to $630**) per month, with potential for significant price reductions (up to **90%**) upon the entry of generics [6][7] 6. **Oral and Long-acting GLP-1s**: Oral and long-acting GLP-1s are expected to drive market expansion, particularly in less developed regions due to lower supply chain requirements and potentially lower prices [7] 7. **Government Reimbursement**: There is caution regarding government reimbursement for obesity treatments due to high costs, although potential exists if cardiovascular or other comorbidity benefits are recognized [3][6] 8. **Online Purchases**: The popularity of purchasing weight loss drugs online is increasing, although this trend may face regulatory changes if serious adverse events arise [6][7] Additional Considerations - The average treatment duration for GLP-1s in China is currently **2-3 months**, with patients not yet viewing it as a lifelong therapy [7] - The KOL was unaware of a compounded GLP-1 market in China but noted sufficient capacity to significantly lower active pharmaceutical ingredient (API) costs [7] - Direct-to-consumer (DTC) advertising significantly impacts patient preferences, especially when potential benefits on comorbidities are recognized [7] This summary encapsulates the critical insights from the KOL event regarding the current state and future potential of the obesity treatment landscape in China, particularly focusing on GLP-1 therapies and market dynamics.

Core Insights - Innovent Biologics announced that the fourth Phase 3 clinical trial DREAMS-3 of mazdutide has met its primary endpoint, demonstrating superior efficacy compared to semaglutide in Chinese patients with type 2 diabetes and obesity [1][2][3] Summary by Sections Clinical Trial Results - In the DREAMS-3 trial, 48.0% of participants in the mazdutide group achieved HbA1c < 7.0% and a 10% body weight reduction from baseline at week 32, compared to 21.0% in the semaglutide group (p<0.0001) [1][3] - The mean change in HbA1c from baseline was 2.03% for mazdutide and 1.84% for semaglutide, while the mean percentage weight reduction was 10.29% for mazdutide and 6.00% for semaglutide, both statistically significant (p<0.05) [1] Study Design - The DREAMS-3 trial was a multi-center, randomized, open-label study involving 349 Chinese adults with early-stage type 2 diabetes and obesity, who had inadequate glycemic and weight control after lifestyle interventions [2] - Participants were randomized to receive either mazdutide 6 mg or semaglutide 1 mg for 32 weeks, with an extension period for those on mazdutide based on weight-loss targets [2] Safety Profile - The overall safety profile of mazdutide was consistent with previous studies, with gastrointestinal symptoms being the most common adverse events, mostly mild to moderate in severity [1] Implications for Treatment - The results indicate that mazdutide could play a critical role in treating patients with type 2 diabetes and comorbid obesity, addressing both glycemic control and weight loss [1][2] - Mazdutide is positioned as a new-generation GLP-1-based therapy suitable for Chinese patients, with multiple metabolic benefits and a favorable safety profile [1] Company Background - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, autoimmune, cardiovascular, and metabolic disorders [8] - The company has launched 16 products and has several assets in clinical trials, indicating a robust pipeline and commitment to innovation in the biopharmaceutical sector [8]

Summary of Innovent Biologics Conference Call Company Overview - **Company**: Innovent Biologics - **Industry**: Biotechnology - **Focus**: Development and commercialization of innovative therapies, particularly in oncology and metabolic diseases Key Takeaways 1. Product Differentiation and Market Positioning - **Mazdutide**: Launched for obesity in July and recently approved for diabetes, it is positioned as a differentiated GLP-1 dual agonist targeting both GLP-1 and GIP pathways, significantly reducing liver fat, which is crucial for Chinese patients with high hepatic fat despite lower BMI [2][18] - **Pricing Strategy**: The 4mg and 6mg doses are priced approximately 30% below tirzepatide and 30% above semaglutide, aiming to balance affordability with premium positioning [2][18] 2. Market Potential and Commercialization Strategy - **Addressable Market**: There are approximately 300 million overweight and 160 million obese adults in China, presenting a significant market opportunity [3][20] - **Multi-Channel Distribution**: Innovent is utilizing a broad distribution strategy that includes public hospitals, private hospitals, retail pharmacies, and online platforms, with non-hospital channels expected to drive incremental growth [3][18] 3. Financial Projections - **Revenue Targets**: Innovent aims for Mazdutide to contribute at least 25% of its RMB 20 billion revenue target by 2027, with an expected RMB 1 billion in the first 12 months [2][21] - **Financial Forecasts**: Projected revenues for FY 2024, 2025, 2026, and 2027 are RMB 9.42 billion, RMB 12.62 billion, RMB 15.46 billion, and RMB 20.03 billion respectively, with net profits expected to turn positive by 2025 [6] 4. Competitive Landscape - **Increasing Competition**: The GLP-1 market in China is becoming more competitive with generics and multinational entrants. Innovent's strategy focuses on brand equity and differentiated mechanisms to maintain market share [5][19] - **Regulatory Environment**: Inclusion in the National Reimbursement Drug List (NRDL) is critical for diabetes treatments, while obesity and specialty indications may rely on cash-pay models and emerging commercial insurance [5][27] 5. Pipeline and Future Developments - **Oncology and Autoimmune Pipeline**: Innovent is advancing a broad pipeline including next-generation immuno-oncology therapies and autoimmune treatments, with key assets like IBI363 and L23 progressing toward pivotal trials [4][28] - **Oral GLP-1 Development**: An oral GLP-1 candidate is in early-stage development, with FDA IND clearance expected and enrollment in China anticipated in the second half of 2025 [4][24] 6. Sustainability and Corporate Governance - **Sustainability Goals**: Innovent has set targets to reduce water and energy consumption and greenhouse gas emissions by 5% and 10% respectively by 2030, aiming for zero waste landfill by 2030 [17] 7. Investment Recommendation - **Rating**: Innovent is rated as a "Buy" with a price target of HK$105.00, reflecting a potential upside of 13% from the current price [7][31] 8. Risks and Challenges - **Market Risks**: Potential risks include fierce competition, pipeline delays, and regulatory challenges that could impact the achievement of financial targets [31][15] Conclusion Innovent Biologics is positioned strongly within the biotechnology sector, particularly with its innovative product Mazdutide. The company is leveraging a multi-channel commercialization strategy to tap into a vast market while navigating competitive dynamics and regulatory landscapes. The robust pipeline and sustainability initiatives further enhance its investment appeal, although risks remain that could affect future performance.

Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, aimed at glycemic control in adults with type 2 diabetes (T2D) [1][6][16] - Mazdutide is expected to provide comprehensive benefits in glycemic control, weight reduction, and improvements in hepato-cardio-renal metabolic indicators, addressing the urgent need for effective diabetes management in China [5][9][11] Industry Context - China has the highest prevalence of T2D globally, with approximately 140 million adults affected, representing 1 in 4 cases worldwide [2][12] - The treatment paradigm for diabetes is shifting towards a comprehensive, patient-centric management strategy that includes glycemic control, weight management, and cardiovascular risk factor mitigation [3][10] Clinical Evidence - The approval of mazdutide was based on two Phase 3 clinical trials (DREAMS-1 and DREAMS-2), which demonstrated its superiority over placebo and dulaglutide in glycemic control and weight reduction [6][7][11] - In DREAMS-1, at Week 24, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.57% and -2.15%, respectively, compared to -0.14% for placebo [6] - In DREAMS-2, at Week 28, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.69% and -1.73%, respectively, compared to -1.38% for dulaglutide [6] Safety and Administration - Mazdutide exhibited a safety profile consistent with previous GLP-1 receptor agonists, with no new safety signals identified [7] - The mazdutide injection device features significant improvements in convenience and safety, including a hidden needle design and single-use functionality, enhancing patient comfort and adherence [8] Future Implications - The approval of mazdutide aligns with the "Healthy China 2030" vision, aiming to improve disease management and reduce the burden of T2D in the population [5][11] - Innovent Biologics has plans for further clinical studies and potential new indications for mazdutide, indicating a commitment to advancing diabetes treatment options [14][15]

Core Viewpoint - Fangzhou Inc. has entered a strategic partnership with Innovent Biologics to integrate AI-driven digital health services with innovative therapies for metabolic diseases and weight management, aiming to enhance patient outcomes in chronic disease care [1][2][4]. Company Overview - Fangzhou Inc. is a leading online chronic disease management platform in China, serving 52.8 million registered users and 229,000 physicians as of June 30, 2025 [10]. - Innovent Biologics specializes in developing and commercializing innovative therapies across various medical fields, including oncology, cardiovascular, and metabolic diseases [9]. Partnership Details - The partnership will combine Fangzhou's AI-enabled "H2H" digital healthcare ecosystem with Innovent's pipeline of novel therapies for diabetes and obesity, creating a new model that integrates AI technology with personalized services [2][4]. - The initial focus of the collaboration will be on diabetes and obesity, utilizing Fangzhou's "XS Core" AI large language model to power five key products aimed at delivering personalized digital care [4][6]. Market Context - China's weight management market is rapidly growing, with JPMorgan estimating that the market for weight management drugs could reach USD 14.9 billion by 2030 [2]. - The Chinese government has prioritized weight management as a public health issue, launching a three-year "Weight Management Year" campaign in 2024 [3]. Product Highlights - Innovent's Mazdutide therapy has shown significant weight reduction and improvements in health markers such as blood pressure and lipids, and it has been recognized as one of the "Top 10 Most Anticipated Medicines" globally for 2025 [5]. Future Plans - The companies plan to deepen their collaboration in AI-powered health management, aiming to expand access to innovative therapies and improve the quality and efficiency of chronic disease care in China [8].

Core Insights - Fangzhou Inc. has entered a strategic partnership with Innovent Biologics to integrate AI-driven digital health services with innovative therapies for metabolic diseases and weight management [1][2][4]. Company Overview - Fangzhou Inc. is a leading online chronic disease management platform in China, serving 52.8 million registered users and 229,000 physicians as of June 30, 2025 [10]. - Innovent Biologics specializes in developing and commercializing innovative therapies across various medical fields, including metabolic diseases [9]. Partnership Details - The collaboration aims to combine Fangzhou's AI-enabled "H2H" digital healthcare ecosystem with Innovent's novel therapies for diabetes and obesity, creating a new model that integrates AI technology with personalized services [2][4]. - The partnership will initially focus on diabetes and obesity, utilizing Fangzhou's "XS Core" AI large language model to enhance patient care through five key products [4][6]. Market Context - China's weight management market is rapidly growing, with JPMorgan estimating that the market for weight management drugs could reach USD 14.9 billion by 2030 [2]. - The Chinese government has prioritized weight management as a public health issue, launching a three-year "Weight Management Year" campaign in 2024 [3]. Future Plans - The companies plan to deepen their collaboration in AI-powered health management, aiming to expand access to innovative therapies and improve chronic disease care quality and efficiency in China [8].

Core Viewpoint - Jianyin International has upgraded the rating of Innovent Biologics to "Outperform" with a target price increase from HKD 110 to HKD 125, citing strong financial performance and product growth as key factors [1] Financial Performance - The company reported a profit of HKD 1.2 billion in the first half of the year, exceeding expectations [1] - Product revenue increased by 37% year-on-year to HKD 5.2 billion [1] Product Development - The launch of Mazdutide and the clinical progress of IBI-363 and IBI-3001 are seen as catalysts for growth [1] - The company's leading position in the Chinese biopharmaceutical sector is further solidified [1]

Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, aimed at chronic weight management in adults with overweight or obesity, marking a significant advancement in obesity treatment options in China [1][2][10]. Industry Context - The rising prevalence of overweight and obesity in China is a pressing public health issue, with over 500 million adults affected, leading to significant economic costs estimated at US$283.3 billion in GDP loss in 2020 [3][12]. - The National Health Commission has included "Healthy Weight Management Action" in the "Healthy China 2030" initiative, emphasizing the need for effective weight management strategies [2][4]. Clinical Significance - Mazdutide is supported by robust clinical data from the GLORY-1 Phase 3 study, demonstrating significant weight loss efficacy and metabolic benefits, including reductions in liver fat content and waist circumference [5][7][14]. - At week 48, participants in the mazdutide 4 mg and 6 mg groups experienced mean percentage changes in body weight of -12.0% and -14.8%, respectively, compared to -0.5% in the placebo group [14]. Regulatory and Market Implications - The approval of mazdutide aligns with national policies advocating for earlier pharmacological interventions in obesity management, reflecting a shift towards more structured outpatient care models [4][10]. - Innovent aims to leverage mazdutide as a cornerstone product in its cardiovascular and metabolic (CVM) pipeline, addressing the growing demand for effective obesity treatments in China [11][17].