Core Insights - Innovent Biologics announced that the Phase 3 clinical trial (DREAMS-1) of mazdutide for type 2 diabetes (T2D) met its primary and key secondary endpoints, demonstrating significant efficacy in glycemic control and weight loss [1][3][6] - The company plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) soon, following the acceptance of its first NDA for chronic weight management in February 2024 [1][10] Clinical Trial Results - DREAMS-1 was a randomized, double-blind, placebo-controlled trial involving 320 participants, showing a reduction in HbA1c of 1.57% for the 4 mg group and 2.15% for the 6 mg group compared to 0.14% for placebo at week 24 [2][3] - Key secondary endpoints indicated that mazdutide led to a higher proportion of patients achieving HbA1c < 7.0% and weight reduction ≥ 5% compared to placebo [3][4] Safety and Tolerability - The safety profile of mazdutide was favorable, with gastrointestinal adverse events being the most common, mostly mild to moderate, and no new safety signals identified [5][6] - The incidence of hypoglycemia was low, with no severe cases reported [5] Broader Implications - The results of the DREAMS-1 study provide significant medical evidence supporting the use of next-generation multi-target GLP-1R/GCGR drugs for T2D treatment, addressing the urgent need for innovative medications in China, where over 140 million people live with diabetes [7][8] - Mazdutide is positioned as a dual agonist that not only lowers blood glucose but also offers multiple cardiometabolic benefits, including weight loss and improved metabolic indicators [4][9] Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, with 10 products currently on the market and several new drug applications under review [11]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 51.05 [5][14]. Core Insights - The company has shown significant clinical data for its drug Mazdutide, which is expected to be approved in the first half of 2025, slightly ahead of previous expectations [2]. - The company has adjusted its revenue and profit forecasts for 2025 and 2026 upwards due to the anticipated earlier launch of Mazdutide and improved clinical results [3]. - The company reported a substantial increase in product sales revenue, with a year-on-year growth of 60% in the first quarter [3]. Financial Summary - Total revenue is projected to grow from RMB 6,206 million in 2023 to RMB 11,845 million by 2026, reflecting a compound annual growth rate (CAGR) of 18.5% [11]. - Shareholder net profit is expected to turn positive by 2025, with a forecasted profit of RMB 182 million in 2025 and RMB 367 million in 2026 [11]. - The company’s earnings per share (EPS) is projected to improve from a loss of RMB 0.66 in 2023 to a profit of RMB 0.24 by 2026 [11]. Adjustments to Forecasts - Revenue forecasts for 2025 and 2026 have been increased by 1.0% and 4.9%, respectively, due to the positive outlook for Mazdutide [3][6]. - The sales expense ratio for 2026 has been revised down from 38.7% to 37.9%, reflecting the company's confidence in managing costs amid high demand for GLP-1 drugs [3]. Clinical Data Highlights - In clinical trials, Mazdutide demonstrated a weight reduction of 13.38% and 14.84% after 32 and 48 weeks, respectively, and an 80.2% reduction in liver fat content after 48 weeks [2][6]. - The drug also showed significant improvements in waist circumference, blood pressure, and lipid levels, indicating a reduced risk of cardiovascular diseases [2][9].

Investment Rating - The report assigns an "Accumulate" rating to the company, indicating a positive outlook for its stock performance relative to the local market index [4][21]. Core Views - The report highlights the promising clinical data from the company's pipeline, particularly in the oncology sector, and anticipates significant market potential for the drug Masitide [4][5]. - The company is expected to receive approval for Masitide in the first half of 2025, which is projected to enhance its market presence and sales [5]. - The report emphasizes the company's strong positioning in the IO+ADC (Immuno-Oncology and Antibody-Drug Conjugates) space, with encouraging clinical results that suggest a robust commercial value for its oncology pipeline [5]. Financial Summary - Revenue projections show a steady increase from 4,270 million RMB in 2021 to an estimated 13,284 million RMB by 2026, reflecting a compound annual growth rate (CAGR) of approximately 35% [4]. - The net loss is expected to narrow significantly, from -3,138 million RMB in 2021 to a profit of 1,646 million RMB by 2026, indicating a turnaround in profitability [4]. - The price-to-earnings (PE) ratio is projected to improve from -20.55 in 2021 to 35.54 by 2026, suggesting a more favorable valuation as the company moves towards profitability [4].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 60, indicating a potential upside of 58% from the current price of HKD 38 [2][6][10]. Core Insights - The recent data from the GLORY-1 trial for the drug Masitidept has met expectations, showing significant weight loss and liver fat reduction, positioning the company favorably in the domestic weight loss market [2][3][6]. - The trial results indicate that the 6mg dosage achieved a weight loss of 14.37% over 48 weeks, which is competitive compared to other GLP-1 drugs [3][6]. - The liver fat reduction data is particularly impressive, with 76% of patients in the 4mg group and 90% in the 6mg group achieving a reduction of at least 50% in liver fat content [3][6]. Financial Projections - Revenue is projected to grow from RMB 4.56 billion in 2022 to RMB 13.22 billion by 2026, reflecting a compound annual growth rate (CAGR) of 32.7% [6][8]. - The net loss is expected to decrease significantly, from RMB 2.18 billion in 2022 to a profit of RMB 1.36 billion by 2026 [6][8]. - The price-to-sales (PS) ratio is forecasted to decline from 10.4 in 2022 to 3.8 by 2026, indicating improved valuation metrics as the company moves towards profitability [6][8]. Market Performance - The stock has shown a 52-week price range of HKD 27.3 to HKD 49.8, with an average daily trading volume of HKD 238 million over the past three months [1][4]. - The target price of HKD 60 aligns with market expectations, suggesting strong confidence in the company's growth trajectory and product pipeline [4][10].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 48.00, indicating a potential upside of 26.5% from the current price of HKD 37.95 [1][4][12]. Core Insights - The report emphasizes the superior weight loss effects of the drug Masitide compared to competitors, with a 14.0% weight reduction at 48 weeks for the 6mg group, significantly outperforming the placebo group [3][4]. - The drug shows promising results in reducing liver fat content, with an 80.2% reduction in the 6mg group compared to only 5.3% in the placebo group, indicating strong potential for treating metabolic diseases [3][4]. - The company is targeting multiple emerging markets, including obesity in adolescents and other conditions with limited treatment options, which could lead to substantial revenue growth [3][4]. Financial Overview - Revenue projections show a significant increase from RMB 4,556 million in 2022 to RMB 12,951 million by 2026, with a compound annual growth rate (CAGR) of approximately 28.4% [2][15]. - Net profit is expected to turn positive by 2025, reaching RMB 2,030 million, after losses in the previous years [2][15]. - The company's gross margin is projected to improve from 79.6% in 2022 to 83.5% by 2026, reflecting operational efficiency [15]. Market Potential - The report highlights a large unmet clinical need in China, with 500 million overweight adults and 160 million obese individuals, creating a significant market opportunity for Masitide [3][4]. - The anticipated approval of Masitide in China by the end of the year could lead to peak sales of RMB 5.2 billion by 2026 [3][4].

Core Insights - Innovent Biologics has presented the results of the Phase 3 clinical trial of mazdutide, demonstrating its efficacy in weight loss and reduction of cardiometabolic risk factors in adults with obesity or overweight [1][2][3] Group 1: Clinical Trial Results - The GLORY-1 trial met all primary and key secondary endpoints, confirming the advantages of mazdutide as a GLP-1R/GCGR dual agonist [1][3] - At week 48, participants receiving mazdutide 6 mg experienced a mean percentage weight change of -14.31% compared to placebo [3][4] - Significant weight loss was observed, with 82.0% of participants on mazdutide 6 mg achieving a weight reduction of 5% or more at week 32 [4][5] Group 2: Cardiometabolic Benefits - Mazdutide treatment resulted in significant reductions in waist circumference and multiple cardiometabolic risk factors, including systolic blood pressure and triglycerides [6][7] - At week 48, the pooled mazdutide group showed a reduction in liver fat content by an average of 80.2% in participants with high baseline liver fat [7] Group 3: Safety and Tolerability - The safety profile of mazdutide was favorable, with a low incidence of serious adverse events comparable to placebo [7] - Common adverse events were mostly mild or moderate gastrointestinal issues, with no new safety signals identified [7] Group 4: Regulatory and Market Potential - The first new drug application (NDA) for mazdutide is currently under review by the CDE of the National Medical Products Administration (NMPA) in China [2][12] - If approved, mazdutide is expected to provide a safe and effective treatment option for obesity, addressing a significant unmet clinical need in the Chinese market [10][11]

Core Insights - Innovent Biologics reported positive results from the Phase 3 study of mazdutide, a dual agonist targeting GLP-1R and GCGR, showing significant reductions in liver fat content in overweight or obese Chinese adults [1][2][3] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, autoimmune, cardiovascular, and metabolic disorders [1][9] - The company has launched 10 products and has multiple assets in clinical trials, including five Phase 3 studies for mazdutide [9] Study Details - The GLORY-1 trial involved 610 Chinese adults with a BMI of ≥28 kg/m² or ≥24 kg/m² with at least one weight-related comorbidity, randomized to receive mazdutide or placebo for 48 weeks [2][3] - The study demonstrated that mazdutide treatment led to a mean relative reduction in liver fat content of −63.3% for the 4 mg dose and −73.2% for the 6 mg dose, compared to an 8.2% increase in the placebo group [3][4] Clinical Implications - The results indicate that mazdutide may be more effective than GLP-1 receptor mono-agonists and other dual-target agonists in reducing liver fat, addressing significant unmet clinical needs in metabolic dysfunction-associated fatty liver disease (MAFLD) [2][4] - A high percentage of participants treated with mazdutide achieved significant reductions in liver fat, with 95.5% achieving a ≥30% relative reduction and 77.3% normalizing liver fat levels [4] Market Context - Obesity is a leading risk factor for various chronic diseases, and the prevalence of obesity in China has reached alarming levels, necessitating effective pharmacological interventions [6] - Traditional obesity treatments in China have shown limited efficacy, highlighting the need for innovative solutions like mazdutide [6] Future Prospects - The promising results from the GLORY-1 study support further exploration of mazdutide's clinical value in treating MAFLD and metabolic disorders [5][7] - The first New Drug Application (NDA) for mazdutide was accepted by the CDE of China's NMPA for chronic weight management, indicating potential market entry [8]

浦银国际研究 公司研究 | 医药行业 信达生物（1801.HK）：三项肿瘤管 阳景 浦 线资产公布积极的一期数据 首席医药分析师 银 Jing_yang@spdbi.com 国 (852) 2808 6434 近期公司在 2024 ASCO 和 ESMO Virtual Plenary 会议上公布了 3项肿 际 瘤管线资产积极的一期数据，包括 IBI363 (PD-1/IL-2)积极的一期 PD-1 胡泽宇 CFA 耐药及冷肿瘤数据、IBI343 (CLDN18.2 ADC)潜在同类最佳的一期胰腺癌 医药分析师 疗效安全性数据以及 IBI389 (CLDN18.2/CD3)初步胃癌胰腺癌数据。肿 ryan_hu@spdbi.com 瘤研发管线的持续推进反映了信达强大的研发能力和执行能力。重申 (852) 2808 6446 我们的“买入”评级和目标价 60港元。 2024年6月19日  IBI363 (PD-1/IL-2)一期疗效和安全性数据积极，有望成为实体瘤 公 PD-1 耐药及不响应的潜在疗法：近期公司在 2024 ASCO 和 ESMO 司 Virtual Plenary 会议上公布了潜在 Firs ...

Core Insights - Innovent Biologics, Inc. provided updates on its oncology pipeline, showcasing clinical data on multiple cancer drug candidates at an investor meeting, emphasizing its R&D strategy focused on global innovation [1][2][3] Oncology Pipeline Development Strategy - The company aims to address unmet clinical needs in cancer treatment through an extensive deployment of "IO + ADC" strategies, targeting limitations in current immunotherapies and anti-angiogenic drugs [2][3] - Innovent has developed a product pipeline consisting of 36 new drug candidates, with 22 focused on oncology, leveraging advanced antibody technology and scientific expertise [3] Key Product Milestones - Innovent is advancing its oncology pipeline through clinical proof-of-concept studies and global multi-regional clinical trials, with several promising molecules entering clinical development [4] - IBI363, a first-in-class PD-1/IL-2 α-bias bispecific antibody, has shown promising anti-tumor efficacy across multiple cancer types, including immunotherapy-treated and 'cold' tumors, with over 300 subjects involved in Phase 1 trials [4][5] - IBI343, an innovative TOPO1-inhibitor CLDN18.2 ADC, demonstrated a 40% objective response rate in pancreatic cancer patients, marking it as the first ADC to show breakthrough efficacy in this area [5] - IBI389, a bispecific antibody targeting CLDN18.2/CD3, has shown significant anti-tumor effects in pancreatic cancer, with an objective response rate of 29.6% in clinical trials [6] Future Directions - Innovent plans to continue advancing its oncology product line, focusing on high-quality clinical development and addressing unmet medical needs in cancer treatment [7] - The company emphasizes its unique competitive advantage in next-generation oncology treatment innovations, aiming to empower patients with affordable, high-quality biopharmaceuticals [7][8]

M N 18 Jun 2024 CMB International Global Markets | Equity Research | Company Update Innovent Biologics (1801 HK) Promising PoC results of the potential FIC asset  IBI363 (PD-1/IL-2) demonstrated encouraging signals in IO-failed and cold Target Price HK$55.75 tumors, especially in IO-resistant sq-NSCLC. IBI363 is a potential FIC PD-1/IL-2 (Previous TP HK$55.00) bsAb with a differentiated α-biased IL-2 arm, distinct from other IL-2 mAbs that Up/Downside 46.5% eliminate the receptor α. IBI363 has shown broad- ...