浦银国际研究 公司研究 | 医药行业 (1801.HK) 信达生物(1801.HK):玛仕度肽首个 三期减重数据符合预期 近期公司在 2024 ADA 大会汇报了玛仕度肽首个 3 期临床研究 GLORY1(4mg/6mg)整体疗效安全性数据以及 GLORY-1 试验和此前 9mg 二 期试验肝脏脂肪减少数据。总体而言,GLORY-1 整体疗效安全性数据 符合预期,肝脏脂肪降低数据亮眼,MASH 将成为未来适应症拓展的 一个重大方向。我们持续看好信达生物在国内减重领域的领先地位和 先发优势,重申我们的"买入"评级和目标价 60 港元。 阳景 首席医药分析师 Jing_yang@spdbi.com (852) 2808 6434 在 GLORY-1 试验中,6mg 剂量于 48 周实现减重 14.37%,符合预 期;安全性数据亦符合预期:在 GLORY-1 研究中,共 610 例中国 超重伴有至少一种体重相关合并症(BMI≥24kg/m2)或肥胖受试 者(BMI≥28kg/m2)按照 1:1:1 随机接受玛仕度肽 4mg(N=203), 6mg(N=202),或安慰剂(N=205)治疗。主要终点为两个,即 32 ...

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- ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 48.00, indicating a potential upside of 26.2% from the current price of HKD 38.05 [1][4]. Core Insights - The report emphasizes the promising early data from the company's next-generation cancer therapies, particularly the PD-1/IL-2 dual antibody IBI363, which shows significant efficacy in treating solid tumors. The overall response rates (ORR) for all solid tumor patients reached 17.3%, with a notable 46.7% ORR in the 3mg/kg Q3W dosage group [3][4]. - The report highlights the company's differentiated positioning in the oncology sector, with strong early clinical data suggesting substantial market potential if future trials maintain similar efficacy levels [4]. Financial Overview - Revenue projections show a strong growth trajectory, with expected revenues increasing from RMB 4,556 million in 2022 to RMB 12,951 million by 2026, reflecting a compound annual growth rate (CAGR) of approximately 28.4% [2][9]. - The net profit is projected to improve significantly from a loss of RMB 2,179 million in 2022 to a profit of RMB 2,030 million by 2026, indicating a turnaround in profitability [2][9]. - The earnings per share (EPS) is expected to transition from a loss of RMB 1.46 in 2022 to a profit of RMB 1.25 by 2026, showcasing a substantial recovery [2][9]. Clinical Development Highlights - The report notes that IBI363 has demonstrated superior efficacy compared to existing immuno-oncology (IO) therapies in cold tumors and previously treated patients, with specific mention of its performance in melanoma and MSS colorectal cancer [3][4]. - The company is set to release further data on its key oncology pipeline, including updates on IBI363 and CLDN18.2 candidates, which are anticipated to be significant catalysts for future growth [4][5].

Core Insights - Innovent Biologics is set to present multiple clinical study results of mazdutide at the American Diabetes Association's 84th Scientific Sessions, highlighting its significance in obesity treatment [1] - Mazdutide is the first GLP-1R/GCGR dual agonist to succeed in a Phase 3 registration study for overweight and obesity, indicating its potential as a weight management option [1][2] Group 1: Clinical Studies and Presentations - The first Phase 3 study of mazdutide in Chinese adults with obesity and overweight (GLORY-1) will be presented, along with an exploratory analysis on liver steatosis and a Phase 2 study of mazdutide 9 mg [1] - The presentation details include an oral presentation on the efficacy and safety of mazdutide, scheduled for June 23, 2024, and two poster presentations [1] Group 2: Drug Development and Mechanism - Mazdutide (IBI362) is a GLP-1R and GCGR dual agonist developed under an exclusive license agreement with Eli Lilly, showing robust weight loss and glucose-lowering effects in clinical studies [2] - The drug has demonstrated improvements in various cardio-metabolic indicators, including waist circumference, blood lipids, and liver fat content [2] Group 3: Regulatory Progress - The first New Drug Application (NDA) for mazdutide was accepted by the CDE of the NMPA of China for chronic weight management in adults with obesity or overweight in February 2024 [3] Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biologics for various diseases, with 10 products currently on the market and several in clinical trials [4] - The company collaborates with over 30 global healthcare leaders, including Eli Lilly and Roche, to advance its biopharmaceutical offerings [5]

Core Viewpoint - Innovent Biologics announced that picankibart (IBI112), a recombinant anti-IL-23p19 antibody, successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 study for moderate to severe plaque psoriasis, demonstrating significant efficacy and a favorable safety profile [1][2][5]. Group 1: Study Results - CLEAR-1 is the first global Phase 3 registration study in the IL-23p19 class, reporting over 80% of subjects achieving PASI 90 after 16 weeks of treatment [1][2]. - At week 16, 80.3% of subjects receiving picankibart achieved PASI 90 compared to 2.0% for placebo, and 93.5% achieved sPGA 0 or 1 compared to 13.1% for placebo, both with p<0.0001 [2]. - The efficacy of picankibart was maintained through week 52, with 84.9% achieving PASI 90 and 85.9% achieving sPGA 0/1 [3]. Group 2: Secondary Endpoints and Quality of Life - All key secondary endpoints were met, including improvements in PASI 75, PASI 100, sPGA scores, and Dermatology Life Quality Index (DLQI) scores, with results maintained through 52 weeks [4]. - Picankibart showed superiority over placebo in improving all measured parameters, significantly enhancing patients' quality of life [4]. Group 3: Safety Profile - The overall safety profile of picankibart was favorable, with no new safety signals identified compared to previous studies [5]. - Ongoing follow-up of the study will provide complete data for future academic presentations [5]. Group 4: Company and Product Information - Picankibart is a monoclonal antibody developed by Innovent, specifically targeting the IL-23p19 subunit, potentially offering a more effective treatment for psoriasis and other autoimmune diseases [9]. - Innovent is a leading biopharmaceutical company focused on developing high-quality biologics for various diseases, with multiple products in the market and ongoing clinical trials [10].