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- ...

交银国际研究 公司更新 医药 收盘价 目标价 潜在涨幅 2024年6月17日 港元38.05 港元48.00 +26.2% 信达生物 (1801 HK) 早期数据密集公布，下一代肿瘤治疗矩阵雏形初显，重申买入  PD-1/IL-2双抗展现出下一代IO疗法潜质：IBI363（PD-1/IL-2α-bias双抗）治 个股评级 疗实体瘤的I期初步数据显示：在所有实体瘤患者（N=300）和IO经治患 买入 者（N=204）中的ORR分别达到17.3%/17.6%，疗效剂量相关性明显，其 中3mg/kg Q3W剂量组中（N=15）的ORR达到46.7%。IBI363在冷肿瘤/IO 1年股价表现 经治的热肿瘤上取得了明显优于现有IO药物的疗效：1）黑色素瘤中的肢 端和黏膜亚型属于冷肿瘤，在该试验中的 IO 经治患者分别取得 1801 HK 恒生指数 40% 42.9%/18.2%的ORR和71.4%/81.8%的DCR；2）MSS结直肠癌有效疗法较 30% 少，其中肝转移患者（占比70%）对IO疗法更是几乎没有任何响应，而 20% 10% IBI363在0.6-1mg/kg Q2W下取得12.7%的ORR，伴/不伴肝转 ...

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].

Investment Rating - The report does not explicitly state the investment rating for Innovent Biologics (1801 HK) Core Insights - Innovent Biologics showcased multiple clinical data at the 2024 ASCO Annual Meeting, highlighting its R&D capabilities with various monoclonal antibodies, bispecific antibodies, and ADCs [3][8] - IBI363 demonstrated promising safety and efficacy in treating cold tumors and IO-resistant tumors, particularly in advanced colorectal cancer patients with a median of ≥3 prior treatment lines [4][9] - IBI389 and IBI343 are positioned well in the market, with IBI389 showing lower treatment-related adverse events compared to standard chemotherapy in pancreatic cancer [4][10] - New data from IBI310 combined with sintilimab indicates significant improvements in pathological complete response rates in MSI-H/dMMR CRC patients [10] Summary by Sections Clinical Data Highlights - In May 2024, Innovent Biologics released clinical data for IBI363, IBI389, IBI343, and IBI310 at ASCO 2024 [3][8] - IBI363 showed good response rates and disease control rates in advanced colorectal cancer, particularly in patients with PD-L1 CPS≥1 [4][9] - IBI389 demonstrated a lower incidence of grade 3 and above treatment-related adverse events compared to standard chemotherapy in advanced pancreatic ductal adenocarcinoma [10] Efficacy and Safety - IBI363 exhibited overall acceptable tolerability and manageable safety, with a lower incidence of grade 3 and above treatment-related adverse events compared to PD-1/PD-L1 therapies [4][9] - IBI343 achieved a notable overall response rate of 40% in a subgroup of pancreatic cancer patients with CLDN18.2 expression ≥60% [5][10] - The combination of IBI310 with sintilimab significantly increased the pathological complete response rate compared to sintilimab monotherapy in CRC patients [10]

2024年5月23日 公司研究 替妥尤单抗注射液上市申请获得受理，商业化前景可期 ——信达生物（1801.HK）公告点评 要点 买入（维持） 当 前价：37.00港元 事件： 公司发布公告，国家药品监督管理局（NMPA）药品审评中心（CDE）已经正式 作者 受理替妥尤单抗注射液（重组抗胰岛素样生长因子1受体抗体（IGF-1R抗体）， 研发代号：IBI311）的新药上市申请（NDA），用于甲状腺眼病（TED）的治疗。 分析师：王明瑞 点评： 执业证书编号：S0930520080004 021-52523867 替妥尤单抗注射液3期注册性临床研究结果积极，详细数据将在学术期刊公布。 wangmingrui@ebscn.com 此次新药申请获得受理是基于一项在中国TED受试者中开展的3期注册临床研 分析师：张瀚予 究RESTORE-1（编号：CTR20223 393）的积极结果。该研究于2024年2月顺 执业证书编号：S0930523070010 利达成主要研究终点，研究显示IBI311组研究眼的眼球突出度、疾病活动程度 021-52523861 zhanghanyu@ebscn.com 和受试者生活质量等方面的改 ...