mazdutide

Search documents
INNOVENT BIOLOGICS(1801.HK):ADVANCING A BROAD PIPELINE OF NEXT-GENERATION THERAPIES
Ge Long Hui· 2025-07-08 16:35
Maintain BUY. We are positive on the global potential of Innovent's rich innovative pipelines. Innovent is on track to achieve EBITDA breakeven this year. Backed by smooth development of IBI363, we improved our possibility of success for the asset and raised our DCF-based TP to HK$102.95 from HK$94.74. 机构:招银国际 研究员:Jill WU/Andy WANG IBI363 positioned as a promising next-generation IO therapy with Ph3 trials underway. Strong survival benefits and broad potential position IBI363 (PD-1/IL-2) as a potential bloc ...
Asia Deep Dive_ Akeso & Innovent
2025-07-07 00:51
Asia Pacific Equity Research July 2025 Asia Deep Dive: Akeso & Innovent China Healthcare Research Yang HuangAC, PhD (852) 2800 3812 yang.huang@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking (Hong Kong) Limited Eric Zhao, CFA (86-21) 6106 6256 eric.zhao@jpmorgan.com SAC Registration Number: S1730524050001 J.P. Morgan Securities (China) Company Limited Derek Choi, CPA (852) 2800-8744 derek.c.choi@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking ( ...
Innovent Biologics (01801) Earnings Call Presentation
2025-07-04 11:26
Innovent Biologics Overview - Innovent Biologics has grown into a China-leading biopharmaceutical company with 16 commercial products and 21 clinical pipeline products[9,10] - Innovent's total revenue exceeded RMB9.4 billion in 2024, marking a 55% increase from the previous year[26,27] - Product revenue is projected to achieve RMB20 billion in 2027[38] Oncology Drug Development in China - China accounted for 35% of the global oncology trials in 2023, exceeding the US[172] - The share of first-approved innovative drugs developed by China rose significantly from 4% in 2015 to 38% in 2024[175] - In the first half of 2025, Chinese pharmaceutical companies executed 20 oncology out-licensing deals totaling nearly $30 billion, with ADCs remaining a key focus[185,187] IBI363 (PD-1/IL-2 α-bias) Clinical Progress - IBI363 is a global first-in-class next-generation IO therapy designed to selectively activate and expand tumor-specific T cells[158,159] - In IO-resistant squamous cell lung cancer, IBI363 at 3 mg/kg showed a confirmed ORR of 36.7% and a median PFS of 9.3 months[160] - In IO-resistant melanoma, IBI363 showed an ORR of 26.7% and a median DoR of 14 months[531,533] - In 3L+ CRC, IBI363 monotherapy achieved a median OS of 16.1 months, and IBI363 + Bevacizumab combination therapy showed a cORR of 15.1%[647,650] ADC Developments in Gastrointestinal Cancers - HER2 ADCs demonstrated remarkable efficacy in HER2 3+ CRC, with T-DXd showing a 57.5% ORR and IBI354 showing a 54% confirmed ORR in earlier-phase trials[203,204] - IBI343, a CLDN18.2 ADC, showed promising efficacy in 3L gastric cancer, with the 6 mg/kg group achieving an ORR of 36.7% and a median PFS of 6.8 months[214,217] - In advanced pancreatic cancer, IBI343 showed an ORR of 22.7% in CLDN18.2-high (IHC ≥60%) population, with mPFS of 5.4 months and mOS of 9.1 months[220,224]
高盛:信达生物-对马兹杜肽有信心;聚焦最大化 IBI363 的潜力
Goldman Sachs· 2025-07-04 03:04
3 July 2025 | 7:34PM HKT Innovent Biologics (1801.HK): China Healthcare Corporate Day 2025 — Confidence on mazdutide; Focus to maximize potential of IBI363 Presenters: Rachel You - Chief Financial Officer, Shu Zhu - IR Director, Samantha Xie - Senior IR Manager Bottom line: We hosted Innovent management team on July 3rd virtually at our China Healthcare Corporate Day. Mgmt highlighted 1) the multi-channel coverage conducted for mazdutide, 2) its target to build a higher competition barrier for mazdutide, 3) ...
X @Bloomberg
Bloomberg· 2025-07-01 13:04
China's homemade weight-loss drug, mazdutide, has been approved, and doctors hope it will help more patients get treatment https://t.co/zTXxsN61IH ...
Innovent Biologics (01801) Update / Briefing Transcript
2025-06-28 01:00
Summary of Innovent Biologics Update / Briefing Company Overview - **Company**: Innovent Biologics (01801) - **Event**: Healthy China 2030 Oncology Innovation Summit and R&D Day - **Date**: June 27, 2025 Key Points Industry Context - The oncology sector is a major health threat globally, affecting individuals regardless of socioeconomic status [10][14] - The biomedicine industry in China has evolved significantly over the past decade, transitioning from generics to innovative biologics [15][20] Company Achievements - Innovent was established in 2011 and has launched 16 products, with over 20 in R&D [21][22] - The company has invested over ¥8 billion (approximately $1.2 billion) and holds 20% of China's total biologics production capacity [21][22] - In 2024, Innovent's total revenue exceeded ¥9.4 billion (approximately $1.4 billion) [24] Market Position - Innovent is a leader in several oncology segments, including PD-1, VEGF, and CD20, with three of the top ten oncology drugs in China coming from Innovent [24] - The company has made significant strides in drug accessibility and affordability, with prices for monoclonal antibodies now a fraction of those in the U.S. [17][18] Future Outlook - By 2027, Innovent aims to achieve product revenue of ¥20 billion (approximately $3 billion) and to be among the top five in sales revenue in China's biopharma sector [26][40] - The company plans to have five assets in global MRCT Phase III trials by 2030 [30][41] R&D Innovations - Innovent is focusing on next-generation technologies, including new generation immuno-oncology (IO) and antibody-drug conjugates (ADC) [32][37] - The company is developing IBI-363, a PD-1 IL-2 fusion protein, which shows promise in enhancing anti-tumor immunity [36] - Collaborations with multinational firms like Roche, Eli Lilly, and Sanofi are ongoing to enhance R&D capabilities [21][22] Challenges and Opportunities - Despite progress, there are still unmet clinical needs in oncology, and Innovent aims to address these through innovative therapies [47][49] - The company is optimistic about the potential of ADCs combined with IO therapies to improve treatment outcomes for lung cancer and other malignancies [93][94] Conclusion - Innovent Biologics is positioned as a key player in the Chinese biopharma landscape, with a strong focus on innovation and collaboration to drive future growth in oncology treatments [49][50]
Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval from China's NMPA for Chronic Weight Management
Prnewswire· 2025-06-27 09:49
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) recepto ...
Innovent announces the Phase 3 Clinical Study DREAMS-1 of Mazdutide in China were Orally Presented at ADA 85th Scientific Sessions
Prnewswire· 2025-06-24 14:02
Core Insights - Innovent Biologics announced positive Phase 3 clinical study results for mazdutide, a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in treating type 2 diabetes (T2D) in Chinese adults, demonstrating significant efficacy in glycemic control and weight loss [1][8] Clinical Study Details - The DREAMS-1 study enrolled 319 Chinese participants with T2D inadequately controlled by diet and exercise, with a mean age of 50.4 years and a mean baseline HbA1c of 8.24% [2] - Participants were randomized to receive either mazdutide 4 mg, mazdutide 6 mg, or placebo for 24 weeks, with the primary endpoint being the change in HbA1c from baseline to week 24 [2] Efficacy Results - Mazdutide achieved an HbA1c reduction of 2.15% after 24 weeks, with 68.6% and 87.4% of participants on mazdutide 4 mg and 6 mg, respectively, achieving HbA1c <7.0%, compared to 10.7% with placebo [3] - Weight reduction was also significant, with participants on mazdutide 4 mg and 6 mg showing a percentage change in body weight of -5.61% and -7.81%, respectively, compared to -1.26% with placebo [4] Cardiometabolic Improvements - Treatment with mazdutide led to significant improvements in multiple cardiometabolic risk factors, including fasting glucose, waist circumference, blood pressure, and lipid levels [5] Safety Profile - Mazdutide exhibited a favorable safety profile, with low incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation, primarily mild to moderate gastrointestinal symptoms [6][7] Market Context - China has a high incidence of T2D, with approximately 140 million adult patients, highlighting the urgent need for effective treatment options [8][9] - The treatment landscape for diabetes is shifting towards a patient-centered approach, integrating glycemic control, weight management, and cardiovascular risk factor management [8] Future Prospects - Mazdutide has two New Drug Applications (NDAs) under review by China's National Medical Products Administration (NMPA) for chronic weight management and glycemic control in adults with T2D [11][12] - Innovent is actively developing a next-generation pipeline in the cardiovascular and metabolic fields, aiming to meet public health needs [12]
Jefferies:2025 年ADA医疗的中国力量
2025-06-23 13:16
China (PRC) | Healthcare Equity Research China Force in ADA 2025 All eyes on ADA'25 with key presentations during this weekend, e.g.LLY's Orfo and Bima. China biotechs will also have a presence with notable data to watch: 1) Ascletis's ASC30 (orfo-structure oral GLP-1) in Ph1, 2) Laekna's LAE102 (muscle preserving) in Ph1 and 3) Innovent's Mazdutide (GLP-1/ GCG) Ph3 data in T2D. We don't anticipate major surprises from China in ADA'25 though given oral GLP-1 and amylin candidates in early stages and no key ...
花旗:中国制药业_未来催化剂_参与 2025 年美国糖尿病协会(ADA)会议的中国企业
花旗· 2025-06-16 03:16
Flash | 12 Jun 2025 08:08:06 ET │ 9 pages China Pharmaceuticals Catalysts ahead: Chinese companies in ADA 2025 CITI'S TAKE The American Diabetes Association (ADA) meeting (6/20-6/23; Chicago) will happen next week, and we summarize the expected presentations from the China companies due to attend. Innovent will likely present mazdutide DREAMS-1 Ph3 study for T2D and the preclinical data for the GLP-1/GIP/GCG/PCSK9 candidate. Oral GLP-1 data including ASC30 (Ph1a), HDM1002(Ph1b) and RGT-075 (Ph2a), as well a ...