Core Viewpoint - Innovent Biologics has initiated a Phase 3 clinical study for picankibart, targeting psoriasis patients who have not responded adequately to anti-IL-17 treatments, aiming to provide robust clinical evidence for biologic switching strategies in psoriasis treatment [1][4][6]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for various diseases, including oncologic, autoimmune, cardiovascular, and metabolic conditions [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [10]. Clinical Study Details - The Phase 3 study (NCT06945107) will enroll approximately 310 participants, randomized in a 1:1 ratio to receive either picankibart or continued IL-17 monoclonal antibody treatment [2]. - The primary endpoint is the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16 [2]. Efficacy and Safety - Previous Phase 2 studies indicated that switching to picankibart resulted in a rapid clinical response, with 64.6% of patients achieving skin lesion clearance after 16 weeks [3][6]. - Nearly half (48.2%) of participants in the Phase 2 study reached the primary endpoint, with a stable response rate of 54.2% through week 44 [5]. Psoriasis Background - Psoriasis is a chronic inflammatory disease affecting 80%-90% of patients with plaque psoriasis, with nearly 30% classified as moderate-to-severe [7]. - Current systemic treatments include various agents, with biologics becoming a central focus since 2019 due to their efficacy and safety [7]. Picankibart Overview - Picankibart (IBI112) is a monoclonal antibody developed by Innovent, targeting the IL-23p19 subunit, which may offer a more effective treatment option for psoriasis and other autoimmune diseases [8]. - The first new drug application for picankibart for moderate-to-severe plaque psoriasis was submitted for review by the NMPA in September 2024 [9].

Summary of Innovent (1801.HK) Conference Call Company Overview - **Company**: Innovent Biologics, Inc. (1801.HK) - **Date**: 23 May 2025 - **Market Cap**: HK$92,786 million (approximately US$11,855 million) [2][9] Key Industry Insights - **Product Focus**: IBI363, an investigational drug for various cancers including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma. - **Clinical Data**: - In IO-treated squamous NSCLC, IBI363 demonstrated an overall response rate (ORR) of 43.3% (13/30) and a median progression-free survival (mPFS) of 7.3 months, suggesting potential superiority over docetaxel (mPFS ~4 months, mOS 10-12 months) [2][4]. - In third-line or later MSS/pMMR CRC, IBI363 showed an ORR of 23.5% (16/68) when combined with Bevacizumab (Beva) [2][4]. - **Regulatory Actions**: Innovent has initiated a registrational trial for IBI363 in IO-naïve melanoma and is in discussions with regulatory agencies regarding potential registrational trials in IO-treated squamous NSCLC and CRC [2][4]. Financial Projections - **Target Price**: HK$60.00, indicating an expected share price return of 6.7% [2][9]. - **Valuation Method**: Discounted Cash Flow (DCF) approach, with a terminal growth rate of 4% and a weighted average cost of capital (WACC) of 10.3% [9]. Risk Factors - **High Risk Rating**: The stock is classified as high risk due to: 1. Historical lack of profitability and forecasted periods without profit. 2. Potential sales underperformance relative to expectations. 3. Intense competition for IBI362 in obesity treatment. 4. Risks associated with research and development failures. 5. Regulatory risks that could hinder stock performance [10][2]. Additional Considerations - **Investment Rating**: The stock is rated as "Buy" with a high-risk designation, reflecting the volatility and fundamental criteria associated with the company [21][22]. - **Expected Dividend Yield**: 0.0%, indicating no dividends are anticipated in the near term [2][9]. This summary encapsulates the critical insights from the Innovent conference call, highlighting the company's clinical advancements, financial outlook, and associated risks.

整理 | GLP1减重宝典内容团队 信达生物宣布，其 GLORY-1 三期临床研究结果在《新英格兰医学杂志》(NEJM) 上发表。该研究评估了玛仕度肽（一种胰高血糖素 (GCG) 和胰高血糖素样肽-1 (GLP-1) 受体双激动剂）在中国超重或肥胖成年患者中的疗效。 该研究的第一作者是北京大学人民医院的纪立农教授和河南科技大学第一附属医院的蒋宏伟教授。纪立农教授和信达生物的钱镭博士 为共同通讯作者。 这是首个提交监管审批的GCG/GLP-1受体双激动剂玛仕度肽的临床试验首次发表在顶级同行评议期刊上。这也标志着中国研发的创 新肥胖治疗药物首次登上《新英格兰医学杂志》(NEJM)，体现了中国在生物制药创新方面的进步。该研究有望为全球肥胖管理临床 指南提供参考。 在NEJM的一篇相关社论中，哈佛大学医学院的Vanita R. Aroda教授和科罗拉多大学安舒茨医学院的Leigh Perreault教授指出了中国 和西方人群在肥胖相关健康结果方面的关键差异。他们强调，中国年轻人出现代谢功能障碍的几率与西方老年人口相当。玛仕度肽不 仅显著降低了体重和BMI，还改善了更广泛的肥胖相关健康指标。他们强调了在中国开展个性化干 ...

Core Viewpoint - The article highlights the successful Phase III clinical trial results of the obesity treatment drug Masitide (GCG/GLP-1 dual receptor agonist), which has been published in the prestigious New England Journal of Medicine (NEJM), marking a significant milestone for China's innovation in the field of endocrine metabolism and potentially transforming obesity treatment globally [1][5][10]. Group 1: Clinical Research and Results - The GLORY-1 study, which included 610 participants, demonstrated that Masitide significantly reduced body weight compared to placebo, with 73.9% and 82.0% of participants in the 4 mg and 6 mg groups, respectively, achieving a weight loss of ≥5% by week 32 [9]. - By week 48, 35.7% and 49.5% of participants in the 4 mg and 6 mg groups, respectively, achieved a weight loss of ≥15%, while only 2.0% in the placebo group did [9]. - The drug also showed significant improvements in various metabolic indicators, including blood lipids, blood pressure, and liver fat content [9]. Group 2: Significance and Implications - The publication of the study in NEJM signifies international recognition of China's innovative drug development in the field of obesity treatment, providing a new direction for global obesity management [3][6]. - The research results are expected to influence clinical guidelines and practices, contributing to the "Healthy China 2030" initiative by addressing the rising obesity rates in the country [6][10]. - The dual-target mechanism of Masitide, which combines appetite suppression and enhanced fat metabolism, represents a breakthrough in obesity treatment strategies [8][10]. Group 3: Broader Context and Public Health - The increasing prevalence of overweight and obesity in China poses significant public health challenges, with obesity-related deaths accounting for 11.1% of chronic non-communicable disease deaths in 2019 [4]. - The Chinese government has initiated a "Weight Management Year" campaign to address these issues, emphasizing the importance of weight management in improving national health [4][6]. - Experts suggest that obesity treatment should consider local population characteristics and implement differentiated strategies, particularly focusing on liver health and lipid management [6][10].

Market Overview - The market experienced fluctuations in the early session, with the ChiNext Index leading the decline. The focus of the market was primarily on the consumer and pharmaceutical sectors [1] ETF Performance - Several ETFs related to innovative drugs saw significant gains, with the Hong Kong Stock Connect Innovative Drug ETF (159570) rising by 2.61% and the Hong Kong Innovative Drug ETF (159567) increasing by 2.22% [2] - The Hong Kong Innovative Drug ETF (513120) also rose over 2%, with a total scale of 95.23 billion, tracking the CSI Hong Kong Innovative Drug Index [5] Investment Logic - The innovative drug industry in China is expected to reach a turning point by 2025, shifting from capital-driven to profit-driven trends, presenting opportunities for both performance and valuation recovery [2] - A new round of technological advancements is anticipated to propel domestic innovative drugs into a new development phase [2] Key Stocks in Innovative Drug Sector - Notable companies in the innovative drug sector include: - Innovent Biologics (信达生物) with a market cap of 885.89 million - BeiGene (百济神州) with a market cap of 2,034.42 million - WuXi Biologics (药明生物) with a market cap of 938.65 million - Other significant players include CanSino Biologics (康方生物), China Biologic Products (中国生物制药), and Hengrui Medicine (翰森制药) [3][6][7] Index Composition - The CSI Hong Kong Innovative Drug Index selects up to 50 listed companies involved in innovative drug research and development, reflecting the overall performance of the innovative drug sector in the Hong Kong market [5][6]

Core Viewpoint - The Chinese innovative pharmaceutical sector is gaining international recognition, highlighted by significant deals and promising clinical data, leading to increased interest in related ETFs [1][3][4]. Group 1: Market Performance - The innovative drug ETF (517110) has rebounded nearly 15% since early April, reflecting strong performance in the pharmaceutical sector [1]. - The biopharmaceutical ETF and vaccine ETF also showed positive movements, with respective increases of 1.17% and 0.89% [2]. Group 2: ASCO Conference Insights - At the 2025 ASCO conference, over 70 research outcomes from Chinese pharmaceutical companies were presented, showcasing advancements in ADC and bispecific antibody technologies [3]. - Notable performances include Zai Lab's ZG005 and Huahai Pharmaceutical's HB0025, which exceeded expectations in early clinical trials for cervical and endometrial cancers, respectively [3]. Group 3: Business Development Trends - Recent business development (BD) activities in the innovative drug sector have seen record-breaking upfront payments, such as the $12.5 billion upfront payment from Pfizer for a PD-1/VEGF bispecific antibody from 3SBio [4][7]. - The increase in upfront payments and total deal values indicates growing international recognition of Chinese innovative drugs [7]. Group 4: Future Outlook - The innovative drug sector is expected to benefit from ongoing BD transactions, advancements in artificial intelligence across the pharmaceutical value chain, and the implementation of new healthcare policies [7]. - The overall sentiment and valuation in the pharmaceutical sector may improve due to domestic policy optimizations and a recovery in medical equipment procurement [7].

Core Viewpoint - The Hong Kong pharmaceutical sector is experiencing a strong performance, with notable gains in stocks such as WuXi Biologics, Innovent Biologics, China National Pharmaceutical Group, and others, reflecting a positive trend in the innovative drug market [1][4]. Group 1: Market Performance - The innovative drug ETF (517110) saw an intraday increase of over 2% [1]. - Major pharmaceutical stocks, including WuXi Biologics and Innovent Biologics, rose by more than 2% [1]. Group 2: Catalysts and Developments - A significant catalyst for the sector is the licensing agreement between 3SBio and Pfizer regarding the PD-1/VEGF bispecific antibody SSGJ-707, marking a milestone with an upfront payment exceeding $1 billion, showcasing the competitiveness of Chinese innovative drugs internationally [4]. - The upcoming ASCO conference is expected to highlight numerous original research outcomes from Chinese pharmaceutical companies, indicating their rapid advancement in innovative R&D [4]. Group 3: Industry Fundamentals - The overall net profit of the pharmaceutical sector decreased by 11.4% year-on-year, but the innovative drug segment showed a positive growth of 4.3% [5]. - The success rate for innovative drugs in the upcoming 2024 medical insurance negotiations is projected to exceed 90%, with domestic products accounting for over 70% [5]. - The pharmaceutical industry is expected to benefit from optimized procurement policies, domestic demand recovery, and continuous technological advancements, leading to a potential valuation recovery [5].

Core Viewpoint - The article discusses the promising results of Mazdutide, a dual agonist of GLP-1 and GCG receptors, in weight management and its potential impact on obesity treatment guidelines globally [2][3]. Group 1: Drug Mechanism and Development - Mazdutide activates GLP-1 receptors to suppress appetite and delay gastric emptying, while also activating GCG receptors to promote liver fat breakdown and enhance energy expenditure, addressing both weight loss and fatty liver issues [2]. - The clinical trial results of Mazdutide were published in the prestigious New England Journal of Medicine, marking a significant milestone for Chinese drug development in the field of metabolic and endocrine diseases [3][6]. Group 2: Clinical Trial Results - In a Phase 3, double-blind, placebo-controlled trial involving 610 participants, the average weight loss at 32 weeks for the 6 mg group was 12.55% (approximately 11 kg), and at 48 weeks, it was 14.01% (approximately 12 kg) [6][9]. - The trial showed that 49.5% of participants in the 6 mg group lost over 15% of their body weight, indicating significant efficacy in weight management [9]. Group 3: Safety and Side Effects - The most commonly reported adverse events were gastrointestinal-related, primarily mild to moderate, with a low incidence of treatment discontinuation due to side effects: 0.5% in the 6 mg group compared to higher rates in similar drugs [8][9]. - The study confirmed the high safety profile of Mazdutide, with side effects concentrated in the initial treatment phase [8].

Core Viewpoint - The recent developments in the innovative drug sector, particularly the record-breaking licensing deal and the upcoming ASCO conference, highlight the growing competitiveness and potential of Chinese pharmaceutical companies in the global market [4][5]. Group 1: Market Performance - The Hong Kong Innovative Drug ETF (159570) opened high but closed lower, experiencing a 1% pullback after four days of gains last week, with trading volume reaching 300 million, indicating strong liquidity [1]. - Major component stocks of the ETF mostly declined, with notable drops including a more than 4% decrease for 3SBio and over 3% for both WuXi AppTec and Rongchang Biopharmaceutical [2]. Group 2: Licensing Deal - A historic licensing agreement was reached where Pfizer will pay a $1.25 billion upfront fee to Chinese companies for the PD-1/VEGF dual antibody SSGJ-707, with potential total payments reaching $4.8 billion [4]. - This deal sets a new record for Chinese innovative drugs entering the international market and is expected to enhance market valuation expectations for the innovative drug sector [4]. Group 3: ASCO Conference Insights - The upcoming ASCO conference is anticipated to showcase the global competitiveness of Chinese pharmaceutical companies, with numerous clinical studies being presented [5]. - Key highlights include the performance of domestic drugs that have shown potential to outperform established treatments, such as the combination of Bemarituzumab and Anlotinib against Keytruda in NSCLC [5]. - CAR-T therapies are also making significant strides, with Kintor Pharmaceuticals presenting promising data for their CLDN18.2 CAR-T therapy [5]. Group 4: Innovative Drug ETF Characteristics - The Hong Kong Innovative Drug ETF (159570) has a high concentration in innovative drugs, with over 85% of its weight in this category, making it the highest among all pharmaceutical indices [6]. - The ETF features a low valuation, with a five-year price-to-sales ratio at the 48.5th percentile, indicating potential undervaluation in the innovative drug sector [6].

Core Viewpoint - The company has presented preliminary data for IBI363 at the ASCO conference, demonstrating breakthrough efficacy in both hot tumors (NSCLC) and cold tumors (MSS CRC/mucosal melanoma) [1][2]. Group 1: Efficacy Data - In NSCLC, patients treated with IBI363 at a dose of 3 mg/kg showed a median progression-free survival (mPFS) of 7.3 months, indicating excellent performance [1][2]. - For MSS CRC, the median overall survival (mOS) reached 16.1 months in a mixed-dose single-agent treatment, approaching the benefits seen in first-line patients [1][3]. - In squamous NSCLC, the clinical objective response rate (cORR) was 36.7% with a disease control rate (DCR) of 90.0% [2]. - In cold tumors, IBI363 demonstrated an mOS of 16.1 months in MSS CRC, significantly exceeding the current treatment standard of 9-10 months [3][4]. Group 2: Safety Profile - The incidence of treatment-emergent adverse events (TEAEs) was reported at 99.3%, with 42.6% being grade 3 or higher [2]. - Only 6.6% of patients discontinued treatment due to TEAEs, and the mortality rate attributed to TEAEs was very low at 2.9% [2]. Group 3: Future Developments - The company plans to communicate with regulatory authorities regarding key registration clinical trials for squamous NSCLC, with expectations to initiate Phase III trials within the year [3][6]. - IBI363 is anticipated to reshape the immune environment for IO-resistant lung cancer patients, potentially replacing docetaxel as the new standard of care [2][4]. Group 4: Pipeline and Financial Outlook - The company is advancing its core pipeline, with expectations for multiple catalysts in 2025, including new indications for existing products [5][6]. - Revenue projections for the company are estimated at 11.856 billion, 15.613 billion, and 21.479 billion yuan for 2025-2027, with a target market valuation of 131.9 billion HKD [6].