Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO conference, demonstrating its potential efficacy in treating advanced non-small cell lung cancer (NSCLC) and other tumor types [1][2][11]. Group 1: Clinical Data and Efficacy - IBI363 has shown a manageable safety profile and encouraging efficacy in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma, with trends indicating long-term survival benefits [1][4][11]. - In a Phase 1 study, IBI363 monotherapy was administered to 136 NSCLC patients, with a focus on those with squamous cell carcinoma and EGFR wild-type adenocarcinoma [3][6]. - The confirmed overall response rate (ORR) for squamous NSCLC patients receiving IBI363 at different dosages was reported as 25.9% and 36.7%, with disease control rates (DCR) of 66.7% and 90.0% respectively [5][6]. Group 2: Long-term Survival Benefits - IBI363 demonstrated potential long-term survival benefits, with median overall survival (OS) of 15.3 months for the 1/1.5 mg/kg dose group and not reached for the 3 mg/kg group, alongside a 12-month OS rate of 70.9% [5][6][10]. - Among patients with PD-L1 TPS<1%, the ORR was 30.0% for the lower dose and 46.2% for the higher dose, indicating IBI363's effectiveness in low PD-L1 expression populations [7]. Group 3: Future Development Plans - Innovent plans to initiate a Phase 3 registration clinical study for IBI363 in locally advanced or metastatic squamous NSCLC patients who have failed prior treatments [11]. - The company has received Breakthrough Therapy Designation (BTD) from China CDE and Fast Track Designation (FTD) from the US FDA for IBI363 in treating squamous NSCLC [11][17]. Group 4: Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, with 15 products launched and multiple assets in clinical trials [18]. - The company collaborates with over 30 global healthcare companies to advance its innovative therapies [18].

Core Insights - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO Annual Meeting, demonstrating its potential to convert "cold tumors" into "hot tumors" in advanced colorectal cancer [1][2][10] Clinical Data Summary - IBI363 monotherapy showed a median overall survival (OS) of 16.1 months in patients with advanced colorectal cancer, significantly better than standard treatments which range from 6.4 to 9.3 months [6][10] - In Phase 1 studies, IBI363 combined with bevacizumab resulted in a confirmed objective response rate (cORR) of 15.1% and a disease control rate (DCR) of 61.6% among 73 participants [9] - The combination therapy showed a median progression-free survival (PFS) of 4.7 months, with a notable increase in efficacy for patients without liver metastases, achieving a cORR of 31.3% and a DCR of 81.3% [9] Mechanism of Action - IBI363 operates by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway, specifically targeting tumor-specific T cells, which enhances its therapeutic efficacy in treating colorectal cancer [11][12] - Tumor immune cell infiltration analysis indicated that higher levels of CD8+ T cells were associated with improved clinical responses to IBI363, supporting its mechanism of action [8] Future Development - Innovent is conducting further clinical studies in multiple countries to explore IBI363's efficacy across various tumor indications, including immune-resistant and cold tumors [12] - The company has initiated a pivotal trial for IBI363 targeting unresectable locally advanced or metastatic mucosal or acral melanoma [12][13] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 15 products to date [14][15] - The company has received fast track and breakthrough designations from regulatory authorities for IBI363, indicating its potential in treating specific cancer types [13]

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, demonstrating breakthrough efficacy in treating "immune cold tumors" such as acral and mucosal melanoma, which are traditionally resistant to treatment [1][2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [16]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline [16]. Clinical Study Insights - IBI363 is currently undergoing clinical studies in China, the United States, and Australia, targeting multiple tumor indications, particularly immune-resistant and cold tumors [2][14]. - The Phase 1/2 studies have shown a confirmed objective response rate (cORR) of 23.3% and a disease control rate (DCR) of 76.7% in patients with advanced melanoma [6][7]. - The median progression-free survival (PFS) for patients treated with IBI363 was reported at 5.7 months, significantly longer than previous studies [7][10]. Efficacy and Safety Profile - IBI363 has demonstrated durable responses with a median duration of response (DoR) of 14.0 months in patients with confirmed responses [7]. - The overall 12-month overall survival (OS) rate was 61.5%, with a median OS of 14.8 months [6][7]. - The treatment was generally well tolerated, with the most common treatment-related adverse events being arthralgia, rash, and hyperthyroidism, primarily Grade 1 or 2 [7]. Future Development Plans - A pivotal Phase 2 registrational study comparing IBI363 with pembrolizumab in patients with unresectable melanoma has been initiated, aiming to enroll 180 patients [8][9]. - The company is also exploring combination therapies with IBI363 across various cancer types, indicating a commitment to expanding its therapeutic applications [9][14]. Market Need and Potential - There is a significant unmet clinical need for effective treatments for advanced acral and mucosal melanoma in China, where current therapies have limited efficacy [10][12]. - IBI363 aims to address this gap by transforming "cold tumors" into "hot tumors" through dual activation of the PD-1 and IL-2 pathways, potentially establishing a new standard in immunotherapy for melanoma [10][13].

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].

IBI363 Data Update in ASCO; Clearer Path to Success CITI'S TAKE Innovent updated the data of IBI363 in IO-treated NSCLC, CRC and IO- treated advanced acral and mucosal melanoma at ASCO. IBI363 showed strong efficacy in IO-treated sqNSCLC with an ORR of 43.3% (13/30) (cORR 36.7%) and mPFS of 7.3 mo. We think this data could give investors more confidence in IBI363 beating docetaxel (mPFS ~4 mo and mOS 10- 12 mo) in this setting. IBI363 also showed positive data in 3L/+ MSS/pMMR CRC, with an ORR of 23.5% (16/ ...

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].

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].

Company Updates - On May 23, 2025 ASCO conference, several significant data were released by Innovent Biologics, including multiple oral presentations, notably the PoC data for IBI363 (PD-1/IL-2) in melanoma, colorectal cancer, and non-small cell lung cancer [1] - IBI363's colorectal cancer data exceeded expectations, with an overall objective response rate (ORR) of 12.7% for monotherapy and 23.5% for combination therapy, and a median overall survival (mOS) of 16.1 months for monotherapy [1] - In the context of IO-treated lung cancer, IBI363 demonstrated strong competitive advantages, with an ORR of 43.3% in the squamous NSCLC group at a 3 mg/kg dose [1] Key Data from ASCO - IBI363 showed an ORR of 26% and a median progression-free survival (mPFS) of 5.7 months in IO-treated mucosal/limb melanoma [2] - IBI343 (CLDN18.2 ADC) reported an ORR of 22.7%, mPFS of 5.4 months, and mOS of 8.5 months in CLDN18.2+ pancreatic ductal adenocarcinoma (PDAC), with 2L patients showing an mOS of 12.1 months [2] Profit Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at 472 million and 1.298 billion respectively, and has raised the target price by 4.5% to HKD 69, indicating a potential upside of 22.7% from the current stock price [2]

Core Insights - The National Medical Products Administration (NMPA) has proposed to include Innovent Biologics' IBI363, a PD-1/IL-2 bispecific antibody fusion protein, in its breakthrough therapy designation for treating locally advanced or metastatic squamous non-small cell lung cancer that has failed platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy [1][2] Group 1: Product Development - IBI363 is a globally innovative PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics, designed to block the PD-1/PD-L1 pathway while activating the IL-2 pathway [1] - The IL-2 arm of IBI363 has been engineered to retain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby lowering toxicity [1] - IBI363 has demonstrated good anti-tumor activity in various tumor-bearing pharmacology models and has shown significant tumor suppression efficacy in PD-1 resistant and metastatic models [1] Group 2: Clinical Research and Regulatory Status - IBI363 has previously been included in the breakthrough therapy drug (BTD) list by CDE, targeting unresectable locally advanced or metastatic acral and mucosal melanoma that has not undergone systemic treatment [2] - Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 against various malignancies [2] - IBI363 has received two Fast Track designations from the U.S. FDA for the treatment of advanced squamous non-small cell lung cancer and melanoma [2]

Core Viewpoint - The CSI Hong Kong Stock Connect Biotechnology Theme Index has shown significant growth, with a 5.26% increase over the past month, 20.82% over the past three months, and 25.29% year-to-date, reflecting strong performance in the biotechnology sector [1]. Group 1: Index Performance - The CSI Hong Kong Stock Connect Biotechnology Theme Index is currently at 1183.16 points, having been established with a base date of December 28, 2018, at 1000.0 points [1]. - The index comprises 50 listed companies involved in biopharmaceuticals, pharmaceuticals, and biotechnology services, selected from the Hong Kong Stock Connect range [1]. Group 2: Index Holdings - The top ten weighted companies in the index include: BeiGene (14.31%), WuXi Biologics (12.72%), Innovent Biologics (10.78%), CanSino Biologics (7.78%), CSPC Pharmaceutical Group (6.03%), China Biologic Products (5.8%), Hansoh Pharmaceutical (3.57%), Kelun-Biotech (3.31%), Zai Lab (3.29%), and WuXi AppTec (3.23%) [1]. - The index is fully composed of stocks listed on the Hong Kong Stock Exchange, with a 100% allocation [1]. Group 3: Industry Composition - The industry composition of the index holdings is as follows: biopharmaceuticals account for 50.37%, chemical drugs for 25.76%, pharmaceutical and biotechnology services for 20.60%, and medical devices for 3.27% [2]. - The index samples are adjusted biannually, with changes implemented on the next trading day following the second Friday of June and December, with a sample adjustment limit of 20% [2].