Core Viewpoint - Innovent Biologics announced promising results from a Phase 2 clinical study of picankibart, an IL-23p19 antibody, showing robust efficacy and a favorable safety profile in patients with plaque psoriasis who had inadequate responses to previous biologic treatments [1][2][5]. Clinical Study Results - The study involved 152 patients who switched from other biologics to picankibart, with 64.6% of patients achieving skin clearance or near clearance after 16 weeks of treatment [2][3]. - The primary endpoint was met with nearly half (48.2%) of patients with prior inadequate responses achieving an sPGA score of 0 or 1 and BSA of <3% [5]. - Secondary endpoints showed that 64.6% of patients with baseline sPGA of ≥2 and BSA of ≥3% achieved sPGA of 0 or 1 [5]. Patient Demographics - Among the 152 enrolled patients, 54.6% were classified as inadequate responders, with a median disease duration of 12 years [4]. - A significant majority (96.4%) of these patients had previously been treated with IL-17 inhibitors [4]. Safety Profile - The safety profile of picankibart was favorable, comparable to other studies, with no new safety signals identified [6]. - Long-term follow-up is ongoing to assess the full data on efficacy and safety [6]. Future Developments - Innovent plans to advance the Phase 3 clinical trial of picankibart, which is currently under review for a New Drug Application (NDA) by the NMPA [7][9]. - The company aims to address unmet clinical needs in psoriasis treatment and provide more options for patients with inadequate responses to existing biologics [7][9]. About Psoriasis - Psoriasis is a chronic inflammatory disease affecting a significant portion of the population, with over 7 million patients in China alone [8]. - Biologics have become the primary systemic treatment for moderate to severe psoriasis, with IL-23 inhibitors showing rapid onset and robust efficacy [8]. About Picankibart - Picankibart (IBI112) is a monoclonal antibody developed by Innovent, targeting the IL-23p19 subunit, with potential applications in treating psoriasis and other autoimmune diseases [9]. - Multiple clinical studies are ongoing, including a Phase 3 study for moderate to severe plaque psoriasis, which has already met its endpoints [9]. About Innovent - Innovent is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, having launched 11 products and with several new drug applications under regulatory review [10][11].

Investment Rating - The report assigns a "Buy" rating for the company, Xinda Biopharma (01801.HK), marking its first coverage [2][6]. Core Insights - Xinda Biopharma has established itself as a comprehensive biopharma entity with significant commercialization achievements. The company is expected to reach a profitability inflection point as new products continue to receive approvals [3][4]. - The company has a robust pipeline in oncology, particularly focusing on IO+ADC strategies, with promising data emerging from its self-developed products [3][4]. - In non-oncology areas, the company is advancing treatments for obesity and Type 2 Diabetes Mellitus (T2DM), with major products expected to be approved within 1-2 years, providing new growth momentum [3][4]. - Overall, the company is viewed as undervalued in the market, with strong growth potential as a leading innovative drug company [3][4]. Summary by Sections Company Overview - Founded in August 2011, Xinda Biopharma has become a significant player in the biopharma sector, with 11 commercialized products and several others in various stages of clinical development [18][19]. - The company has established strategic partnerships with major international firms, enhancing its research and development capabilities [18][19]. Oncology Pipeline - The company has a deep focus on the oncology pipeline, with its PD-1 monoclonal antibody, Sintilimab, achieving nearly 2.8 billion yuan in sales in 2023, leading the domestic market [3][4]. - The PD-1/IL-2 dual antibody, IBI363, shows significant efficacy in PD-1 resistant cancer patients, positioning it as a potential leader in second-generation IO therapies [3][4]. - Multiple ADCs are in clinical stages, including IBI343 targeting CLDN18.2, which is in Phase III trials [3][4]. Cardiovascular and Metabolic Pipeline - The GLP-1 dual-target product, Masitide, is progressing well, with NDAs submitted for obesity and T2DM treatments, indicating a substantial market opportunity [3][4]. - The company has also received approval for its PCSK9 monoclonal antibody, marking a significant milestone in treating high cholesterol [3][4]. Autoimmune and Ophthalmology Pipeline - The company is expanding its autoimmune and ophthalmology product lines, with several innovative drugs entering clinical trials [3][4]. - Notable products include IBI302 for age-related macular degeneration and IBI112 for plaque psoriasis, both showing promising clinical data [3][4]. Financial Projections and Valuation - Revenue projections for 2024-2026 are estimated at 80.19 billion, 108.53 billion, and 139.04 billion yuan, with growth rates of 29.22%, 35.34%, and 28.11% respectively [4][6]. - The company is expected to achieve profitability by 2025, with a reasonable equity value estimated at 966.1 billion yuan, corresponding to a target stock price of 64.91 HKD [4][6].

Investment Rating - Buy (First Coverage) [2] Core Views - The company is a leading Biopharma in China, transitioning successfully from Biotech to Biopharma with 11 approved products and a robust pipeline in oncology, immunology, metabolism, and ophthalmology [2] - The oncology segment is a key driver, with a strategy combining IO (Immuno-Oncology) and ADC (Antibody-Drug Conjugate) to solidify its leadership position [2] - Non-oncology pipelines, particularly in cardiovascular, metabolic, and autoimmune diseases, are expected to open new growth curves [3] - The company's revenue is projected to grow significantly, with 2024-2026 revenue estimates of 8.094 billion, 11.327 billion, and 14.551 billion RMB, respectively, representing a CAGR of 30.43%, 39.94%, and 28.46% [3][6] Oncology Segment - The company's PD-1 inhibitor, Sintilimab, is the only PD-1 drug in China that covers first-line treatment for five major cancer types and is included in the national medical insurance [2] - The company is advancing its IO+ADC strategy with promising candidates like IBI363 (PD-1/IL-2), IBI343 (CLDN18.2 ADC), and IBI389 (CLDN18.2/CD3 bispecific antibody), which show potential in overcoming immune resistance and treating cold tumors [2] - IBI363, a PD-1/IL-2 bispecific fusion protein, has shown promising efficacy and safety in clinical trials, particularly in treating immune-resistant non-small cell lung cancer (NSCLC) and melanoma [23][29][34] Non-Oncology Segment - The company's GLP-1R/GCGR dual-target drug, Mazdutide, is a key growth driver, with NDA submissions for obesity and type 2 diabetes in 2024 [3] - In the autoimmune space, the IL-23p19 inhibitor, IBI112, has shown potential as a best-in-class drug for psoriasis, with its NDA submitted in September 2024 [3] - In ophthalmology, IBI311 (IGF-1R) for thyroid eye disease (TED) has submitted its NDA in May 2024, giving the company a first-mover advantage [3] Financial Projections and Valuation - The company's revenue is expected to grow from 8.094 billion RMB in 2024 to 14.551 billion RMB in 2026, with a DCF-based valuation of 93.9 billion RMB, equivalent to 101.5 billion HKD [3][6] - The company is projected to achieve profitability by 2025, driven by its diversified product portfolio and operational efficiency improvements [6][8] Key Catalysts - The commercialization of Mazdutide in 2025 is expected to be a significant growth driver, leveraging the large market potential for GLP-1 drugs in China [3][8] - The advancement of IBI363 in clinical trials and its potential for global expansion could further enhance the company's oncology portfolio [2][29] - The company's focus on operational efficiency and commercialization capabilities is expected to drive sustained growth [6][8]

Clinical Study Results - The primary endpoint of the 12-week induction period was met in a Phase 2 clinical study of picankibart (IBI112) for treating moderately to severely active ulcerative colitis (UC) in Chinese subjects [1] - The study enrolled 150 subjects randomized to receive placebo, picankibart 200 mg, or picankibart 600 mg during the induction period [2] - Clinical remission rates at week 12 were 20.0% for the 200 mg group and 14.0% for the 600 mg group, significantly higher than the 2.0% in the placebo group (p < 0.05) [3] - Clinical response rates were 54.0% for the 200 mg group and 68.0% for the 600 mg group, significantly higher than the 22.0% in the placebo group (p < 0.001) [3] - The maintenance period is ongoing, with continued increases in clinical remission, response, and other efficacy measures compared to the induction period [4] Picankibart (IBI112) Development - Picankibart is a recombinant anti-IL-23p19 antibody injection developed by Innovent [1] - It has shown potential for treating psoriasis, ulcerative colitis, and other autoimmune diseases [7] - Multiple clinical studies are underway, including Phase 3 studies for plaque psoriasis and Phase 2 studies for UC [7] - The NMPA accepted the first NDA for picankibart for treating moderate to severe plaque psoriasis in September 2024 [8] Ulcerative Colitis Market - UC is a chronic inflammatory disease with increasing prevalence in China, currently at 11.6/100,000 [6] - Current treatments include traditional immunosuppressants and biologics, but there are unmet needs due to adverse reactions and loss of response [6] - No IL-23p19 targeted drugs are approved for UC treatment in China, representing a significant market opportunity [6] Innovent Biologics Overview - Innovent is a leading biopharmaceutical company founded in 2011, focusing on oncology, autoimmune, cardiovascular, metabolic, and ophthalmology diseases [9] - The company has launched 11 products, with 5 NDAs under regulatory review and 3 assets in Phase III or pivotal trials [9] - Innovent has partnerships with over 30 global healthcare companies, including Eli Lilly, Sanofi, and Incyte [9]

Investment Rating - The report assigns a "Buy" rating for the company with a 6-month outlook [1] Core Viewpoints - The company's 2024 interim report met expectations with strong product sales growth and multi-sector breakthroughs [1] - Total revenue for 2024H1 reached 3.95 billion yuan, a 46.3% year-on-year increase [1] - Product revenue grew to 3.81 billion yuan, up 55.1% year-on-year [1] - The company demonstrated significant sales efficiency improvements with multiple quarters of high growth [1] Financial Performance - Gross margin improved to 84.1%, up 1.8 percentage points [1] - Sales and marketing expense ratio decreased to 48.6%, down 5.9 percentage points [1] - Management expense ratio reduced to 5.2%, down 4.9 percentage points [1] Pipeline Development - The company made significant progress in weight loss, oncology (ADC, next-gen IO), autoimmune, and ophthalmology fields [1] - Masdutide is expected to become the first domestic GLP-1 dual-target weight loss drug, with NDA submissions in 2024 [1] - IBI343 (CLDN18.2 ADC) and IBI363 (PD-1/IL-2α-bias) showed promising early data in oncology [1] - Picankibart (IL-23p19) is expected to submit NDA in H2 2024 for psoriasis treatment [1] - IBI311 (IGF-1R) is under NDA review, while IBI302 (VEGF/C) 8mg is in Phase III trials [1] Revenue Projections - 2024 revenue forecast increased from 7.225 billion yuan to 7.970 billion yuan [1] - 2025 revenue forecast raised from 9.193 billion yuan to 10.235 billion yuan [1] - 2026 revenue is projected to reach 13.143 billion yuan [1] Profit Projections - 2024 net loss forecast adjusted from -766 million yuan to -756 million yuan [1] - 2025 net profit forecast changed from -170 million yuan to 89 million yuan [1] - 2026 net profit is projected to be 1.003 billion yuan [1]

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /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, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a thi ...

Innovent 2024 INTERIM REPORT 中期報告 信達生物製藥 Innovent Biologics, Inc. (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立之有限公司) Stock Code 股份代號:1801 | --- | --- | |------------------------------|-------| | 目錄 | | | 公司簡介 | 2 | | 公司資料 | 3 | | 財務摘要 | 5 | | 業務摘要 | 8 | | 管理層討論與分析 | 12 | | 其他資料 | 34 | | 簡明綜合財務報表審閱報告 | 57 | | 簡明綜合損益及其他全面收入表 | 58 | | 簡明綜合財務狀況表 | 59 | | 簡明綜合權益變動表 | 61 | | 簡明綜合現金流量表 | 62 | | 簡明綜合財務報表附註 | 64 | | 釋義 | 87 | 公司簡介 2 信達生物製藥 公司簡介概覽 信達生物製藥集團成立於2011年，以開發出老百姓用得起的 高質量生物藥為使命和目標，公司 ...

SAN FRANCISCO and SUZHOU, China, Sept. 26, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center f ...

SAN FRANCISCO and SUZHOU, China, Sept. 17, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that clinical data of IBI363 (first-in-class PD1/IL-2α-bias bispecific antibody fusion protein) combined with bevacizumab in advanced colorectal cancer is present ...

SAN FRANCISCO and SUZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical trial results for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with ...