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- ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 48.00, indicating a potential upside of 26.2% from the current price of HKD 38.05 [1][4]. Core Insights - The report emphasizes the promising early data from the company's next-generation cancer therapies, particularly the PD-1/IL-2 dual antibody IBI363, which shows significant efficacy in treating solid tumors. The overall response rates (ORR) for all solid tumor patients reached 17.3%, with a notable 46.7% ORR in the 3mg/kg Q3W dosage group [3][4]. - The report highlights the company's differentiated positioning in the oncology sector, with strong early clinical data suggesting substantial market potential if future trials maintain similar efficacy levels [4]. Financial Overview - Revenue projections show a strong growth trajectory, with expected revenues increasing from RMB 4,556 million in 2022 to RMB 12,951 million by 2026, reflecting a compound annual growth rate (CAGR) of approximately 28.4% [2][9]. - The net profit is projected to improve significantly from a loss of RMB 2,179 million in 2022 to a profit of RMB 2,030 million by 2026, indicating a turnaround in profitability [2][9]. - The earnings per share (EPS) is expected to transition from a loss of RMB 1.46 in 2022 to a profit of RMB 1.25 by 2026, showcasing a substantial recovery [2][9]. Clinical Development Highlights - The report notes that IBI363 has demonstrated superior efficacy compared to existing immuno-oncology (IO) therapies in cold tumors and previously treated patients, with specific mention of its performance in melanoma and MSS colorectal cancer [3][4]. - The company is set to release further data on its key oncology pipeline, including updates on IBI363 and CLDN18.2 candidates, which are anticipated to be significant catalysts for future growth [4][5].

那么今天我们非常荣幸的邀请到了公司的CFO游飞女士总流临床开发高级副总裁周辉博士总流生物学与ABC药物研究副总裁何开杰博士以及IR团队的各位领导那么今天跟我一起主持的还有我们制药和生物科技团队的首席原青会以及分析师赵旭 那接下来我就把时间交给清慧由清慧来主持接下来的环节好的谢谢何老师谢谢信达的各位领导以及参会的投资人我是中心箭头的分析师袁清慧那么大家也看到就是上周五的凌晨我们在欧洲总联内科学会上面看到的信达生物IBI363的一个口头报告 然后以及之前在ASCO看到的系列的研究数据今天是基于这个数据来解读我们研究了363的数据之后初步觉得是非常惊艳的一个结果一个是这个分子是一个首创新药是星达生物基于对IL2的生物学的全新理解和产序来设计的一个首创新药 那么相关文章也发表在顶级刊物Nature Cancer上面我个人也是拜读了很多次然后第二个也非常欣喜的就是看到这个基于生物学驱动的一个首创新药已经初步体现出展现出非常好的疗效了我们也总结了在最新的点评里面总结了几个亮点第一个是入主患者非常难治像肺癌黑色素瘤大部分都是免疫精致的 然后肠癌本身对免疫力也不敏感第二我们看到即便是在丹尿的情况下就已经展现出了优异的一个初步 ...

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]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The acceptance of the new drug application for IBI311 (Teplizumab) by the National Medical Products Administration (NMPA) indicates promising commercialization prospects for the treatment of Thyroid Eye Disease (TED) [2][3] - The Phase III clinical trial results for IBI311 were positive, showing significant improvements in eye protrusion, disease activity, and quality of life compared to the placebo group [3] - IBI311 is the first IGF-1R antibody drug to submit an NDA in China, addressing a significant unmet clinical need in TED treatment [4] Financial Forecasts and Valuation - Revenue projections for 2024 and 2025 are estimated at 76.44 billion and 94.73 billion CNY, respectively, with a new forecast for 2026 at 114.55 billion CNY, reflecting year-on-year growth rates of 23.17%, 23.93%, and 20.92% [4][5] - The net profit forecast for 2024 and 2025 has been adjusted to -6.33 billion and 3.06 billion CNY, respectively, with a new forecast for 2026 net profit at 13.30 billion CNY [4][5] - The report highlights strong sales performance of core products and a robust pipeline of late-stage products, supporting the optimistic outlook for the company's commercial product portfolio [4]

Financial Performance - Total revenue for 2023 reached RMB 6,206.1 million, a year-on-year increase of 36.2%, with product revenue at RMB 5,728.3 million, up 38.4%[7] - LBITDA decreased significantly by 73.0% year-on-year to RMB 600.1 million, driven by strong product sales growth and improved cost efficiency[7] - The company's cash and short-term financial assets amounted to approximately RMB 10,969.6 million (over USD 1.5 billion), ensuring a strong financial position[7] - Gross margin increased by 2.0 percentage points, while the ratio of sales and marketing expenses to total revenue decreased by 7.3 percentage points[7] - Total revenue for the year ended December 31, 2023, was RMB 6,206.1 million, a 36.2% increase compared to RMB 4,556.4 million in 2022[15] - Product revenue reached RMB 5,728.3 million in 2023, up 38.4% from RMB 4,139.1 million in 2022[15] - Gross profit margin for 2023 was 81.7%, an increase of 2.1 percentage points from 79.6% in 2022[15] - R&D expenses for 2023 were RMB 2,227.6 million, down from RMB 2,871.2 million in 2022[15] - Sales and marketing expenses for 2023 were RMB 3,100.7 million, accounting for 50.0% of total revenue, compared to 56.9% in 2022[15] - Adjusted LBITDA for 2023 was RMB 600.1 million, a 73.0% decrease from RMB 2,221.5 million in 2022[17] - Adjusted net loss for 2023 was RMB 514.5 million, a 79.1% reduction from RMB 2,461.8 million in 2022[17] - Revenue from customer contracts increased to RMB 6,206.1 million in 2023, up from RMB 4,556.4 million in 2022, driven by growth in pharmaceutical product sales, licensing fees, and R&D service income[95] - Pharmaceutical product sales reached RMB 5,728.3 million in 2023, a significant increase from RMB 4,139.1 million in 2022[95] - Licensing fee income rose to RMB 447.4 million in 2023, compared to RMB 417.1 million in 2022, with a notable one-time licensing fee of RMB 5.1 million recorded in 2023[95] - R&D service income surged to RMB 30.3 million in 2023, up from RMB 0.2 million in 2022[95] - Gross profit improved to RMB 5,069.8 million in 2023, up from RMB 3,625.4 million in 2022, reflecting higher revenue and controlled sales costs[94] - R&D expenses decreased to RMB 2,227.6 million in 2023, down from RMB 2,871.2 million in 2022, as the company optimized its R&D investments[99] - Sales and marketing expenses increased to RMB 3,100.7 million in 2023, up from RMB 2,590.8 million in 2022, as the company expanded its market presence[101] - Other income, primarily from interest and government subsidies, rose to RMB 552.4 million in 2023, up from RMB 279.7 million in 2022[97] - The company recorded a tax credit of RMB 116.5 million in 2023, compared to a tax expense of RMB 8.8 million in 2022, due to a refund of withholding tax on licensing fees[103] - Total comprehensive loss for the year improved to RMB 1,013.8 million in 2023, down from RMB 2,200.6 million in 2022, reflecting better operational performance[94] - Adjusted gross profit for 2023 was RMB 5,141,648 thousand, compared to RMB 3,682,300 thousand in 2022[104] - Adjusted R&D expenses for 2023 were RMB 1,974,933 thousand, a decrease from RMB 2,664,708 thousand in 2022[105] - Adjusted administrative and other expenses for 2023 were RMB 543,759 thousand, down from RMB 641,812 thousand in 2022[105] - Adjusted sales and marketing expenses for 2023 were RMB 3,057,482 thousand, up from RMB 2,578,373 thousand in 2022[105] - Adjusted LBITDA for 2023 was RMB 600,148 thousand, an improvement from RMB 2,221,450 thousand in 2022[107] - Adjusted net loss for 2023 was RMB 514,540 thousand, compared to RMB 2,461,834 thousand in 2022[107] - Total assets increased to RMB 20,627,360 thousand in 2023 from RMB 17,588,845 thousand in 2022[109] - Cash and cash equivalents increased to RMB 10,969.6 million in 2023 from RMB 9,166.0 million in 2022[110] - The company has unused long-term bank loan facilities of approximately RMB 2,620.0 million as of December 31, 2023[110] - The company has pledged assets totaling RMB 1,804.9 million for property, plant, and equipment, RMB 275.6 million for land use rights, and RMB 849.8 million for bank deposits as collateral for loans and bank financing[115] - The company's total revenue from the top five customers accounted for 60.8% of the total revenue in 2023, with the largest customer contributing approximately 53.1%[127] - The company's total procurement from the top five suppliers accounted for 53.2% of the total procurement in 2023, with the largest supplier contributing approximately 26.2%[128] - The company's charitable donations for the year ending December 31, 2023, amounted to approximately RMB 154.7 million, compared to RMB 247.2 million in 2022[133] - The company did not issue any bonds during the year ending December 31, 2023[134] - The Board of Directors did not recommend the distribution of a final dividend for the year ending December 31, 2023[135] - The distributable reserve from the share premium account as of December 31, 2023, was RMB 27,324,496,000, compared to RMB 24,705,638,000 in 2022[136] Product Pipeline and R&D - The product pipeline includes 36 high-value candidates, with 10 products already approved for marketing and 3 under NMPA review[3] - Two new innovative products, Fucasso (Igeolonsa Injection) and Xinbile (Tolexizumab Injection), were approved for marketing in China[8] - Tyvyt (Sintilimab Injection) and Byvasda (Bevacizumab Injection) were approved for new indications and included in the NRDL (2023 edition)[8] - The company's product portfolio expanded to 10 commercialized products, with continued addition of new indications and NRDL coverage[8] - R&D efforts focus on oncology, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology, with 18 new drug candidates in clinical trials[3] - Orelabrutinib tablets received approval for a second indication, benefiting more CML patients[9] - The company has 3 products under NMPA review, 5 products in Phase 3 or key clinical studies, and 18 molecules in early clinical research[9] - Fuzerex (KRAS G12C) and Taletrectinib (ROS1) are under NDA priority review, expected to be approved in 2024[9] - Sintilimab (Tyvyt®) achieved a new NSCLC indication and submitted an sNDA for EMC treatment in April 2024[9] - IBI362 (Mazdutide) reached primary and key secondary endpoints in the GLORY-1 study, with NDA submission for weight loss in February 2024[11] - IBI311 (anti-IGF-1R) achieved primary endpoints in the RESTORE-1 Phase 3 trial, with NDA submission planned for TED treatment[11] - The company plans to initiate a Phase 1 trial for Mazdutide in obese adolescents in China in 2024[11] - IBI112 (IL-23p19) demonstrated best-in-class long-term efficacy in a 58-week Phase 2 trial, with Phase 3 registration expected to support NDA submission in 2024[12] - The company’s Suzhou facility has 60,000L antibody production capacity, and the Hangzhou facility has 170,000L capacity (80,000L completed, 90,000L planned)[13] - The company's commercial product portfolio expanded to 10 products, with two new innovative products approved in China[18] - Four NDAs and sNDAs are under review by the NMPA, including IBI344, IBI351, and IBI362[18][19] - IBI362 (Mazdutide), a GLP-1R/GCGR dual agonist, is undergoing five Phase 3 clinical trials in China for overweight or obese adults (GLORY-1 and GLORY-2) and T2D patients (DREAMS-1, DREAMS-2, and DREAMS-3). The company expects to read out Phase 3 results for DREAMS-1 and DREAMS-2 in 2024 to support a second NDA submission for T2D treatment[20] - IBI112 (Piconcibart), a recombinant anti-IL-23p19 antibody, completed the first patient dosing in its Phase 3 trial (CLEAR) for moderate-to-severe plaque psoriasis in February 2023. The company expects to read out Phase 3 results in 2024 to support NDA submission[20] - IBI311, a recombinant anti-IGF-1R monoclonal antibody, achieved the primary endpoint in its Phase 3 trial (RESTORE-1) for TED in February 2024, with NDA submission expected in 2024[20] - IBI302 (Efdamrofusp alfa), an anti-VEGF/complement bispecific fusion protein, showed positive PoC results and completed the first patient dosing in its Phase 3 trial (STAR) for nAMD in October 2023[20] - IBI310, a novel anti-CTLA-4 monoclonal antibody, demonstrated positive PoC results and plans to initiate a Phase 3 trial in 2024 for neoadjuvant treatment of resectable MSI-H/dMMR colon cancer in combination with Sintilimab[20] - IBI363 (PD-1/IL-2) showed encouraging preliminary efficacy and safety in IO-resistant or non-responsive tumors, with preclinical results published in Nature Cancer[21][22] - The company advanced eight innovative molecules to the IND preparation stage in 2023, adding long-term momentum for global innovation and sustainable growth[22] - Strategic collaborations were established, including a partnership with Shengxin Biotech to develop SGB-3908, an siRNA candidate targeting AGT for hypertension treatment[22] - The company has 10 commercialized products, with 3 under NMPA review and 5 in Phase 3 or pivotal clinical studies, along with 18 molecules in early clinical research[31] - Two innovative products, Fucasso (Igeocel Injection) and Xinbile (Tolexizumab Injection), were approved in China in 2023[27] - The company expects to receive approval for two innovative products, Fuzerex (KRAS G12C) and Taletrectinib (ROS1), in 2024 for NSCLC treatment[28] - The company submitted an sNDA for Tyvyt (Sintilimab Injection) combined with Fruquintinib for 2L EMC treatment, which was accepted by NMPA with priority review status in April 2024[31] - The company initiated a Phase 3 trial for IBI310 (CTLA-4) combined with Sintilimab for colon cancer neoadjuvant therapy in March 2024[31] - IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) are advancing in early clinical studies, with early clinical data expected to be released at medical conferences in 2024[32] - IBI362 (Mazdutide) achieved primary and key secondary endpoints in the GLORY-1 study, and the company submitted the first NDA for weight loss in February 2024, with plans to submit a second NDA for T2D treatment based on DREAMS-1 and DREAMS-2 results[33] - IBI311, the first domestic anti-IGF-1R monoclonal antibody for TED, reached the primary endpoint in the RESTORE-1 Phase 3 trial in February 2024, with plans to submit an NDA and release full results at medical conferences in 2024[34] - IBI112 (Piconcibai, IL-23p19) is in Phase 3 registration clinical studies for psoriasis, expected to be completed in 2024 to support NDA submission, showing best-in-class long-term efficacy and extended dosing intervals[35] - IBI343 (CLDN18.2 ADC) demonstrated best-in-class potential in MRCT Phase 1b studies for 3L GC, with preparations underway for MRCT Phase 3 trials[36] - The company has 10 products on the market, 3 under NDA review, 5 in Phase 3 or key clinical trials, and 18 molecules in early clinical stages[37] - IBI362 (Mazdutide) is in five Phase 3 clinical trials for obesity and T2D, with GLORY-1 results to be presented at medical conferences in 2024[33] - IBI128, a potential best-in-class XOI, is undergoing overseas Phase 3 clinical studies for hyperuricemia in gout patients, with plans to initiate Phase 1 and 2 trials in China in 2024[34] - The company is advancing a diverse pipeline of innovative drugs in CVM, with plans to enter clinical stages in 2024, aiming to strengthen its strategic position in the field[34] - IBI112 (Piconcibai, IL-23p19) demonstrated superior long-term efficacy and extended dosing intervals in a 58-week Phase 2 trial, supporting its advancement in autoimmune diseases[35] - The company's commercialized product portfolio has expanded to 10 products, including Tyvyt (sintilimab injection), Bevacizumab injection, Suliximab (adalimumab injection), Rituximab injection, Pemigatinib tablets, Olverembatinib tablets, Ramucirumab injection, Selpercatinib, Igeocel injection, and Tolezumab injection[40] - Tyvyt (sintilimab injection) has been approved for seven indications in China, including lung cancer, liver cancer, gastric cancer, esophageal cancer, and classical Hodgkin lymphoma[41] - In May 2023, the NMPA approved the seventh indication for Tyvyt (sintilimab injection) for the treatment of EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy[42] - In February 2024, Tyvyt (sintilimab injection) was approved for marketing in Macau by the Macau Drug Administration[42] - In April 2024, the company submitted an sNDA for Tyvyt (sintilimab injection) combined with fruquintinib for the treatment of 2L EMC, which was accepted by the NMPA[42] - In January 2023, two new indications for Tyvyt (sintilimab injection) for 1L GC and 1L ESCC were included in the 2022 NRDL, making it the first and only PD-1 inhibitor for GC included in the NRDL[43] - In December 2023, the seventh indication for Tyvyt (sintilimab injection) for EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy was included in the 2023 NRDL[43] - In June 2023, the NMPA approved the eighth indication for Bevacizumab injection, combined with Tyvyt (sintilimab injection) and chemotherapy for the treatment of EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy[46] - In January 2023, seven indications for Bevacizumab injection were included in the 2022 NRDL, including three new indications for epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer[47] - In December 2023, the eighth indication for Bevacizumab injection was included in the 2023 NRDL[47] - Dabao Hua (Rituximab Injection) had all approved indications included in the 2022 NRDL, including two new indications for maintenance therapy of previously untreated follicular lymphoma and treatment of chronic lymphocytic leukemia[48] - Sulixin (Adalimumab Injection) was approved for eight indications in China, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn's disease, and pediatric Crohn's disease[49] - Sulixin (Adalimumab Injection) had eight indications included in the 2022 NRDL, including two new indications for Crohn's disease and pediatric Crohn's disease[50] - Dabotan (Pemigatinib Tablets) was included in Taiwan's health insurance reimbursement for the treatment of adult patients with locally advanced or metastatic CCA who have received at least one systemic therapy and have confirmed FGFR2 fusion or rearrangement[51] - Olverembatinib Tablets were approved by NMPA for the treatment of CML-CP patients resistant and/or intolerant to first- and second-generation TKIs[53] - Olverembatinib Tablets were included in the 2022 NRDL for the treatment of adult patients with CML-CP and CML-AP with T315I mutation[53] - Cyramza (Ramucirumab) was approved for two indications in mainland China, including second-line treatment for advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma and treatment for hepatocellular carcinoma patients with AFP ≥400 ng/mL who have previously received sorafenib treatment[55] - Retsevmo (Selpercatinib) was conditionally approved in mainland China for the treatment of adult patients with RET gene fusion-positive locally advanced or metastatic NSCLC and adult and pediatric patients 12 years and older with advanced or metastatic MTC

Investment Rating - The report assigns a "Buy" rating to Innovent Biologics (01801 HK) with a target price of HKD 56, compared to the current price of HKD 36 [1][2] Core Views - Innovent Biologics has demonstrated strong operational efficiency and leading positioning in large therapeutic areas, with 10 commercialized products and rapid revenue growth of 39% YoY in 2023 [1] - The company has established a robust R&D pipeline through both in-house development and strategic collaborations, aiming to commercialize around 20 products by 2027 with estimated sales of RMB 20 billion [1] - Innovent has leading products in four major therapeutic areas: oncology, metabolism, autoimmune diseases, and ophthalmology, with several products in advanced clinical stages [1] Financial Performance - Innovent's product sales revenue exceeded RMB 5 7 billion in 2023, representing a YoY growth of over 39% [1] - The company's EBITDA loss narrowed significantly to RMB 600 million in 2023, down 73% from RMB 2 221 billion in 2022 [1] - Revenue is projected to grow to RMB 7 308 billion, RMB 9 466 billion, and RMB 12 378 billion in 2024, 2025, and 2026, respectively, with YoY growth rates of 8 1%, 29 5%, and 30 8% [2][3] R&D and Pipeline - Innovent has a 1500+ member R&D team and collaborates with global partners like Eli Lilly, Roche, and Sanofi, with 30 strategic collaborations in place [1] - The company has 10 commercialized products, with 8 in oncology, 1 in autoimmune diseases, and 1 in metabolic diseases [12] - Key pipeline highlights include IBI343 (CLDN18 2 ADC) in Phase III for gastric cancer, IBI351 (KRAS G12C inhibitor) with NDA submitted, and IBI363 (PD-1 IL-2 bispecific antibody) in Phase II [22][30][35] Commercialization and Market Potential - Innovent has built a 3000+ member commercial team covering over 300 cities, 5000+ hospitals, and 1000+ pharmacies in China [16] - The company's sales and marketing expenses as a percentage of product revenue decreased to 49 3% in 2023, down 7 3 percentage points YoY [16] - In the metabolic disease area, Innovent has Masdutide (GLP-1R GCGR dual agonist) in Phase III for obesity and type 2 diabetes, with NDA submitted for obesity indication [42][43]