信达生物(01801) - 2025 - 中期业绩

Company Information and Announcement Statements Innovent Biologics released its H1 2025 unaudited condensed consolidated results, reviewed by its audit committee and auditor Announcement Overview Innovent Biologics announced its unaudited condensed consolidated results for the six months ended June 30, 2025, which have been reviewed by the company's audit committee and auditor Deloitte Touche Tohmatsu - Innovent Biologics (Stock Code: 1801) released its interim results announcement for the six months ended June 30, 2025[2] - The unaudited condensed consolidated results have been reviewed by the company's audit committee and auditor Deloitte Touche Tohmatsu[3] Financial Highlights The company achieved significant IFRS and Non-IFRS profitability in H1 2025, with revenue up 50.6% and profit turning positive, demonstrating enhanced operational efficiency IFRS Financial Metrics The company's H1 2025 IFRS revenue increased by 50.6% to RMB 5,953.1 million, gross profit grew by 56.3% to RMB 5,119.6 million, achieving a profit of RMB 834.3 million for the period, successfully turning losses into profits 2025 H1 IFRS Key Financial Data | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 5,953,094 | 3,952,291 | 50.6% | | Gross Profit | 5,119,642 | 3,274,740 | 56.3% | | Profit (Loss) for the Period | 834,321 | (392,620) | N/A* | - Revenue growth primarily driven by strong performance of oncology products, expansion of comprehensive product lines, and increased licensing fee income[5] - Profit for the period significantly improved, reflecting continuous enhancement in operational efficiency[5] Non-IFRS Financial Metrics The company's H1 2025 Non-IFRS profit increased to RMB 1,213.2 million, and Non-IFRS EBITDA rose to RMB 1,412.8 million, also achieving significant profitability, further confirming excellent operational efficiency 2025 H1 Non-IFRS Key Financial Data | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | YoY Change | | :--- | :--- | :--- | :--- | | Non-IFRS Profit (Loss) for the Period | 1,213,152 | (160,226) | N/A* | | Non-IFRS EBITDA (LBITDA) for the Period | 1,412,829 | (160,789) | N/A* | - Non-IFRS measures eliminate the impact of non-cash items (such as share-based payments, foreign exchange gains/losses) that management believes do not reflect the Group's operating performance, to better compare operating performance across different periods and companies[6] Business Overview and Strategy Guided by "dual-driven" and "global innovation" strategies, the company achieved strong H1 2025 growth, expanding its product portfolio, advancing R&D pipelines globally, and strengthening market access Strategic Guidance and Execution Guided by "dual-driven" and "global innovation" strategies, Innovent Biologics achieved strong revenue growth and significant profit improvement in H1 2025, successfully commercializing five new drugs and advancing next-generation pipelines into registrational clinical development, accelerating its global expansion - The company adheres to "dual-driven" and "global innovation" strategies, achieving strong revenue growth and significant improvement in profitability[9] - Strategic progress is accelerating, expanding from oncology leadership to comprehensive product line commercialization, and moving from China-focused to global development[9] 2025 H1 Key Business Data | Indicator | Amount (RMB Million) | YoY Growth | | :--- | :--- | :--- | | Total Revenue | 5,953.1 | 50.6% | | Product Revenue | 5,233.8 | 37.3% | Product Portfolio Expansion and Commercialization The company's product portfolio has expanded to 16 products, with five new drugs successfully commercialized during the reporting period, covering oncology and comprehensive product lines, and two drug candidates and three new indications in NDA review, continuously driving product launches and indication expansion - The product portfolio has expanded to 16 products, with five new drugs successfully commercialized during the reporting period, including oncology products Dabole®, Aoyixin®, Jiepali®, and comprehensive product lines Xinbimin®, Xinermai®[10] - Two drug candidates (IBI112, IBI310) and three new indications for approved products (Daboshu®, Mazdutide) are currently under New Drug Application (NDA) review[10] R&D Pipeline Progress and Global Innovation The company's core R&D pipelines have achieved positive Proof-of-Concept (PoC) data and advanced to registrational or Phase III clinical development, including the global first-in-class IO bispecific antibody IBI363, highly effective and low-toxicity ADC drugs IBI343 and IBI354, and cornerstone products Mazdutide and Picankibart in CVM and autoimmune fields, injecting new momentum for sustainable growth - Global first-in-class IO bispecific antibody IBI363 (PD-1/IL-2α-bias) entered registrational clinical studies, including the first global Phase III clinical study for lung cancer, and presented breakthrough clinical data at the ASCO annual meeting[11] - Next-generation ADC drugs IBI343 (CLDN18.2 ADC) and IBI354 (HER2 ADC) entered registrational clinical studies, respectively targeting pancreatic ductal adenocarcinoma, gastric cancer, and platinum-resistant ovarian cancer[11] - Mazdutide (GCG/GLP-1) and Picankibart (IL-23p19), as cornerstone products in CVM and autoimmune fields, have multiple Phase III clinical studies ongoing or newly initiated[11] - National Institute of Biological Sciences (NIBS) successfully advanced 3 new molecules into IND-enabling stage, covering bispecific antibodies, bispecific dual-payload ADCs, and novel comprehensive product molecules[13] Strategic Partnerships and Market Access The company actively expands its global innovation footprint through a global exclusive collaboration and licensing agreement with Roche for IBI3009, approval of multiple products in Macau, and accelerated registration processes in Southeast Asian and Latin American markets - Reached a global exclusive collaboration and licensing agreement with Roche for IBI3009 (DLL3 ADC)[14] - Dabote®, Xinbile®, and Dayoutong® received approval for market launch from the Macao SAR Pharmaceutical Administration[14] - Collaborating with regional partners to accelerate the registration process of products like Daboshu® and Dayoutong® in Southeast Asian and Latin American markets[14] R&D Achievements Publication and ESG The company published high-quality R&D data at several internationally renowned academic conferences and top-tier journals, showcasing its R&D capabilities and global competitiveness. Concurrently, it continues to invest in production line construction and achieved an MSCI AAA ESG rating, becoming the only biotech company in China with this rating - Published preclinical and clinical data for multiple innovative drugs at international academic conferences such as AACR, ASCO, ADA, and in top-tier journals like The New England Journal of Medicine and Nature Medicine[15][16] - The company's operational capacity is 140,000 liters, ensuring product portfolio expansion and continuous business growth[15] - Released the 2024 ESG report, achieving an MSCI ESG rating of AAA, making it the only biotech company in China with this rating[15] Management Discussion and Analysis The company's H1 2025 performance reflects robust revenue growth and improved profitability, driven by a diversified product matrix and accelerated global clinical development Revenue and Profitability Enhancement In H1 2025, the company's revenue reached RMB 5,953.1 million, a 50.6% year-on-year increase, primarily driven by growth in oncology products, comprehensive product lines, and licensing fee income. Non-IFRS net profit and EBITDA significantly improved, validating the sustainable development of domestic business and providing solid support for the globalization strategy 2025 H1 Revenue and Profitability Overview | Indicator | Amount (RMB Million) | YoY Growth | | :--- | :--- | :--- | | Revenue | 5,953.1 | 50.6% | | Non-IFRS Net Profit | 1,213.2 | Turned Loss into Profit | | Non-IFRS EBITDA | 1,412.8 | Turned Loss into Profit | - Strong revenue growth stemmed from the continued robust performance of oncology products, increased contributions from comprehensive product lines, and higher licensing fee income[19] - As of the announcement date, the company's cash reserves were approximately US$2 billion, providing a solid financial foundation for sustainable growth and global innovation[19] Dual-Driven Strategy: Product Matrix The company's commercialized product pipeline has expanded to 16 products, with two new approved products expected by the end of 2025. By expanding core product indications and advancing new products into registrational studies, the company continuously strengthens its advantages in oncology and comprehensive product areas, building new growth drivers - The commercialized product pipeline has expanded to 16 products, including 12 oncology products and 4 comprehensive pipeline products, with IBI112 and IBI310 expected to be approved by the end of 2025[20] Strengthening Leadership in Oncology The company reinforced its oncology leadership with strong growth from key products, new commercialized drugs, and advanced next-generation IO and ADC pipelines - Key products (including Daboshu®) maintained good growth momentum; Dabole®, Aoyixin®, and Jiepali® three new products were successively commercialized, further enriching the product portfolio[20] - Daboshu®'s ninth and tenth indications are undergoing NDA review, and another Phase III clinical trial for perioperative treatment of NSCLC is expected to read out data in early 2026[21] - Next-generation IO and ADC pipelines (IBI363, IBI343, IBI354) are accelerating into late-stage development, with the potential to establish new treatment standards in multiple tumor types[21] Building New Growth Drivers with Comprehensive Pipeline The comprehensive pipeline is building new growth drivers with successful launches, advanced clinical studies for cornerstone products, and plans for new Phase III trials - Xinbimin® and Xinermai® were approved and successfully launched as scheduled, and Xinbile® was successfully included in the National Reimbursement Drug List (NRDL)[22] - Mazdutide, as a cornerstone CVM product, has seven Phase III clinical studies ongoing, covering overweight/obesity, T2D, MAFLD, OSA, etc., with the second indication for T2D expected to be approved in H2 2025[23] - IBI112 (Picankibart) is expected to be approved for psoriasis treatment by the end of 2025, and a Phase III clinical study for patients with poor response to IL-17 treatment has been initiated[24] - Xinbimin® plans to initiate two new Phase III clinical studies, IBI302 for nAMD Phase III clinical study is expected to read out primary endpoints in 2026, and IBI128 for hyperuricemia in gout achieved positive results in Phase II and plans to initiate Phase III[23][11] Leading Pipeline Enters Global Registrational Clinical Development Leveraging NIBS's scientific insights and cutting-edge technology platforms, the company has built a globally competitive product pipeline, with new-generation IO+ADC therapies and comprehensive product lines achieving significant progress in oncology, CVM, autoimmune, and ophthalmology fields, and accelerating the establishment of overseas organizational structures to support efficient implementation of the global innovation strategy - Innovative pipeline focuses on next-generation "IO+ADC" therapies, aiming to reshape global cancer standard treatments; comprehensive product lines cover CVM, autoimmune, and ophthalmology fields[25] - Next-generation pipelines such as IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC) have read out PoC data and advanced to registrational study stages[25] - The company is accelerating the establishment of overseas organizational structures and professional teams, including building clinical development and operational capabilities in key markets such as the United States[25] IBI363 (PD-1/IL-2α-bias) IBI363 demonstrated breakthrough efficacy in IO-resistant tumors, advancing to registrational Phase II and global Phase III clinical studies - IBI363 presented Ib/II PoC study data at the ASCO annual meeting, covering IO-resistant lung cancer, melanoma, MSS CRC, and other "cold" tumors, demonstrating unique mechanism advantages and strong efficacy potential[26] - Three registrational studies are planned for IBI363, including a pivotal Phase II study for melanoma in China, and global multi-regional Phase III clinical studies for MSS CRC and squamous NSCLC[26] IBI343 (CLDN18.2 ADC) IBI343 initiated a global Phase III study for pancreatic cancer, becoming the first ADC in this indication, and showed significant efficacy in gastric cancer - IBI343 recently initiated a Phase III clinical study for third-line treatment of pancreatic cancer, becoming the first ADC drug globally to enter registrational clinical stage for this refractory cancer type[27] - The first international multi-center Phase III clinical study for gastric cancer started in 2024 and is ongoing, with plans to discuss MRCT Phase III clinical study protocol for second-line PDAC treatment with regulatory agencies[27] Next-Generation Oncology and Comprehensive Product Pipelines The company's next-generation pipelines, including novel ADCs, IO therapies, and autoimmune/CVM candidates, are progressing through early-stage clinical development - Next-generation ADCs (e.g., IBI3001, IBI3005, IBI3020) and novel IO therapies (IBI3003) have all entered Phase I clinical study stages[28] - Phase I clinical study data for next-generation autoimmune and CVM drug candidates (e.g., IBI355, IBI356, IBI3002, IBI3016, IBI3032) from the comprehensive product line will be successively read out[28] Collaborations and Expanded Market Access Strategic partnerships, including a global licensing deal with Roche for IBI3009, and expanded market access in Macau and other regions, bolster global innovation - Achieved global collaboration and licensing for IBI3009 (DLL3 ADC) with Roche, and continuously expanding market access for approved products in multiple countries and regions, including Hong Kong, Macau, Southeast Asia, and Latin America[28] Conclusion Innovent Biologics, with its comprehensive R&D layout and continuously strengthening commercialization capabilities, continues to consolidate its leading position in the Chinese biopharmaceutical industry and lays a solid foundation for global development, striving to become a world-class biopharmaceutical enterprise - The company adheres to its mission of "developing high-quality biologics affordable for the public," continuously strengthening its China business and actively expanding its global footprint[29] - In the future, it will fully leverage its industry insights, strategic planning, execution, and corporate culture advantages, striving to become a world-class biopharmaceutical enterprise[29] Product Portfolio and Pipeline Details The company's extensive product portfolio of 16 commercialized drugs and numerous clinical-stage candidates spans oncology, CVM, autoimmune, and ophthalmology, with significant milestones achieved Commercialized Products Innovent Biologics has 16 commercialized products covering oncology, cardiovascular metabolism, autoimmune, and ophthalmology. During the reporting period, several core products achieved significant milestones in regulatory approval, clinical progress, and data publication, further consolidating market position and expanding treatment scope - The company's commercialized product portfolio includes 16 approved products, covering oncology, CVM, autoimmune, and ophthalmology fields[33] Daboshu® (Sintilimab) Daboshu® has multiple approved indications and is advancing with new NDA submissions and ongoing Phase III studies for NSCLC and cHL - Seven indications approved in China and included in NRDL; the eighth indication for endometrial cancer conditionally approved; two other NDAs for MSI-H/dMMR colorectal cancer and renal cell carcinoma are under NMPA review[34] - The ninth indication (in combination with IBI310 for neoadjuvant treatment of resectable MSI-H/dMMR colorectal cancer) has received NMPA priority review and is expected to be approved by the end of 2025[35] - The tenth indication (in combination with fruquintinib for TKI-failed RCC) NDA has been accepted by NMPA[35] - Phase III clinical study for perioperative treatment of NSCLC is ongoing, with data readout expected in early 2026[36] - Phase III data for second-line cHL treated with combination of ifosfamide, carboplatin, and etoposide (ICE) was presented as an oral report at the ASCO annual meeting[38] Dayoutong® (Bevacizumab) Dayoutong® has eight approved indications in China and was recently approved for market access in Macau - Eight indications approved in China and included in NRDL[39] - Approved by Macao ISAF in July 2025[40] Dabote® (Fluzeretinib) Dabote® is approved for KRAS G12C mutated NSCLC in China and Macau, with ongoing combination therapy studies - Approved in China for the treatment of adult patients with advanced NSCLC carrying KRAS G12C mutation[40] - Approved by Macao ISAF in June 2025[41] - Ib/III clinical study of combination therapy for initial treatment of KRAS G12C mutated advanced NSCLC patients is ongoing[42] Dabole® (Taletrectinib) Dabole® is approved for ROS1-positive NSCLC in China and the US, and recommended by NCCN guidelines for various treatment lines - Approved in China for first-line and second-line treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC[43] - In June 2025, the US FDA approved IBTROZI™ (taletrectinib adipate capsules) for the treatment of adult patients with ROS1-positive NSCLC[43] - In June 2025, IBTROZI™ was recommended by NCCN guidelines as a preferred drug for ROS1+ NSCLC first-line and later-line treatment, especially for patients with brain metastases and resistant mutations[48] Jiepali® (Pirtobrutinib) Jiepali® is approved in China for relapsed or refractory MCL patients who have received prior BTK inhibitors - Approved by NMPA in October 2024 for monotherapy in adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies, including a BTK inhibitor[45] Aoyixin® (Liertinib) Aoyixin® is approved for EGFR T790M mutated NSCLC and first-line EGFR-mutated NSCLC in China, with Phase III data published - Approved by NMPA in January 2025 for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation NSCLC[49] - In April 2025, NMPA approved the second NDA for first-line treatment of adult patients with NSCLC carrying EGFR exon 19 deletion or exon 21 L858R mutation[49] - Phase III study for first-line treatment of EGFR-mutated NSCLC published in The Lancet Respiratory Medicine[49] Xinbile® (Tolecimab) Xinbile® is approved for hypercholesterolemia in China, included in NRDL as the first domestic PCSK9 inhibitor, and approved in Macau - Approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia and included in NRDL[50] - In November 2024, successfully became the first domestic original PCSK9 inhibitor included in China's National Medical Insurance Drug List, effective January 1, 2025[55] - Approved by Macao ISAF in May 2025[55] Xinbimin® (Tepezza) Xinbimin® is the first IGF-1R drug approved in China for TED, filling a 70-year gap, and is approved in Macau with new Phase III studies planned - Approved in China for the treatment of TED, it is the first IGF-1R drug approved in China, filling a 70-year treatment gap in the Chinese TED field[52][56] - Approved by Macao ISAF in August 2025[56] - Plans to initiate new Phase III clinical studies for inactive TED and head-to-head steroid therapy for TED in H2 2025[53] Mazdutide (Mazdutide) Mazdutide, the world's first GLP-1/GCG dual agonist for weight management, is advancing with NDA review for T2D and positive Phase III data published in NEJM - The world's first GLP-1/GCG dual receptor agonist approved for long-term weight management in overweight or obese adults[53][57] - NDA for glycemic control in T2D patients is under NMPA review, expected to be approved in H2 2025[57] - Seven Phase III clinical studies initiated or completed, covering obesity, T2D, MAFLD, OSA, etc., with GLORY-1, DREAMS-1, and DREAMS-2 studies reaching their endpoints[58] - Phase III clinical study results of GLORY-1 published in The New England Journal of Medicine (NEJM), marking the first time a Chinese-developed innovative metabolic and endocrine therapy was published in NEJM[59][61] - Phase III clinical study results of DREAMS-1 presented at the 85th ADA Scientific Sessions, demonstrating strong hypoglycemic efficacy and weight loss effects[61] Clinical Stage Drug Candidates - Oncology The company has a rich pipeline of clinical-stage drug candidates in oncology, including CTLA-4 mAb, CLDN18.2 ADC, HER2 ADC, PD-1/IL-2α-bias bispecific antibody, and multiple novel ADCs and trispecific antibodies, with several drugs entering pivotal clinical studies or receiving breakthrough therapy designations, demonstrating significant therapeutic potential Ipilimumab N01 Injection (IBI310) IBI310's NDA for MSI-H/dMMR colorectal cancer neoadjuvant treatment is under priority review, with approval expected by end of 2025 - IBI310's NDA has been accepted by NMPA and granted priority review, in combination with sintilimab for neoadjuvant treatment of resectable MSI-H/dMMR colorectal cancer, expected to be approved by the end of 2025[60] IBI343 (CLDN18.2 ADC) IBI343 initiated a global Phase III study for pancreatic cancer, becoming the first ADC in this indication, and showed significant efficacy in gastric cancer - MRCT Phase III clinical study for third-line treatment of advanced GC is ongoing in China and Japan[62] - Phase III clinical study for third-line treatment of PDAC has completed first patient dosing[62] - IBI343 for PDAC and GC has received NMPA BTD, and for second-line treatment of PDAC has received US FDA FTD[62] - Latest Phase I data for IBI343 in PDAC patients presented at ASCO annual meeting, showing significant efficacy signals[63][67] - Nature Medicine published Phase I clinical study results of IBI343 for advanced gastric/gastroesophageal junction adenocarcinoma, showing a cORR of 32.3% and DCR of 90.3%[67] IBI354 (HER2 ADC) IBI354 is in a China Phase III study for PROC and showed excellent safety and efficacy in early-stage trials for various HER2-expressing tumors - China Phase III clinical study as monotherapy for PROC patients completed first subject dosing; this indication has been granted NMPA BTD[64] - Latest Phase I/II data presented at ASCO annual meeting, showing excellent safety and encouraging efficacy in PROC, HER2-low breast cancer, and other solid tumors[65] IBI363 (PD-1/IL-2α-bias) IBI363 demonstrated breakthrough efficacy and safety in IO-resistant tumors, advancing to registrational Phase II and global Phase III studies - Clinical Phase I/Ib study showed IBI363 demonstrated controllable safety, breakthrough efficacy, and clear survival benefits in multiple cancer types, including IO-resistant NSCLC, IO-resistant/naïve melanoma, and immune "cold" tumors like CRC[66] - The first registrational Phase II clinical study for IO-naïve mucosal and acral melanoma, head-to-head with pembrolizumab, has been initiated and granted NMPA BTD[71] - The IND for the first global Phase III clinical study (MarsLight-11) was approved by the US FDA for the treatment of immune-resistant squamous NSCLC patients, with plans to enroll patients in multiple regions globally[71] - Three Phase I PoC clinical study results presented at ASCO annual meeting, confirming its unique immune mechanism and therapeutic potential as a differentiated next-generation immunotherapy[70][71] IBI3009 (DLL3 ADC) IBI3009 is under global development with Roche, securing an US$80 million upfront payment and up to US$1 billion in milestone payments - Reached a global exclusive collaboration and licensing agreement with Roche, granting Roche exclusive rights for global development, manufacturing, and commercialization of IBI3009; the company received an US$80 million upfront payment and up to US$1 billion in milestone payments[72] - IBI3009 is undergoing MRCT Phase I clinical studies in Australia, China, and the United States[73] IBI3020 (CEACAM5 ADC) IBI3020, the world's first dual-payload ADC of its kind, has completed first-in-human dosing in a Phase I clinical trial for advanced solid tumors - The world's first dual-payload ADC of its kind to complete first-in-human dosing; MRCT Phase I clinical trial for advanced solid tumor patients has completed first patient dosing[74] IBI3001 (B7-H3/EGFR ADC) IBI3001 is currently undergoing an international multi-center Phase I clinical study - IBI3001's international multi-center Phase I clinical study is ongoing[75] IBI3003 (GPRC5D/BCMA/CD3 Tri-specific) IBI3003 is in multi-regional Phase I clinical trials in China and Australia, with dose escalation ongoing - IBI3003 is undergoing multi-regional Phase I clinical trials in China and Australia, with the dose escalation phase currently in progress[76] Clinical Stage Drug Candidates - Comprehensive Product Line The company continues to advance clinical development of multiple innovative drugs in its comprehensive product line, covering autoimmune, ophthalmology, and cardiovascular metabolic diseases, with several drugs entering Phase III clinical trials or achieving positive Phase II data, and plans to initiate more new studies to meet unmet global chronic disease needs IBI112 (Picankibart) IBI112's NDA for moderate-to-severe plaque psoriasis is under NMPA review, with new studies planned for PsA and juvenile psoriasis - NDA for the treatment of moderate-to-severe plaque psoriasis is under NMPA review, expected to be approved by the end of 2025[78] - Phase III clinical study for the treatment of psoriasis patients with poor response to previous IL-17 biologics has completed first subject dosing[79][84] - Plans to initiate new studies for PsA and juvenile psoriasis in H2 2025[84] IBI302 (Emovop) IBI302 is in Phase III for nAMD, with primary endpoint readout expected in 2026, and Phase II for diabetic macular edema initiated - Phase III clinical study (STAR) of 8mg IBI302 for nAMD is ongoing, with primary clinical endpoint readout expected in 2026[81][84] - Phase II clinical study for the treatment of diabetic macular edema has completed first subject dosing, comparing the efficacy and safety of IBI302 with faricimab[84] - Phase II study results of 6.4/8mg IBI302 for nAMD presented at the 2025 AVRO annual meeting[82] IBI128 (Tigulixostat) IBI128 showed positive Phase II results for hyperuricemia in gout, demonstrating superior uric acid reduction and safety, with Phase III planned - Phase II study for the treatment of hyperuricemia in gout patients achieved positive results, demonstrating more potent uric acid reduction and superior safety compared to febuxostat[83][85] - Plans to initiate Phase III study of tigulixostat in China in H2 2025[85] IBI356 (OX40L) IBI356 showed encouraging efficacy and tolerability in Phase I for moderate-to-severe AD, with Phase II and US IND submission planned - Preliminary results from Phase I clinical study in moderate-to-severe AD showed encouraging efficacy and good tolerability[86][89] - Plans to initiate Phase II clinical study of IBI356 in H2 2025 and submit IND application to the US FDA[89] IBI355 (CD40L) IBI355 demonstrated good safety and encouraging efficacy in Phase I for primary Sjögren's syndrome, with potential for monthly dosing - Preliminary results from Phase I clinical study in primary Sjögren's syndrome (pSS) showed good safety, encouraging efficacy, and potential for monthly dosing interval[86] IBI3002 (TSLP/IL-4α) IBI3002 has initiated Phase I clinical studies in Australia and China, exploring indications such as asthma - Phase I clinical studies initiated in Australia in 2024 and China in 2025, will continue to explore indications such as asthma[87][90] IBI3016 (AGT siRNA) IBI3016 is currently undergoing Phase I clinical trials in healthy subjects and patients with mild hypertension - Undergoing Phase I clinical trials in healthy subjects and patients with mild hypertension[87] IBI3032 (Oral GLP-1R) IBI3032 received US FDA IND approval, with NMPA review ongoing, and Phase I clinical studies planned in China and the US - IND approval received from the US FDA, and NMPA is also reviewing the IND application[88][91] - Plans to initiate Phase I clinical studies in China and the United States in H2 2025[91] Financial Review and Analysis The company's H1 2025 financial performance shows strong revenue growth, improved profitability, and efficient cost management, supported by strategic licensing agreements Revenue Composition Total revenue in H1 2025 reached RMB 5,953.1 million, a 50.6% year-on-year increase. Product sales revenue was RMB 5,233.8 million, up 37.3%; licensing fee income significantly grew to RMB 665.6 million, primarily due to the upfront payment from the exclusive license and collaboration agreement with Roche 2025 H1 Revenue Composition | Revenue Source | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Pharmaceutical Product Sales | 5,233,773 | 3,811,406 | | Licensing Fee Income | 665,619 | 115,931 | | R&D Service Fee Income | 53,702 | 24,954 | | Total Revenue | 5,953,094 | 3,952,291 | - Significant increase in licensing fee income primarily due to the US$80 million upfront payment received from the exclusive license and collaboration agreement with Roche[94] Cost of Sales Cost of sales in H1 2025 was RMB 833.5 million, an increase from RMB 677.6 million in the same period last year, mainly related to the growth in product sales Cost of Sales Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Cost of Sales | 833,452 | 677,551 | - Cost of sales includes raw materials, direct labor, manufacturing costs, depreciation and amortization, and inventory impairment expenses[95] Other Income Other income in H1 2025 was RMB 238.9 million, a decrease from RMB 300.6 million in H1 2024, primarily comprising interest income and various government grants Other Income Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Other Income | 238,865 | 300,606 | - Other income mainly includes interest income and various government grants, which comprise amounts related to capital expenditures, R&D activities, and unconditional awards[96] Other Gains and Losses Other gains and losses in H1 2025 resulted in a gain of RMB 1.0 million, a significant decrease from RMB 85.5 million in H1 2024, primarily due to the impact of foreign exchange rate fluctuations, with a foreign exchange loss of RMB 36.4 million recorded during the reporting period Other Gains and Losses Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Other Gains and Losses | 1,043 | 85,516 | | Net Foreign Exchange Loss (Gain) | (36,448) | 65,328 | - Other gains and losses primarily include foreign currency exchange rate changes, fair value changes of financial assets and liabilities, and gains or losses from disposal of property[97] Research and Development Expenses R&D expenses in H1 2025 were RMB 1,008.8 million, a decrease from RMB 1,399.4 million in H1 2024, reflecting the company's continued global development of next-generation innovative pipelines while maintaining high investment efficiency R&D Expenses Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | R&D Expenses | 1,008,799 | 1,399,432 | - R&D expenses include third-party contractor costs, clinical trial expenses, raw material costs, staff costs and benefits, depreciation and amortization, and payments under collaboration agreements[98] Administrative and Other Expenses Administrative and other expenses in H1 2025 were RMB 442.1 million, a 38.2% year-on-year increase. However, benefiting from rapid revenue growth, this expense as a percentage of total revenue decreased from 8.1% to 7.4%, indicating continuous improvement in operating leverage Administrative and Other Expenses Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Administrative and Other Expenses | 442,111 | 319,801 | | As % of Total Revenue | 7.4% | 8.1% | - Administrative and other expenses as a percentage of total revenue decreased by 0.7 percentage points, reflecting continuous improvement in operating leverage[99] Selling and Marketing Expenses Selling and marketing expenses in H1 2025 were RMB 2,375.1 million, a 26.4% year-on-year increase. This expense as a percentage of total revenue decreased from 47.6% to 39.9%, indicating improved commercialization efficiency, and the company plans to further increase sales and marketing investment for new products in H2 Selling and Marketing Expenses Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Selling and Marketing Expenses | 2,375,070 | 1,879,356 | | As % of Total Revenue | 39.9% | 47.6% | - Selling and marketing expenses as a percentage of total revenue decreased by 7.7 percentage points, reflecting improved commercialization efficiency[100] - The company plans to further increase sales and marketing investment for new products in H2 2025[100] Royalty Payments and Other Related Payments Royalty payments and other related payments in H1 2025 were RMB 551.6 million, an increase from RMB 416.8 million in H1 2024, primarily related to royalties, sales milestones, and profit sharing for co-developed and licensed products in the commercialization stage Royalty Payments and Other Related Payments Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Royalty Payments and Other Related Payments | 551,627 | 416,838 | - These payments refer to royalties, sales milestones, profit-sharing payments, and other related payments to third parties for various co-developed and licensed products in the commercialization stage[101] Income Tax Expense Income tax expense in H1 2025 was RMB 62.8 million, a significant increase from RMB 0.04 million in H1 2024, primarily due to the recognition of licensing fee income during the reporting period Income Tax Expense Comparison | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Income Tax Expense | 62,796 | 35 | - The increase in income tax expense was primarily due to the recognition of licensing fee income during the reporting period[102] Non-IFRS Financial Metrics Reconciliation The company provided reconciliation for Non-IFRS profit, EBITDA, gross profit, R&D expenses, administrative and other expenses, and selling and marketing expenses, which, by excluding non-cash items like share-based payment expenses and foreign exchange gains/losses, more clearly reflect core operating performance, showing significant profitability for both Non-IFRS profit and EBITDA Reconciliation of Profit (Loss) for the Period to Non-IFRS Profit (Loss) for the Period | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Profit (Loss) for the Period | 834,321 | (392,620) | | Add: Share-based Payment Expenses | 342,383 | 297,722 | | Add: Net Foreign Exchange Loss (Gain) | 36,448 | (65,328) | | Non-IFRS Profit (Loss) for the Period | 1,213,152 | (160,226) | Reconciliation of Profit (Loss) for the Period to Non-IFRS EBITDA (LBITDA) for the Period | Indicator | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Profit (Loss) for the Period | 834,321 | (392,620) | | Add: Interest Income | (190,373) | (237,288) | | Add: Finance Costs | 61,264 | 38,020 | | Add: Depreciation and Amortization | 265,990 | 198,670 | | Add: Income Tax Expense | 62,796 | 35 | | Add: Share-based Payment Expenses | 342,383 | 297,722 | | Add: Net Foreign Exchange Loss (Gain) | 36,448 | (65,328) | | Non-IFRS EBITDA (LBITDA) for the Period | 1,412,829 | (160,789) | - Non-IFRS measures, by eliminating non-cash items that management believes do not reflect the Group's operating performance, help compare operating performance across different periods and companies within applicable limits[103] Liquidity and Capital Resources The company maintains healthy liquidity with increased cash reserves and improved financial ratios, while managing asset pledges and foreign exchange risks Balance Sheet Overview As of June 30, 2025, the company's total assets were RMB 23,594.3 million, an increase from December 31, 2024. Net current assets reached RMB 8,080.4 million, indicating healthy liquidity Balance Sheet Overview (RMB Thousand) | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | 13,092,874 | 10,272,837 | | Total Non-Current Assets | 10,501,398 | 11,329,765 | | Total Assets | 23,594,272 | 21,602,602 | | Total Current Liabilities | 5,012,466 | 4,368,869 | | Total Non-Current Liabilities | 4,159,986 | 4,116,004 | | Total Liabilities | 9,172,452 | 8,484,873 | | Net Current Assets | 8,080,408 | 5,903,968 | Cash and Liquidity As of June 30, 2025, the company's bank balances and cash, time deposits, etc., totaled RMB 11,002.9 million, current assets were RMB 13,092.9 million, current liabilities were RMB 5,012.5 million, and it had approximately RMB 4,011.5 million in unutilized long-term bank loan facilities - Bank balances and cash, time deposits and other deposits, structured products, and investment notes in other financial assets totaled RMB 11,002.9 million, an increase from RMB 10,221.1 million at the end of 2024[107] - Current assets were RMB 13,092.9 million, of which bank balances and cash amounted to RMB 9,540.1 million[107] - Possesses unutilized long-term bank loan facilities of approximately RMB 4,011.5 million[107] Key Financial Ratios As of June 30, 2025, the company's current ratio was 2.6 and quick ratio was 2.4, both improving from December 31, 2024, indicating enhanced short-term solvency. The debt-to-equity ratio is not meaningful as interest-bearing borrowings less cash equivalents is negative Key Financial Ratios Comparison | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 2.6 | 2.4 | | Quick Ratio | 2.4 | 2.2 | | Debt-to-Equity Ratio | N/A | N/A | - Both current ratio and quick ratio improved, indicating enhanced short-term solvency[108][113] Material Investments, Acquisitions, and Disposals For the six months ended June 30, 2025, the company held no material investments and had no material acquisitions or disposals of subsidiaries, consolidated affiliated entities, or associates - For the six months ended June 30, 2025, the Group held no material investments[109] - For the six months ended June 30, 2025, the Group had no material acquisitions or disposals of subsidiaries, consolidated affiliated entities, or associates[109] Pledged Assets and Contingent Liabilities As of June 30, 2025, the company had pledged certain property, plant and equipment, land use rights, and bank deposits to secure loans and bank facilities. During the reporting period, the company had no material contingent liabilities - Pledged property, plant and equipment totaling RMB 1,960.8 million, land use rights of RMB 266.4 million, and bank deposits of RMB 32.3 million to secure its loans and bank facilities[110] - As of June 30, 2025, the company had no material contingent liabilities[111] Foreign Exchange Risk Most of the company's transactions are settled in RMB, but a significant portion of bank balances and cash are denominated in USD. Except for certain foreign currency-denominated bank balances, cash, receivables, and payables, the company's operations had no significant foreign currency risk as of June 30, 2025 - Most of the Group's transactions are settled in RMB, while most bank balances and cash are denominated in USD[112] - Except for certain foreign currency-denominated bank balances and cash, other receivables, and trade and other payables, the Group's operations had no significant foreign currency risk as of June 30, 2025[112] Employee Information The company's employee base grew to 6,190, with significant R&D and sales personnel, supported by a comprehensive remuneration and training system Employee Profile and Remuneration As of June 30, 2025, the company had 6,190 employees, with a significant proportion in R&D, CMC, and sales & marketing. The company's remuneration policy is regularly reviewed, including salaries, bonuses, provident funds, social security, and share-based payments, and provides external and internal training programs. Total staff costs for H1 2025 were RMB 1,603.4 million - As of June 30, 2025, the company had a total of 6,190 employees (December 31, 2024: 5,659 employees), including over 1,100 R&D personnel, over 1,000 CMC personnel, and over 3,600 sales and marketing personnel[114] - Remuneration packages include salaries, bonuses, employee provident fund and social security contributions, other welfare payments, and share-based payment expenses[114] - For the six months ended June 30, 2025, the Group incurred total staff costs of RMB 1,603.4 million, an increase from RMB 1,391.6 million in the same period of 2024[115] - The company has adopted multiple share award schemes to incentivize employees[115] - For the six months ended June 30, 2025, the company did not encounter any significant labor disputes or difficulties in recruiting employees[116] Dividend Policy The Board does not recommend an interim dividend for the six months ended June 30, 2025 Interim Dividend Recommendation The Board does not recommend the distribution of an interim dividend for the six months ended June 30, 2025 - The Board does not recommend the distribution of an interim dividend for the six months ended June 30, 2025 (2024: nil)[117] Corporate Governance and Other Information The company maintains high corporate governance standards, with compliance to Listing Rules, established committees, and transparent reporting on placings and litigation Compliance with Corporate Governance Code The company is committed to high-level corporate governance, having complied with all applicable code provisions of the Corporate Governance Code in Appendix C1 of the Listing Rules for the six months ended June 30, 2025, with a deviation where the Chairman and CEO are the same person, which the Board believes ensures consistent leadership and efficient strategic planning - For the six months ended June 30, 2025, the company has complied with all applicable code provisions of the Corporate Governance Code set out in Appendix C1 of the Listing Rules[119] - There is a deviation where the Chairman and Chief Executive Officer are the same person (Dr. Yu Dechao), which the Board believes helps ensure consistent leadership and makes overall strategic planning more effective and efficient[119] Standard Securities Dealing Code for Directors The company has adopted the Standard Code for Securities Transactions by Directors of Listed Issuers as set out in Appendix C3 of the Listing Rules, and all directors have confirmed compliance for the six months ended June 30, 2025 - The company has adopted the Standard Code for Securities Transactions by Directors of Listed Issuers as set out in Appendix C3 of the Listing Rules[121] - All directors confirmed compliance with the Standard Code for the six months ended June 30, 2025[121] Audit Committee and Other Committees The company has established an Audit Committee, comprising four independent non-executive directors, which has reviewed these interim results. Additionally, the company has also established a Nomination Committee, Remuneration Committee, and Strategy Committee - The Audit Committee comprises four independent non-executive directors, with Ms. Xu Yiyin as Chairperson[122] - The Audit Committee has reviewed the Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025[122] - The company has also established a Nomination Committee, Remuneration Committee, and Strategy Committee[123] Dealings in Listed Securities On June 26, 2025, the company completed the 2025 placing, placing 55,000,000 new shares, with net proceeds of approximately HK$4,265.4 million. Other than this, neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities during the reporting period - On June 26, 2025, the company entered into a placing agreement with Morgan Stanley Asia Limited and Goldman Sachs (Asia) L.L.C. to place 55,000,000 new shares, with net proceeds of approximately HK$4,265.4 million[124] - Save for the 2025 placing, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities on the Stock Exchange during the reporting period[124] Material Litigation For the six months ended June 30, 2025, the company was not involved in any material litigation or arbitration, nor were there any pending or threatened material litigation or claims - For the six months ended June 30, 2025, the company was not involved in any material litigation or arbitration[125] - To the best of the Directors' knowledge, for the six months ended June 30, 2025, the Group had no pending or threatened material litigation or claims[125] Use of Proceeds The company disclosed the use of proceeds from two placings in 2023 and 2025. The 2023 placing generated net proceeds of approximately RMB 2,163.0 million, primarily for global pipeline R&D and the development, marketing, and commercialization of IBI362 (Mazdutide). The 2025 placing generated net proceeds of approximately HK$4,265.4 million, mainly for advancing global R&D of key innovative pipelines and global facility and equipment layout 2023 Placing The 2023 placing generated RMB 2,163.0 million, primarily allocated to global pipeline R&D and Mazdutide's development and commercialization, with remaining funds for future use - Net proceeds from the 2023 placing were approximately RMB 2,163.0 million, used to accelerate R&D of multiple priority preclinical and clinical programs in the global pipeline (60%), develop, market, and commercialize IBI362 (Mazdutide) (30%), and for general and corporate purposes (10%)[127] Use of Proceeds from 2023 Placing (As of June 30, 2025) | Use of Net Proceeds | Unutilized as of Dec 31, 2024 (RMB Million) | Utilized for H1 2025 (RMB Million) | Unutilized as of June 30, 2025 (RMB Million) | | :--- | :--- | :--- | :--- | | Accelerate global pipeline R&D and build global infrastructure | 651.0 | 274.3 | 376.7 | | Develop, market, and commercialize IBI362 (Mazdutide) | 275.6 | 92.7 | 182.9 | | General and corporate purposes | – | – | – | | Total | 926.6 | 367.0 | 559.6 | - The remaining net proceeds (RMB 559.6 million) will be gradually utilized for their intended purposes within the next 12 months[128] 2025 Placing The 2025 placing raised HK$4,265.4 million, mainly for global R&D of innovative pipelines and infrastructure, with funds to be utilized over the next 60 months - Net proceeds from the 2025 placing were approximately HK$4,265.4 million, of which approximately 90% is for advancing global R&D of key innovative pipelines and global facility and equipment layout, and approximately 10% for general and corporate purposes[129] - All proceeds will be used for previously disclosed intended purposes and the remaining portion will be gradually utilized within the next 60 months[129] Notes to Condensed Consolidated Financial Statements The condensed consolidated financial statements are prepared under IAS 34 and HKEX Listing Rules, with consistent accounting policies and no significant impact from revised IFRS Basis of Preparation and Accounting Policies The condensed consolidated financial statements are prepared in accordance with IAS 34 "Interim Financial Reporting" and the applicable disclosure requirements of the HKEX Listing Rules. Accounting policies remain consistent with the 2024 annual consolidated financial statements, except for new or changed policies due to the application of revised IFRS accounting standards - The condensed consolidated financial statements are prepared in accordance with IAS 34 "Interim Financial Reporting" and the applicable disclosure requirements of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited[133] - Except for new accounting policies/changes in accounting policies resulting from the application of revised IFRS accounting standards, the accounting policies and methods of computation are the same as those presented in the Group's annual consolidated financial statements for the year ended December 31, 2024[134] - The application of revised IFRS accounting standards during this interim period had no significant impact on the Group's financial position and performance for the current and prior periods[135] Revenue and Segment Information The company's revenue is derived from pharmaceutical product sales, licensing fee income, and R&D service fee income. The Group operates in a single operating segment, with most operations and non-current assets located in China, but revenue sources have expanded to the US and European markets Revenue by Timing of Recognition (RMB Thousand) | Timing of Revenue Recognition | 2025 | 2024 | | :--- | :--- | :--- | | At a point in time (Pharmaceutical product sales, Licensing fee income) | 5,782,397 | 3,811,406 | | Over a period of time (R&D service fee income, Licensing fee income) | 170,697 | 140,885 | | Total | 5,953,094 | 3,952,291 | - The Group has only one single operating segment, and the chief executive officer focuses on and reviews the Group's overall results and financial position[138] Revenue by Geographical Location (RMB Thousand) | Region | 2025 | 2024 | | :--- | :--- | :--- | | China | 5,284,636 | 3,820,059 | | United States | 116,995 | 115,931 | | Europe | 551,463 | – | | Other | – | 16,301 | | Total | 5,953,094 | 3,952,291 | Income Tax Expense Income tax expense in H1 2025 was RMB 62.8 million, primarily comprising China corporate income tax and Singapore corporate income tax, a significant increase from the same period last year Income Tax Expense Composition (RMB Thousand) | Tax | 2025 | 2024 | | :--- | :--- | :--- | | China Corporate Income Tax | 734 | 35 | | Singapore Corporate Income Tax | 62,062 | – | | Total | 62,796 | 35 | Earnings (Loss) Per Share In H1 2025, basic earnings per share were RMB 0.51, and diluted earnings per share were RMB 0.49, successfully achieving profitability. For the same period in 2024, basic and diluted loss per share was RMB 0.24 Earnings (Loss) Per Share Comparison | Indicator | 2025 (RMB) | 2024 (RMB) | | :--- | :--- | :--- | | Basic Earnings (Loss) Per Share | 0.51 | (0.24) | | Diluted Earnings (Loss) Per Share | 0.49 | (0.24) | - Basic earnings per share calculation includes restricted shares that have vested but not yet been issued[141] - As a loss was incurred in H1 2024 and the inclusion of potential ordinary shares would be anti-dilutive, diluted loss per share was the same as basic loss per share[142] Trade Receivables and Payables As of June 30, 2025, trade receivables were RMB 1,722.4 million, with an average credit period of 45 to 60 days. Trade payables and bills payable totaled RMB 432.3 million, with an average credit period of 0 to 90 days Ageing Analysis of Trade Receivables (RMB Thousand) | Ageing | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | 0-60 days | 1,717,090 | 1,184,407 | | 61-180 days | 1,030 | – | | 181-365 days | 4,233 | – | | Total | 1,722,353 | 1,184,407 | - The Group provides an average credit period of 45 to 60 days to its trade customers[143] Ageing Analysis of Trade Payables and Bills Payable (RMB Thousand) | Ageing | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Trade Payables (0-30 days) | 150,118 | 140,871 | | Trade Payables (31-60 days) | 169,713 | 159,874 | | Trade Payables (Over 60 days) | 87,904 | 46,798 | | Bills Payable (0-90 days) | 9,479 | 10,134 | | Bills Payable (91-180 days) | 15,078 | – | | Total | 432,292 | 357,677 | - The average credit period for trade purchases is 0 to 90 days[144] Dividends For the periods ended June 30, 2025 and 2024, the company neither paid, declared, nor proposed any dividends to shareholders - For the periods ended June 30, 2025 and 2024, no dividends were paid, declared, or proposed to the company's shareholders, nor have any dividends been proposed since the end of the reporting period[146] Publication of Announcement The interim results announcement is published on the HKEX and company websites, with the full interim report to follow for shareholder reference Publication of Interim Results Announcement and Interim Report This interim results announcement has been published on the HKEX website and the company's website. The Group's interim report for the six months ended June 30, 2025, will be published in due course for shareholders' reference - This interim results announcement is published on the HKEX website www.hkexnews.hk and the company's website www.innoventbio.com[147](index=147&type=chunk) - The Group's interim report for the six months ended June 30, 2025, will be published in due course and made available to shareholders in accordance with the company's communication arrangements[147]