{"success":true,"data":{"pressRelease":{"id":"125008","rtpr_id":"nPn2f19Lxa","ticker":"2696","exchange":"HKEX","all_tickers":["2696"],"title":"Henlius Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation, and Accelerating Progress Towards C-MNC","author":"PR Newswire","published_at":"2026-08-21T12:59:19.516Z","article_body":"Henlius Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation, and Accelerating Progress Towards C-MNC\n\nPR Newswire\n\nSHANGHAI, Aug. 21, 2026\n\nSHANGHAI, Aug. 21, 2026 /PRNewswire/ -- On August 21, Henlius (2696.HK)\nannounced its interim results for the 2026 fiscal year. During the reporting\nperiod, the company showcased strong organic growth momentum and sustainable\nearnings generation, with revenue reaching RMB 3.5882 billion, a 27.3%\nincrease YoY, and net profit amounting to RMB 430.4 million, up 10.3% YoY. In\nthe first half of 2026, Henlius reported non-IFRS profit of RMB 572.3 million,\na 46.7% YoY increase, and adjusted EBITDA (a non-IFRS measure) of RMB 904.1\nmillion, rising 35.2% YoY. Key financial and operational metrics maintained a\nsteady upward trajectory. Driven by sustained global growth of its core\nproducts and end-to-end lean operations across the entire value chain, the\ncompany continues to strengthen both revenue scale and earnings quality.\n\nDr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius,\nstated: \"2026 marks a pivotal year of acceleration in Henlius' journey toward\nbecoming a C-MNC. In the first half of the year, our core products continued\nto generate tangible value through global commercialization, while multiple\ndifferentiated pipeline assets entered critical stages of value validation.\nThe benefits of this dual-engine growth model are increasingly taking shape.\nLooking ahead, we will remain anchored in addressing unmet patient needs,\nbuild on the virtuous cycle of 'global commercialization fueling innovation\nand differentiated innovation driving global expansion', further deepen our\nGlobalization 2.0 strategy, and advance steadily toward high-quality,\nsustainable growth.\"\n\nGlobal Commercialization Advances Across Multiple Fronts, Core Portfolio\nReinforces the Foundation for Growth\n\nAs of the reporting period, Henlius has 10 products approved in over 60\ncountries and regions across Asia, Europe, Latin America, North America, and\nOceania, and has benefited over 1.1 million patients worldwide. In the first\nhalf of 2026, the company maintained its strategic focus on key therapeutic\nareas, including breast cancer, lung cancer, and gastrointestinal cancers.\nGlobal product sales revenue amounted to RMB 2.9386 billion, up 14.9% YoY.\nNotably, sales revenue from ex-China markets increased significantly by 159.4%\nyear on year to RMB 105.3 million, while product profit from ex-China markets\nreached RMB 59.5 million, more than four times that of the same period last\nyear, further strengthening the company's ability to generate value from\nglobal commercialization.\n\nIn the breast cancer therapeutic area, the company continued to advance its\n\"Full-Course, All-Domain, Global\" breast cancer treatment landscape, with\nglobal sales revenue from its breast cancer product portfolio reaching RMB\n1.6983 billion during the reporting period. The four marketed products\ncollectively delivered strong volume growth, with HANQUYOU (trastuzumab,\nHERCESSI™ in the U.S. and Zercepac(®) in Europe), HANBEIYOU (pertuzumab,\nPOHERDY(®) in the U.S. and Europe), HANNAIJIA (neratinib), and fovinaciclib\ngenerating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5\nmillion, and RMB 10.7 million, respectively. In the first half of 2026,\nHANBEIYOU received sequential marketing authorizations from the European\nCommission and China's NMPA, marking it as the first and only**\nChinese-developed pertuzumab biosimilar approved across all three major\nmarkets—China, the U.S., and the EU. In combination with HANQUYOU, it\nestablishes the first Chinese-developed dual HER2-targeted regimen combining\ntrastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning\nthe treatment continuum from neoadjuvant setting to first-line treatment of\nadvanced disease. Furthermore, the company is accelerating the development of\na diversified breast cancer pipeline including lasofoxifene (HLX78), a novel\nendocrine therapy; dulpatatug* (HLX22), a novel-epitope monoclonal antibody\n(mAb) targeting HER2; HLX87, a HER2-targeted ADC; HLX97, an oral KAT6A/B\ninhibitor; HLX49, a HER2 biparatopic ADC; and HLX319, the first\nChinese-developed fixed-dose subcutaneous co-formulation of pertuzumab and\ntrastuzumab—all aimed at establishing a comprehensive, multidimensional\nbreast cancer treatment portfolio across the disease continuum.\n\nIn solid tumor indications, including lung cancer and gastrointestinal\nmalignancies, a multi-product synergistic strategy is cultivating new growth\nmomentum. Serplulimab (Hetronifly(®) in Europe) recorded global sales\nrevenue of RMB 0.5975 billion in the first half of 2026. In June, the product\nreceived approval in China for the perioperative treatment of gastric cancer\nthrough a priority review pathway, becoming the first and only*** anti-PD-1\nmAb globally to be approved for this indication and thereby addressing a\nsignificant unmet need in this treatment setting. In terms of international\nexpansion, serplulimab has secured marketing approvals in over 50 countries\nand regions. During the reporting period, it has obtained approvals for three\nadditional first-line indications—non-squamous non-small cell lung cancer\n(nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small\ncell lung cancer (sqNSCLC) in the EU—and has been incorporated into the\nnational healthcare or public reimbursement systems of 12 European countries,\nincluding the United Kingdom (UK), Germany, Italy, Spain, and Sweden.\nHANBEITAI (bevacizumab), another key oncology product in the company's\nportfolio, generated sales revenue of RMB 0.2182 billion in the first half of\nthe year, up 87.6% YoY, with a decision on its Biologics License Application\nexpected in the second half of 2026. Furthermore, HLX903, a third-generation\noral EGFR-TKI introduced via a licensing-in arrangement, is expected to\nreceive marketing approval in the first half of 2027 and address targeted\ntreatment needs among patients with EGFR-mutant NSCLC upon approval.\n\nIn parallel, mature products including HANLIKANG (rituximab) and HANDAYUAN\n(adalimumab) continued to deliver stable cash flow contributions in the\nhematology and autoimmune disease therapeutic areas, generating RMB 335.7\nmillion and RMB 30.4 million in sales revenue and licensing income,\nrespectively, in accordance with the relevant collaboration agreements. HLX14\n(denosumab), available in two dosage strengths as BILDYOS(®) (60mg/mL) and\nBILPREVDA(®) (120mg/1.7mL), secured regulatory approvals in the U.S. and\nEuropean Union, and UK during the second half of 2025, and contributed sales\nrevenue and licensing income of RMB 73.1 million in the reporting period.\n\nIn the first half of 2026, with China as its global headquarters, the company\nmoved swiftly to build out its international proprietary commercialization\norganization, establishing five core functional pillars—commercial alliance,\naffiliate commercial, market access and pricing, commercial strategy and\noperations, and medical affairs—thereby creating a dual-engine model\ncombining in-house commercialization with strategic partnerships. Since the\nstart of 2026, the company has announced three major international strategic\ncollaborations in succession, reinforcing its Globalization 2.0 strategy\nacross multiple fronts: in high-value mature markets, the company entered into\nan agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization\nrights for serplulimab in Japan; to accelerate its presence in emerging\nmarkets, the company formed a strategic collaboration with Abbott to expand\nserplulimab's commercial footprint across Asia-Pacific, Africa, Central Asia,\nand Eastern Europe; and to maximize the global potential of its biosimilar\nportfolio, the company established a broad-based strategic partnership with\nSandoz, covering up to ten biosimilar products, thereby substantially\nbroadening the commercial reach of its pipeline assets across key global\nmarkets.\n\nInnovation Pipeline Accelerates, Global Biosimilar Expansion Drives Further\nValue Creation\n\nMeanwhile, the company continues to ramp up its innovation efforts, with\nR&D expenditure reaching RMB 1.4507 billion during the reporting period,\nrepresenting a 45.7% YoY increase. The company's differentiated innovation\npipeline continues to expand, and it has now established multiple technology\nplatforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager\n(TCE), and AI—with more than 50 early-stage pipeline molecules in reserve,\ncovering therapeutic areas including oncology, immunology and inflammation,\nneuroscience, and metabolism diseases.\n\nAs a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, HLX43\nhas demonstrated encouraging preliminary efficacy and a favorable safety\nprofile across multiple solid tumors, including NSCLC. Its phase 2 and phase\n2/3 international multi-center studies in NSCLC are advancing across regions\nincluding China, Europe, the United States, Japan, and Australia.\nSpecifically, the phase 2/3 study in advanced sqNSCLC has received implied\napproval from Japan's PMDA and has dosed its first patient in China. In\naddition, the phase 1b/2 study of HLX43 in combination with serplulimab or\npimurutamab (HLX07) for the treatment of advanced/metastatic colorectal cancer\n(mCRC) has also completed first-patient-in dosing in China. To date, the\ncompany has initiated more than ten clinical studies of HLX43 as monotherapy\nor in combination regimens, with over 1,500 patients enrolled globally,\ncontinuing to evaluate its broad therapeutic potential across multiple solid\ntumors.\n\nOther key pipeline assets are also advancing efficiently. Among them,\ndulpatatug* is making steady progress in an international multi-center phase 3\nclinical study that features a head-to-head comparison against the current\nfirst-line standard of care for HER2-positive gastric cancer. First patient\nenrollment has been completed across a broad geographic footprint, including\nChina, the U.S., Europe, Japan, Australia, South Korea, and Latin America.\nConcurrently, a phase 2 study of dulpatatug* for HER2-low breast cancer and a\nphase 2/3 study of dulpatatug* in combination with the HER2-directed ADC HLX87\nfor first-line treatment of HER2-positive breast cancer are also advancing\nsteadily. The phase 2/3 clinical trial of pimurutamab in combination with\nserplulimab and chemotherapy for first-line treatment of advanced sqNSCLC has\ncompleted clinical trial notification with Australia's Therapeutic Goods\nAdministration (TGA) and has reached first patient dosing in China. Meanwhile,\nnext-generation innovative molecules with BIC/FIC potential, including HLX3901\n(DLL3 x DLL3 x CD3 x CD28 tetra-specific TCE), HLX3902 (STEAP1 x CD3 x CD28\ntri-specific TCE), HLX48( c-MET x EGFR bispecific ADC) , HLX97 (small-molecule\nKAT6A/B inhibitor) and HLX316 (B7-H3 sialidase fusion protein), are advancing\nefficiently in parallel with high efficiency, continuously strengthening the\ncompany's long-term growth pipeline. Furthermore, the Company will accelerate\nthe development of early-stage assets, including HLX105 (PD-1×IL-2v fusion\nprotein), HLX109 (IL-1R3 mAb), HLX49 (HER2 biparatopic ADC), and HLX403 (CDH17\nADC), with plans to submit Investigational New Drug (IND) applications for\nthese candidates in the second half of 2026. By leveraging its robust CMC\ncapabilities, the company is further increasing the probability of success in\ndeveloping complex molecules, thereby enhancing overall drug developability.\nIn addition, the company is proactively applying AI-powered approaches to the\nR&D of innovative molecules such as HLX203, with the goal of continuously\nimproving the efficiency of drug discovery and development.\n\nIn line with its Globalization 2.0 strategy, the company remains committed to\nunlocking the global potential of its biosimilar portfolio through a parallel\nChina-U.S. development and registration pathway. HLX05-N (proposed cetuximab\nbiosimilar) and HLX18 (proposed nivolumab biosimilar) have each received\nclinical trial authorizations from regulators in both China and the U.S., and\ndosed their first patient. In addition, HLX13 (proposed ipilimumab\nbiosimilar), HLX15 (proposed daratumumab biosimilar), and HLX17 (proposed\npembrolizumab biosimilar) have all achieved first subject dosing in both China\nand the U.S. The company is continuously accumulating global clinical data for\nthese assets, laying the foundation for subsequent regulatory development and\ncommercialization.\n\nGlobalization 2.0 in Place, Integrated End-to-End Capabilities Reinforce the\nC-MNC Ambition\n\nHenlius has established a comprehensive and systematic capability for global\nexpansion spanning R&D, clinical development, regulatory affairs,\nmanufacturing, and commercialization, steadily advancing its Globalization 2.0\nstrategy and marking the initial formation of its \"C-MNC\" model—a\nChina-headquartered multinational biopharmaceutical company.\n\nOn clinical development and regulatory affairs, the company has established\ndedicated in-house teams in Europe, the U.S., Japan, and Australia, with\nclinical trials concurrently ongoing in nearly 30 countries and regions, in\npartnership with over 1,000 clinical research centers. During the reporting\nperiod, the company received 32 new clinical trial approvals and 25 marketing\nauthorizations worldwide, covering nearly 50 countries and regions. On\nmanufacturing and supply, its delivery capabilities continued to strengthen.\nTo date, the company has completed more than 1,400 GMP commercial production\nbatches and successfully passed over 100 on-site inspections and audits\nconducted by regulatory authorities worldwide and international collaborators,\nwith a 100% pass rate. During the period, it also completed 9 first commercial\nshipments and 18 batch shipments to ex-China markets.\n\nIn the first half of 2026, the clinical value of Henlius' core innovative\npipeline continued to emerge, while international regulatory and\ncommercialization milestones were achieved in succession. Synergies across\nglobal R&D, manufacturing, and commercialization were further\nstrengthened, collectively demonstrating that the company's Globalization 2.0\nstrategy has entered a critical phase of accelerated validation. Looking\ntoward 2030, Henlius will continue to pursue innovation-driven and global\ngrowth, accelerating its journey toward becoming a C-MNC. The company aims to\nbring 10 new products to markets worldwide, with over 5 expected to reach\nEuropean and U.S. markets, and to grow into a globally influential innovative\nbiopharmaceutical company.\n\n* Status: pINN\n** Received U.S. FDA approval in November 2025, EC approval in April 2026, and\nNMPA approval in May 2026. As of August 2026, it remains the only one.\n*** In June 2026, serplulimab received NMPA approval as the world's first\nanti-PD-1 mAb for perioperative gastric cancer treatment. As of August 2026,\nit remains the only one.\n\nAbout Henlius\n\nShanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven\nbiopharmaceutical company committed to delivering high-quality, affordable\nbiologic therapies to patients worldwide. The Company focuses on major disease\nareas including oncology, autoimmune diseases, and ophthalmic diseases.\nFounded in 2010, Henlius has established an integrated, end-to-end\nbiopharmaceutical platform encompassing global R&D, clinical operations,\nregulatory affairs, manufacturing, and commercialisation. The Company employs\nnearly 4,000 people globally and operates across multiple regions, including\nChina, the United States, and Japan. Leveraging the stable cash flow generated\nfrom its biosimilar portfolio to support innovation, Henlius is steadily\nadvancing into its \"Globalisation 2.0\" phase, building a scalable and\nsustainable global growth model. Up to date, Henlius has achieved regulatory\napprovals for 10 products across over 60 countries and regions worldwide,\nincluding eight approvals in China. The Company has also reached multiple\nmilestones in major biopharmaceutical markets, with four products approved by\nthe U.S. Food and Drug Administration (FDA) and five products approved by the\nEuropean Commission (EC), reflecting its globally aligned R&D\ncapabilities, quality systems, and manufacturing standards.\n\nDriven by innovation, Henlius has built a diversified, platform-based\ntechnology ecosystem through coordinated R&D efforts across Shanghai, the\nUnited States, and other regions. Its innovation platforms span immune\ncheckpoint inhibitors, immune cell engager technologies (including\nmultispecific T cell engagers), antibody-drug conjugates (ADCs), and\nAI-enabled early discovery platforms. The Company currently has more than 50\nearly-stage innovative assets, approximately 70% of which are expected to be\nbest-in-class, with over 30 clinical trials ongoing globally. Henlius' core\nproduct, serplulimab (trade name: Hetronifly(®) in Europe), is the world's\nfirst anti–PD-1 mAb approved for first-line treatment of small cell lung\ncancer and for perioperative gastric cancer. Up to date, it has been approved\nin 50 markets worldwide with an accelerated globalisation process. In\nparallel, multiple high-potential innovative assets—including the PD-L1 ADC\nHLX43 and the novel epitope anti-HER2 mAb dulpatatug (HLX22) — are advancing\nthrough global pivotal clinical development. Supported by a biologics\nmanufacturing network with a total capacity of 84,000L and GMP certifications\nfrom regulatory authorities in China, Europe, and the United States, Henlius\nhas established a stable global supply system serving six continents. Guided\nby a patient-centred mission, Henlius remains focused on addressing unmet\nmedical needs and translating scientific innovation into meaningful clinical\nvalue and patient access, contributing sustainably to the global\nbiopharmaceutical ecosystem.\n\nTo learn more about Henlius, visit https://www.henlius.com/en/index.html\n(https://www.henlius.com/en/index.html) and connect with us on LinkedIn at\nhttps://www.linkedin.com/company/henlius/\n(https://www.linkedin.com/company/henlius/) .\n\nView original\ncontent:https://www.prnewswire.com/news-releases/henlius-reports-2026-interim-results-sustained-profitability-leap-advancing-global-value-validation-and-accelerating-progress-towards-c-mnc-302857339.html\n(https://www.prnewswire.com/news-releases/henlius-reports-2026-interim-results-sustained-profitability-leap-advancing-global-value-validation-and-accelerating-progress-towards-c-mnc-302857339.html)\n\nSOURCE Henlius\n\n\n\nJiayi_Han@henlius.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn2f19Lxa","title":"Henlius Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation, and Accelerating Progress Towards C-MNC","author":"PR Newswire","ticker":"2696","created":"2026-08-21T12:59:19.516Z","tickers":["2696"],"exchange":"HKEX","article_body":"Henlius Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation, and Accelerating Progress Towards C-MNC\n\nPR Newswire\n\nSHANGHAI, Aug. 21, 2026\n\nSHANGHAI, Aug. 21, 2026 /PRNewswire/ -- On August 21, Henlius (2696.HK)\nannounced its interim results for the 2026 fiscal year. During the reporting\nperiod, the company showcased strong organic growth momentum and sustainable\nearnings generation, with revenue reaching RMB 3.5882 billion, a 27.3%\nincrease YoY, and net profit amounting to RMB 430.4 million, up 10.3% YoY. In\nthe first half of 2026, Henlius reported non-IFRS profit of RMB 572.3 million,\na 46.7% YoY increase, and adjusted EBITDA (a non-IFRS measure) of RMB 904.1\nmillion, rising 35.2% YoY. Key financial and operational metrics maintained a\nsteady upward trajectory. Driven by sustained global growth of its core\nproducts and end-to-end lean operations across the entire value chain, the\ncompany continues to strengthen both revenue scale and earnings quality.\n\nDr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius,\nstated: \"2026 marks a pivotal year of acceleration in Henlius' journey toward\nbecoming a C-MNC. In the first half of the year, our core products continued\nto generate tangible value through global commercialization, while multiple\ndifferentiated pipeline assets entered critical stages of value validation.\nThe benefits of this dual-engine growth model are increasingly taking shape.\nLooking ahead, we will remain anchored in addressing unmet patient needs,\nbuild on the virtuous cycle of 'global commercialization fueling innovation\nand differentiated innovation driving global expansion', further deepen our\nGlobalization 2.0 strategy, and advance steadily toward high-quality,\nsustainable growth.\"\n\nGlobal Commercialization Advances Across Multiple Fronts, Core Portfolio\nReinforces the Foundation for Growth\n\nAs of the reporting period, Henlius has 10 products approved in over 60\ncountries and regions across Asia, Europe, Latin America, North America, and\nOceania, and has benefited over 1.1 million patients worldwide. In the first\nhalf of 2026, the company maintained its strategic focus on key therapeutic\nareas, including breast cancer, lung cancer, and gastrointestinal cancers.\nGlobal product sales revenue amounted to RMB 2.9386 billion, up 14.9% YoY.\nNotably, sales revenue from ex-China markets increased significantly by 159.4%\nyear on year to RMB 105.3 million, while product profit from ex-China markets\nreached RMB 59.5 million, more than four times that of the same period last\nyear, further strengthening the company's ability to generate value from\nglobal commercialization.\n\nIn the breast cancer therapeutic area, the company continued to advance its\n\"Full-Course, All-Domain, Global\" breast cancer treatment landscape, with\nglobal sales revenue from its breast cancer product portfolio reaching RMB\n1.6983 billion during the reporting period. The four marketed products\ncollectively delivered strong volume growth, with HANQUYOU (trastuzumab,\nHERCESSI™ in the U.S. and Zercepac(®) in Europe), HANBEIYOU (pertuzumab,\nPOHERDY(®) in the U.S. and Europe), HANNAIJIA (neratinib), and fovinaciclib\ngenerating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5\nmillion, and RMB 10.7 million, respectively. In the first half of 2026,\nHANBEIYOU received sequential marketing authorizations from the European\nCommission and China's NMPA, marking it as the first and only**\nChinese-developed pertuzumab biosimilar approved across all three major\nmarkets—China, the U.S., and the EU. In combination with HANQUYOU, it\nestablishes the first Chinese-developed dual HER2-targeted regimen combining\ntrastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning\nthe treatment continuum from neoadjuvant setting to first-line treatment of\nadvanced disease. Furthermore, the company is accelerating the development of\na diversified breast cancer pipeline including lasofoxifene (HLX78), a novel\nendocrine therapy; dulpatatug* (HLX22), a novel-epitope monoclonal antibody\n(mAb) targeting HER2; HLX87, a HER2-targeted ADC; HLX97, an oral KAT6A/B\ninhibitor; HLX49, a HER2 biparatopic ADC; and HLX319, the first\nChinese-developed fixed-dose subcutaneous co-formulation of pertuzumab and\ntrastuzumab—all aimed at establishing a comprehensive, multidimensional\nbreast cancer treatment portfolio across the disease continuum.\n\nIn solid tumor indications, including lung cancer and gastrointestinal\nmalignancies, a multi-product synergistic strategy is cultivating new growth\nmomentum. Serplulimab (Hetronifly(®) in Europe) recorded global sales\nrevenue of RMB 0.5975 billion in the first half of 2026. In June, the product\nreceived approval in China for the perioperative treatment of gastric cancer\nthrough a priority review pathway, becoming the first and only*** anti-PD-1\nmAb globally to be approved for this indication and thereby addressing a\nsignificant unmet need in this treatment setting. In terms of international\nexpansion, serplulimab has secured marketing approvals in over 50 countries\nand regions. During the reporting period, it has obtained approvals for three\nadditional first-line indications—non-squamous non-small cell lung cancer\n(nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small\ncell lung cancer (sqNSCLC) in the EU—and has been incorporated into the\nnational healthcare or public reimbursement systems of 12 European countries,\nincluding the United Kingdom (UK), Germany, Italy, Spain, and Sweden.\nHANBEITAI (bevacizumab), another key oncology product in the company's\nportfolio, generated sales revenue of RMB 0.2182 billion in the first half of\nthe year, up 87.6% YoY, with a decision on its Biologics License Application\nexpected in the second half of 2026. Furthermore, HLX903, a third-generation\noral EGFR-TKI introduced via a licensing-in arrangement, is expected to\nreceive marketing approval in the first half of 2027 and address targeted\ntreatment needs among patients with EGFR-mutant NSCLC upon approval.\n\nIn parallel, mature products including HANLIKANG (rituximab) and HANDAYUAN\n(adalimumab) continued to deliver stable cash flow contributions in the\nhematology and autoimmune disease therapeutic areas, generating RMB 335.7\nmillion and RMB 30.4 million in sales revenue and licensing income,\nrespectively, in accordance with the relevant collaboration agreements. HLX14\n(denosumab), available in two dosage strengths as BILDYOS(®) (60mg/mL) and\nBILPREVDA(®) (120mg/1.7mL), secured regulatory approvals in the U.S. and\nEuropean Union, and UK during the second half of 2025, and contributed sales\nrevenue and licensing income of RMB 73.1 million in the reporting period.\n\nIn the first half of 2026, with China as its global headquarters, the company\nmoved swiftly to build out its international proprietary commercialization\norganization, establishing five core functional pillars—commercial alliance,\naffiliate commercial, market access and pricing, commercial strategy and\noperations, and medical affairs—thereby creating a dual-engine model\ncombining in-house commercialization with strategic partnerships. Since the\nstart of 2026, the company has announced three major international strategic\ncollaborations in succession, reinforcing its Globalization 2.0 strategy\nacross multiple fronts: in high-value mature markets, the company entered into\nan agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization\nrights for serplulimab in Japan; to accelerate its presence in emerging\nmarkets, the company formed a strategic collaboration with Abbott to expand\nserplulimab's commercial footprint across Asia-Pacific, Africa, Central Asia,\nand Eastern Europe; and to maximize the global potential of its biosimilar\nportfolio, the company established a broad-based strategic partnership with\nSandoz, covering up to ten biosimilar products, thereby substantially\nbroadening the commercial reach of its pipeline assets across key global\nmarkets.\n\nInnovation Pipeline Accelerates, Global Biosimilar Expansion Drives Further\nValue Creation\n\nMeanwhile, the company continues to ramp up its innovation efforts, with\nR&D expenditure reaching RMB 1.4507 billion during the reporting period,\nrepresenting a 45.7% YoY increase. The company's differentiated innovation\npipeline continues to expand, and it has now established multiple technology\nplatforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager\n(TCE), and AI—with more than 50 early-stage pipeline molecules in reserve,\ncovering therapeutic areas including oncology, immunology and inflammation,\nneuroscience, and metabolism diseases.\n\nAs a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, HLX43\nhas demonstrated encouraging preliminary efficacy and a favorable safety\nprofile across multiple solid tumors, including NSCLC. Its phase 2 and phase\n2/3 international multi-center studies in NSCLC are advancing across regions\nincluding China, Europe, the United States, Japan, and Australia.\nSpecifically, the phase 2/3 study in advanced sqNSCLC has received implied\napproval from Japan's PMDA and has dosed its first patient in China. In\naddition, the phase 1b/2 study of HLX43 in combination with serplulimab or\npimurutamab (HLX07) for the treatment of advanced/metastatic colorectal cancer\n(mCRC) has also completed first-patient-in dosing in China. To date, the\ncompany has initiated more than ten clinical studies of HLX43 as monotherapy\nor in combination regimens, with over 1,500 patients enrolled globally,\ncontinuing to evaluate its broad therapeutic potential across multiple solid\ntumors.\n\nOther key pipeline assets are also advancing efficiently. Among them,\ndulpatatug* is making steady progress in an international multi-center phase 3\nclinical study that features a head-to-head comparison against the current\nfirst-line standard of care for HER2-positive gastric cancer. First patient\nenrollment has been completed across a broad geographic footprint, including\nChina, the U.S., Europe, Japan, Australia, South Korea, and Latin America.\nConcurrently, a phase 2 study of dulpatatug* for HER2-low breast cancer and a\nphase 2/3 study of dulpatatug* in combination with the HER2-directed ADC HLX87\nfor first-line treatment of HER2-positive breast cancer are also advancing\nsteadily. The phase 2/3 clinical trial of pimurutamab in combination with\nserplulimab and chemotherapy for first-line treatment of advanced sqNSCLC has\ncompleted clinical trial notification with Australia's Therapeutic Goods\nAdministration (TGA) and has reached first patient dosing in China. Meanwhile,\nnext-generation innovative molecules with BIC/FIC potential, including HLX3901\n(DLL3 x DLL3 x CD3 x CD28 tetra-specific TCE), HLX3902 (STEAP1 x CD3 x CD28\ntri-specific TCE), HLX48( c-MET x EGFR bispecific ADC) , HLX97 (small-molecule\nKAT6A/B inhibitor) and HLX316 (B7-H3 sialidase fusion protein), are advancing\nefficiently in parallel with high efficiency, continuously strengthening the\ncompany's long-term growth pipeline. Furthermore, the Company will accelerate\nthe development of early-stage assets, including HLX105 (PD-1×IL-2v fusion\nprotein), HLX109 (IL-1R3 mAb), HLX49 (HER2 biparatopic ADC), and HLX403 (CDH17\nADC), with plans to submit Investigational New Drug (IND) applications for\nthese candidates in the second half of 2026. By leveraging its robust CMC\ncapabilities, the company is further increasing the probability of success in\ndeveloping complex molecules, thereby enhancing overall drug developability.\nIn addition, the company is proactively applying AI-powered approaches to the\nR&D of innovative molecules such as HLX203, with the goal of continuously\nimproving the efficiency of drug discovery and development.\n\nIn line with its Globalization 2.0 strategy, the company remains committed to\nunlocking the global potential of its biosimilar portfolio through a parallel\nChina-U.S. development and registration pathway. HLX05-N (proposed cetuximab\nbiosimilar) and HLX18 (proposed nivolumab biosimilar) have each received\nclinical trial authorizations from regulators in both China and the U.S., and\ndosed their first patient. In addition, HLX13 (proposed ipilimumab\nbiosimilar), HLX15 (proposed daratumumab biosimilar), and HLX17 (proposed\npembrolizumab biosimilar) have all achieved first subject dosing in both China\nand the U.S. The company is continuously accumulating global clinical data for\nthese assets, laying the foundation for subsequent regulatory development and\ncommercialization.\n\nGlobalization 2.0 in Place, Integrated End-to-End Capabilities Reinforce the\nC-MNC Ambition\n\nHenlius has established a comprehensive and systematic capability for global\nexpansion spanning R&D, clinical development, regulatory affairs,\nmanufacturing, and commercialization, steadily advancing its Globalization 2.0\nstrategy and marking the initial formation of its \"C-MNC\" model—a\nChina-headquartered multinational biopharmaceutical company.\n\nOn clinical development and regulatory affairs, the company has established\ndedicated in-house teams in Europe, the U.S., Japan, and Australia, with\nclinical trials concurrently ongoing in nearly 30 countries and regions, in\npartnership with over 1,000 clinical research centers. During the reporting\nperiod, the company received 32 new clinical trial approvals and 25 marketing\nauthorizations worldwide, covering nearly 50 countries and regions. On\nmanufacturing and supply, its delivery capabilities continued to strengthen.\nTo date, the company has completed more than 1,400 GMP commercial production\nbatches and successfully passed over 100 on-site inspections and audits\nconducted by regulatory authorities worldwide and international collaborators,\nwith a 100% pass rate. During the period, it also completed 9 first commercial\nshipments and 18 batch shipments to ex-China markets.\n\nIn the first half of 2026, the clinical value of Henlius' core innovative\npipeline continued to emerge, while international regulatory and\ncommercialization milestones were achieved in succession. Synergies across\nglobal R&D, manufacturing, and commercialization were further\nstrengthened, collectively demonstrating that the company's Globalization 2.0\nstrategy has entered a critical phase of accelerated validation. Looking\ntoward 2030, Henlius will continue to pursue innovation-driven and global\ngrowth, accelerating its journey toward becoming a C-MNC. The company aims to\nbring 10 new products to markets worldwide, with over 5 expected to reach\nEuropean and U.S. markets, and to grow into a globally influential innovative\nbiopharmaceutical company.\n\n* Status: pINN\n** Received U.S. FDA approval in November 2025, EC approval in April 2026, and\nNMPA approval in May 2026. As of August 2026, it remains the only one.\n*** In June 2026, serplulimab received NMPA approval as the world's first\nanti-PD-1 mAb for perioperative gastric cancer treatment. As of August 2026,\nit remains the only one.\n\nAbout Henlius\n\nShanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven\nbiopharmaceutical company committed to delivering high-quality, affordable\nbiologic therapies to patients worldwide. The Company focuses on major disease\nareas including oncology, autoimmune diseases, and ophthalmic diseases.\nFounded in 2010, Henlius has established an integrated, end-to-end\nbiopharmaceutical platform encompassing global R&D, clinical operations,\nregulatory affairs, manufacturing, and commercialisation. The Company employs\nnearly 4,000 people globally and operates across multiple regions, including\nChina, the United States, and Japan. Leveraging the stable cash flow generated\nfrom its biosimilar portfolio to support innovation, Henlius is steadily\nadvancing into its \"Globalisation 2.0\" phase, building a scalable and\nsustainable global growth model. Up to date, Henlius has achieved regulatory\napprovals for 10 products across over 60 countries and regions worldwide,\nincluding eight approvals in China. The Company has also reached multiple\nmilestones in major biopharmaceutical markets, with four products approved by\nthe U.S. Food and Drug Administration (FDA) and five products approved by the\nEuropean Commission (EC), reflecting its globally aligned R&D\ncapabilities, quality systems, and manufacturing standards.\n\nDriven by innovation, Henlius has built a diversified, platform-based\ntechnology ecosystem through coordinated R&D efforts across Shanghai, the\nUnited States, and other regions. Its innovation platforms span immune\ncheckpoint inhibitors, immune cell engager technologies (including\nmultispecific T cell engagers), antibody-drug conjugates (ADCs), and\nAI-enabled early discovery platforms. The Company currently has more than 50\nearly-stage innovative assets, approximately 70% of which are expected to be\nbest-in-class, with over 30 clinical trials ongoing globally. Henlius' core\nproduct, serplulimab (trade name: Hetronifly(®) in Europe), is the world's\nfirst anti–PD-1 mAb approved for first-line treatment of small cell lung\ncancer and for perioperative gastric cancer. Up to date, it has been approved\nin 50 markets worldwide with an accelerated globalisation process. In\nparallel, multiple high-potential innovative assets—including the PD-L1 ADC\nHLX43 and the novel epitope anti-HER2 mAb dulpatatug (HLX22) — are advancing\nthrough global pivotal clinical development. Supported by a biologics\nmanufacturing network with a total capacity of 84,000L and GMP certifications\nfrom regulatory authorities in China, Europe, and the United States, Henlius\nhas established a stable global supply system serving six continents. Guided\nby a patient-centred mission, Henlius remains focused on addressing unmet\nmedical needs and translating scientific innovation into meaningful clinical\nvalue and patient access, contributing sustainably to the global\nbiopharmaceutical ecosystem.\n\nTo learn more about Henlius, visit https://www.henlius.com/en/index.html\n(https://www.henlius.com/en/index.html) and connect with us on LinkedIn at\nhttps://www.linkedin.com/company/henlius/\n(https://www.linkedin.com/company/henlius/) .\n\nView original\ncontent:https://www.prnewswire.com/news-releases/henlius-reports-2026-interim-results-sustained-profitability-leap-advancing-global-value-validation-and-accelerating-progress-towards-c-mnc-302857339.html\n(https://www.prnewswire.com/news-releases/henlius-reports-2026-interim-results-sustained-profitability-leap-advancing-global-value-validation-and-accelerating-progress-towards-c-mnc-302857339.html)\n\nSOURCE Henlius\n\n\n\nJiayi_Han@henlius.com\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-08-21T12:59:19.585506685Z","server_sent_at_ms":1787317159585},"received_at":"2026-08-21T12:59:19.736Z","source_url":"https://www.prnewswire.com/news-releases/henlius-reports-2026-interim-results-sustained-profitability-leap-advancing-global-value-validation-and-accelerating-progress-towards-c-mnc-302857339.html"},"analysis":{"id":"113970","press_release_id":"125008","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["GAAP net profit growth (10.3%) significantly lags non-IFRS profit growth (46.7%), indicating substantial one-off costs or stock-based compensation impacting reported earnings."],"eventType":"earnings","narrative":"Henlius delivered strong H1 2026 results with revenue of RMB 3.59 billion, up 27.3% year-over-year, and non-IFRS profit surging 46.7% to RMB 572.3 million, driven by global commercialization and lean operations.\n\nOperational milestones included the first-in-class approval of serplulimab for perioperative gastric cancer in China and the launch of a Globalization 2.0 strategy via major partnerships with Eisai, Abbott, and Sandoz.\n\nR&D investment increased 45.7% to RMB 1.45 billion, accelerating the pipeline of innovative assets like the PD-L1 ADC HLX43 and the pertuzumab biosimilar HANBEIYOU, which is now approved in China, the U.S., and EU.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Profitability surges 46% on non-IFRS basis backed by first-in-class gastric cancer approval and a triad of major global partnerships."},"keyFigures":{"revenueYoy":"27.3%","customDimensions":{"ebitda":904100000,"net_profit":430400000,"ex_china_sales":105300000,"non_ifrs_profit":572300000,"rnd_expenditure":1450700000,"breast_cancer_sales":1698300000}},"quotedText":"2026 marks a pivotal year of acceleration in Henlius' journey toward becoming a C-MNC. In the first half of the year, our core products continued to generate tangible value through global commercialization, while multiple differentiated pipeline assets entered critical stages of value validation.","namedEntities":{"people":[{"name":"Dr. Jason Zhu","role":"Executive Director and Chief Executive Officer"}],"products":["HANQUYOU","HERCESSI","Zercepac","HANBEIYOU","POHERDY","HANNAIJIA","fovinaciclib","Serplulimab","Hetronifly","HANBEITAI","HLX14","BILDYOS","BILPREVDA","lasofoxifene","dulpatatug","HLX43","HLX903","pimurutamab"],"companies":[{"name":"Henlius","ticker":"2696"},{"name":"Eisai Co., Ltd.","relationship":"partner"},{"name":"Abbott","relationship":"partner"},{"name":"Sandoz","relationship":"partner"}],"dollarAmounts":[{"amount":"RMB 3.5882 billion","context":"H1 2026 revenue"},{"amount":"RMB 430.4 million","context":"H1 2026 net profit"},{"amount":"RMB 572.3 million","context":"H1 2026 non-IFRS profit"},{"amount":"RMB 904.1 million","context":"H1 2026 adjusted EBITDA"},{"amount":"RMB 2.9386 billion","context":"H1 2026 global product sales revenue"},{"amount":"RMB 105.3 million","context":"H1 2026 ex-China sales revenue"},{"amount":"RMB 1.6983 billion","context":"H1 2026 breast cancer product portfolio revenue"},{"amount":"RMB 1.4507 billion","context":"H1 2026 R&D expenditure"}]},"materialImpact":{"score":4,"reasoning":"Robust H1 earnings with revenue up 27.3% YoY and non-IFRS profit surging 46.7%, coupled with a first-in-class FDA approval for serplulimab in gastric cancer and major strategic partnerships with Eisai, Abbott, and Sandoz."},"tickerRelevance":{"others":[],"primary":"2696"},"globalImportance":35,"audienceRelevance":20,"eventTypeSecondary":["operations_update","partnership"],"importanceComponents":{"tickerTier":"small-mid-cap-hk","eventGravity":"earnings-beat-and-strategic-milestones","sectorWeight":"biotech-innovation","retailFavoriteBoost":false}},"event_type":"earnings","event_type_secondary":["operations_update","partnership"],"sentiment":"bullish","material_impact_score":4,"narrative":"Henlius delivered strong H1 2026 results with revenue of RMB 3.59 billion, up 27.3% year-over-year, and non-IFRS profit surging 46.7% to RMB 572.3 million, driven by global commercialization and lean operations.\n\nOperational milestones included the first-in-class approval of serplulimab for perioperative gastric cancer in China and the launch of a Globalization 2.0 strategy via major partnerships with Eisai, Abbott, and Sandoz.\n\nR&D investment increased 45.7% to RMB 1.45 billion, accelerating the pipeline of innovative assets like the PD-L1 ADC HLX43 and the pertuzumab biosimilar HANBEIYOU, which is now approved in China, the U.S., and EU.","key_figures":{"revenueYoy":"27.3%","customDimensions":{"ebitda":904100000,"net_profit":430400000,"ex_china_sales":105300000,"non_ifrs_profit":572300000,"rnd_expenditure":1450700000,"breast_cancer_sales":1698300000}},"named_entities":{"people":[{"name":"Dr. Jason Zhu","role":"Executive Director and Chief Executive Officer"}],"products":["HANQUYOU","HERCESSI","Zercepac","HANBEIYOU","POHERDY","HANNAIJIA","fovinaciclib","Serplulimab","Hetronifly","HANBEITAI","HLX14","BILDYOS","BILPREVDA","lasofoxifene","dulpatatug","HLX43","HLX903","pimurutamab"],"companies":[{"name":"Henlius","ticker":"2696"},{"name":"Eisai Co., Ltd.","relationship":"partner"},{"name":"Abbott","relationship":"partner"},{"name":"Sandoz","relationship":"partner"}],"dollarAmounts":[{"amount":"RMB 3.5882 billion","context":"H1 2026 revenue"},{"amount":"RMB 430.4 million","context":"H1 2026 net profit"},{"amount":"RMB 572.3 million","context":"H1 2026 non-IFRS profit"},{"amount":"RMB 904.1 million","context":"H1 2026 adjusted EBITDA"},{"amount":"RMB 2.9386 billion","context":"H1 2026 global product sales revenue"},{"amount":"RMB 105.3 million","context":"H1 2026 ex-China sales revenue"},{"amount":"RMB 1.6983 billion","context":"H1 2026 breast cancer product portfolio revenue"},{"amount":"RMB 1.4507 billion","context":"H1 2026 R&D expenditure"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-21T13:02:03.501Z","global_importance":35,"audience_relevance":20,"importance_components":{"tickerTier":"small-mid-cap-hk","eventGravity":"earnings-beat-and-strategic-milestones","sectorWeight":"biotech-innovation","retailFavoriteBoost":false}},"durationMs":163750,"modelName":"glm-4.7"}}