{"success":true,"data":{"pressRelease":{"id":"32678","rtpr_id":"nPNAMjfkwa","ticker":"6990","exchange":"HKEX","all_tickers":["6990"],"title":"Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody","author":"PR Newswire","published_at":"2026-05-13T00:00:00.067Z","article_body":"Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118,\na PD-1 x VEGF Bispecific Antibody\nPR Newswire\n\nCHENGDU, China, May 12, 2026\n\nCHENGDU, China, May 12, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech\nBiopharmaceutical Co., Ltd. (\"Kelun-Biotech\" or the \"Company\", 6990.HK)\nannounced that it has received a clinical trial notice from the Center for\nDrug Evaluation (CDE) of the National Medical Products Administration (NMPA)\napproving the Investigational New Drug (IND) application for PD-1 x VEGF\nbispecific antibody SKB118 (also known as CR-001) for the treatment of\nadvanced solid tumors.\n\n(https://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.html)\n\nIn December 2025, Kelun-Biotech and Crescent Biopharma (\"Crescent\") entered\ninto a strategic collaboration for SKB118/CR-001. Under the collaboration,\nCrescent granted Kelun-Biotech exclusive rights to research, develop,\nmanufacture and commercialize SKB118/CR-001 in Greater China (including\nMainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent\nannounced the regulatory clearance of the IND application for SKB118/CR-001 by\nthe U.S. Food and Drug Administration (FDA) to initiate its global ASCEND\nPhase I/II clinical trial (NCT07335497) for the treatment of locally advanced\nor metastatic solid tumors. The trial is ongoing and expected to initially\nenroll up to 290 patients.\n\nDr. Michael Ge, CEO of Kelun-Biotech, stated: \"We are pleased to see the\napproval of the IND application for SKB118 in China, which marks the\nsimultaneous advancement of clinical development in China and globally. Since\nentering into the collaboration with Crescent, we have worked closely and\nleveraged complementary advantages with each other to efficiently drive the\nR&D of the collaborative product candidates. Based on our ADC+IO strategies,\nwe will actively explore the potential of combining SKB118 with our\nproprietary ADC assets to unlock the synergistic value of our portfolio and\nexpand more treatment possibilities for cancer patients.\"\n\nAbout SKB118 (also known as CR-001)\n\nSKB118 is a tetravalent bispecific antibody being developed for the treatment\nof solid tumors that combines two complementary, validated mechanisms in\noncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed\nat restoring T cells' ability to recognize and destroy tumor cells, and\nblocking VEGF is intended to reduce blood supply to tumor cells and to inhibit\ntumor growth. In preclinical studies, SKB118 demonstrated cooperative\npharmacology with increased binding to PD-1 and signal blockade in the\npresence of VEGF as well as robust anti-tumor activity. SKB118's anti-VEGF\nactivity may also normalize the vasculature at the tumor site, which has the\npotential to improve the localization and effectiveness of combination\ntherapies, such as in combination with antibody-drug conjugates (ADCs).\n\nAbout Kelun-Biotech\n\nKelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which\nfocuses on the R&D, manufacturing, commercialization and global collaboration\nof innovative biological drugs and small molecule drugs. Kelun-Biotech focuses\non major disease areas such as solid tumors, autoimmune, and metabolic\ndiseases, and in establishing a globalized drug development and\nindustrialization platform to address the unmet medical needs in China and the\nrest of world. Kelun-Biotech is committed to becoming a leading global\nenterprise in the field of innovative drugs. At present, Kelun-Biotech has\nmore than 30 ongoing key innovative drug projects, of which 4 projects with 8\nindications have been approved for marketing, 1 project is in the NDA stage\nand more than 10 projects are in the clinical stage. Kelun-Biotech has\nestablished one of the world's leading proprietary ADC and novel DC platforms,\nOptiDC™, and has 2 ADC projects with 5 indications approved for marketing,\nand multiple ADC and novel DC assets in clinical or preclinical research\nstage. For more information, please visit https://en.kelun-biotech.com/\n\nView original content to download\nmultimedia:https://www.prnewswire.com/apac/news-releases/kelun-biotech-receives-investigational-new-drug-approval-from-cde-for-skb118-a-pd-1-x-vegf-bispecific-antibody-302769694.html\n\nSOURCE Kelun-Biotech\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPNAMjfkwa","title":"Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody","author":"PR Newswire","ticker":"6990","created":"2026-05-13T00:00:00.067Z","tickers":["6990"],"exchange":"HKEX","article_body":"Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118,\na PD-1 x VEGF Bispecific Antibody\nPR Newswire\n\nCHENGDU, China, May 12, 2026\n\nCHENGDU, China, May 12, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech\nBiopharmaceutical Co., Ltd. (\"Kelun-Biotech\" or the \"Company\", 6990.HK)\nannounced that it has received a clinical trial notice from the Center for\nDrug Evaluation (CDE) of the National Medical Products Administration (NMPA)\napproving the Investigational New Drug (IND) application for PD-1 x VEGF\nbispecific antibody SKB118 (also known as CR-001) for the treatment of\nadvanced solid tumors.\n\n(https://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.html)\n\nIn December 2025, Kelun-Biotech and Crescent Biopharma (\"Crescent\") entered\ninto a strategic collaboration for SKB118/CR-001. Under the collaboration,\nCrescent granted Kelun-Biotech exclusive rights to research, develop,\nmanufacture and commercialize SKB118/CR-001 in Greater China (including\nMainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent\nannounced the regulatory clearance of the IND application for SKB118/CR-001 by\nthe U.S. Food and Drug Administration (FDA) to initiate its global ASCEND\nPhase I/II clinical trial (NCT07335497) for the treatment of locally advanced\nor metastatic solid tumors. The trial is ongoing and expected to initially\nenroll up to 290 patients.\n\nDr. Michael Ge, CEO of Kelun-Biotech, stated: \"We are pleased to see the\napproval of the IND application for SKB118 in China, which marks the\nsimultaneous advancement of clinical development in China and globally. Since\nentering into the collaboration with Crescent, we have worked closely and\nleveraged complementary advantages with each other to efficiently drive the\nR&D of the collaborative product candidates. Based on our ADC+IO strategies,\nwe will actively explore the potential of combining SKB118 with our\nproprietary ADC assets to unlock the synergistic value of our portfolio and\nexpand more treatment possibilities for cancer patients.\"\n\nAbout SKB118 (also known as CR-001)\n\nSKB118 is a tetravalent bispecific antibody being developed for the treatment\nof solid tumors that combines two complementary, validated mechanisms in\noncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed\nat restoring T cells' ability to recognize and destroy tumor cells, and\nblocking VEGF is intended to reduce blood supply to tumor cells and to inhibit\ntumor growth. In preclinical studies, SKB118 demonstrated cooperative\npharmacology with increased binding to PD-1 and signal blockade in the\npresence of VEGF as well as robust anti-tumor activity. SKB118's anti-VEGF\nactivity may also normalize the vasculature at the tumor site, which has the\npotential to improve the localization and effectiveness of combination\ntherapies, such as in combination with antibody-drug conjugates (ADCs).\n\nAbout Kelun-Biotech\n\nKelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which\nfocuses on the R&D, manufacturing, commercialization and global collaboration\nof innovative biological drugs and small molecule drugs. Kelun-Biotech focuses\non major disease areas such as solid tumors, autoimmune, and metabolic\ndiseases, and in establishing a globalized drug development and\nindustrialization platform to address the unmet medical needs in China and the\nrest of world. Kelun-Biotech is committed to becoming a leading global\nenterprise in the field of innovative drugs. At present, Kelun-Biotech has\nmore than 30 ongoing key innovative drug projects, of which 4 projects with 8\nindications have been approved for marketing, 1 project is in the NDA stage\nand more than 10 projects are in the clinical stage. Kelun-Biotech has\nestablished one of the world's leading proprietary ADC and novel DC platforms,\nOptiDC™, and has 2 ADC projects with 5 indications approved for marketing,\nand multiple ADC and novel DC assets in clinical or preclinical research\nstage. For more information, please visit https://en.kelun-biotech.com/\n\nView original content to download\nmultimedia:https://www.prnewswire.com/apac/news-releases/kelun-biotech-receives-investigational-new-drug-approval-from-cde-for-skb118-a-pd-1-x-vegf-bispecific-antibody-302769694.html\n\nSOURCE Kelun-Biotech\n\n\n\nPhoto: \nhttps://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.jpg\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-05-13T00:00:00.139918149Z","server_sent_at_ms":1778630400139},"received_at":"2026-05-13T00:00:00.204Z","source_url":null},"analysis":{"id":"23461","press_release_id":"32678","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Kelun-Biotech has received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for SKB118, a PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors.\n\nIn December 2025, Kelun-Biotech entered into a strategic collaboration with Crescent Biopharma, granting Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China.\n\nCrescent Biopharma also received regulatory clearance from the U.S. FDA in January 2026 to initiate a global ASCEND Phase I/II clinical trial for SKB118, which is ongoing and expected to initially enroll up to 290 patients.\n\nDr. Michael Ge, CEO of Kelun-Biotech, expressed satisfaction with the IND approval, noting the simultaneous advancement of clinical development in China and globally. The company plans to explore the potential of combining SKB118 with its proprietary ADC assets to unlock synergistic value and expand treatment possibilities for cancer patients.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"IND approval for SKB118 in China and global Phase I/II trial underway — significant milestone for Kelun-Biotech's oncology pipeline."},"keyFigures":{"drugName":"SKB118 (also known as CR-001)","phaseOfTrial":"Phase I/II"},"quotedText":"We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally.","namedEntities":{"people":[{"name":"Dr. Michael Ge","role":"CEO"}],"products":["SKB118","CR-001","OptiDC™"],"companies":[{"name":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","ticker":"6990.HK","relationship":"filer"},{"name":"Crescent Biopharma","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"IND approval for a bispecific antibody is a significant milestone in drug development, especially for a company with a strong pipeline. The partnership with Crescent Biopharma adds additional value and global reach."},"tickerRelevance":{"others":[],"primary":"6990"},"globalImportance":45,"audienceRelevance":60,"eventTypeSecondary":["partnership"],"importanceComponents":{"tickerTier":"mid-cap","eventGravity":"IND approval and global trial","sectorWeight":"Health Care","householdBrandBoost":"moderate","marketCapAdjustment":"positive"}},"event_type":"regulatory","event_type_secondary":["partnership"],"sentiment":"bullish","material_impact_score":3,"narrative":"Kelun-Biotech has received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for SKB118, a PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors.\n\nIn December 2025, Kelun-Biotech entered into a strategic collaboration with Crescent Biopharma, granting Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China.\n\nCrescent Biopharma also received regulatory clearance from the U.S. FDA in January 2026 to initiate a global ASCEND Phase I/II clinical trial for SKB118, which is ongoing and expected to initially enroll up to 290 patients.\n\nDr. Michael Ge, CEO of Kelun-Biotech, expressed satisfaction with the IND approval, noting the simultaneous advancement of clinical development in China and globally. The company plans to explore the potential of combining SKB118 with its proprietary ADC assets to unlock synergistic value and expand treatment possibilities for cancer patients.","key_figures":{"drugName":"SKB118 (also known as CR-001)","phaseOfTrial":"Phase I/II"},"named_entities":{"people":[{"name":"Dr. Michael Ge","role":"CEO"}],"products":["SKB118","CR-001","OptiDC™"],"companies":[{"name":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","ticker":"6990.HK","relationship":"filer"},{"name":"Crescent Biopharma","relationship":"partner"}],"dollarAmounts":[]},"model_name":"Qwen/Qwen2.5-72B-Instruct-AWQ","prompt_hash":"sha256:a68c0d5c02b24190","schema_hash":"sha256:4b22e0a142e5d4b1","created_at":"2026-05-13T00:01:18.949Z","global_importance":45,"audience_relevance":60,"importance_components":{"tickerTier":"mid-cap","eventGravity":"IND approval and global trial","sectorWeight":"Health Care","householdBrandBoost":"moderate","marketCapAdjustment":"positive"}},"durationMs":78739,"modelName":"george-droid-qwen-72b"}}