{"success":true,"data":{"pressRelease":{"id":"152698","rtpr_id":"nPn2FstbRa-20260925","ticker":"2228","exchange":"HKEX","all_tickers":["2228"],"title":"XtalPi Submits U.S. FDA IND Application for KQTD-126, a Potential First-in-Class, Gut-Restricted Pan-TRK Inhibitor for Chronic Intestinal Pain","author":"PR Newswire","published_at":"2026-09-25T00:30:00.690Z","article_body":"XtalPi Submits U.S. FDA IND Application for KQTD-126, a Potential First-in-Class, Gut-Restricted Pan-TRK Inhibitor for Chronic Intestinal Pain\nPR Newswire\n\nBOSTON and SHENZHEN, CHINA, Sept. 24, 2026\n\n * This milestone marks the first IND submission from XtalPi's proprietary\npipeline, recently unveiled in its interim results, validating the company's\nAI and robotics-driven drug discovery platform and its transition to a\nclinical-stage organization.\n * Preclinical data demonstrate sub-nanomolar potency (< 1 nM) alongside a\ngut-to-blood exposure ratio exceeding 1,000:1, confining pharmacological\nactivity to the gastrointestinal tract to limit systemic exposure.\n * The candidate is the industry's first gut-restricted pan-TRK inhibitor\ndeveloped for IBS and IBD, targeting a critical therapeutic gap in the\nlong-term management of chronic pain without the neurological liabilities of\nsystemic inhibitors.\nBOSTON and SHENZHEN, CHINA, Sept. 24, 2026 /PRNewswire/ -- XtalPi (HKEX:\n2228), an AI- and robotics-driven drug and materials discovery company, today\nannounced the submission of an Investigational New Drug (IND) application to\nthe U.S. Food and Drug Administration (FDA) for KQTD-126. Developed\ninternally, the candidate is a potential first-in-class gut-restricted\npan-tropomyosin receptor kinase (pan-TRK) inhibitor designed to treat chronic\nintestinal pain associated with irritable bowel syndrome (IBS) and\ninflammatory bowel disease (IBD).\n\nIBS affects approximately 10%–15% of the global population, while more than\n10 million people live with IBD. Chronic abdominal pain is a major burden for\npatients with IBS and can persist in some patients with IBD even when standard\ntherapies control their underlying inflammation. Despite available treatments,\nadditional options that provide sustained pain relief and are suitable for\nlong-term use remain an unmet clinical need. According to BCC Research, the\nglobal IBS and IBD therapeutics market is projected to reach US$52.6 billion\nby 2030.\n\nKQTD-126 targets the TRK family of receptors (TRKA, TRKB, and TRKC), which\ndirectly regulate nerve activity and pain-signal amplification in the gut.\nWhile inhibiting these pathways can effectively manages this pain, TRK\nreceptors also operate throughout the central nervous system. Consequently,\ntraditional systemic TRK inhibitors carry a high risk of neurological side\neffects. A viable chronic pain treatment must therefore confine its activity\nstrictly to the gastrointestinal tract.\n\nAchieving this precise biological profile required navigating a vast chemical\nspace to balance target affinity and kinase selectivity with properties\ngoverning tissue distribution. To resolve these competing design objectives,\nXtalPi leveraged its generative and predictive AI models integrated with its\nfleet of automated chemistry robots. This closed-loop process of computational\ndesign, automated synthesis, empirical screening, and molecular refinement\nallowed the company to iterate across structural variants and achieve robust\ngut restriction while preserving strong target activity and selectivity.\n\nIn preclinical studies, KQTD-126 achieved pan-TRK inhibition at sub-nanomolar\nconcentrations (IC₅₀ < 1 nM) and maintained high selectivity over other\nkinases. The candidate also demonstrated a gut tissue-to-blood exposure ratio\nexceeding 1,000:1. Together, these findings support KQTD-126's development as\na locally acting treatment intended to deliver sustained pain relief with a\nwider therapeutic window.\n\nKQTD-126 is the first program in XtalPi's proprietary pipeline to reach an IND\nsubmission since the portfolio was unveiled in the company's recent interim\nresults. As a global scientific utility platform, XtalPi draws on a shared\nfoundation of quantum physics, AI, and robotics to deliver discovery\ncapabilities spanning small molecules, antibodies, peptides, siRNA\ntherapeutics, and molecular glues. This comprehensive infrastructure empowers\nthe company and its partners to pursue high-value targets using the modality\nbest suited to the underlying biology. By advancing internal assets alongside\nestablished collaborations, XtalPi maximizes the impact of its technology to\nresolve complex drug design challenges and deliver transformative therapies\nfor patients worldwide.\n\nAbout XtalPi\n\nXtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three\nphysicists from the Massachusetts Institute of Technology (MIT). It is an\ninnovative R&D platform powered by quantum physics, artificial\nintelligence, and robotics. By integrating first-principles calculations, AI\nalgorithms, high-performance cloud computing, and standardized automation\nsystems, XtalPi provides digital and intelligent R&D solutions for\ncompanies in the pharmaceutical, materials science, agricultural technology,\nenergy, new chemicals, and cosmetics industries.\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/xtalpi-submits-us-fda-ind-application-for-kqtd-126-a-potential-first-in-class-gut-restricted-pan-trk-inhibitor-for-chronic-intestinal-pain-302889891.html\n(https://www.prnewswire.com/news-releases/xtalpi-submits-us-fda-ind-application-for-kqtd-126-a-potential-first-in-class-gut-restricted-pan-trk-inhibitor-for-chronic-intestinal-pain-302889891.html)\n\nSOURCE XtalPi Inc.\n\n\n\nWangRuyu, ruyu.wang@xtalpi.com, +1 (617) 717 9867\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1968595/XtalPi_EN_Logo.jpg?id=OA2970750\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn2FstbRa-20260925","title":"XtalPi Submits U.S. FDA IND Application for KQTD-126, a Potential First-in-Class, Gut-Restricted Pan-TRK Inhibitor for Chronic Intestinal Pain","author":"PR Newswire","ticker":"2228","created":"2026-09-25T00:30:00.690Z","tickers":["2228"],"exchange":"HKEX","article_body":"XtalPi Submits U.S. FDA IND Application for KQTD-126, a Potential First-in-Class, Gut-Restricted Pan-TRK Inhibitor for Chronic Intestinal Pain\nPR Newswire\n\nBOSTON and SHENZHEN, CHINA, Sept. 24, 2026\n\n * This milestone marks the first IND submission from XtalPi's proprietary\npipeline, recently unveiled in its interim results, validating the company's\nAI and robotics-driven drug discovery platform and its transition to a\nclinical-stage organization.\n * Preclinical data demonstrate sub-nanomolar potency (< 1 nM) alongside a\ngut-to-blood exposure ratio exceeding 1,000:1, confining pharmacological\nactivity to the gastrointestinal tract to limit systemic exposure.\n * The candidate is the industry's first gut-restricted pan-TRK inhibitor\ndeveloped for IBS and IBD, targeting a critical therapeutic gap in the\nlong-term management of chronic pain without the neurological liabilities of\nsystemic inhibitors.\nBOSTON and SHENZHEN, CHINA, Sept. 24, 2026 /PRNewswire/ -- XtalPi (HKEX:\n2228), an AI- and robotics-driven drug and materials discovery company, today\nannounced the submission of an Investigational New Drug (IND) application to\nthe U.S. Food and Drug Administration (FDA) for KQTD-126. Developed\ninternally, the candidate is a potential first-in-class gut-restricted\npan-tropomyosin receptor kinase (pan-TRK) inhibitor designed to treat chronic\nintestinal pain associated with irritable bowel syndrome (IBS) and\ninflammatory bowel disease (IBD).\n\nIBS affects approximately 10%–15% of the global population, while more than\n10 million people live with IBD. Chronic abdominal pain is a major burden for\npatients with IBS and can persist in some patients with IBD even when standard\ntherapies control their underlying inflammation. Despite available treatments,\nadditional options that provide sustained pain relief and are suitable for\nlong-term use remain an unmet clinical need. According to BCC Research, the\nglobal IBS and IBD therapeutics market is projected to reach US$52.6 billion\nby 2030.\n\nKQTD-126 targets the TRK family of receptors (TRKA, TRKB, and TRKC), which\ndirectly regulate nerve activity and pain-signal amplification in the gut.\nWhile inhibiting these pathways can effectively manages this pain, TRK\nreceptors also operate throughout the central nervous system. Consequently,\ntraditional systemic TRK inhibitors carry a high risk of neurological side\neffects. A viable chronic pain treatment must therefore confine its activity\nstrictly to the gastrointestinal tract.\n\nAchieving this precise biological profile required navigating a vast chemical\nspace to balance target affinity and kinase selectivity with properties\ngoverning tissue distribution. To resolve these competing design objectives,\nXtalPi leveraged its generative and predictive AI models integrated with its\nfleet of automated chemistry robots. This closed-loop process of computational\ndesign, automated synthesis, empirical screening, and molecular refinement\nallowed the company to iterate across structural variants and achieve robust\ngut restriction while preserving strong target activity and selectivity.\n\nIn preclinical studies, KQTD-126 achieved pan-TRK inhibition at sub-nanomolar\nconcentrations (IC₅₀ < 1 nM) and maintained high selectivity over other\nkinases. The candidate also demonstrated a gut tissue-to-blood exposure ratio\nexceeding 1,000:1. Together, these findings support KQTD-126's development as\na locally acting treatment intended to deliver sustained pain relief with a\nwider therapeutic window.\n\nKQTD-126 is the first program in XtalPi's proprietary pipeline to reach an IND\nsubmission since the portfolio was unveiled in the company's recent interim\nresults. As a global scientific utility platform, XtalPi draws on a shared\nfoundation of quantum physics, AI, and robotics to deliver discovery\ncapabilities spanning small molecules, antibodies, peptides, siRNA\ntherapeutics, and molecular glues. This comprehensive infrastructure empowers\nthe company and its partners to pursue high-value targets using the modality\nbest suited to the underlying biology. By advancing internal assets alongside\nestablished collaborations, XtalPi maximizes the impact of its technology to\nresolve complex drug design challenges and deliver transformative therapies\nfor patients worldwide.\n\nAbout XtalPi\n\nXtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three\nphysicists from the Massachusetts Institute of Technology (MIT). It is an\ninnovative R&D platform powered by quantum physics, artificial\nintelligence, and robotics. By integrating first-principles calculations, AI\nalgorithms, high-performance cloud computing, and standardized automation\nsystems, XtalPi provides digital and intelligent R&D solutions for\ncompanies in the pharmaceutical, materials science, agricultural technology,\nenergy, new chemicals, and cosmetics industries.\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/xtalpi-submits-us-fda-ind-application-for-kqtd-126-a-potential-first-in-class-gut-restricted-pan-trk-inhibitor-for-chronic-intestinal-pain-302889891.html\n(https://www.prnewswire.com/news-releases/xtalpi-submits-us-fda-ind-application-for-kqtd-126-a-potential-first-in-class-gut-restricted-pan-trk-inhibitor-for-chronic-intestinal-pain-302889891.html)\n\nSOURCE XtalPi Inc.\n\n\n\nWangRuyu, ruyu.wang@xtalpi.com, +1 (617) 717 9867\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1968595/XtalPi_EN_Logo.jpg?id=OA2970750\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-09-25T00:30:00.733882878Z","server_sent_at_ms":1790296200733},"received_at":"2026-09-25T00:30:00.784Z","source_url":"https://www.prnewswire.com/news-releases/xtalpi-submits-us-fda-ind-application-for-kqtd-126-a-potential-first-in-class-gut-restricted-pan-trk-inhibitor-for-chronic-intestinal-pain-302889891.html"},"analysis":{"id":"141500","press_release_id":"152698","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["Candidate remains pre-Phase 1; IND submission does not guarantee clinical trial clearance","Pan-TRK mechanism carries known neurological risk if gut restriction fails in humans"],"eventType":"clinical_trial","narrative":"XtalPi (HKEX: 2228) submitted a U.S. FDA IND application for KQTD-126, a potential first-in-class gut-restricted pan-TRK inhibitor targeting chronic intestinal pain in IBS and IBD.\n\nPreclinical data show sub-nanomolar pan-TRK potency (IC50 < 1 nM) and a gut-to-blood exposure ratio exceeding 1,000:1, designed to limit systemic neurological risk.\n\nThis is the first IND from XtalPi's proprietary pipeline, validating its AI and robotics-driven discovery platform and its transition to a clinical-stage organization.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First internal IND moves XtalPi into clinical-stage territory with a first-in-class gut-restricted pain asset."},"keyFigures":{"drugName":"KQTD-126","phaseOfTrial":"IND submission (pre-Phase 1)","customDimensions":{"ic50":"< 1 nM pan-TRK inhibition","ibd_patients":">10 million","ibs_prevalence":"10-15% of global population","ibs_ibd_market_2030":"US$52.6 billion (BCC Research)","gut_to_blood_exposure_ratio":">1,000:1"}},"quotedText":"This milestone marks the first IND submission from XtalPi's proprietary pipeline, recently unveiled in its interim results, validating the company's AI and robotics-driven drug discovery platform and its transition to a clinical-stage organization.","namedEntities":{"people":[{"name":"WangRuyu","role":"media contact"}],"products":["KQTD-126"],"companies":[{"name":"XtalPi Holdings Limited","ticker":"2228","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Massachusetts Institute of Technology","relationship":"founders' affiliation"},{"name":"BCC Research","relationship":"market research source"}],"dollarAmounts":[{"amount":"US$52.6 billion","context":"projected global IBS and IBD therapeutics market by 2030 per BCC Research"}]},"materialImpact":{"score":3,"reasoning":"First IND submission from XtalPi's proprietary pipeline, marking its transition to a clinical-stage company with a potential first-in-class gut-restricted pan-TRK inhibitor. Still a preclinical-to-clinical milestone, not approval or data readout."},"tickerRelevance":{"others":[],"primary":"2228"},"globalImportance":30,"audienceRelevance":20,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap HKEX listing","eventGravity":"IND submission, early pipeline milestone","issuerAuthored":true,"marketCapAdjustment":"non-U.S. listed, lower U.S. audience overlap"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"XtalPi (HKEX: 2228) submitted a U.S. FDA IND application for KQTD-126, a potential first-in-class gut-restricted pan-TRK inhibitor targeting chronic intestinal pain in IBS and IBD.\n\nPreclinical data show sub-nanomolar pan-TRK potency (IC50 < 1 nM) and a gut-to-blood exposure ratio exceeding 1,000:1, designed to limit systemic neurological risk.\n\nThis is the first IND from XtalPi's proprietary pipeline, validating its AI and robotics-driven discovery platform and its transition to a clinical-stage organization.","key_figures":{"drugName":"KQTD-126","phaseOfTrial":"IND submission (pre-Phase 1)","customDimensions":{"ic50":"< 1 nM pan-TRK inhibition","ibd_patients":">10 million","ibs_prevalence":"10-15% of global population","ibs_ibd_market_2030":"US$52.6 billion (BCC Research)","gut_to_blood_exposure_ratio":">1,000:1"}},"named_entities":{"people":[{"name":"WangRuyu","role":"media contact"}],"products":["KQTD-126"],"companies":[{"name":"XtalPi Holdings Limited","ticker":"2228","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Massachusetts Institute of Technology","relationship":"founders' affiliation"},{"name":"BCC Research","relationship":"market research source"}],"dollarAmounts":[{"amount":"US$52.6 billion","context":"projected global IBS and IBD therapeutics market by 2030 per BCC Research"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-25T00:30:06.815Z","global_importance":30,"audience_relevance":20,"importance_components":{"tickerTier":"mid-cap HKEX listing","eventGravity":"IND submission, early pipeline milestone","issuerAuthored":true,"marketCapAdjustment":"non-U.S. listed, lower U.S. audience overlap"}},"durationMs":6020,"modelName":"glm-5.3-flashx"}}