Summit, Merck must navigate new regulatory terrain in China-first cancer landscape

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  "data": {
    "url": "https://www.biospace.com/drug-development/summit-merck-must-navigate-new-regulatory-terrain-in-china-first-cancer-landscape",
    "title": "Summit, Merck must navigate new regulatory terrain in China-first cancer landscape - BioSpace",
    "excerpt": "Last week, Summit Therapeutics and China-based partner Akeso revealed new data indicating that the efficacy of their PD-1/VEGF-targeting antibody ivonescimab can translate across geographies. This is a promising start, as China-partnered cancer assets typically must show efficacy in U.S. or global trials to attain the pinnacle: FDA approval. Why they must do so - and how sponsors should go about this - is more complicated. “Probably the biggest thing to keep in mind is this is just a flip of a process that has existed for, I don’t know, the last 20 years in drug development,” Daina Graybosch, senior managing director, immuno-oncology at Leerink Partners, told BioSpace . “It used to be that global studies were bridged to Asian countries.” Graybosch pointed to Merck’s immuno-oncology blockbuster Keytruda as an example. Merck ran a global study, KEYNOTE-407 , of Keytruda in first-line non-small cell lung cancer (NSCLC). The company then conducted a bridging study - or a smaller substudy - for Chinese regulators, “with the theory that there might be something different about the disease” in this population. Today, China hosts more of the world’s clinical trials than the U.S. or any other country, and the gap is widening, with more and more valuable assets being tested there first. “What I feel has completely transformed the conversation is that many of the assets and the trials...",
    "product": "sacituzumab tirumotecan",
    "summary": "Merck and China-based Kelun-Biotech are developing the antibody-drug conjugate (ADC) sacituzumab tirumotecan, or sac-TMT.",
    "planning": true,
    "image_url": "https://static.biospace.com/dims4/default/5666401/2147483647/strip/true/crop/2121x1193+0+110/resize/1440x810!/quality/90/?url=https%3A%2F%2Fk1-prod-biospace.s3.us-east-2.amazonaws.com%2Fbrightspot%2F25%2F72%2F3beea6af4c969b14983af0df65b9%2Fistock-1739186501.jpg",
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    "product_data": {
      "name": "sacituzumab tirumotecan",
      "full_text": "antibody-drug conjugate (ADC) sacituzumab tirumotecan, or sac-TMT",
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    "product_tags": [
      "medical"
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    "published_at": "2026-07-27T04:09:30Z",
    "article_sentence": "Earlier this month, Merck and China-based Kelun-Biotech reported positive Phase 3 results for their antibody-drug conjugate (ADC) sacituzumab tirumotecan, or sac-TMT, which, when combined with Keytruda, showed the potential to replace platinum-based chemotherapy in first line NSCLC.",
    "related_company_name": "Kelun-Biotech",
    "related_company_domain": "kelun-biotech.com"
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