{
  "id": 10855066,
  "title": "China approves Jaypirca for chronic lymphocytic leukaemia treatment indications",
  "url": "https://urgent.news/2026/09/30/china-approves-jaypirca-for-chronic-lymphocytic-leukaemia-treatment",
  "topic": "business",
  "section": "Business",
  "published": "2026-09-30T04:04:49.000Z",
  "source": {
    "name": "Vietnam Investment Review",
    "slug": "vietnam-investment-review",
    "url": "https://vir.com.vn/china-approves-jaypirca-for-chronic-lymphocytic-leukaemia-treatment-indications-161782.html"
  },
  "original_language": "en",
  "account": "China's National Medical Products Administration (NMPA) has granted approval for Jaypirca, a non-covalent Bruton tyrosine kinase (BTK) inhibitor, to be used as a monotherapy for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This decision expands Jaypirca's indications to encompass patients with CLL/SLL across all treatment stages, regardless of prior exposure to covalent BTK inhibitors.\n\nThe approval is validated by the results of the global Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials. The BRUIN CLL-313 study revealed a statistically significant improvement in progression-free survival for pirtobrutinib compared to bendamustine plus rituximab in treatment-naïve patients. BRUIN CLL-314, the first head-to-head trial comparing covalent and non-covalent BTK inhibitors in a BTK inhibitor-naïve population, demonstrated noninferiority for overall response rate in both ITT and previously treated patients, with numerically higher ORR than ibrutinib.\n\nProf. Jianyong Li, Principal Investigator of the BRUIN CLL-313 Study in China, emphasized that pirtobrutinib has demonstrated meaningful clinical benefits in both previously treated and treatment-naïve patients with CLL/SLL. Prof. Luqiu Qiu, Principal Investigator of the BRUIN CLL-314 Study, highlighted the novel head-to-head evidence of pirtobrutinib against a covalent BTK inhibitor in a BTK inhibitor-naïve population. Dr. Hui Zhou, Chief R&D Officer of Innovent, and Dr. Li Wang, Lilly Corporate Senior Vice President, expressed their commitment to accelerating patient access to this innovative therapy and advancing the management of CLL/SLL in China.",
  "summary": "Healthcare regulator National Medical Products Administration approved Innovent Biologics drug Jaypirca for treating chronic lymphocytic leukaemia and small lymphocytic lymphoma across all lines of therapy in China",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}