Komori
Nippon Shinyaku (4516) · InitiativeAdvanced

Domestic marketing partnership for pirtobrutinib and international joint Phase 3 trial

First written in FY2024. 2 of 3 entries say "Advanced", first in FY2025-H1. Latest entry: FY2026-H1.

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ProgressHeldSoftenedWorseFirst statedFY2024AdvancedFY2025-H1 – FY2026-H12024: 220242025: 12025
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  1. FY2026-H1AdvancedAnnual report

    「• For the reversible non-covalent BTK inhibitor LY3527727 (product name: Jaypirca® tablets 50 mg and 100 mg; generic name: pirtobrutinib), we entered into a domestic alliance agreement with Eli Lilly Japan K.K. in March 2024. Eli Lilly Japan K.K. is conducting a global Phase 3 trial in mantle cell lymphoma and chronic lymphocytic leukemia. In September 2025, Eli Lilly Japan K.K. obtained approval in Japan for an additional indication, relapsed or refractory chronic lymphocytic leukemia, including small lymphocytic lymphoma, resistant or intolerant to other BTK inhibitors.」

    While continuing the global Phase 3 trial for pirtobrutinib, we obtained approval in September 2025 for an additional indication covering chronic lymphocytic leukemia and other conditions.
  2. FY2025-H1AdvancedAnnual report

    「• For the reversible non-covalent BTK inhibitor LY3527727 (product name: Jaypirca® tablets 50 mg and 100 mg; generic name: pirtobrutinib), we entered into a domestic alliance agreement with Eli Lilly Japan K.K. in March 2024. Eli Lilly Japan K.K. obtained approval in June 2024 for the indication of relapsed or refractory mantle cell lymphoma resistant or intolerant to other BTK inhibitors and began marketing the product in August. A global Phase 3 trial is ongoing in mantle cell lymphoma and chronic lymphocytic leukemia.」

    For pirtobrutinib, the program progressed from the domestic alliance agreement and global Phase 3 trial stage, with approval obtained in June 2024 and marketing launched in August.
  3. FY2024First statedAnnual report

    「For the reversible non-covalent BTK inhibitor LY3527727 (generic name: pirtobrutinib), we entered into a domestic alliance agreement with Eli Lilly Japan in March 2024. Eli Lilly Japan is currently seeking approval for the mantle cell lymphoma indication and conducting a global Phase 3 trial in mantle cell lymphoma and chronic lymphocytic leukemia.」

    For pirtobrutinib, we entered into a domestic alliance agreement with Eli Lilly Japan in March 2024, and disclosed the status of the marketing application and global Phase 3 trial for the first time.
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Nippon Shinyaku's next results are scheduled for 2026-11-13. Read the earnings preview
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