On February 12, 2026, Eli Lilly announced that its BTK inhibitor “Pirtobrutinib Tablets” had been approved for marketing in China for a new indication, specifically for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment regimen including a Bruton’s tyrosine kinase (BTK) inhibitor. In China, Pirtobrutinib was first approved for marketing in October 2024 for the third-line treatment of MCL. This approval marks the second indication for the drug in China.

Pirtrobrutinib (Trade name is Jaypirca^®) is a highly selective, non-covalent BTK inhibitor. By reversibly binding to BTK, it maintains activity in the presence of the acquired resistance C481 mutation, provides continuous high target coverage, and avoids complications caused by off-target effects of other non-covalent BTK inhibitors.

This drug is a blockbuster product acquired by Eli Lilly through the $8 billion acquisition of Loxo Oncology in early 2019. In December 2024, Innovent Biologics reached a cooperation agreement with Eli Lilly, introducing the import, sales, promotion, and distribution rights of Pembrolizumab in Chinese Mainland.

Pirtrobrutinib was initially approved for marketing in the United States on January 27, 2023, and has subsequently been approved for marketing in major markets such as Canada and China. Currently, the drug has been approved for two types of cancer: 1) third-line treatment for relapsed or refractory mantle cell lymphoma (MCL); 2) second-line and third-line treatment for CLL/SLL.

As the first non-covalent and reversible BTK inhibitor, Pirtobrutinib has demonstrated its therapeutic potential through multiple phase III clinical trials that have head-to-head defeated previous drugs, and is actively expanding its indications for different hematological malignancies, pushing the treatment line forward. In 2024, Pirtobrutinib generated revenue of $337 million, and in 2025, it reached $506 million, still experiencing rapid growth.

In addition, Pirtobrutinib has begun to expand its autoimmune indications, and in December 2024, it initiated its first clinical study on autoimmune diseases-a Phase I/II study targeting adult patients with immune thrombocytopenia.

Currently, the China National Medical Products Administration (NMPA) Drug Patent Information Registration Platform links to seven patents for Pirtobrutinib, as shown in the table below. Patents 2-7 are divisional patents of Patent 1. The expiration dates for all seven patents are December 16, 2036. This indicates that the patent protection for Pirtobrutinib in China is strong and not easily breached by generic pharmaceutical companies.

Reference materials:

1. https://mp.weixin.qq.com/s/FCHoFUgdPKdxuM5HnM3fXA

2. https://news.qq.com/rain/a/20260105A04KJK00