Qilu Pharma Gains Approval for China's First Ibrutinib Tablet Generic, Challenging J&J's Imbruvica

Jan 16, 2025 16:00 CST Updated 16:00

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Johnson & Johnson

Medical Device R&D and Manufacturer

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On January 8, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical Co., Ltd. successfully obtained approval for the generic version of Ibrutinib tablets, marking the birth of China's first generic Ibrutinib tablet. Ibrutinib (trade name: Imbruvica), a BTK inhibitor jointly developed by Johnson & Johnson and AbbVie, pioneered the global BTK inhibitor market.

Currently, Ibrutinib has been launched in three dosage forms: tablets, capsules, and suspensions. Among them, the capsule form was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2013, available in two strengths: 70mg and 140mg; the tablet form received FDA approval in February 2018, with strengths covering 140mg, 280mg, 420mg, and 560mg; additionally, a 70mg/mL suspension form was also approved in the United States in August 2022.

Ibrutinib has received six FDA approvals in the United States for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), and chronic graft-versus-host disease (cGVHD), with peak sales nearing 10 billion USD.

The success of Ibrutinib has ushered in a new era in the field of hematological tumor treatment, followed by the introduction of several drugs targeting the same point, such as Acalabrutinib (AstraZeneca), Tirabrutinib (Gilead), Zanubrutinib (BeiGene), Orelabrutinib (InnoCare Pharma), and Pirtobrutinib (Eli Lilly). In the Chinese market, the compound patent for Ibrutinib is set to expire on December 28, 2026. Prior to this, Simcere Pharmaceutical had already obtained the first generic qualification for Ibrutinib capsules in October 2022.

In addition, Natco Pharma's Ibrutinib capsules, developed in collaboration with Haibu Pharmaceutical/Yabao Biotech, are also expected to gain approval in 2024. Several companies in China, including Double-Crane Pharmaceutical, Huadong Medicine, and Nanjing Chia Tai Tianqing, have entered the Ibrutinib generic drug market. However, only Hunan Kelun Pharmaceutical and Qilu Pharmaceutical have ventured into the Ibrutinib tablet generics sector.

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