Third Generic Abemaciclib Tablet Submitted for Market Approval in China

On May 13, the CDE website showed that the thirdSubmission of Generic Abemaciclib Tablets for Market Approval. Previously,Qilu Pharmaceutical andCorey PharmaceuticalsAbemaciclib TabletsApplications for market entry were submitted in December 2024 and January 2025, respectively, including CorePharm's.Abemaciclib Tablets have beenRecently Approved for Marketing。

The original Abemaciclib was developed by Eli Lilly.CDK4/6 inhibitors,Induction of Senescence and Apoptosis in Breast Cancer Cells by Inhibiting Cyclin D. September 2017,Abemaciclib tablets were approved for marketing in the United States for the first time, andApproved for marketing in China in December 2020.

As of now,Abemaciclib TabletsUsed for:

1）InHR+/HER2- Locally Advanced or Metastatic Breast CancerPostmenopausal WomenAmong the patients,UnitedAromatase InhibitorsAsInitial Endocrine Therapy；

2）Combined with Fulvestrant TreatmentPreviously experienced disease progression after receiving endocrine therapyHR+/HER2- locally advanced or metastatic breast cancer patients;

3) Combination endocrine therapy as adjuvant treatment for adult patients with HR+/HER2-, lymph node-positive, high-risk of recurrence, and Ki-67 ≥20% early breast cancer;

4）Adjuvant treatment in combination with endocrine therapy for adult patients with HR+/HER2-, lymph node-positive, high-risk early breast cancer.

Eli Lilly's 2025 annual report shows,Abemaciclib global sales reached 5.723 billion US dollars.