Race Heats Up in Blockbuster Generic Drug Market: CORNERSTONE and Qilu Secure Approvals for Abemaciclib

　　【Pharmaceutical Network | Industry Trends] Recent public notices on the website of the National Medical Products Administration (NMPA) indicate that Qilu Pharmaceutical’s Class 4 generic drug, abemaciclib tablets, has been officially approved for market launch, deemed as having passed the consistency evaluation. It is understood that in the second half of 2025, Qilu Pharmaceutical began submitting an Investigational New Drug (IND) application under Category 2.4 for expanded indications of abemaciclib tablets. This signifies that, building upon the approval of its generic version, Qilu is further exploring the therapeutic potential of abemaciclib in other indications, thereby pursuing a strategy that integrates generic manufacturing with innovative development.
 

Publicly available information indicates that abemaciclib is an oral CDK4/6 inhibitor developed by Eli Lilly and Company. It was first approved for marketing in the United States in September 2017 under the brand name Verzenio. In 2021, abemaciclib received approval for adjuvant treatment of HR+/HER2- early breast cancer, and its sales have been rising steadily since the new indication was approved. In 2025, the drug’s global sales reached RMB 40.7 billion; its domestic hospital-end sales exceeded RMB 800 million, representing a year-on-year increase of 11.80%.
 

Although the generic development of abemaciclib involves complex impurity control requirements—including process-related impurities (such as the piperazine N-methylated impurity and defluorinated analogs), degradation impurities (with N-oxide as the primary degradation product), and screening for genotoxic impurities—thereby setting a high bar for the R&D capabilities and quality control of generic manufacturers, the battle for generics in this field has already begun, driven by the substantial market size and the expected expiration of the drug’s core compound patent in China (US7855211) in 2028.
 

In addition to the approval granted to Qilu Pharmaceutical, Kerui Pharmaceutical secured the first domestic generic version on May 6. On May 13, Shandong Bainuo Pharmaceutical also submitted a marketing application for its generic abemaciclib tablets.
 

Furthermore, on May 21, Shanghai CD Pharmaceutical Co., Ltd. initiated a postprandial bioequivalence study of abemaciclib tablets in healthy Chinese subjects. The drug formulation is tablets, administered as a single 150 mg dose. The primary objective of this trial is to evaluate the postprandial oral bioequivalence of the test formulation compared to the reference formulation; the secondary objective is to assess the safety of a single oral dose of abemaciclib tablets in healthy female participants.
 

Industry analysts believe that with the approval of an increasing number of generic drugs, the accessibility of this medication will be significantly improved, particularly for breast cancer patients requiring long-term treatment, thereby substantially reducing their medication burden. Furthermore, this development will trigger a chain reaction across the entire domestic market for CDK4/6 inhibitors.
 

Currently, the CDK4/6 inhibitor market in China includes not only abemaciclib but also palbociclib and ribociclib. Among these, generic competition for palbociclib has become increasingly intense. The rapid advancement of abemaciclib generics will further accelerate the pace of generic competition across the entire therapeutic class, compelling manufacturers of other generic products to expedite their regulatory submissions. This trend is expected to drive down the overall prices of CDK4/6 inhibitors, thereby benefiting a larger number of patients.
 

Overall, in the next 2–3 years, as more companies receive approval, this product is highly likely to be included in centralized volume-based procurement (VBP), leading to a substantial price reduction and significantly improved patient accessibility. For relevant generic drug manufacturers, the key focus of competition in the next phase will be how to leverage first-mover and cost advantages to secure a favorable position in VBP bids.
 

　　Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice for any person.