On May 13, the CDE website showed that the thirdAbemaciclib Tablets Generic Drug Submission for Market Application from Shandong Baina.Previously,Qilu Pharmaceutical and Jiangxi, a subsidiary of Qingfeng PharmaceuticalCorePharmTheAbemaciclib TabletsScheduled for market application in December 2024 and January 2025, respectively.Including Kexin PharmaceuticalAbemaciclib Tablets were approved for marketing on May 6, becoming the first domestically produced generic drug in China.Abemaciclib is a product 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.Eli Lilly's 2025 annual report shows,Abemaciclib global sales reached 5.723 billion US dollars.In China, according toMox Entropy PharmaceuticalsData shows that the sales revenue of Abemaciclib in China's full-terminal hospital market will exceed 800 million yuan in 2025.Source: Mosan PharmaceuticalsBehind the steady market growth lies a large patient base and clear clinical positioning—HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for more than 70% of all breast cancer cases.CDK4/6 inhibitors have become a treatment for patients with advanced stages of this subtype.The standard treatment regimen effectively blocks tumor cell cycle progression, induces senescence and apoptosis in breast cancer cells, and significantly prolongs progression-free survival in patients.Currently, abemaciclib is globallyThe top-selling CDK4/6 inhibitor.Therefore, it is not justCorePharm, Qilu has also made an early layout, and compared toCorey Pharmaceutical earlier, Qilu Pharmaceutical Co., Ltd.AbemaciclibThe first company to have its generic drug market application accepted.Qilu completed the BE trial and submitted it for marketing at the end of 2024, while Core Pharma followed shortly after and was accepted at the beginning of 2025. It was initially believed that Qilu would be the first domestically produced generic drug in China, but unexpectedly, Core Pharma was ultimately approved first.ViaBoth have gone through the release phase. CoreRay completed the supplementary materials earlier, while Qilu Pharmaceutical just finished the supplementary materials task on May 6th and should be proceeding soon.There will be results as well.AbemaciclibBesides Qilu,In addition to CorePharm and Shandong Baina, which have submitted for listing, another company, Shanghai CrePharm, has completed the BE trial.Source: Mosana PharmaceuticalsHowever, CorePharm's first generic product does not pose a temporary threat to Eli Lilly.The core patent for abemaciclib will not expire until 2029. Both Qilu Pharmaceutical and Core Pharma have issued Class 3 statements, meaning they cannot sell the product even if approved.But that said, the trend of involution has become increasingly clear.The competition for CDK4/6 inhibitors is extremely fierce, whether from the perspective of generic drugs or innovative drugs, it is a battleground.Globally, Pfizer's Palbociclib and Novartis'Ribociclib and Eli Lilly's Abemaciclib, three inCDK4/6 inhibitors, inWith nearly $5 billion in sales globally, the quality of this target is evident.The higher the quality of the target, the more brutal the iteration. Let's take a look at the global market situation of these three drugs over the years.Three ProductsCDK4/6 InhibitorsGlobal Sales; Unit: Million USD2024 is the moment of transition between the old and new leaders, Pfizer'sPalbociclib was launched in the U.S. in 2015 and has been the leading drug since then, developed by Eli Lilly.Abemaciclib and Novartis'Ribociclib showed an ultra-high growth rate in the U.S. market since its launch in 2017, until 2024 when Abemaciclib took its place.Palbociclib has become the best-selling drug for this target.As early as 2022, the sales of Palbociclib began to gradually decline under the influence of two newer drugs, which is stillPalbociclib's U.S. patent has not yet expired, but it will expire by 2027. Under the impact of generic drugs,Palbociclib will face a patent cliff.Lilly'sAbemaciclib, Beyond 2024PalbociclibThe growth rate reached 37%, but by 2025, the growth rate will be only 8%, while Novartis'sRibociclib, with a staggering growth rate by 202557%. At this growth rate, sales will surpass abemaciclib by 2026.Abemaciclib andThe patents for Palbociclib will not expire until 2029-30, and it will not be affected by generic drugs for the time being.Such intense competition is more familiar with GLP-1 drugs, which have become extremely competitive both in China and internationally.How can CDK4/6 inhibitors not be competitive?The focus returns to China domestically.Palbociclib was the first to be marketed.CDK4/6 Inhibitor, Tablet Launched in 2018, China Patent Expires in 2023, In ChinaThe progress of generic drugs is rapid. Palbociclib capsules have been included in the national procurement in China. The original research drug failed to win the bid, and the overall sales have started to decline.Pfizer launched the tablet formulation in 2022, and so far, only Shiyao and Zhengdatianqing have received approval. The competition for this product has become extremely intense.Abemaciclib, the first generic version has been released, but cannot be sold.There are currently no generic manufacturers of Ribociclib in China.The best-selling CDK4/6 inhibitor is Abemaciclib, so it’s no surprise that Qilu Pharmaceutical and Qingfeng Pharmaceutical entered the market early.
In China, there is not only competition in generic drugs but also rapid progress in innovative drug development.The most proficient in China is in "me-too" and "me-better" target drugs. As of now, domestically...A total of 10 CDK4/6 inhibitors have been launched, 5 of which are self-developed in China, 2 were introduced by domestic companies, and more than ten other companies are still in the research and development stage.
In 2021, Hengrui's self-developedDaluxil tablet has been successfully launched with sales exceeding 500 million yuan. This target is expected to see an explosive growth period in recent years, with four domestically produced self-developed drugs hitting the market by 2025, at an astonishing speed.By 2029, it is unknown how intense the competition will be.↓⭐Follow Yaotong Society, Insight into Industry Trends ↓Submission/Corporate Cooperation/Content Communication:Editor-in-Chief of PharmaTong Society—Huaji Meiren (Ww_150525)*Please indicate remarks and intentions when adding.
