On May 13, the CDE website showed that the third generic version of abemaciclib tablets had submitted a market authorization application, from Shandong Bionuo.
Previously, Qilu Pharmaceutical and Jiangxi Kerui Pharmaceutical (a subsidiary of Qingfeng Pharmaceutical) had submitted market authorization applications for abemaciclib tablets in December 2024 and January 2025, respectively.
Among them, Kerui Pharmaceutical's abemaciclib tablets received approval on May 6, becoming the first domestic generic.
Abemaciclib is a CDK4/6 inhibitor developed by Eli Lilly. It induces senescence and apoptosis of breast cancer cells by inhibiting cyclin D. The abemaciclib tablet was first approved in the United States in September 2017 and was approved in China in December 2020.
According to Lilly's 2025 annual report, global sales of abemaciclib reached $5.723 billion.
In China, data from Mosheng Pharma shows that abemaciclib's sales in the domestic all-terminal hospital market exceeded RMB 800 million in 2025.

Behind this stable 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 over 70% of all breast cancer cases.
CDK4/6 inhibitors have become the standard treatment for advanced patients with this subtype, effectively blocking tumor cell cycle progression, inducing senescence and apoptosis of breast cancer cells, and significantly extending patient progression-free survival.
Currently, abemaciclib has the highest sales among all CDK4/6 inhibitors globally.
Thus, it is not only Kerui Pharmaceutical that has made moves; Qilu had also entered the race early, and even earlier than Kerui. Qilu was the first company to have its generic abemaciclib marketing application accepted.
Qilu completed its BE trial and filed for market authorization before Kerui, with its application accepted in late 2024. Kerui was slightly slower, with its application accepted in early 2025. Many expected Qilu to be the first domestic generic, but surprisingly, it was Kerui that received approval first.
Upon review, both companies went through the supplementary materials phase. Kerui completed its supplementary submissions earlier, while Qilu just concluded its supplementary materials task on May 6, so Qilu's results should be forthcoming soon.
In addition to Qilu, Kerui Pharmaceutical, and Shandong Bionuo, another company—Shanghai Chuangnuo—has completed its BE trial.
However, Kerui's first generic approval does not pose an immediate threat to Lilly. Abemaciclib's core patent expires in 2029. Both Qilu and Kerui submitted Class 3 certifications, meaning their products cannot be marketed even after approval.
That said, the trend toward intense competition is becoming increasingly clear.
From a global market perspective, Pfizer's palbociclib, Novartis's ribociclib, and Lilly's abemaciclib—the three major CDK4/6 inhibitors—have collectively generated nearly $5 billion in global sales, demonstrating the high quality of this target.
The higher the quality of a target, the more brutal the competitive dynamics become. Looking at the global market performance of these three drugs over the years:
2024 marked the moment of transition between the old and new champions. Pfizer's palbociclib, approved in the US in 2015, had long been the market leader. Lilly's abemaciclib and Novartis's ribociclib, both approved in the US in 2017, began to demonstrate exceptional growth rates. By 2024, abemaciclib had overtaken palbociclib to become the top seller in this target class.
As early as 2022, palbociclib's sales began to decline under the influence of its two successors—and this happened while palbociclib's US patent was still in effect. In 2027, its US patent will expire, and with the impact of generics, palbociclib will face a patent cliff.
Lilly's abemaciclib achieved a 37% growth rate when it surpassed palbociclib in 2024, but by 2025, its growth rate had dropped to just 8%. Meanwhile, Novartis's ribociclib achieved an astonishing 57% growth rate in 2025. At this pace, ribociclib's 2026 sales will surpass abemaciclib's.
The patents for abemaciclib and palbociclib both expire around 2029–2030, so they are not yet affected by generic competition.
Turning back to the domestic market, palbociclib was the first CDK4/6 inhibitor approved in China, with its tablet form reaching the market in 2018. Its Chinese patent expired in 2023, and domestic generic development has progressed rapidly. Palbociclib capsules have been included in the national centralized procurement program, with the original manufacturer not winning the bid, and overall sales have already begun to decline.
Pfizer also launched a tablet formulation in 2022, but currently only CSPC and Chia Tai Tianqing have passed the consistency evaluation. Competition in this category has become white-hot.
For abemaciclib, the first generic has been approved but cannot be sold. No generic company has yet developed ribociclib. Currently, abemaciclib has the best sales among CDK4/6 inhibitors in China, so it is not surprising that Qilu and Qingfeng Pharmaceutical entered the race so early.

Conclusion
In 2021, Hengrui's self-developed dalpiciclib tablet was successfully launched, and it has already achieved sales of over RMB 500 million. This target class is set to explode in the coming years—in 2025 alone, four domestically developed drugs were approved at an astonishing pace.
By 2029, it is hard to predict just how intense the competitive landscape will become.