//news.yaozh.com/archive/48019.html Abesilli tablets

May 15, 2026  Source: drugdu 42

"/Abesilli tablets: The first imitation breakthrough on the CDK4/6 track.
Abeciclib, an original CDK4/6 inhibitor developed by Eli Lilly, was approved by the FDA in 2017 and entered the Chinese market at the end of 2020. From a global perspective, abeciclib's rise is a textbook example of a latecomer surpassing its predecessor. Pfizer's palbociclib, as the first CDK4/6 inhibitor, long dominated the market in this field, but abeciclib, with its unique clinical advantages—a continuous dosing regimen (unlike other CDK4/6 inhibitors that require intermittent dosing) and the only approved indication in China for adjuvant therapy in early breast cancer—successfully wrested the baton from palbociclib. Abeciclib's global sales surged from 8.8 billion yuan in 2021 to 17.3 billion yuan in 2023, and further exceeded 37.7 billion yuan in 2024, officially becoming the world's best-selling CDK4/6 inhibitor.
Returning to the Chinese market, abexicillin's sales have also surged rapidly. Data shows that domestic sales of this product reached 1.972 billion yuan in 2025, with a compound annual growth rate of approximately 45% over the past three years. From 802 million yuan in 2022 to nearly 2 billion yuan today, its growth momentum can be described as "strong." Currently, Eli Lilly still holds 100% of the domestic market share for abexicillin tablets, but this position is about to be broken with Qingfeng Pharmaceutical's first generic approval. It is worth mentioning that abexicillin tablets have been included in the 2025 National Medical Insurance Negotiation Catalog (Category B), and the coverage of medical insurance payments provides continuous support for its market expansion. Of course, Qingfeng Pharmaceutical's abexicillin tablets also face pressure from competitors. Data shows that Qilu Pharmaceutical submitted its marketing application in December 2024 but has not yet received approval, while Shanghai Chuangnuo Pharmaceutical and Shandong Bainuo Pharmaceutical have completed bioequivalence trials.

Bricetan injection: From tablet exclusivity to "dual dosage form" extension
If abexicillin tablets represent a breakthrough for Kerui Pharmaceuticals in the oncology field, then briracetam injection demonstrates the company's deep strategic layout in the central nervous system. Developed by UCB, briracetam is a next-generation antiepileptic drug targeting the SV2A protein. Compared to traditional antiepileptic drugs, briracetam's advantages lie in its higher SV2A protein selectivity and affinity, as well as better safety profiles—no black box warnings, and it is not a Class II controlled substance, reducing the complexity of clinical use management. Qingfeng Pharmaceuticals has already established a first-mover advantage in the briracetam field—its briracetam tablets have previously been exclusively approved. The first generic approval of the injection means that Qingfeng has completed its dual-dosage form layout of tablets and injections in the briracetam field. From a market perspective, the overall antiepileptic drug market has maintained stable growth in recent years. Data shows that the domestic antiepileptic drug market size is approximately RMB 8.85 billion in 2025, with a compound annual growth rate of approximately 8% over the past five years. Antiepileptic drugs, as a chronic disease requiring long-term medication, are characterized by long treatment cycles, high patient loyalty, and strong market stability. Injectable formulations have irreplaceable clinical value in acute treatment and hospitalized patients, filling the gap previously only available in tablet form.
However, the competition for briracetam injection is not without its challenges. Data shows that seven companies are currently developing this product. Yangtze River Hairong Pharmaceutical submitted its marketing application as early as February 2021, but it was ultimately not approved, demonstrating the high technological barriers to this product. Chengdu Aobang Pharmaceutical submitted its marketing application in January 2026, and it is still under review.

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