From 9 Approvals to Price Wars: The Changing CDK4/6 Landscape in China and Its U.S. Contrast

Since Pfizer’s palbociclib hit China in 2018, the CDK4/6 inhibitor market has entered a phase of intense 'involution.' Nine approved drugs now compete aggressively, and while the U.S. market remains dominated by three HR+/HER2- originators—palbociclib, ribociclib, and abemaciclib—protected by extended patents, China’s stage is set for price erosion and generic battles.

China’s CDK4/6 Approvals Surge

2025 has been particularly active, with four new approvals—Tairuiciclib (Betta Pharmaceuticals), Lerociclib (Genor Biopharma), Vevociclib (Fosun Pharma), and Pyrgeciclib (Sihuan Pharmaceutical)—joining earlier domestic and multinational entrants. Hengrui’s dalpiciclib (Ai Rui Kang), approved in 2021, had already positioned itself as the first locally developed CDK4/6.

This wave of approvals highlights both the innovation drive of Chinese biopharma and the government’s accelerated review pathways. It also signals an impending price war, as multiple players compete in a largely saturated breast cancer market.

China vs. U.S.: Diverging Market Dynamics

While China now has 9 CDK4/6 approvals, the U.S. market tells a different story:

• Only three main branded leaders (Ibrance, Kisqali, Verzenio) dominate HR+/HER2- breast cancer, each launched several years earlier.
• Patent extensions, secondary claims, and exclusivity strategies have largely shielded the U.S. market from generic erosion.
• In contrast, China’s patent cliff came much sooner—Pfizer’s Ibrance lost exclusivity in January 2023, unleashing over 20 generic competitors.

Note: Trilaciclib (Cosela) is also approved in the U.S. (Feb 2021) and in China (July 2022), but it is indicated for myeloprotection during chemotherapy in extensive-stage small cell lung cancer (ES-SCLC) rather than HR+/HER2- breast cancer, so it does not directly compete with the other three.

This divergence underscores a broader theme: China’s oncology market evolves through rapid approvals and fast commoditization, while the U.S. remains innovation-led but patent-protected.

China and U.S. Approved CDK4/6 Inhibitors (Ranked by China Approval Date)

*Trilaciclib is approved in China and the U.S. for myeloprotection in ES-SCLC, not HR+/HER2- breast cancer.

Generics Flood and Patent Landscape

Palbociclib (Ibrance, Pfizer): China core patent CN107666914B expired Jan 2023 → ~20 generics. U.S. core patent US7456168 expired Dec 2023; secondary patents US10723730 (Feb 2034) and US11065250 (Aug 2036) delay broad generic entry. Limited approvals granted in June 2024 (Teva, Sun Pharma).

Abemaciclib (Verzenio, Eli Lilly): China expiry Dec 2029; U.S. US9181257 expires Sept 2031. Qilu Pharma and Kerui Pharma filed generics in China.

Ribociclib (Kisqali, Novartis): China expiry Aug 2029; U.S. patents US8324225 (June 2028) and US12064434 (Apr 2036). No U.S. generics yet.

*Trilaciclib approved in China and the U.S. for myeloprotection, not for HR+/HER2- breast cancer.

💵 Pricing Trends in China and the U.S.

China (CNY / USD):

• Palbociclib generics: ¥5–9 per 125 mg tablet (~$0.70–$1.26 USD)
• Dalpiciclib: ¥178 per 125 mg tablet (~$24.80 USD)
• Abemaciclib: ¥290.35 per tablet (~$40.50 USD)
• Ribociclib: ¥328.89 per tablet (~$45.70 USD)

U.S.:

• Palbociclib (Ibrance) 28-day supply (21 tablets, 125 mg): ~$16,462 USD

China’s centralized procurement has pushed prices sharply down, leaving a narrow window for new entrants to compete.

Market Size and U.S./China Context

The global CDK4/6 inhibitor market is projected to reach USD 15.82 billion in 2025, with a compound annual growth rate (CAGR) of over 16.7% from 2025 to 2037 (Research Nester).

• U.S. Market: The U.S. remains dominated by three branded inhibitors—palbociclib (2015), ribociclib (2017; adjuvant expansion 2024), and abemaciclib (2017; expanded adjuvant 2021)—with a 2024 market value of USD 5.6 billion, projected to reach USD 12.4 billion by 2033 (GlobalData, 2024). Strong patent protections and delayed generic entry provide originators a decade-long revenue buffer compared to China’s crowded market.
• China’s Market: In contrast, China’s CDK4/6 inhibitor market is growing rapidly, fueled by multiple approvals, generics, and inclusion in the national medical insurance list, leading to a more price-sensitive, volume-driven landscape.

Target-Driven Competition: CDK4/6, PD-1, EGFR, and GLP-1

China’s CDK4/6 market shows classic 'involution': like PD-1, EGFR, and GLP-1, a crowded field of competitors is driving rapid approvals, generics, and clinical activity.

• PD-1: Toripalimab, sintilimab, camrelizumab, and generics expand access and lower prices.
• EGFR: Generics for gefitinib, erlotinib, and icotinib have cut monthly treatment costs.
• GLP-1: Biosimilars for liraglutide and semaglutide intensify competition and reduce prices.

CDK4/6 is following the same path: nine approvals and 20+ palbociclib generics are fueling price competition while improving patient access, illustrating how high-value targets in China drive volume-led competition and rapid commoditization.

Emerging Competitors Beyond CDK4/6

Resistance is common, opening space for alternatives:

• PI3K inhibitors: Alpelisib (Piqray, Novartis)
• AKT inhibitors: Capivasertib (Truqap, AstraZeneca)
• mTOR inhibitors: Everolimus (Afinitor, Novartis)
• Oral SERDs: Elacestrant (Orserdu, Stemline Therapeutics)
• ADCs: Sacituzumab govitecan (Trodelvy, Gilead)
• PARP inhibitors (gBRCA): Olaparib (Lynparza, AstraZeneca); Talazoparib (Talzenna, Pfizer)
• Immunotherapy: Pembrolizumab (Keytruda, Merck, PD-L1+ cases)

These classes, particularly SERDs and ADCs, are positioned to capture patients progressing after CDK4/6 therapy.

Outlook

China’s CDK4/6 landscape is highly dynamic: nine approvals, generics, and price wars are reshaping access and competition. The U.S. market remains patent-protected and revenue-rich, but post-2030 Chinese generics may influence global pricing. Meanwhile, next-generation therapies, including ADCs, SERDs, and combination regimens, will challenge CDK4/6 dominance over the next decade.

References

• Insight Database – Drug Approvals, China NMPA
• FDA Drugs@FDA Database
• Pharsight GreyB – Patent Expirations
• GlobalData, 2024 – CDK4/6 Market Report
• Roots Analysis, 2024 – CDK4/6 Inhibitors Market, 2024–2035
• Research Nester, 2025 – CDK4/6 Inhibitor Drugs Market: Global Demand Analysis & Opportunity Outlook
• Nature, 2025 – China CDK4/6 Growth