CDK4/6 Inhibitors in a 'Three-Horse Race': Qilu Pharma Submits First Domestic ANDA for Abemaciclib

Dec 18, 2024 20:30 CST Updated 20:30

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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On December 18, according to the latest announcement on the CDE official website,Qilu PharmaceuticalSubmitted Generic Drug Class 4Abemaciclib TabletsThe listing application has been accepted. According to the Mosun Pharmaceutical Database,Abemaciclib TabletsNo generic drug companies have been approved in China yet, and Qilu Pharmaceutical is the first company to submit a generic application for this variety.If Qilu Pharmaceutical can obtain approval smoothly, it is expected to secure the first generic drug in China.

Screenshot source: CDE

CDK4/6 Inhibitors in "Tripartite Standoff": Qilu Pharmaceutical Enters the Market with China's First Generic

As the first CDK4/6 inhibitor included in the National Medical Insurance Catalog,AbemaciclibSince 2021, it has been included in the medical insurance system, and the sales revenue in the Chinese market has continued to rise. 2023Abemaciclib TabletsSales in the Chinese hospital market exceeded 600 million yuan, with a year-on-year increase of 70.28%. Entering 2024, its market performance remains strong, with sales in the first half of the year approaching 400 million yuan.

Screenshot source:MosoMed (formerly Yaoke Rongyun)National Hospital Sales Database

Currently,AbemaciclibIt is the only CDK4/6 inhibitor that simultaneously covers the treatment of both early and advanced breast cancer patients and is included in the scope of China's national medical insurance. In the global CDK4/6 inhibitor market, a "tripod competition" has long been established, with Pfizer taking the lead since the launch of its product in 2015.PalbociclibTake the lead in occupying the market; and Eli Lilly'sAbemaciclibWith NovartisRibociclibAll received U.S. regulatory approval in 2017 and initially focused on the treatment of advanced HR+/HER2- breast cancer. However, Eli Lilly'sAbemaciclibWith its breakthrough in the indication for early breast cancer, it has successfully reshaped the market landscape.

Currently,Abemaciclib TabletsIn China, only the original research pharmaceutical company has been approved for marketing, and Eli Lilly has completely monopolized this niche market, enjoying a 100% market share.

Screenshot source:MaxEntropy Pharma (formerly Yaoke Rongyun) China Drug Approval Database

In the broader treatment field of early-stage breast cancer, Eli Lilly currently faces no direct competitors, with a solid market position and promising prospects. However, with the gradual advancement of the generic drug market in China,Qilu PharmaceuticalSubmittedAbemaciclib TabletsThe Category 4 generic drug application has become the first company to submit an application for this variety. If Qilu Pharmaceutical Co., Ltd. can obtain approval smoothly, it is expected to secure the first generic drug approval in China, breaking the market dominance of the original research pharmaceutical company and bringing new changes to the market.

Screenshot source:Moxie Pharma (formerly Yaoke Rongyun)China Drug Evaluation Database

Qilu Pharmaceutical Co., Ltd. Expands to Over 50 Product Varieties, Aims for First Generic Approvals on 13 Varieties

As of now, Qilu Pharmaceutical(Including Subsidiaries)More than 50 generic drug applications have been submitted. Since this year, the pharmaceutical company has already reported over 20 varieties under review for production, covering multiple therapeutic areas: including six drugs for the nervous system and anti-infective system, four cardiovascular system drugs, three anti-tumor and immunomodulatory drugs, as well as two drugs each for the sensory system, respiratory system, digestive system and metabolism, and blood and hematopoietic system, in addition to one dermatological drug.

Qilu Pharmaceutical's Generic Drugs Under Review This Year

(Red highlightedVariety(No generic drugs have been approved for marketing in China)

Screenshot source:Moxie Pharma (formerly Yaorong Cloud)China Drug Evaluation Database

In addition, Qilu Pharmaceutical Co., Ltd. submittedAbemaciclib Tablets, Meloxicam Pregabalin Sulfate Tablets, Fluticasone Propionate Nasal Spray, Brexpiprazole Orally Disintegrating Tablets, Brexpiprazole TabletsIncluding 13 varieties, and currently no domestic pharmaceutical companies have been approved for generic production,Qilu Pharmaceutical Will Compete with Multiple Pharmaceutical Companies for the First Generic.

From 2024 to present, Qilu Pharmaceutical(Including subsidiaries)With over 40 varieties approved, including securingRiociguat Tablets, Metformin and Empagliflozin Tablets (Ⅵ), Emtricitabine, Rilpivirine, and Tenofovir Alafenamide Tablets, Chlorbenzazole Pamoate Soft Capsules, Bendamustine Hydrochloride Injection Concentrate, Eltrombopag Ethanolamine Tablets, Apalutamide TabletsSeven First-to-Market Generic Varieties.

Conclusion

In the fierce competition within the pharmaceuticals industry, innovation is the key driver of progress. The field of CDK4/6 inhibitors is equally competitive, with numerous companies actively exploring the development of early-stage breast cancer indications, bringing more hope to patients. As a leader in the first-to-market generics sector, Qilu Pharmaceutical will continue to uphold the spirit of innovation, offering patients more high-quality and efficient medication options, and contributing to the thriving growth of the pharmaceuticals industry.

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