Qilu Pharmaceutical's Class 4 Generic Palbociclib Capsules Approved as China's First Domestic CDK4/6 Inhibitor

On December 18, the NMPA issued an approval document, granting market authorization to Qilu Pharmaceutical’s Class 4 generic drug “Palbociclib Capsules,” marking the first domestic generic approval for this product. Its indicated use is in combination with aromatase inhibitors as first-line therapy for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

Palbociclib, initially developed by Pfizer, is the first CDK4/6 inhibitor approved globally. In February 2015, palbociclib (brand name: Ibrance) received approval from the U.S. FDA through the accelerated review pathway for use in combination with letrozole as initial endocrine therapy for HR+/HER2- advanced breast cancer. Currently, Ibrance has been marketed in multiple countries and regions, including the European Union and Japan.

This product is undoubtedly a blockbuster drug. Since its launch, its global sales have grown year after year, reaching an annual sales volume of $4.961 billion (+20.47%) by 2019.

In July 2018, the originator palbociclib was first approved in China under the brand name Ibrance, for use in combination with aromatase inhibitors as initial endocrine therapy for the treatment of HR+/HER2- locally advanced or metastatic breast cancer.

Currently, in addition to the originator Pfizer, 19 companies have laid out their generic drug plans. Among them, Simcere Pharmaceutical has submitted its production application in March this year; six companies including Aosaikang, Hansoh Pharmaceutical, Kelun Pharmaceutical, and Chia Tai Tianqing are in the BE trial stage; and another 11 companies have received clinical trial approval.

From the Insight database (http://db.dxy.cn/v5/home/)

Currently, three CDK4/6 inhibitors have been approved globally: Pfizer’s palbociclib, Novartis’s ribociclib, and Eli Lilly’s abemaciclib. However, apart from Pfizer’s palbociclib, no other CDK4/6 inhibitors have been approved in China; only Eli Lilly’s abemaciclib tablets submitted a marketing application in November 2019.

The approval of Qilu Pharmaceutical’s generic palbociclib marks the advent of China’s first domestically produced CDK4/6 inhibitor, offering breast cancer patients a new treatment option.

Furthermore, CDK4/6 is a popular investigational target in China. There are currently 11 domestic companies with novel drugs targeting this pathway in clinical development, including Fosun Pharma, Hansoh Pharma, and Chia Tai Tianqing. Among them, Hengrui’s SHR6390 is the most advanced. On November 17, an international, multicenter, randomized, double-blind Phase III clinical trial of SHR6390 in combination with endocrine therapy as adjuvant treatment for HR-positive, HER2-negative breast cancer in women was approved, and the trial is expected to commence shortly.