Hansoh Pharmaceutical’s Generic Ibrance Approved by NMPA

China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s Ibrance (palbociclib). The drug can now be used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women, in combination with an aromatase inhibitor as initial endocrine therapy.

Drug Profile
Ibrance, a global first-in-class drug, was first approved in China in July 2018. It inhibits the activity of CDK4/6 and blocks the progression of cells from the G1 phase to the S phase, thereby reducing cell proliferation of tumor cell lines and inhibiting abnormal cell replication.

Market Landscape
The first generic version of Ibrance was approved quickly, with Qilu Pharma gaining approval in December 2020. Other companies looking to enter the market include Chia Tai Tianqing, Fosun Pharma, Aosaikang, Kelun Pharma, Simcere Pharma, Qingfeng Pharma, and others. Eli Lilly’s abemaciclib and Novartis’s ribociclib are other CDK4/6 inhibitors available globally, with the former also marketed in China. CDK4/6 products generated USD 7 billion in global sales in 2020, and their global market size is expected to exceed USD 15 billion by 2025.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry