A few days ago, CSPC Pharmaceutical Group announced that its subsidiary, Ouyi Pharmaceutical, palbociclib tablets, was approved for marketing by the State Food and Drug Administration, which is the first generic of the drug dosage form in China.
It is understood that palbociclib is a small molecule CDK4/6 inhibitor, the original research company is Pfizer, divided into tablets and capsules two dosage forms, palbociclib capsules (75/100/125mg) was approved by the US FDA in February 2015, becoming the world's first CDK4/6 inhibitor approved for marketing, and in November 2019, palbociclib tablets (75/100/125mg) were also approved for marketing. At present, palbociclib has become a first-line therapy for HR+/HER2- breast cancer patients, and has been approved for the first- and second-line treatment of HR+/HER2- breast cancer in more than 90 countries around the world, accounting for most of the CDK4/6 inhibitor market.
According to Pfizer's annual financial report, from 2018 to 2021, palbociclib achieved performance revenue of US$4.118 billion, US$4.961 billion, US$5.392 billion, US$5.43 billion, and US$5.12 billion, respectively, In January 2023, palbociclib's compound patent expired, and it also ushered in more fierce market competition. reached US$4.753 billion, a year-on-year decrease of 6%.
At present, there are a number of domestic companies in the layout of palbociclib generic drugs, among which, according to the information on the official website of the State Food and Drug Administration, 13 Chinese pharmaceutical companies have been approved for marketing of palbociclib capsule generic drugs, including Haosen Pharmaceutical, Qilu Pharmaceutical, Shanxiang Pharmaceutical, Chia Tai Tianqing, Kelun Pharmaceutical, Simcere Pharmaceutical, Jilin Aodong Taonan Pharmaceutical, etc.
Partially approved palbociclib capsules in China
At present, Qilu's generic drug marketing application for the drug has not been approved, and Nanjing Chia Tai Tianqing's generic drug application for palbociclib tablets is being reviewed by the Food and Drug Administration.
It is also worth mentioning that in addition to palbociclib, there are four other CDK4/6 inhibitors approved worldwide, namely Novartis' Kisqali (rebociclib), Eli Lilly's Verzenio (abeciclib), G1 Therapeutics' (Trilaciclib) trilaciclib, and Hengrui Pharmaceutical's Ererikon (darcilib), among which dalcilib is the first domestic original CDK4/6 inhibitor approved for marketing, which has now entered the new version of the medical insurance catalog.
Source: Yigu Network