China's cornerstone pharmaceutical announced that the listing registration application of Taijihua (Apatinib Tablets) transferred to domestic production has been approved by the National Medical Products Administration. It is expected to gradually replace the existing imported products from the end of 2024 or the beginning of 2025, thus achieving domestic supply.
The listing registration application of 100mg specification Taijihua for localized production is expected to be approved soon, providing doctors and patients with flexible medication specification choices. In addition, the domestic listing registration application of another precision treatment drug of cornerstone pharmaceutical, Pujihua (Pirfenidone Capsules), was accepted in April of this year and is currently in the review stage.
Taijihua was approved for marketing by China's National Medical Products Administration (NMPA) in March 2021 for the treatment of adult patients with unresectable or metastatic GIST carrying PDGFRA exon 18 mutations (including PDGFRA D842V mutations).