CSPC PHARMA's high-concentration hydrochloride hydroxocobalamin injection has been approved to conduct clinical trials for the treatment of the rare disease methylmalonic acidemia

Zhitong
2025.07.03 10:45

CSPC PHARMA's high-concentration hydroxocobalamin injection has been approved by the National Medical Products Administration to conduct clinical trials for the treatment of the rare disease methylmalonic acidemia (MMA). This product is the first hydroxocobalamin injection approved in China, indicated for children with MMA (cblC type) accompanied by elevated homocysteine, providing new treatment options for patients and possessing high clinical development value

According to the Zhitong Finance APP, CSPC PHARMA (01093) announced that the high-concentration hydrochloride hydroxocobalamin injection developed by the group has been approved by the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China for the treatment of the rare disease methylmalonic acidemia (MMA).

The approved clinical indication is for children with MMA (cblC type) accompanied by elevated homocysteine. This product becomes the first hydroxocobalamin injection in China approved to conduct clinical trials for MMA, and its development is expected to provide new treatment options for MMA patients, with high clinical development value