China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
Around 75% of breast cancer cases in postmenopausal patients show estrogen receptor (ER) expression. There is a need for new long-acting formulations for selective estrogen receptor degradation inducers (SERDs) because the efficacy of current options, such as the approved SERD fulvestrant, is limited due to poor solubility and stability.
The Chinese government has invested $2.6 billion into building up the traditional Chinese medicine infrastructure and is actively exploring new models to integrate Chinese and Western medicine.
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease. The microsphere formulation delivers the dopamine agonist in a weekly injection. If approved, LY-03003 would be the first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease (PD). The drug is also being developed in parallel in the U.S. and Japan.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.