Luye Pharma USA Ltd.

#BoanBiotech (6955.HK) announced that the first patient in Phase III clinical trial of its #Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to #Opdivo® to undergo a Phase III study in China. As a broad-spectrum anticancer medication, Nivolumab has been approved for multiple indications both in China and abroad. These include its use as a neoadjuvant, an adjuvant, or a first-line or later-line therapy for advanced cancers. It can be used as a standalone treatment, in combination with chemotherapy, or alongside novel immune checkpoint inhibitors. Nivolumab has become a product of basic therapy for a variety of solid tumors.  

#LuyePharma Group today announced that its exclusive new drug, #Rivastigmine Twice Weekly Transdermal Patch, has been approved by China's National Medical Products Administration (NMPA), for the symptomatic treatment of mild to moderate #Alzheimer's disease (AD). The Rivastigmine Twice Weekly Transdermal Patch, being the world’s first patch formulation of Rivastigmine to be administered twice weekly, has been approved for marketing in several European countries prior to China. Luye Pharma is also collaborating with local partners about this drug in multiple European countries, as well as Japan and Mexico.  

#LuyePharma announced the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) through the 505(b)(2) pathway for its #LY03010 (#Paliperidone Palmitate Extended-release Injectable Suspension) for the treatment of #schizophrenia and #schizoaffective disorder. LY03010 is developed on Luye Pharma’s platform for long-acting and extended-release drug delivery systems. It is expected to become China’s first long-acting paliperidone palmitate injectable suspension to be approved in the U.S.   For detail: https://lnkd.in/e-nUiWJg

#LuyePharma Group and #BeiGene announced that a new indication for Luye Pharma's innovative formulation, #Goserelin Microspheres for Injection (Baituowei), has been approved by China’s National Medical Products Administration (NMPA): to be used for treating #breastcancer in premenopausal and perimenopausal women that can be treated with hormones. Luye Pharma and BeiGene have been working together to accelerate the commercialization of the product. The approval of the new indication will further expand the patient groups that can benefit from #Baituowei. With its innovative microsphere formulation, Baituowei is able to ensure efficacy and safety while significantly improving patient experience. 

Luye Pharma Group announced that the New Drug Application (NDA) of its weekly-dosed #Rotigotine Extended-Release Microspheres for Injection (LY03003) for the treatment of #Parkinson’sDisease (PD) has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (#NMPA). Developed on the company’s industry-leading microsphere platform, LY03003 is the world's first long-acting extended-release microsphere formulation for the treatment of PD. This drug is also being developed in the U.S. and Japan. According to statistics, approximately 10 million people worldwide are living with PD The number of PD patients in China is expected to increase from 1.99 million in 2005 to nearly 5 million by 2030, which will be almost half of all the PD patients in the world. LY03003 will be a new option for treating the disease.