Tags : Luye Pharma

PharmaShots Weekly Snapshot (December 23-27, 2019)

1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005 Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US 2. Immunomedics Reports the US FDA’s Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer Published: Dec 26, 2019 | Tags: Acceptance, BLA, FDA, Immunomedics, […]Read More

Luye Pharma Reports Submission of NDA to the US FDA

Shots: The application is based on the agreement reached with the FDA under End-Of-Phase 2-CMC (EOP2-CMC) & PNDA meeting, marking the second NDA submission to the US FDA in CNS filed by Luye Pharma Luye Pharma has obtained patents covering the chemical compound, crystal form, and formulation of LY03005 in the US, EU, China, Japan […]Read More

AstraZeneca Signs an Exclusive Promotion Agreement with Luye Pharma for

Shots: AstraZeneca to get exclusive promotion rights in China including Taiwan, Hong Kong, Singapore, Malaysia for Luye’s Xuezhikang capsules. Luye Pharma will retain its IPR, commercialization rights, asset rights & registration permit rights The focus of the agreement is to promote Xuezhikang in cardiovascular disorders and strengthening Luye’s footprints in cardiology, with its further expansion […]Read More