Caring for public health and paying attention to the needs of patients
Ceftobiprole Medocaril Sodium for Injection is the latest generation cephalosporin, its antibacterial spectrum covers most of Gram-positive and Gram-negative bacteria, and it has high activity for Gram-positive resistant bacteria and high safety profile. In 2017, CR Gosun signed license agreement with Basilea, and acquired rights of develop and manufacture of ceftobiprole in China market. Now the product was approved by NMPA in October 2020.
Ceftobiprole is for the treatment of community-acquired pneumonia (CAP) and hospital-acquired pneumonia(HAP),
except for ventilator-associated pneumonia (VAP), and is aming to provide great benefits to the improvement of early clinical symptoms in patients with theses moderate and severe diseases.
Furthermore, the product is undergoing clinical trails for new indications including acute bacterial skin and skin structure infection and staphylococcus aureus(MSSA/MRSA) bacteremia in USA.
Mitoxantrone Hydrochloride Injection for Tracing is a new drug belonging to Class 2.2 and a new type of lymph node tracing agent jointly developed with a domestic university. The product is suitable for many tumor surgeries including thyorid cancer, breast cancer and etc, with good lymph node-targeted guidance during surgery and excellent tracing effect. Its use for tracing in surgeries for thyroid cancer has been approved for marketing by NMPA in 2021. For its indications for other tumors, the related clinical trails are in progress.
Quetiapine Fumarate Extended-release Tablet is an important medicine for treatment of schizophrenia and bipolar affective disorder; and due to its technological difficulty, only few brands exist in China market. CR Gosun cooperated with PHARMATHEN Group to introduce its advanced technology, developed and filed the drug successfully to NMPA and finally approved in 2021.The case is showing the excellent tech-transfer and registration capability of GOSUN's R&D team.
Under the policy of "centralized procurement of drugs”, all the products need to be re-evaluated the consistency with RLD before it can join national centralized procurement and win bidding, Gosun R&D team has conducted several consistency evaluations of drugs projects; and of these projects, Azithromycin tablet, Cefazolin Sodium for Injection and Ceftazidime for Injection were completed within very short time and high quality, which won the bidding in the first round of national centralized procurement, and lays solid foundation for Gosun's development under the new market circumstance.
