ZSPH, GSK, and Bio-Thera Announce New Drug Approvals for Influenza, COPD, and Autoimmune Disorders

Zhongsheng Pharmaceutical's New Anti-Influenza Drug Approved for Marketing

Recently, the NMPA official website showed that Zhongsheng Pharmaceutical's Class 1 innovative drug Amladiweipian (trade name: Anruiwei®, R&D code: ZSP1273 tablets) has been approved for marketing to treat adult patients with simple type A influenza.

Screenshot from: NMPA official website

Public information shows that Alvadew is a small molecule RNA polymerase PB2 protein inhibitor, with global independent intellectual property rights owned by Zhongsheng Pharmaceutical. As a "cap" structure analog, Alvadew binds to the PB2 subunit of RNA polymerase, inhibiting the normal initiation of the RNA polymerase complex replication function, thereby suppressing the transcription and replication of the viral life cycle genome, achieving an anti-influenza A virus effect.

GSK’s Mepolizumab Approved in the U.S.

Recently, the large track of chronic obstructive pulmonary disease (COPD), which has 390 million patients, has welcomed its second biotargeted drug. On May 22 local time, GSK announced that the U.S. FDA had approved the listing of a new indication for its IL-5 monoclonal antibody, mepolizumab (Nucala), for use as an adjunctive maintenance treatment for eosinophilic COPD patients.

This is the first IL-5 monoclonal antibody approved for the treatment of COPD, and also the world's first biologic approved for once-monthly dosing in COPD patients, representing a breakthrough advancement in COPD treatment.

Screenshot source: Company official website

This approval means that Mepolizumab has become the first IL-5 monoclonal antibody approved for the treatment of COPD, the world's first biological agent that can be administered once a month for the treatment of COPD, and also the second biological targeted drug for COPD globally.

Bio-Thera's Ustekinumab Approved for Marketing in the U.S.

Recently, Bio-Thera announced that its BAT2206 (Ustekinumab) injection has been approved for marketing by the U.S. FDA. The product has also been submitted to China's NMPA and the European EMA for marketing authorization applications, which have been accepted.

Source: Bio-Thera Company Announcement

BAT2206 is a ustekinumab biosimilar developed by Bio-Thera in accordance with the relevant guidelines for biosimilars from China's NMPA, the U.S. FDA, and the European EMA. It has currently achieved authorized partnerships in multiple countries and regions.

Source: Bio-Thera Announcement

Ustekinumab is a fully human monoclonal antibody that targets the shared p40 subunit of interleukin IL-12 and IL-23. IL-12 and IL-23 are naturally occurring cytokines that participate in inflammatory and immune responses. They can specifically bind to the p40 subunit with high affinity, blocking its interaction with cell surface receptors, thereby disrupting IL-12 and IL-23 mediated signal transduction and cytokine effects.