The board of Grand Pharmaceutical Group Limited announced that the Phase III clinical trial conducted in China of Ryaltris® Compound Nasal Spray ("GSP 301 NS") ("GSP 301-308"), the group's global innovation drug for the treatment of seasonal allergic rhinitis ("SAR") for patients aged 12 years and above, has been completed and successfully met primary endpoint recently. This is another significant progress of the Group in the field of respiratory and severe diseases anti-infection. GSP 301-308 is a randomized, double-blinded, double-simulated, three-arm, multicenter, parallel-controlled Phase III clinical study.

It enrolled 535 patients aged 12 and above with SAR in total, which were randomly assigned to GSP 301 NS treatment group and two monomer positive control originator drugs treatment group [Olopatadine Hydrochloride Nasal Spray ("Patanase NS") and Mometasone Furoate Nasal Spray ("Nesuna® NS") at a ratio of 1:1:1. It means that the test drug is more effective if the test drug group decreases more than the control group. The clinical results of the study showed that, the least square means of changes from baseline in the average morning and afternoon 12-hour rTNSS self-assessment of subjects in the GSP 301 NS group, Patanase NS group and Nesuna® NS group during the 14 days of treatment were -3.84, -2.58 and -3.35 respectively. According to statistical data, the decrease in rTNSS in the GSP301 NS group was greater than that in the Patanase NS group andNesuna® NS group, and the inter-group difference was clinically and statistically significant (GSP 301 NS vs.

Patanase NS, P<0.0001; GSP 301 NS vs. Nesona®?NS, P=0.0018), proving the efficacy scores of GSP 301 NS are better than the monomer originator preparations Patanase NS and Nesuna®? NS.

As a compound preparation, GSP 301 NS can bring more convenient treatment methods to patients with SAR, improve patient compliance, and bring new treatment methods to patients with SAR. The product was approved for commercialization by the U.S. Food and Drug Administration (FDA) in January 2022, and before that it has been approved for commercialization in several countries and regions such as Australia, South Korea, Russia, the United Kingdom and the European Union. GSP 301 NS was approved by the National Medical Products Administration of the People's Republic of China in October 2021 to conduct Phase III clinical trials, completed the first subject enrollment in April 2022, and completed all subjects' enrollment in May 2023.

GSP 301-308 are a registration clinical study of GSP 301 NS in China, and its successful completion is another important milestone in the implementation of the project in China. Among which, the group's star products, Qie Nuo and Jinsang Series Products, are both national exclusive products and have been clearly recommended by a number of guidelines and expert consensus. In terms of products under research, the Group's innovative strategic plan in research products focuses on the significant unmet clinical needs, with a number of products under research, covering allergic rhinitis, sepsis, acute respiratory distress syndrome (" ARDS"), parainfluenza and SARS-CoV-2 infection ("COVID-19"), etc.

Among which, STC3141, a global innovative drug for severe diseases such as sepsis, has received seven clinical approvals in five countries and regions, and has completed 3 clinical studies on patients. Its Phase Ib clinical study in patients with ARDS conducted in China, the Phase IIa clinical study for the treatment of sepsis conducted in Europe, and the Phase Ib clinical study for the treatment of Sepsis conducted in Australia and Belgium have all met clinical endpoints. And it has been approved to conduct Phase II clinical study for the treatment ofsepsis in China.

Another global innovative product for the treatment of sepsIS APAD has been approved to conduct Phase I clinical study for the treatment of SEAD has been approved to conducted in China. Another global innovative drug for the treatment of seps is approved to conduct Phase I clinical studies on patients. Another global innovative product for The treatment of sepsis APAD have been approved to conduct Phase I.