{"id":13862,"date":"2023-09-14T23:55:00","date_gmt":"2023-09-14T15:55:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13862"},"modified":"2024-11-20T23:58:03","modified_gmt":"2024-11-20T15:58:03","slug":"grand-pharmaceuticals-gsp301-ns-meets-primary-endpoint-in-phase-iii-sar-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13862","title":{"rendered":"Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study"},"content":{"rendered":"\n

China-based Grand Pharmaceutical Group Limited (HKG: 0512<\/a>) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China.<\/p>\n\n\n\n

Study Design and Patient Enrollment<\/strong>
The randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III study enrolled 535 patients aged 12 and above with SAR. Participants were randomly assigned to the GSP 301 NS treatment group and two original positive control drug treatment groups, namely olopatadine nasal spray (Patanase NS) and mometasone nasal spray (Nesuna NS), in a ratio of 1:1:1. The patients underwent a 14-day treatment period, with symptom improvement scores collected for the evaluation of GSP 301 NS\u2019s efficacy, safety, tolerability, and pharmacokinetics.<\/p>\n\n\n\n

Positive Results and Clinical Significance<\/strong>
The results demonstrated that the GSP 301 NS group experienced a greater decrease in the average morning and afternoon total reflexive nasal symptom score (rTNSS) over a 12-hour period compared to both the Patanase NS group and the Nesuna NS group. These differences were both clinically and statistically significant, indicating that GSP 301 NS outperformed the originator drugs in terms of efficacy. Additionally, GSP 301 NS met the default clinical endpoints for safety, tolerability, and pharmacokinetic characteristics.<\/p>\n\n\n\n

Global Approvals and Potential Impact<\/strong>
GSP301 NS, a fixed combination of olopatadine and mometasone, was first approved in the US in January 2022 and has since gained approvals in Australia, South Korea, Russia, the UK, and the EU. The success of the Phase III study in China further solidifies the drug’s potential as a treatment for SAR patients globally.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[17,683,1184],"class_list":["post-13862","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-grand-pharmaceutical","tag-hkg-0512"],"yoast_head":"\nGrand Pharmaceutical's GSP301 NS Meets Primary Endpoint in Phase III SAR Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=13862\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Grand Pharmaceutical's GSP301 NS Meets Primary Endpoint in Phase III SAR Study\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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