The Phase III Clinical Trial in China of Grand Pharma’s Global Innovative Drug Ryaltris Compound Nasal Spray Successfully Completed the First Patient Enrollment, Milestone Progress in the Landing Process of Innovative Products and Continuously Consolidating Core Competitiveness in Pharmaceutical Industry
(April 7, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the multicenter Phase III clinical trial of Ryaltris Compound Nasal Spray (“GSP 301”), the group's global innovation drug for the treatment of seasonal allergic rhinitis (“SAR”) and rhinoconjunctivitis in patients aged 12 years and above, recently completed the first patient enrollment in China. The clinical trial was carried out in more than 20 well-known hospitals including Beijing Tongren Hospital, CMU. The purpose of this clinical trial is to evaluate the efficacy, safety, tolerability and pharmacokinetics of the product, and to provide supporting basis for the registration and commercialization of the product in China.
Respiratory and ENT are the traditional advantage field of the Group’s pharmaceutical industry segment. The existing products include prescription drugs, over-the-counter drugs, proprietary Chinese medicines, devices, etc., which provide doctors and patients with treatment methods in various aspects, and have multi-channel industry advantages and brand recognition. Among them, the Group's exclusive product “QieNuo” (Eucalyptol, Limonene and Pinene Enteric Soft Capsules), as a mucolytic expectorant, is widely used in respiratory diseases such as rhinitis, bronchitis and pneumonia, and continues to lead the market of oral expectorant drugs in the hospital; a product used to relieve nasal congestion symptoms “NuoTong” (Xylometazoline Hydrochloride Nasal Spray) also has a good brand influence. The existing products can also play a good synergistic effect with GSP 301 in the treatment of rhinitis in the future, and GSP 301 will also become an important supplement to the Group’s product pipeline in the respiratory and ENT fields, further consolidating the Group's competitive advantage in this field.
GSP 301 is a novel antihistamine and corticosteroid combination nasal spray consisting of olopatadine hydrochloride and mometasone furoate for the treatment of SAR in adults and adolescents. The product was approved by the U.S. Food and Drug Administration (FDA) in January 2022, and before that it has been approved in several countries and regions such as Australia, South Korea, Russia, the United Kingdom and the European Union. The results of the two Phase III clinical trials completed overseas showed that the efficacy of the product is superior to olopatadine hydrochloride and mometasone furoate used alone, and the safety is similar to that of olopatadine hydrochloride or mometasone furoate used alone. As a compound preparation, GSP 301 can bring more convenient treatment methods to SAR patients, improve patient compliance, and bring new treatment methods to SAR patients. The Group submitted a new drug clinical trial application to the National Medical Products Administration of the People’s Republic of China (“NMPA”) in August 2021, and received the “Drug Clinical Trial Approval Letter” issued by NMPA in October 2021 for conducting Phase III clinical trials of the product. The completion of the first patient enrollment in the Phase III clinical trial for SAR is another important milestone for the implementation of the project in China.
China is one of the countries with the highest incidence of allergic rhinitis in the world. According to the relevant epidemiological survey results in China, the prevalence of allergic rhinitis in Chinese adults is about 17.6%, of which SAR accounts for more than 30%. According to the 2019 edition of the "Allergic Rhinitis and Its Influence on Asthma (ARIA)" guideline, nasal antihistamines and nasal corticosteroids are the first choice for SAR. For patients with moderate or severe SAR, it is recommended to use a combination of nasal antihistamines and nasal corticosteroids. At present, there is no compound nasal spray on the market in China and the clinical demand is urgent and the market prospect is huge.
The Board of Grand Pharmaceutical Group Limited, commented, “The Group always put a high value on the R&D of innovative products and world-leading technologies in the field of respiratory and ENT. The clinical progress of Ryaltris Compound Nasal Spray successfully completed the first patient enrollment in China, which will provide a supporting basis for the registration and commercialization of the product in China. It also further enrich the Group's product pipeline in this field. Looking forward, the Group will continue to adopt the strategy of ‘global expansion and dual-cycle operation’ to increase the investment and development of global innovative products continuously. It will also make full use of its industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.”