GP (HK)’s Global Innovative Drug Ryaltris Compound Nasal Spray Has Been Granted Phase Three Clinical Trial Approval

2021-10-20    Hit:52     Information Sources:Grand Pharma

(October 20, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that after the Group submitted the investigational new drug application to the National Medical Products Administration (“NMPA”) for its global innovative drug Ryaltris compound nasal spray in August 2021 and was accepted, and it recently obtained “Notice of Approval for Clinical Trial of Drugs” issued by the NMPA which approves the product to conduct Phase III clinical trials for the treatment of allergic rhinitis or rhinoconjunctivitis symptoms in patients aged 12 years and above.

Respiratory, ophthalmic and ENT are the traditional advantage fields of the Group and the current products in these fields include prescription drugs, over-the-counter drug, Chinese patent medicines, and medical devices etc., providing treatment solutions to doctors and patients from various aspects, with multi-channel industrial advantages and strong brand awareness. Among them, an exclusive product of the Group, “Qie Nuo”, as a mucolytic expectorant, is widely used in rhinitis, bronchitis, pneumonia and other respiratory diseases, and has been the leading product in sales of oral expectorants in hospitals. “Nuo Tong”, a product for relieving nasal congestion, also has a well brand influence.

The Group always focuses on new, innovative, patient-centric technologies and will continue to increase its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs, enrich product pipeline, and improve supply chain. The Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other. In this way, the Group can make full use of its industrial advantages and R&D capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.

China is one of the countries with the highest incidence of allergic rhinitis in the world. According to the relevant domestic epidemiological investigation results, the incidence rate of allergic rhinitis in Chinese adults is about 17.6%, of which the seasonal allergic rhinitis (“SAR”) accounts for more than 30%. According to the Allergic Rhinitis and its Impact on Asthma 2019, nasal antihistamines and nasal corticosteroids are the preferred drugs for SAR. For the moderate and severe SAR patients, it is recommended to use nasal antihistamines and nasal corticosteroids in combination. At present, there is no compound nasal spray in the China market. The clinical demand is urgent and the market prospect is considerable.

Ryaltris is a new type of antihistamine and corticosteroids compound nasal spray, and is used to treat SAR in adults and adolescents. Each spray of Ryaltris compound nasal spray contains 665μg olopatadine hydrochloride and 25μg mometasone furoate. Three overseas Phase III clinical trials have been completed and the results show that the efficacy of the product is superior to single use of olopatadine hydrochloride or single use of mometasone furoate, and its safety is similar to single use olopatadine hydrochloride or use mometasone furoate alone. As a compound preparation, Ryaltris nasal spray provides a more convenient treatment method to SAR patients, improves patients’ compliance, and bring a new treatment method to SAR patients in China.

Ryaltris nasal spray has submitted the new drug application to the United States Food and Drug Administration (FDA) in July 2021 and is currently under review. Ryaltris compound nasal spray has been launched in different countries and regions such as Australia, South Korea, Russia and the European Union. The Phase III clinical trial being approved in China will evaluate the effectiveness, safety, tolerability, and pharmacokinetics of the product in more than 500 Chinese adult and adolescent SAR patients, and will provide evidence for the product’s commercialization in China.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The field of respiratory, ophthalmic and ENT is one of GP(HK)’s key strategic plan, the group has devoted to build the most comprehensive supply chain of respiratory, ophthalmic and ENT in China. In the future, the Group’s existing products can play a good synergistic effect with Ryaltris compound nasal spray in the treatment of rhinitis. Ryaltris compound nasal spray will be an important supplement to the Group’s pipeline in the field of respiratory, ophthalmic and ENT, and further consolidating the Group’s competitive advantages in this field. Regarding ‘introduction and landing’ and ‘synchronously independent and localized R&D’ as its development direction, the Group will realize the construction of a dual system of local + global R&D and production, as well as accelerate product launches and improve its own R&D capability, provide patients with more advanced and diverse treatment options in the world, as well as creating greater returns for shareholders.”