Luoxin Pharmaceutical Signs Licensing Agreement With Austria-Based Marinomed Biotech AG For Budesolv Budesonide Nasal Spray

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. a subsidiary of Luoxin Pharmaceutical Group Stock Co., Ltd  , signed a licensing agreement with Austria-based Marinomed Biotech AG whereby Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Budesolv (Budesonide Nasal spray) in China (including Chinese mainland, Hong Kong and Macao SAR, Taiwan region). The signing of the license agreement will further expand Luoxin Pharmaceutical’s product line and enhance Luoxin’s competitive edge in the area of respiratory diseases.

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Budesolv^®, a new formulation of the glucocorticoid budesonide, which is a steroid nasal spray and is not yet available for domestic and overseas market. Budesolv^® is the first medication originating from Marinomed’s proprietary Marinosolv^® platform. Budesolv^® has successfully completed a pivotal Phase III clinical study, necessary for marketing authorization in Europe. The recently completed pivotal clinical trial successfully demonstrated non-inferiority of the Budesonide nasal spray when compared to Rhinocort^® Aqua 64. Furthermore, the trial demonstrated that Budesolv^® was equally effective with a 85 % reduction in dosage and showed significantly faster onset of action within 3 hours.

Budesolv^® is indicated for allergic rhinitis. Allergic rhinitis is a chronic disease with high rate of incidence, long duration and easy recurrence. Statistics reveal that over the past six years, the prevalence of allergic rhinitis in China has increased from 11.1% to 17.6% (data from the International Forum of Allergy & Rhinology). Statistics from IQVIA and MENET show that the global market size of steroid nasal spray in 2020 is US$2.15 billion (ex-factory price), and the total Chinese market size (domestic hospitals with more than 100 beds and retail pharmacies) is 1.305 billion yuan.

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Under the terms of the agreement, Shandong Luoxin shall pay to Marinomed an upfront payment in the amount of USD 2,000,000, and will pay to Mainomed development and sales milestone payments not to exceed $ 20 Million. Once budesonide nasal spray suspension has been launched, Shandong Luoxin will pay to Marinomed tiered royalties based on net sales.

Dr. Andreas Grassauer, CEO of Marinomed, said, “We are honored to reach an agreement with a quality partner in the Chinese market like Luoxin Pharmaceutical and are proud of the partnership based on the Marinosolv^® technology platform. Luoxin Pharmaceutical has rich experience in product innovation and commercialization, while Budesolv^® is the first drug developed on the Marinosolv^® platform, with a dosage reduction of 85% and faster efficacy. We hope to provide better treatment options for patients with allergic rhinitis through this close cooperation.”

Ryan Liu, Chairman and CEO of Luoxin Pharmaceutical said, “We are looking forward to the cooperation with Marinomed. Respiratory disease is one of our key focus areas. Thanks to the combination of Marinomed’s unique innovative product research and development platform and Luoxin’s integrated whole industrial chain advantages in research, production and marketing, we believe that the joint exploration with Marinomed’s outstanding scientific team will pay off and help enhance the treatment of allergic rhinitis patients in China.”

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