Altamira Therapeutics Secures China Approval for Bentrio Nasal Spray in Allergic Rhinitis Market
Key Insights
Altamira Therapeutics' Bentrio (search) nasal spray received marketing approval from China's NMPA for allergic rhinitis (search) treatment, targeting nearly 200 million affected Chinese patients.
The drug-free, preservative-free nasal spray demonstrated statistically significant efficacy in clinical trials, with a p-value of 0.013 for symptom reduction compared to saline.
Nuance Pharma (search) will launch and distribute Bentrio (search) in Mainland China, marking a major milestone for the company's international growth strategy.
Altamira Therapeutics has achieved a significant regulatory milestone with the approval of its Bentrio (search) nasal spray by China's National Medical Products Administration (search) (NMPA) for allergic rhinitis (search) treatment. The clearance positions the company to address a substantial unmet medical need in one of the world's largest consumer health markets, where nearly 200 million people are estimated to suffer from allergic rhinitis with increasing prevalence.
Market Launch Strategy
Nuance Pharma (search), Altamira Medica (search)'s licensee and distribution partner, will spearhead the marketing and distribution of Bentrio (search) across Mainland China. Mark G. Lotter, CEO and Founder of Nuance Pharma, emphasized that "the regulatory approval of Bentrio represents an important milestone for Nuance Pharma's effort in the allergy space," highlighting the company's existing commercial capabilities in China and respiratory disease franchise.
Clinical Efficacy and Safety Profile
Bentrio (search)'s approval is supported by robust clinical evidence from four clinical trials, with the pivotal NASAR study providing the strongest efficacy data. The randomized controlled trial enrolled 100 patients with seasonal allergic rhinitis (search) who self-administered either Bentrio or saline nasal spray three times daily for two weeks.
The study demonstrated statistically significant clinical benefits across multiple endpoints. Bentrio (search) achieved a significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) compared to saline (p = 0.013). More notably, patients experienced a statistically highly significant improvement in health-related quality of life as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (p < 0.001).
Patient and investigator assessments further validated Bentrio (search)'s efficacy, with superior global ratings of efficacy compared to controls (p < 0.001). The treatment also demonstrated practical clinical benefits, with fewer Bentrio-treated patients requiring relief medication and more patients experiencing symptom-free days compared to saline treatment.
Innovative Mechanism of Action
Bentrio (search) operates through a unique triple mode of action that distinguishes it from conventional allergic rhinitis (search) treatments. The drug-free, preservative-free nasal spray forms a protective gel layer on the nasal mucosa upon application. This thin film prevents airborne particles from contacting nasal cells while simultaneously binding allergens and facilitating their discharge from the nasal cavity.
Thomas Meyer, Chairman and CEO of Altamira Medica (search), noted that Bentrio (search)'s efficacy "does not require any drug ingredient for protecting against airborne allergens," representing a novel approach to allergic rhinitis (search) management with demonstrated strong efficacy and good tolerability across clinical trials.
Regulatory Expansion Strategy
The China approval follows Altamira's recent achievement of Medical Device Regulation (MDR) certification in the European Union, marking another crucial regulatory milestone. The EU certification required substantial investments and efforts, including additional clinical trials and independent certification by a designated Notified Body, as nasal sprays like Bentrio (search) are classified as "Class IIa" medical devices under the more stringent MDR framework.
The MDR certification serves as a key reference for regulatory agencies outside the EU, potentially facilitating marketing clearance in various countries and supporting Altamira's international growth strategy. The company initially launched Bentrio (search) in certain EU markets in 2021 under the previous Medical Device Directive as a "Class I" medical device.
Market Opportunity and Commercial Outlook
China represents one of the world's largest markets for over-the-counter consumer health products, providing significant commercial potential for Bentrio (search). The substantial patient population of nearly 200 million people affected by allergic rhinitis (search), combined with increasing prevalence rates, creates a compelling market opportunity for the innovative nasal spray.
Altamira's partnership approach through Nuance Pharma (search) leverages established commercial capabilities and respiratory disease expertise in the Chinese market. This strategy aligns with the company's broader international expansion plans, utilizing a network of marketing and distribution partners to commercialize Bentrio (search) globally.