Nuance Pharma Receives NMPA Clearance for Actair® Phase III Trial in China
核心洞察
Nuance Pharma (搜索) announced that China's National Medical Products Administration (NMPA) has cleared its IND application for Actair®, enabling a pivotal Phase III clinical trial for house dust mite-induced allergic rhinitis.
The upcoming study will be a randomized, double-blind, placebo-controlled trial evaluating Actair® efficacy and safety over 12 months in patients with allergic rhinitis, with or without concomitant asthma.
Actair® is already commercialized across 21 countries and territories under multiple brand names, with Nuance Pharma (搜索) having established an exclusive partnership with Stallergenes Greer for Chinese market development.
Nuance Pharma (搜索) announced that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for Actair®, marking a significant regulatory milestone for advancing house dust mite allergy immunotherapy to Chinese patients. The clearance enables the company to initiate a pivotal clinical trial for the treatment of house dust mite-induced allergic rhinitis in China.
Phase III Trial Design
Under the IND clearance, Nuance Pharma (搜索) will conduct a Phase III randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Actair® over a 12-month treatment period. The trial will enroll patients with allergic rhinitis, with or without concomitant asthma, representing a comprehensive approach to addressing this allergic condition.
"We are thrilled to introduce this novel allergy treatment to China to address significant unmet medical needs," said Dr. Charlie Chen, Chief Operating Officer of Nuance Pharma (搜索). "We look forward to working closely with leading investigators as we evaluate Actair® in patients across China."
Global Market Presence
Actair® is already commercialized across 21 countries and territories under the brand names Actair®, Orylmyte®, and Aitmyte (搜索)®, with further market expansions currently underway. This established international presence provides a foundation of clinical experience and regulatory precedent for the Chinese market entry.
Strategic Partnership and Recent Milestones
The IND clearance follows a series of recent developments reinforcing Nuance Pharma (搜索)'s commitment to the Chinese allergy market. In September 2025, the company entered into an exclusive long-term partnership with Stallergenes Greer for the development and registration of Actair® tablet in China, with Nuance Pharma retaining responsibility for subsequent commercialization.
Additional regulatory progress includes approval from the Pharmaceutical Administration Bureau of Macau in January 2026, followed by the launch of Actair® in China's Hainan Boao Pilot Zone through an early access program in May 2026.
Industry Leadership Perspectives
Mark Lotter, Founder and Chief Executive Officer of Nuance Pharma (搜索), emphasized the significance of this regulatory achievement: "We are truly excited by the NMPA's clearance of the Actair® IND application, a significant milestone for our allergy franchise. Together with the progress made through our early access programs, we look forward to bringing novel therapeutic solutions to support the growing needs of patients and healthcare professionals in this field."
Dr. Andreas Amrein, Chairman and Chief Executive Officer of Stallergenes Greer, added: "This IND clearance is a significant achievement for our development partner, Nuance Pharma (搜索), as they begin the Actair® pivotal study in China. It further strengthens our confidence in both the potential of our house dust mite tablet Actair® and of our broader portfolio to address the growing demand for innovative allergy treatments among Chinese patients."
Company Background
Nuance Pharma (搜索) operates as an innovation-driven biopharmaceutical company with a late-stage clinical pipeline and portfolio of commercial-stage assets. The company focuses on specialty care with a differentiated combination of commercialized products and an innovative pipeline spanning respiratory disease, pain management, emergency care, and iron deficiency anemia. Nuance Pharma deploys its proprietary Dual Wheel model, simultaneously advancing a globally competitive pipeline while maintaining a self-sustaining commercial operation in China and across Asia.
Stallergenes Greer, headquartered in Baar, Switzerland, is a global healthcare company specializing in allergy diagnosis and treatment through allergen immunotherapy products and services. With more than 120 years of expertise and innovation, the company's products are available to patients in 46 countries.