Nuance Pharma Announces IND Clearance for Actair® Pivotal Clinical Trial in China

NMPA Approval Marks Key Milestone in Advancing House Dust Mite Allergy Immunotherapy to Chinese Patients

SHANGHAI, May 22, 2026 /PRNewswire/ -- Nuance Pharma today announced that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application, enabling the company designed to initiate a pivotal clinical trial of Actair^® for the treatment of house dust mite-induced allergic rhinitis in China.

Actair^® is already commercialized across 21 countries and territories (under the brand names Actair^®, Orylmyte^®, and Aitmyte^®), with further market expansions underway.

Under the IND clearance, Nuance Pharma will initiate a Phase III randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Actair^® over a 12-month treatment period in patients with allergic rhinitis, with or without concomitant asthma.

"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. "We look forward to working closely with leading investigators as we evaluate Actair^® in patients across China."

The IND clearance follows a series of recent milestones reinforcing Nuance Pharma'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 the company's Actair^® tablet in China, with Nuance Pharma retaining responsibility for subsequent commercialization. In January 2026, Actair^® received approval from the Pharmaceutical Administration Bureau of Macau. Most recently, in May 2026, Nuance Pharma launched Actair^® in China's Hainan Boao Pilot Zone through an early access program.

"We are truly excited by the NMPA's clearance of the Actair^® IND application, a significant milestone for our allergy franchise," said Mark Lotter, Founder and Chief Executive Officer of Nuance Pharma. "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, 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."

About Nuance Pharma

Nuance Pharma is an innovation-driven biopharmaceutical company with a late-stage clinical pipeline and a portfolio of commercial-stage assets. Focused on specialty care, Nuance has established a differentiated combination of commercialized products and an innovative pipeline spanning respiratory disease, pain management, emergency care, and iron deficiency anemia. With a mission to address critical unmet medical needs across the Asia-Pacific region, 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. For more information, please visit www.nuancepharma.com.

About Stallergenes Greer International AG

Headquartered in Baar, Switzerland, Stallergenes Greer is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy products and services. Backed by more than 120 years of expertise and innovation, its products are available to patients in 46 countries. For more information, please visit www.stallergenesgreer.com.

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SOURCE Nuance Pharma Limited