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Press release for Eklira entering China NRDL_AZ 06.23.2026

PP-EKL-7577-CHI-EN-v1

Nang Kuang Medicine Trading Limited and Azurity Pharmaceuticals Announce that Aclidinium Bromide Powder for Inhalation (marketed under the trademark Eklira® Genuair®) is Now Included in China’s National Reimbursement Drug List for Chronic Obstructive Pulmonary Disease Treatment

[HongKong 7th December] — Nang Kuang Medicine Trading Limited and Azurity Pharmaceuticals announced that aclidinium bromide powder for inhalation (marketed under the trademark Eklira® Genuair®) has been included in China’s National Reimbursement Drug List (NRDL), improving patient access to Chronic Obstructive Pulmonary Disease (COPD) treatment.

“The strategic partnership between Nang Kuang and Azurity is aimed at bringing important respiratory therapies to patients in China,” said Zhao Bing, General Manager at Nang Kuang. “The medicines are specifically for the maintenance treatment of patients with COPD, which is a rapidly growing respiratory condition in China.”

Through this collaboration, Nang Kuang has also obtained long-term exclusive rights to commercialize aclidinium bromide/formoterol fumarate powder for inhalation (marketed under trademark Duaklir® Genuair®) in the Chinese market. Nang Kuang will lead commercialization to ensure rapid access for patients across China.

“Azurity is proud to partner with Nang Kuang to make these treatment options available to more people with COPD,” said Ronald van der Rol, Chief Commercial Officer for Europe and International at Azurity Pharmaceuticals. “We strive to transform how medicine is experienced globally and this is an important milestone for expanding access to our growing portfolio of medicines.”

About Aclidinium Bromide Powder for Inhalation
Aclidinium bromide powder for inhalation is an imported original medicine primarily used for long-term maintenance treatment of adult patients with COPD. Positive results from the AVANT Phase 3 clinical trial for aclidinium bromide/formoterol fumarate powder for inhalation were previously reported. The 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate-to-severe COPD. There was no new safety concerns raised in the study and the findings were consistent with the known safety profiles of aclidinium bromide and aclidinium bromide/formoterol fumarate. The study involved 1,060 adult patients with moderate-to-severe COPD, with 70% of participants enrolled from China across 48 local study sites.

Aclidinium bromide powder for inhalation was approved in China in 2024. As of January 1, 2026, it is included in the National Reimbursement Drug List (NRDL) as a Category B drug.

Core Drug Information
• Generic Name: Aclidinium Bromide Powder for Inhalation (imported original)
• Indication: For symptom control and reduction of acute exacerbations in patients with COPD. Recommended dosage: one inhalation twice daily.
• Drug Category: Category B (effective from 2026)

Explanation of Reimbursement Policy
As a Category B drug, Aclidinium Bromide requires patients to pay a certain percentage of the cost out-of-pocket before the remainder is reimbursed under the outpatient chronic and special disease policy. The specific reimbursement rate may vary and depends on the hospital level and type of insurance coverage.

Application Process for Outpatient Chronic and Special Diseases
• As of January 1, 2026 Aclidinium Bromide is reimbursable under the NRDL Category B policy.
• Chronic/Special Disease Designation: Patients may be required to provide their ID card, social security card/medical insurance code, and a diagnosis certificate (including lung function report and medical records) from a Grade II or higher hospital. Applications can be submitted online via the National Medical Insurance Service Platform APP, or in person at the medical insurance office of a county-level hospital or a government affairs hall.
• Special Drug Registration (if required): Some high-cost drugs may require a “Five-Part Management” system. Patients must visit a designated respiratory specialist at an authorized hospital for assessment and to obtain a designation form. After an initial review by the hospital’s medical insurance office and a final review by the medical insurance authority, the patient’s record will be flagged in the system to enable direct settlement.
• Designated Pharmacy Purchase and Settlement: The product may be dispensed through a designated hospital or specialty pharmacy using your social security card or electronic medical insurance credential. The settlement system is expected to automatically recognize your outpatient chronic/special disease benefits, and you will only need to pay the out-of-pocket portion.

References
Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study. Respiratory Medicine, 2023; 218 https://www.resmedjournal.com/article/S0954-6111(23)00281-0/fulltext

European Medicines Agency https://www.ema.europa.eu/en/medicines/human/EPAR/eklira-genuair

About Nang Kuang Medicine Trading Co.
Nang Kuang Group is a China-based, innovation-driven pharmaceutical company with a global outlook. Dedicated to improving patient care through high-quality therapies, Nang Kuang has built long-term partnerships with leading international pharmaceutical companies. Learn more at www.nangkuang-med.com.

About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 50 medicines across 10 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com.

Media Contacts
Nang Kuang: info@nangkuang-medicine.com
Azurity Pharmaceuticals: media@azurity.com

©2026 Nang Kuang Medicine Trading Co., Ltd. All rights Reserved. This press release contains forward looking statements, including statements regarding anticipated commercialization and patient access in China. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.

2026 年 7 月 28 日 未分类
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