Recruitment Background:
RC1416 injection, developed by Nanjing RegeneCore Biotech Co.,Ltd, is currently undergoing a Phase Ib clinical study to "evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary effectiveness of RC1416 injection in patients with moderate to severe asthma." The lead institution for this study is the China-Japan Friendship Hospital in Beijing, and it is simultaneously being conducted at dozens of renowned hospitals across the country.
RC1416 can inhibit the activation of inflammatory pathways and alleviate asthma symptoms. Clinically, it is intended for use as an add-on maintenance therapy for moderate to severe asthma, meaning that patients' existing treatment plans remain unchanged, with RC1416 injection added to their original regimen.
This study has been approved by the National Medical Products Administration and the ethics committees of the participating hospitals. Eligible and voluntary patients will be provided with the study drug, examination fees stipulated in the study, corresponding subsidies that meet regulatory requirements, as well as attentive consultation and correct medication guidance by the project team members.

Inclusion Criteria:
Age: 18 years or older and 75 years or younger (inclusive);
Diagnosed with asthma for at least 1 year;
Receiving stable treatment with medium-to-high doses of inhaled corticosteroids (ICS) (e.g., fluticasone propionate with a daily dose of ≥250 μg or an equivalent dose of ICS) combined with at least one controller medication [such as long-acting β2 agonists (LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), or slow-release theophylline] for at least 3 months;
FEV1 ≤80% of the predicted value before bronchodilator use at screening;
Able to fully understand the requirements of this study, comply with the medication requirements and all study-related procedures and assessments; not considered potentially unreliable and/or uncooperative.

Patients or their families who wish to learn more can consult the doctors at the participating research centers. The final decision on eligibility will be made by the clinicians.