Core Viewpoint - Connect Biopharma's collaborator, Simcere Pharmaceutical, has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China, indicating significant progress in the development of this potential best-in-class therapy for inflammatory diseases [1][2]. Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory diseases, with rademikibart as its lead product candidate targeting IL-4Rα [6]. - Simcere Pharmaceutical is an R&D-driven company focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection [5]. Product Development - Rademikibart is a fully human monoclonal antibody that targets IL-4Rα, blocking the Th2 inflammatory pathway, which is relevant for treating atopic dermatitis and asthma [4]. - The AD market in China presents a considerable opportunity, with an estimated 70 million patients suffering from the condition [3]. Collaboration Agreement - In 2023, Connect Biopharma and Simcere entered an exclusive license and collaboration agreement for rademikibart in Greater China, granting Simcere exclusive rights for development, manufacturing, and commercialization [2][3]. - Connect Biopharma is eligible for milestone payments totaling approximately $110 million and tiered royalties on net sales in Greater China [3].

Core Insights - Rademikibart has shown significant improvements in lung function and asthma control for patients with eosinophilic-driven type 2 asthma [1][2] - The treatment has led to a reduction in annualized exacerbation rates in the same patient group [1][10] - Ongoing Phase 2 studies for acute exacerbations in asthma and COPD are expected to report topline data in the first half of 2026 [1] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on asthma and COPD treatment [6] - The company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody [6] - Rademikibart targets acute exacerbations, addressing a significant unmet need among asthma and COPD patients [6] Clinical Data Highlights - In a Phase 2b trial, rademikibart improved prebronchodilator forced expiratory volume in one second (FEV1) within one week, sustained through 24 weeks [3] - The treatment showed greater improvement in patients with elevated baseline eosinophil counts compared to the overall population [3] - Rademikibart demonstrated a 63% reduction in annualized asthma exacerbation rates (AAER) in patients with elevated eosinophils, 69% in those with elevated FeNO, and 74% in patients with both markers [10]

SAN DIEGO, June 03, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually. The presentation details a ...

SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) ("Connect Biopharma" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced that company management will participate in the following upcoming conferences: Noble Capital Markets Virtual Conference Format: Corporate Presentation Date: Wednesday, June 4, 2025 Time: 9:00 a.m. ET Jefferies H ...

– Rademikibart significantly improved airway function, as measured by FEV1 , within a day and significantly reduced acute exacerbations in patients with inflammation-mediated chronic asthma strongly supporting ongoing Phase 2 acute exacerbation studies in asthma and COPD which are expected to report topline data in 1H26 – – New preclinical data highlights differentiated structural and molecular dynamics of rademikibart with enhanced interleukin-4 receptor alpha (IL-4Rα) inhibition compared to dupilumab prov ...

Initiated Phase 2 Seabreeze STAT Asthma and Seabreeze STAT COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations in Asthma and COPD in May 2025; topline data expected in 1H 2026 Published positive data from its global Phase 2 study supporting potential of rademikibart as a novel biologic treatment for patients with asthma and Type 2 inflammation Strong balance sheet with cash runway into 2027 through key clinical catalysts SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Connect Bi ...

– Expect to report topline data from the Seabreeze STAT COPD study in 1H 2026 – SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced the initiation of its Phase 2 Seabreeze STAT COPD study (NCT06940154) following written agreement on the final study protocol f ...

– FDA aligned on plan to initiate parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation – – Expect to initiate both trials in Q2 2025 – SAN DIEGO, April 01, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) (Connect or Connect Biopharma), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced positive fe ...