Leruiping (rademikibart) / Suzhou Connect Biopharma, Simcere - LARVOL DELTA

Rapid, 24-hour, lung function improvement with rademikibart for asthma: post hoc analyses from a phase 2b randomised trial. (PubMed, Eur Respir J) - No abstract available

Journal • P2b data • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: Connect Biopharm LLC | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD) (clinicaltrials.gov) - P2 | N=159 | Completed | Sponsor: Connect Biopharm LLC | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adult and Adolescent Participants with Asthma and Type 2 Inflammation (The Manila Times) - "Rademikibart demonstrated a statistically significant increase from baseline in post-bronchodilator FEV1 on Day 7 of 250 mL compared to 120 mL with placebo (130mL greater improvement compared to placebo; p=0.023); Rademikibart reduced the treatment failure rate by approximately 66% over 28 days compared to placebo (p=0.153): The endpoint missed statistical significance due to an overall lower treatment failure rate than projected; 50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms compared to placebo; Rademikibart was well tolerated and no new safety signals were observed through the end of the study."

P2 data • Asthma • Immunology • Inflammation

Connect expects to report topline data from the ongoing Phase 2 Seabreeze STAT COPD study (CBP-201-207) of rademikibart for the treatment of acute exacerbations in COPD patients with type 2 inflammation later this month and plans to move quickly to meet with the FDA to gain alignment on a Phase 3 program. (The Manila Times)

New P3 trial • P2 data • Chronic Obstructive Pulmonary Disease • Immunology

Rademikibart for Asthma With Type 2 Biomarkers: Exploratory Subgroup Analyses From a Phase 2b Randomized Clinical Trial. (PubMed, Allergy) - P2 | "Rapid and sustained improvements were more pronounced in patients with type 2-high biomarkers than previously reported in the overall study population."

Biomarker • Clinical • Journal • P2b data • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Rademikibart IV for Acute Asthma and COPD Exacerbation (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Connect Biopharm LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Connect Biopharma…Provides Business Update (The Manila Times) - "Completed enrollment of the Phase 2 Seabreeze STAT asthma and COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations. Topline data from both studies are expected in September 2026, which should help determine a potential Phase 3 endpoint and sample size requirements. Following topline results, the Company plans to meet with the FDA to gain alignment on a Phase 3 program."

Enrollment closed • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Rademikibart IV for Acute Asthma and COPD Exacerbation (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Connect Biopharm LLC

New P2 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Connect Biopharm LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Rademikibart: Regulatory approval in China for atopic dermatitis in H2 2026 (Connect Biopharma) - Corporate Presentation

China approval • Atopic Dermatitis • Immunology

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Connect Biopharm LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Connect Biopharma announced the completion of enrollment in its Phase 2 Seabreeze STAT Asthma study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in participants with asthma and type 2 inflammation (The Manila Times) - "Connect expects to report topline data from the Phase 2 Seabreeze STAT Asthma study of rademikibart for acute exacerbations in early September 2026...The Company plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program later this year."

Enrollment closed • New P3 trial • P2 data • Asthma • Inflammation

Connect Biopharma Announces Completion of Enrollment of Phase 2 Seabreeze STAT Asthma Study Evaluating Rademikibart for the Treatment of Acute Exacerbations in Asthma (GlobeNewswire) - "Connect expects to report topline data from the Phase 2 Seabreeze STAT Asthma study of rademikibart for acute exacerbations in early September 2026...."

Enrollment closed • P2 data • Asthma • Immunology

On track to also complete enrollment in the Seabreeze STAT COPD study this month (GlobeNewswire) - "The Company plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program later this year."

Enrollment status • New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology

Rademikibart: Expiry of patents in US related to composition-of-matter in June 2037 (Connect Biopharma) - Corporate Presentation: Expiry of patents related to formulation in March 2040; Biologic exclusivity until 2040; Patent term extension until 2042; Expiry of patents related to method of treatment in Sep 2045

Commercial • Patent • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Rademikibart: "Rademikibart treatment in patients with moderate-to-severe atopic dermatitis demonstrated: Rapid and sustained efficacy through 52 weeks, with minimal plateau and near-maximal response achieved by ~90% of patient"; Atopic dermatitis (Connect Biopharma) - Corporate Presentation: "Greater long-term benefit with early initiation, with higher Week-52 IGA response versus delayed switch from placebo at Week 16"

P3 data • Atopic Dermatitis • Immunology

Efficacy and Safety of IL-4Rα Inhibitors for Atopic Dermatitis: A Systematic Review and Meta Analysis of Randomised Controlled Trials. (PubMed, Australas J Dermatol) - "Other agents (MG-K10, GR1802, 611, AK120) provided encouraging but limited data...Dupilumab remains the reference standard, while stapokibart and rademikibart emerge as promising next-generation options. Further large, long-term, head-to-head RCTs are warranted to confirm their comparative performance. PROSPERO Registration: CRD420251129343."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

Development Highlights (GlobeNewswire) - "Recruitment of participants into the Phase 2 Seabreeze STAT asthma and COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations is ongoing with topline data from both studies expected mid-2026. Following topline data, the Company plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program."

New P3 trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Simcere Pharmaceutical Group said the National Medical Products Administration has accepted its resubmitted New Drug Application for Rademikibart, an innovative monoclonal antibody targeting IL-4Rα for the treatment of atopic dermatitis in adults and adolescents. (TipRanks)

China filing • Atopic Dermatitis

Eosinophil Counts in Adults with Asthma Treated with Anti-IL-4Rα Rademikibart: Exploratory Analyses in a Randomized Trial. (PubMed, Chest) - P2 | "Exploratory analyses suggest that rademikibart therapy may not result in hypereosinophilia, although larger confirmatory analyses are required."

Journal • Asthma • Cardiovascular • Eosinophilia • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Crystal structure and molecular dynamics simulations of rademikibart Fab-IL-4Rα complex reveal biochemical basis for next-generation potent IL-4Rα inhibition in type 2 allergic and inflammatory diseases. (PubMed, bioRxiv) - "Through analysis of the x-ray crystallography structures, MD-equilibrated structures, and computational point-mutation analysis of rademikibart, we identified residue Y50 and R55 of the light chain and R97, R99, and Y101 of the heavy chain of rademikibart as key residues interacting with IL-4Rα's third interface loop. Our data provides a molecular and structural rationale for the enhanced IL-4Rα inhibition by rademikibart over dupilumab, confirming rademikibart as an optimized second-generation IL-4Rα inhibitor."

Journal • Inflammation • IL13 • IL4R • STAT6

Simcere Pharmaceutical Group has voluntarily withdrawn and plans to promptly resubmit its New Drug Application in China for rademikibart, an innovative IL-4Rα-targeting monoclonal antibody for atopic dermatitis co-developed with Connect Biopharma, as part of a strategic optimization of its commercialization plan. (TipRanks) - "Phase 3 data showed rapid onset and strong long-term efficacy, with EASI-75, EASI-90 and IGA 0/1 response rates climbing to 96.6%, 85.3% and 87.1% by week 52, underscoring the drug’s potential to strengthen Simcere’s position in the competitive inflammatory and autoimmune therapeutics market and support its broader innovation-led growth strategy."

China filing • Atopic Dermatitis

Connect Biopharma Announces Enrollment in Phase 2 Seabreeze STAT Studies Will Continue as Planned Following Pre-Specified Interim Analysis (GlobeNewswire) - "The independent DMC reviewed interim data based on a pre-specified analysis of treatment failure at 28 days, the rate of new exacerbations through 28 days, and the change from baseline in FEV1 following treatment of a minimum of 50 patients in each study with at least 28 days of follow-up...The DMC also conducts a review of the safety data for both studies on a regular basis and indicated that it has no safety concerns.....Connect expects to report topline data from both ongoing Phase 2 Seabreeze STAT studies of rademikibart for acute exacerbations of asthma and of COPD in mid-2026 and plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program."

DSMB • New P3 trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Comparative Study of the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China (clinicaltrials.gov) - P1 | N=178 | Completed | Sponsor: Simcere Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed

Trial completion