rademikibart (CBP-201) / Suzhou Connect Biopharma, Simcere - LARVOL DELTA

Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): A 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD) (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • Monotherapy • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Ocular Adverse Events of Biologic Therapies Targeting the IL-4/IL-13 Pathway in Atopic Dermatitis: A Systematic Review and Meta-analysis (AAD 2026) - "Biologic therapies targeting the IL-4/IL-13 pathway, including dupilumab, tralokinumab, and lebrikizumab, have transformed management but raised concerns about ocular adverse events, particularly conjunctivitis. With emerging agents such as cendakimab and rademikibart, the true incidence of these events remains uncertain...In contrast, the risk of keratitis was not increased (0.41% vs 0.21%; RR, 1.14; 95% CI, 0.34–3.83;​​p=0.83; I²=0%), Similarly, keratoconjunctivitis did not differ significantly between groups (0.28% vs 0.11%; RR, 1.65; 95% CI, 0.34–7.98; p=0.53; I²=0%). Conclusion This meta-analysis suggests that treatment with IL-4/IL-13 inhibitors is associated with an increased risk of conjunctivitis in patients with atopic dermatitis, while no association was observed with keratitis or keratoconjunctivitis.."

Adverse events • Retrospective data • Review • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13 • IL4

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents. (PubMed, Cureus) - "This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures.  A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing."

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

Results from Phase 3 Study of Rademikibart in Moderate-to-Severe Atopic Dermatitis to be Presented in the Late-Breaking Research Session at the 2026 American Academy of Dermatology (AAD) Annual Meeting (The Manila Times) - "'We believe the results obtained in this Phase 3 study provide a strong basis for the ultimate approval of Simcere’s pending New Drug Application (NDA) for rademikibart in China.'"

Late-breaking abstract • P3 data • Atopic Dermatitis

Connect Biopharma…CEO Barry Quart told investors at Oppenheimer’s 36th Annual Healthcare Life Science Conference that the company is advancing its lead asset, rademikibart, into what it described as a novel treatment approach for acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD). (MarketBeat) - "Quart said the company believes rademikibart’s binding characteristics and rapid effects on lung function could differentiate it from existing IL-4Rα–targeting therapies and from currently marketed asthma and COPD biologics, which are not indicated for acute exacerbations....He said Connect has completed studies in atopic dermatitis and chronic asthma."

Clinical • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease

Connect Biopharma (CNTB) highlighted new mechanism of action data for rademikibart and outlined its priorities for 2026 (TipRanks) - "New mechanism of action data supports the use of rademikibart in combination with standard of care beta-agonists to reverse acute exacerbations and for maintenance therapy in asthma and COPD; Initiated Phase 1b clinical pharmacology study with IV rademikibart to evaluate opportunity to reverse bronchoconstriction even more quickly than subcutaneous dosing; expect to report topline results in the first quarter of 2026; Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT 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 in mid-2026."

Clinical data • Preclinical • Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. (PubMed, Pharmacoepidemiol Drug Saf) - "Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety."

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

Development Highlights (GlobeNewswire) - "Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT 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 in the first half of 2026."

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

Abstract Title: Rapid and Sustained FEV1 Improvements with Rademikibart in Type 2 Asthma: Impact of Eosinophils and FeNO (GlobeNewswire) - "Rademikibart treatment led to rapid and sustained improvement in lung function and asthma control in subgroups with elevated baseline markers of Type 2 inflammation, with greatest improvements observed in patients with both high EOS and high FeNO; At Week 24, treatment with rademikibart improved prebronchodilator FEV1 by 507 mL in patients with high EOS and high FeNO, 284 mL in patients with low EOS and high FeNO, 209 mL in patients with high EOS and low FeNO, and 108 mL in patients with low EOS and low FeNO; In addition to lung function and asthma control, a reduction in asthma exacerbations was observed in subgroups with at least one high type 2 inflammatory biomarker at baseline, with a 63% reduction in patients with high EOS and a 69% reduction in patients with high FeNO."

Biomarker • P2b data • Asthma • Immunology • Inflammation

Abstract Title: Rademikibart in Moderate-to-Severe Asthma: Impact of Eosinophils and Regional Differences on Response (GlobeNewswire) - "A post-hoc analysis of the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma investigated the prespecified primary endpoint....Rademikibart rapidly and significantly improved lung function in adults with asthma, with greater benefit observed in patients with higher baseline EOS, in both the overall trial population and ROW subgroup; In Poland, placebo response was greater and rademikibart response was less than in the ROW subgroup and overall trial population. Four patients in the placebo group demonstrated unusually large improvements in lung function, potentially related to baseline factors, such as EOS <150 cells/μL, high FEV1, and/or daily use of inhalers."

P2b data • Asthma • Immunology

Rapid and sustained FEV1 improvements with rademikibart in type 2 asthma: Impact of eosinophils and FENO (ERS 2025) - P2 | "Rademikibart treatment leads to rapid and clinically meaningful improvements in lung function within the first Week in patients with type 2 asthma, particularly in those with elevated blood eosinophils and/or F E NO. This benefit was maintained for the entire 24-week treatment period."

Asthma • Immunology • Inflammation • Respiratory Diseases • IL4

Rademikibart in moderate-to-severe asthma: Impact of eosinophils and regional differences on response (ERS 2025) - P2 | "Overall, rademikibart rapidly and significantly improved lung function, with greater benefits in patients with higher eosinophils. Participants from Poland demonstrated greater placebo responses across all eosinophil strata. The unexpected Polish placebo response indicates regional differences affecting treatment outcomes and suggests a stronger response with rademikibart than first reported."

Asthma • Immunology • Respiratory Diseases

Biologic Therapies Targeting Type 2 Signaling in Atopic Dermatitis: A Comparative Review of Structural and Thermodynamic Differences in Mechanism of Action. (PubMed, J Invest Dermatol) - "It describes the structural and thermodynamic properties of IL-4/IL-13 signaling and how these properties inform MOA differences between the AD biologics dupilumab, tralokinumab, lebrikizumab, and rademikibart and translates the molecular science into potential clinical implications of these MOA differences. The fundamental conclusion is that each of the biologics currently in clinical use for treating AD function very uniquely by disrupting the assembly of the cytokine-receptor signaling complex at different energetic steps."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IFNG • IL13 • IL22 • IL4 • TSLP

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Connect Biopharm LLC | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Rademikibart monotherapy for moderate-to-severe atopic dermatitis in a 1-year, randomized, phase II trial (SEASIDE CHINA): initial two-week dosing, followed by two-week or four-week dosing. (PubMed, Br J Dermatol) - P2 | "Rademikibart Q2W induced rapid improvements in AD lesions and pruritus during the initial 16 weeks, which were maintained/improved further with rademikibart Q2W or Q4W across an additional 36 weeks. Rademikibart Q2W and Q4W were similarly efficacious and well tolerated. These findings are compatible with those from the published WW001 international phase II rademikibart trial."

Journal • Monotherapy • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Vitiligo

Connect Biopharma Holdings Limited…announced two poster presentations at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually. (GlobeNewswire) - "Abstract Title: Rademikibart in Moderate-to-Severe Asthma: Impact of Eosinophils and Regional Differences on Response; Abstract Title: Rapid and Sustained FEV1 Improvements with Rademikibart in Type 2 Asthma: Impact of Eosinophils and FENO"

Clinical data • Asthma

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Connect Biopharm LLC | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Development Highlights (GlobeNewswire) - "Recruitment of participants into the Phase 2 Seabreeze STAT asthma and Seabreeze STAT 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 in the first half of 2026."

P2 data • Asthma • Chronic Obstructive Pulmonary Disease

Financial Results for the Three and Six Months Ended June 30, 2025 (GlobeNewswire) - "License and collaboration revenues relate to the license agreement with Simcere under which Simcere has been granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. License and collaboration revenues for the three and six months ended June 30, 2025, were $48,000 for cost reimbursements for clinical materials."

Commercial • Asthma • Atopic Dermatitis

NEW DRUG APPLICATION (NDA) OF RADEMIKIBART WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that, on July 8, 2025, the new drug application (NDA) of the innovative drug Rademikibart, jointly developed by the Group and Connect Biopharma HongKong Limited...was accepted by the National Medical Products Administration...of China (NMPA) for the treatment of atopic dermatitis in adults and adolescents."

China filing • Atopic Dermatitis

Reduction in Annualized Exacerbations with Rademikibart in Eosinophilic Driven, Type 2 Asthma (EAACI 2025) - "2024; 209(1_MeetingAbstracts):A7003. doi:10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A7003"

Immunology • Inflammation • IL4R

Improvement in Lung Function with Rademikibart in Eosinophilic Driven, Type 2 Asthma (EAACI 2025) - "Am J Respir Crit Care Med 2024 , 209 (1_MeetingAbstracts), A7003. https://doi.org/10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A7003."

Immunology • IL4R

Improvement in Lung Function with Rademikibart in Eosinophilic Driven, Type 2 Asthma (GlobeNewswire) - P2b | N=322 | NCT04773678 | Sponsor: Connect Biopharm LLC | "Rademikibart rapidly improved prebronchodilator forced expiratory volume in one second (FEV1) at the first in-clinic assessment at Week 1, which was sustained through 24 weeks of treatment, with greater improvement demonstrated in the elevated baseline eosinophil subgroups than in the overall population; In addition to objective lung function, rapid and sustained improvements in patient reported asthma control in the rademikibart treatment groups were also noted, evidenced by increased change from baseline in Asthma Control Questionnaire (ACQ-6) scores in the elevated baseline eosinophil subgroups as compared to placebo; Rademikibart treatment groups were associated with substantially lower reports of patients experiencing high post-baseline eosinophil counts compared to published dupilumab data."

P2b data • Asthma

Reduction in Annualized Exacerbations with Rademikibart in Eosinophilic Driven, Type 2 Asthma (GlobeNewswire) - P2b | N=322 | NCT04773678 | Sponsor: Connect Biopharm LLC | "Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were investigated in a post-hoc analysis to determine the annualized asthma exacerbation rate (AAER) in patients with Type 2 inflammation-driven asthma, as indicated by elevated baseline eosinophil counts of ≥150 or ≥300 cells/µL. The analysis also evaluated changes in annualized asthma exacerbation rate based on elevated exhaled nitric oxide (FeNO ≥25 ppb), an additional, independent marker of Type 2 inflammation....Rademikibart also achieved clinically meaningful reductions in AAER in subgroups with markers of Type 2 inflammation: 63% in patients with elevated baseline eosinophils, 69% in patients with elevated FeNO, and 74% in patients with elevated baseline eosinophils and elevated FeNO."

P2b data • Asthma

Connect Biopharma Announces Two Oral Presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress (GlobeNewswire) - "Connect Biopharma Holdings Limited...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."

Clinical • Asthma • Immunology • Inflammation