A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Start Date12 Aug 2025

Sponsor / Collaborator

Suzhou Connect Biopharma Co. Ltd.

NCT06940141

/ RecruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Start Date08 Aug 2025

Sponsor / Collaborator

Suzhou Connect Biopharma Co. Ltd.

NCT06701149

/ Not yet recruitingPhase 1

A Randomized, Open-label, Single-dose, Parallel Group Study to Compare the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China

A study to compare the pharmacokinetics, safety and immunogenicity of SIM0718 injection in healthy adult subjects in China

Start Date28 Nov 2024

Sponsor / Collaborator

Simcere Pharmaceutical Group Ltd.

100 Clinical Results associated with Rademikibart

100 Translational Medicine associated with Rademikibart

100 Patents (Medical) associated with Rademikibart

Literatures (Medical) associated with Rademikibart

BRITISH JOURNAL OF DERMATOLOGY

Rademikibart monotherapy for moderate-to-severe atopic dermatitis in a 1-year, randomized phase II trial (S EASI DE CHINA): initial 2-week dosing, followed by 2-week or 4-week dosing

Article

Author: Yun, Jili ; Collazo, Raúl ; Pan, Wuban ; Guo, Jiawang ; Wei, Zheng ; Silverberg, Jonathan I ; Zhang, Jianzhong

Abstract:

Background:

Rademikibart (CBP-201) is a potent, next-generation human monoclonal antibody optimized to bind with high affinity to interleukin-4 receptor subunit alpha.

Objectives:

To evaluate rademikibart efficacy and safety, initially dosed every other week (Q2W), and Q2W or every fourth week (Q4W) from week 16, in Chinese adults/adolescents with moderate-to-severe atopic dermatitis (AD).

Methods:

SEASIDE CHINA (NCT05017480) was a phase II randomized trial: stage 1 was a 16-week treatment period, and stage 2 comprised 36-week treatment and 8-week follow-up periods. The primary endpoint was the proportion of patients with a validated Investigator Global Assessment Scale for AD score of 0 or 1 (vIGA 0/1) and ≥ 2-point reduction from baseline at week 16. Overall, 330 patients were randomized 2 : 1 double-blind to receive subcutaneous rademikibart 600 mg on day 1 and 300 mg Q2W from week 2–14, or placebo. Predose at week 16, patients were assessed for minimal important change [≥ 50% improvement from baseline in Eczema Area and Severity Index score (EASI 50)] and rerandomized 1 : 1 double-blind to rademikibart 300 mg Q2W or Q4W.

Results:

In stage 1, 29.0% of patients attained vIGA 0/1 and ≥ 2-point reduction with rademikibart Q2W (P < 0.001) at week 16, without plateauing, vs. 5.9% with placebo. Rapid, significant improvements were also observed with all other rating scales in stage 1, including ≥ 75% improvement from baseline in EASI (EASI 75) (58.6% vs. 22.6%) and ≥ 4-point reduction in Peak Pruritus Numeric Rating Scale (PP-NRS) (36.3% vs. 10.5%) with rademikibart Q2W vs. placebo, respectively, at week 16. In stage 2, week 16 EASI 50 responders from stage 1 continued to improve through week 52 when treated with rademikibart Q2W or Q4W, including vIGA response (Q2W 59.1%; Q4W 62.6%), EASI 75 (Q2W 84.6%; Q4W 84.8%), and ≥ 4-point reduction in PP-NRS (Q2W 60.4%; Q4W 70.3%). Most patients with improvements during rademikibart Q2W therapy at week 16 maintained these responses through week 52 in both the rademikibart Q2W and Q4W groups: vIGA (Q2W 78.0%; Q4W 87.1%), EASI 75 (Q2W 90.1%; Q4W 92.3%) and ≥ 4-point reduction in PP-NRS (Q2W 85.3%; Q4W 94.8%). Injection site reactions were grade 1 (mild). No serious treatment-emergent adverse events (TEAEs) were treatment related. Three patients discontinued rademikibart owing to TEAEs (AD flare, vitiligo, pregnancy).

Conclusions:

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 international phase II rademikibart trial, CBP-201-WW001.

01 Aug 2025·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Biologic Therapies Targeting Type 2 Signaling in Atopic Dermatitis: A Comparative Review of Structural and Thermodynamic Differences in Mechanism of Action

Review

Author: Bunick, Christopher G

Atopic dermatitis (AD) is a chronic skin disease characterized by heterogeneous clinical morphology, immune dysregulation, and disease burden. A key component of the immune dysregulation in AD occurs through type 2 immunity, with elevations in IL-4 and IL-13. Multiple other cytokines contribute to both acute and chronic states of AD, including IL-31, IL-22, IFN-γ, and thymic stromal lymphopoietin. Several biologic therapies targeting type 2 cytokine (IL-4 and IL-13) signaling through distinct mechanisms of action (MOAs) have been developed, with more expected in the future, including with multivalency. Although biologics targeting the IL-4/IL-13 pathway have good overall efficacy for AD, variable individual patient responses to different biologics have been observed. This review analyzes and addresses the function of biologic therapies for AD from a fresh molecular perspective. 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.

01 May 2025·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial

Article

Author: Guo, Jiawang ; Adivikolanu, Radha ; Yun, Jili ; Longphre, Malinda ; Wang, Junying ; Collazo, Raúl ; Kerwin, Edward ; Su, Nan ; Yang, Ting ; Pan, Wuban ; Wei, Zheng

RATIONALE:

Rademikibart (formerly CBP-201) is an IL-4Rα-targeting antibody.

OBJECTIVES:

To evaluate rademikibart in adults with moderate-to-severe, persistent, uncontrolled asthma.

METHODS:

In this global phase 2b trial (NCT04773678), 322 patients were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every other week, following a 600 mg loading dose) or placebo, administered subcutaneously, for 24 weeks.

MEASUREMENTS AND MAIN RESULTS:

Prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV₁) at Week 12 (primary endpoint) improved with rademikibart 150 mg and 300 mg: least squares mean changes (95% CI), above placebo, were +140 mL (+44-236 mL; p=0.005) and +189 mL (+92-286 mL; p<0.001), respectively. Prebronchodilator trough FEV₁ improvements occurred rapidly during Week 1, were sustained through Week 24, and greatest in patients with high baseline blood eosinophils (patients with ≥300 eosinophils/mL experienced placebo-adjusted FEV₁ improvement at Week 24 of +420 mL [95% CI, +239-600 mL] in the 300 mg group). Rapid and sustained statistically significant improvements were also observed in percent predicted FEV₁ and Asthma Control Questionnaire score across 24 weeks. Through Week 24, proportions of patients with ≥1 exacerbation were 7.5% (150 mg) and 9.3% (300 mg) vs 16.7% (placebo). 88% of patients completed treatment. Treatment-emergent adverse events (TEAEs) were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common TEAEs (10-12% of patients) were cough, COVID-19, and dyspnea.

CONCLUSIONS:

Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www.

CLINICALTRIALS:

gov, ID: NCT04773678.

News (Medical) associated with Rademikibart

01 Oct 2025

·www.globenewswire.com

Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025

– Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, with greatest improvements observed in those with elevated baseline levels of key type 2 inflammatory markers – – Significant reduction in annualized exacerbations observed in patients with one or more elevated type 2 inflammatory markers at baseline – – Data supports ongoing Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in 1H26 – Sept. 29, 2025 -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today presented data supporting rademikibart, the Company’s investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually. “We are excited to share additional analyses from our Phase 2b asthma study at ERS. These data continue to expand our data package for rademikibart and reinforce its potential to deliver best-in-class efficacy for patients with moderate to severe asthma and COPD,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “These data build on previously reported Phase 2b study outcomes demonstrating rapid and sustained lung function improvements, with the greatest outcomes being observed in patients with elevated levels of key type 2 inflammatory biomarkers. In addition, these analyses have helped to refine our clinical development plans and clinical site strategies for our ongoing Seabreeze STAT asthma and COPD studies. We look forward to reporting topline data from both in the first half of 2026.” Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were evaluated in a post-hoc analysis to investigate the efficacy of rademikibart in subgroups of patients with asthma based on baseline levels of type 2 inflammatory biomarkers, indicated by blood eosinophil counts (EOS) of 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. These results highlight rademikibart’s potential to improve lung function and reduce asthma exacerbations, particularly in patients with elevated markers of Type 2 inflammation. A post-hoc analysis of the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma investigated the prespecified primary endpoint, absolute change in prebronchodilator FEV1 at Week 12, in subgroups of patients enrolled in Poland and in the Rest of the World (ROW). 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 1, and/or daily use of inhalers. In Poland, rademikibart-treated patients also had milder disease compared to the ROW subgroup, increased percent predicted FEV1, and despite similar FeNO levels, this baseline imbalance may have impacted treatment effects. These results underscore the importance of rigorous trial conduct and comprehensive patient guidance and have informed the Company’s ongoing Phase 2 Seabreeze STAT clinical site strategy. Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect also has an exclusive license and collaboration agreement for rademikibart with Simcere in China. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultLicense out/in

04 Sep 2025

·www.globenewswire.com

Connect Biopharma Announces Two Presentations at the European Respiratory Society (ERS) Congress 2025

SAN DIEGO, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced two poster presentations at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually. The presentation details are as follows: Abstract Title: Rademikibart in Moderate-to-Severe Asthma: Impact of Eosinophils and Regional Differences on ResponsePoster Number: PA2480Presenter: Raúl Collazo, Ph.D.Session#218: Biologics for Asthma and Allergic Rhinitis: Novel Trial DataDate and Time: Monday, September 29th from 8:00 a.m. – 9:30 a.m. CET Abstract Title: Rapid and Sustained FEV1 Improvements with Rademikibart in Type 2 Asthma: Impact of Eosinophils and FENOPoster Number: PA2481Presenter: Raúl Collazo, Ph.D.Session#218: Biologics for Asthma and Allergic Rhinitis: Novel Trial DataDate and Time: Monday, September 29th from 8:00 a.m. – 9:30 a.m. CET Following the presentations, each presentation will be available on Connect’s website under the presentations and publications section. About RademikibartRademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. About Connect BiopharmaConnect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect also has an exclusive license and collaboration agreement for rademikibart with Simcere in China. For more information visit www.connectbiopharma.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the Act). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our cash balance, financial guidance, future financial and operating results and related expectations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations or market opportunities for our prospective products, if approved, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements. This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the National Medical Products Administration, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Investor Relations Contact:Alex Lobo Precision AQ Alex.lobo@precisionaq.com (212) 698-8802 Media Contact:Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310 or (646) 942-5604

License out/inClinical Study

03 Sep 2025

·www.globenewswire.com

Connect Biopharma Completes Termination of its American Depositary Receipt Program and Directly Lists its Ordinary Shares on Nasdaq

SAN DIEGO, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that it has completed the termination of the Deposit Agreement dated March 18, 2021, as amended, among the Company, Deutsche Bank Trust Company Americas, and the holders and beneficial owners of American Depositary Shares evidenced by American Depositary Receipts (“ADRs”) issued thereunder (the “Deposit Agreement”), and that the Company’s ordinary shares are now directly listed on the Nasdaq Global Market (“Nasdaq”). The ADR program and the Deposit Agreement terminated on September 2, 2025. At such time, the Company’s ADRs were mandatorily cancelled and exchanged for ordinary shares at a one-for-one ratio. The Company’s ordinary shares commence trading directly on Nasdaq today under the Company’s existing symbol “CNTB”. “Directly listing our ordinary shares on Nasdaq represents our continued evolution into a U.S.-centric company,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We believe our work over the last 12 months has positioned Connect both operationally and clinically to deliver on the promise of a best-in-class treatment for asthma and COPD patients. As we look ahead, we are focused on executing our Phase 2 Seabreeze STAT studies for rademikibart, and we believe this transition will enable us to drive greater institutional access with U.S. investors as we aim to build long-term shareholder value.” About Rademikibart Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. About Connect Biopharma Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect also has an exclusive license and collaboration agreement for rademikibart with Simcere in China. For more information visit www.connectbiopharma.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding our expectation that the termination of the ADR program will facilitate institutional visibility and the strengthening of our investor base; and the likelihood of success of our rapid Phase 2 clinical development program for rademikibart. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “look forward to,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements. This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the National Medical Products Administration, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Investor Relations Contact: Alex Lobo Precision AQ Alex.Lobo@precisionaq.com (212) 698-8802 Media Contact: Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310 or (646) 942-5604

Phase 2

100 Deals associated with Rademikibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	NDA/BLA	China	MabPlex International Co., Ltd.	08 Jul 2025
Moderate Atopic Dermatitis	NDA/BLA	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	08 Jul 2025
Severe Atopic Dermatitis	NDA/BLA	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	08 Jul 2025
Severe Atopic Dermatitis	NDA/BLA	China	MabPlex International Co., Ltd.	08 Jul 2025
Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	23 Jul 2024
Eosinophilic Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	23 Jul 2024
Severe asthma	Phase 3	China	Suzhou Connect Biopharma Co. Ltd.	01 Jul 2024
Asthma chronic	Phase 3	China	Suzhou Connect Biopharma Co. Ltd.	-
Pulmonary Disease, Chronic Obstructive	Phase 2	United States	Suzhou Connect Biopharma Co. Ltd.	12 Aug 2025
Pulmonary Disease, Chronic Obstructive	Phase 2	Australia	Suzhou Connect Biopharma Co. Ltd.	12 Aug 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04773678 (Phase 2b Trial, ATS2025)	Phase 2	Pulmonary Disease, Chronic Obstructive \| Asthma	322	Rademikibart 150 mg Q2W	vgfnbwkqqe(rehybtwdvv) = zagenbtstk jjahsfiyui (hwoxzmttqs, -40 to 370)	Positive	16 May 2025
				Rademikibart 300 mg Q2W	vgfnbwkqqe(rehybtwdvv) = rxeenvriyh jjahsfiyui (hwoxzmttqs, 0 - 320)
NCT04773678 (Phase 2b trial, ATS2025)	Phase 2	Asthma blood eosinophil count	322	Rademikibart 600 mg loading dose	eximoqvvzz(ocuevfbzcn) = ditjdreixo mpqgyonzop (ixbsledtxe )	Positive	16 May 2025
				Placebo	eximoqvvzz(ocuevfbzcn) = siqpnfsdqc mpqgyonzop (ixbsledtxe )
NCT04773678 (Pubmed \| Am J Respir Crit Care Med)	Phase 2	Moderate asthma \| Severe asthma blood eosinophils	322	Rademikibart 150 mg	jezwkwsgyd(ynxjvbyygt) = qawycfking tropvpbozz (kivqklouui, 44 - 236) View more	Positive	01 May 2025
				Rademikibart 300 mg	jezwkwsgyd(ynxjvbyygt) = tdtfhdbfsg tropvpbozz (kivqklouui, 92 - 286) View more
ATS2024	Not Applicable	Asthma	-	Rademikibart 150 mg Q2W	uhvzswndui(dunmtwoqkb) = Treatment emergent adverse events (TEAEs) were relatively similar across all groups, with the most common TEAEs being COVID-19, cough, dyspnea, and wheezing nrigayhxxc (ysngfahlia )	-	19 May 2024
				Rademikibart 300 mg Q2W
NCT05017480 (CN002 \| CBP-201-CN002, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	330	CBP-201 (Group A: CBP-201 300mg Q2W)	kiaoobttgl = wnswzxgedk aqyfmumuja (sncslxyeid, giubgpxnpe - kwujmxvmbk) View more	-	01 May 2024
				Placebo (Group B: Placebo Q2W)	kiaoobttgl = gxpfqbputh aqyfmumuja (sncslxyeid, wqahlwvlvp - nfnfxvueyb) View more
NCT04773678 (GlobeNewswire) Manual	Phase 2	Persistent asthma	322	Placebo	nqtnjmprkl(tlyouhmvph) = jvmsmyfdxq difvoegeww (wcgcuvrzbk )	Positive	12 Dec 2023
				rademikibart 150 mg	nqtnjmprkl(tlyouhmvph) = firdknntfd difvoegeww (wcgcuvrzbk ) View more
NCT05017480 (CN002, Corporate Publications) Manual	Phase 2	Dermatitis, Atopic	330	Rademikibart300 mg Q4W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	zbtdetihga(bnkzcnrvgv) = hylxxkkekv gazebwimiy (fsvhvmwdnh ) View more	Positive	21 Nov 2023
				Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	zbtdetihga(bnkzcnrvgv) = fdcydyfsny gazebwimiy (fsvhvmwdnh ) View more
NCT04444752 (CBP-201-WW001, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	226	placebo	grwxigdusj(oricqqvpqg) = rjqellgbnf btwllbumac (kyymkhowtu, 4.638) View more	-	01 Aug 2023
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	zdetpxjbrg(lqluzxapjo) = fmtdyfjsbz qrbwfgaqub (cunhoytuhx ) View more	-	03 Jul 2023
				Placebo	zdetpxjbrg(lqluzxapjo) = olmxnlaebu qrbwfgaqub (cunhoytuhx ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	ahpofdhcnd(elegzaawgz) = jwlvowlkgj bexpsponvj (nslypvrwtr ) View more	-	03 Jul 2023
				Placebo	ahpofdhcnd(elegzaawgz) = ismooxnrca bexpsponvj (nslypvrwtr ) View more

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