Company: CNTB
Filing Date: 2025-06-10
Form Type: F-3
Source: 0001193125-25-138482
Chunk: 76

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-06-10
Form: F-3
Chunk 76
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 the NMPA or comparable foreign regulatory authorities may seek to withdraw accelerated approval. |

| • |     | We have only one Product Candidate, rademikibart, currently in clinical development. If we are unable to                          
 successfully develop our Product Candidates or experience significant delays in doing so, our business will be materially harmed. |

| • |     | Our approach to the discovery and development of Product Candidates based on potent T cell modulation activity                                                                                                                           
 is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our Product Candidates or render our approach obsolete. |

| • |     | We have never submitted an NDA or Biologics License Application (“BLA”), and may be unable to do so 
 for any of our Product Candidates.                                                                  |

| • |     | The regulatory approval processes of the FDA, the NMPA and comparable foreign authorities are lengthy, time                                                       
 consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our Product Candidates, our business will be substantially harmed. |

| • |     | Disruptions at the FDA, the NMPA, comparable foreign regulatory authorities, and other government agencies                                                                                                                                              
 caused by shifting governmental policies and priorities, reductions in the federal workforce, funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent 
 new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.                                                                                                     |

4

| • |     | Our Product Candidates for which we intend to seek approval as biologic products may face competition sooner 
 than anticipated.                                                                                            |

| • |     | The proposed revision of the EU legislation on pharmaceuticals could lead to uncertainties over the regulatory 
 framework that will be applicable to medicinal products in the EU.                                             |

Risks Related to Our Reliance on Third Parties

| • |     | We rely, and expect to continue to rely, on third parties, including independent clinical investigators and                                                                                                                                    
 contract research organization (“CROs”), to conduct some aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements 
 or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our Product Candidates and our business could be substantially harmed.                                                                       |

| • |     | We contract with third parties