Company: CNTB
Filing Date: 2025-07-09
Form Type: 8-K
Source: 0001628280-25-034551
Chunk: 1

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-07-09
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

On July 9, 2025, the Company announced that Simcere has submitted its NDA for rademikibart to the NMPA for the treatment of AD in adults and adolescents.

Forward-Looking Statements

This disclosure, including the press release furnished herewith as Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained herein include, but are not limited to, statements regarding the Company’s strategy and plans, the potential clinical effects, benefits, safety and efficacy of rademikibart, the timing, nature and significance of enrollment and data from the Company’s trials evaluating rademikibart, the timing of any further releases of data or of any presentations or investor conference calls, the Company’s plans and expectations for its asthma and COPD program, anticipated patient populations or market opportunities for the Company’s prospective products, if approved, whether the NMPA approves Simcere’s NDA and the timing of any such approval, whether the Company becomes eligible for any additional milestone or royalty payments under its agreement with Simcere, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by the Company’s competitors; changes in expected or existing competition; delays in or disruptions to the Company’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. 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 should not place undue reliance on these statements