Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 142

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 142
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ponsors are required to register and disclose certain clinical trial information on a single portal, CTIS (Clinical Trial Information System), replacing Eudra-CT, set up by the European Medicines Agency (EMA). CTIS is a single entry point centralizing information and databases on clinical trials in the EU. Eudra-CT will be definitively abandoned at the end of the transition period, i. e., on January 30, 2025. Information related to the product, patient population, Phase of investigation, study sites and

investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors of applicable clinical trials are also obligated to disclose the results of their clinical trials within a certain timeframe after completion. Disclosure of the results of these trials may be delayed until the new product or new indication being studied has been approved, subject to time-based limitations. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

Regulations concerning marketing authorizations

In order to be marketed, a drug product must have regulatory authorization (known as approval of a New Drug Application (NDA) or licensure of a Biologics License Application (BLA) in the United States, a Marketing Authorization Application (MAA) in the European Union and a Great Britain Marketing Authorisation Application). The competent authorities are the FDA in the United States, the EMA in the European Union and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Companies apply for a marketing authorization based on quality, safety and efficacy data. In the European Union, the United States and Japan, the dossier is a standard dossier referred to as a CTD, or Common Technical Document. Generally, the dossier describes the manufacturing of the drug substance (active substance), the manufacturing of the final product and the clinical and non-clinical studies common to all jurisdictions while providing a separate module for region-specific information.

United States review and approval process for biological products

In the United States, the FDA licenses complex biological products under the Public Health Service Act, or PHSA. In order to obtain approval to market a biological product in the United States, a BLA must be submitted to the FDA with data establishing the safety, purity and potency of the proposed biological product for its intended indication. The application includes all relevant data available from pertinent preclinical and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls