Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 88

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 88
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 requirements will be accepted by the Japanese authorities. There is no similar agreement with the U.S., but this is not a significant issue because of the OECD arrangement.
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A marketing license-holder that has obtained marketing approval for a new molecular entity, administration route, combination drugs, indication, or posology must have that pharmaceutical re-examined by the PMDA for a specified period after receiving marketing approval. Such re-examination period for EPKINLY is stated to be eight (8) years after the marketing approval in September 2023. The purpose of this re-examination process is to ensure the safety and efficacy of a newly approved pharmaceutical by imposing on the marketing license-holder the obligation to gather clinical data for a certain period after the marketing approval was granted in order for the PMDA to have the opportunity to re-examine the product. Results of use and other pertinent data must be attached for an application for a re-examination. A marketing license holder that has obtained marketing approval is also required to investigate, among other things, the results of use and to periodically report to the PMDA pursuant to the Pharmaceuticals and Medical Devices Act. During the re-examination period, exclusivity on the market is granted regardless of effective patent.
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The MHLW may require additional post-approval studies (Phase IV) for some specific cases, to further evaluate safety and/or to gather information on the use of the product under specified conditions.
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In Japan, public medical insurance systems cover the entire Japanese population. The public medical insurance system, however, does not cover any medical product which is not listed on the National Health Insurance (“NHI”) price list published by the Minister of the MHLW. Accordingly, a marketing license-holder of medical products must first have a new medical product listed on the NHI price list in order to obtain its coverage under the public medical insurance system. New regulatory approved drugs are listed on the NHI price list within 60 or 90 days after its regulatory approval. The NHI price list listed EPKINLY in November 2023.
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The NHI price of a medical product is determined either by price comparison of comparable medical products with necessary adjustments for innovativeness, usefulness or size of the market; or, in the absence of comparable medical products, by the cost calculation method, determined after considering the opinion of the manufacturer. Prices on the NHI price list are subject to revision, generally once every year, on the basis of the actual prices at which the medical products are purchased