Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 116

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 116
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 incentives, it is unlikely that sales of the drug in the EU
would be sufficient to justify the necessary investment in developing the drug. In the United States, under the Orphan Drug Act the
FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined
as a patient population of fewer than 200,000 individuals in the United States or a patient population of greater than 200,000 individuals
in the United States, but for which there is no reasonable expectation that the cost of developing the drug will be recovered from
sales in the United States

The designation of a product
candidate as an orphan product does not mean that any regulatory agency will accelerate regulatory review of, or ultimately approve, that
product candidate, nor does it limit the ability of any regulatory agency to grant orphan drug designation to product candidates of other
companies that treat the same indications as its product candidates prior to Kadimastem’s product candidates receiving exclusive
marketing approval.

Generally, if a product candidate
with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation,
the drug may be entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application
for the same drug for that time period, except in limited circumstances.

Although Kadimastem has obtained
orphan drug exclusivity from the FDA for AstroRx®, that exclusivity may not effectively protect the product from competition
because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA may subsequently approve
another drug for the same condition if the FDA concludes that the latter drug is not the same drug or is clinically superior in that it
is shown to be safer, more effective or makes a major contribution to patient care. In the EU, marketing authorization may be granted
to a similar medicinal product for the same orphan indication if:

  the second applicant can establish in its application that                                                                                    

  the holder of the marketing authorization for the original                              

  the holder of the marketing authorization for the original                                 

Sales of Kadimastem’s
approved products, if any, will be subject to the regulatory requirements governing marketing approval in the countries in which Kadimastem
obtains regulatory approval, and where it plans to seek itself or with collaborators regulatory approval to commercialize its product
candidates in North America, the EU and in additional foreign countries. Clinical trials conducted in