橫幅
25
2025.06
Tulex Pharmaceuticals, the U.S. subsidiary,announced that TLX-047, an anti-inflammatory drug,has received FDA approval notification.
1.Date of occurrence of the event:2025/06/25
2.New drug name or code:TLX-047
3.Indication:anti-inflammatory drug
4.Planned development stages:N/A
5.Current development stage:
(1) Application Submission / Approval Status / ClinicalTrial Results (including interim analysis) / Other Major EventsAffecting New Drug Development:Approved
(2) In the event of disapproval by the competent authority, lackof statistical significance in clinical trial results(including interim analysis), or other major events affecting newdrug development – potential risks and response measures:N/A
(3) In the event of approval by the competent authority,statistically significant clinical trial results(including interim analysis), or other major events affecting newdrug development – future business plans:N/A
(4) Cumulative R&D expenses incurred:In consideration of potential future partnerships inother countries, details will not be disclosed at thistime to avoid affecting negotiations.
6.Upcoming development plan:
(1) Expected completion time: N/A
(2) Expected obligations to be undertaken: N/A
7.Market situation:Based on statistics from the IQVIA database,total sales over the past four quarters were approximatelyUSD 39 million. Current market competitors include,but are not necessarily limited to, PAI and Chartwell.
8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of
the securities on public companies.):None.
9.New drug development requires long process, vast investments and withno guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.:
2.New drug name or code:TLX-047
3.Indication:anti-inflammatory drug
4.Planned development stages:N/A
5.Current development stage:
(1) Application Submission / Approval Status / ClinicalTrial Results (including interim analysis) / Other Major EventsAffecting New Drug Development:Approved
(2) In the event of disapproval by the competent authority, lackof statistical significance in clinical trial results(including interim analysis), or other major events affecting newdrug development – potential risks and response measures:N/A
(3) In the event of approval by the competent authority,statistically significant clinical trial results(including interim analysis), or other major events affecting newdrug development – future business plans:N/A
(4) Cumulative R&D expenses incurred:In consideration of potential future partnerships inother countries, details will not be disclosed at thistime to avoid affecting negotiations.
6.Upcoming development plan:
(1) Expected completion time: N/A
(2) Expected obligations to be undertaken: N/A
7.Market situation:Based on statistics from the IQVIA database,total sales over the past four quarters were approximatelyUSD 39 million. Current market competitors include,but are not necessarily limited to, PAI and Chartwell.
8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of
the securities on public companies.):None.
9.New drug development requires long process, vast investments and withno guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.: