1. Date of Occurrence: May 21, 115 2. Company Name: Paion Biotech Co., Ltd. 3. Relationship to the Company (Input Parent Company or Subsidiary): Parent Company 4. Mutual Shareholding Ratio: Not applicable 5. Reason for Occurrence: The primary active ingredient, Ferric Citrate (generic name in China: Ferric Citrate), for our company's new kidney disease drug, Nephoxil 500mg Capsule, has been reviewed and approved for market registration by the China National Medical Products Administration (NMPA). 6. Response: Disclosure of material information 7. Other relevant information (If the subject of the event or resolution is a public offering company or higher, this material information is deemed to have a significant impact on shareholder rights or securities prices pursuant to Article 7, Paragraph 9 of the Securities Trading Act Enforcement Rules):

(1) Ferric Citrate is the primary ingredient for our kidney disease drug, Nephoxil. Obtaining approval for this active ingredient in China helps strengthen the supply chain for Nephoxil in the Chinese market and deepens our strategy for vertical integration of active ingredients. (2) The subject of this approval is the active ingredient (Ferric Citrate). This is separate from the market approval for the Nephoxil 500mg Capsule drug product announced on April 27, 115, as they fall under individual inspection and registration procedures. This announcement discloses the approval concerning the active ingredient. (3) New drug development is a long-term process requiring significant investment without guaranteed success; investors should exercise prudent judgment.

FACT BOX

  • Source: PR Times
  • Category: New Product