PharmaEngine, Inc. filed post-approval change application for a new indication of ONIVYDE to TFDA. Cause of occurrence: PharmaEngine has filed post-approval change application for a new indication of ONIVYDE to Taiwan Food and Drug Administration (TFDA). The new indication is using ONIVYDE in combination with oxaliplatin, 5-fluorouracil and leucovorin as first line treatment for patients with metastatic adenocarcinoma of the pancreas.

Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 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.): (1) Name of the product: NAPOLI-3; (2) Indication: in combination with oxaliplatin, 5-fluorouracil and leucovorin for the first line treatment of patients with metastatic adenocarcinoma of pancreas; (3) The next step in development: file post-approval change for a new indication. Current stage of the Research and Development: A. Submit application/Approved/Not approved: Post-approval change in indication, drug administration and dosage B. Risks faced by the company, if it failed to receive the approval from Governmental Authority: N/A; C. Future direction if it receives the approval from Governmental Authority: PharmaEngine’s sales team to conduct sales activities in Taiwan; D. Cumulative research and development expenses: N/A (IPSEN France was solely responsible for all Phase 3 clinical trial expenses). The next step in development: obtain approval and certification: A. Estimated timeline: PharmaEngine will rapidly submit any additional documentation requested by the TFDA.

However, the duration of the review and approval process depends on the TFDA. Abiding to regulations, PharmaEngine will make material information announcements if the Company receives any response from the TFDA during this process. Market: According to the Cancer Registry Annual Report from Health Promotion Administration, in 2020, there were 3,012 patients with initial diagnosis of pancreatic cancer, and 2,450 patients’ cause of death was pancreatic cancer.

New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.