Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
OncoZenge AB (publ) ("OncoZenge" or the "Company") today provides an update on the status of the regulatory process in China for the investment agreement entered into by the Company and Sichuan-Yangtian Biopharmaceuticals Co, Ltd ("Yangtian Pharma" or the "Investor") on January 27th, 2025. Following amendments NDRC has accepted the completeness of the investor's filing, and a subsequent filing has been made with Ministry of Commerce.
On January 27th the Company announced the intention to partner with Yangtian Pharma as a new strategic investor in the Company, by entering into an investment agreement that through four tranches of directed share issues to Yangtian Pharma will provide the financing for the phase 3 trial for BupiZenge™ targeting European market approval. The investment is conditional on customary regulatory approvals, through a shareholder resolution in Sweden granted on March 3rd, and the successful completion of the mandatory Overseas Direct Investment (ODI) process in China.
The Company has received notice that the National Development and Reform Commission (NDRC) has reviewed the filing and requested amendments, which Yangtian Pharma has prepared and submitted. Following the acknowledgement of a complete and accepted NDRC file an inter-departmental case number was issued, enabling the Investor to also complete the mandatory filing with the Ministry of Commerce (MOFCOM). The Investor will proceed to file with the State Administration of Foreign Exchange (SAFE) as per the ODI process.
To cater for the lead-time in the ODI process to complete, OncoZenge and Yangtian Pharma has today entered into an amendment to the investment agreement, with the timeframe of the ODI process being extended to May 31st, 2025, all other terms unaffected.
Yangtian Pharma and OncoZenge fully expect the process to conclude with a positive outcome, which will release the phase 3 funding in accordance with the investment agreement.
BupiZenge™ - Potential to be the leading treatment for oral pain.
For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About this release
The information in this release was submitted for publication, through the agency of the contact persons set out above, at 08:30 CEST on April 25, 2025.
About OncoZenge
OncoZenge is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options fall short, often due to insufficient pain relief or significant side effects. BupiZenge™ is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge™ is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to severe physical and psychological distress, representing a significant unmet medical need for an effective, opioid-sparing treatment. In Phase 2 trials, BupiZenge™ demonstrated substantially better pain relief compared to the standard of care.
OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.