OncoZenge AB (publ) ("OncoZenge" or the "Company") has today received confirmation that the NDRC has issued a certificate of approval for the investment agreement entered into by the Company and Sichuan-Yangtian Biopharmaceuticals Co, Ltd ("Yangtian Pharma" or the "Investor") on January 27th, 2025.
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 completed its review and issued a certificate of approval in support of the investment agreement.
As announced in the Company's regulatory progress update on April 25th, the mandatory filing with the Ministry of Commerce (MOFCOM) was submitted. The Investor has been informed that a central review is not required, and the file has been transferred for local review.
Upon completion of the review at the Sichuan Provincial Department of Commerce, the Investor will proceed to file with the State Administration of Foreign Exchange (SAFE), as per the ODI process, for administration of the foreign exchange transfers.
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 09:30 CEST on May 12, 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.
