Zhaoke （Guangzhou）Oncology Pharmaceutical Ltd.had a very successful...
September 9, 2019, Zhaoke （Guangzhou）Oncology Pharmaceutical Ltd.had a very successful meeting with the reviewers from the Center for Drug Evaluation of NMPA of China. The purpose of the meeting was to discuss the planed combination trial of the new drugs, anti-PD-L1 monoclonal antibody and Oncolytic virus Pexa-vec. During the meeting, reviewers gave positive feedback and clear guidance to Zhaoke’s request and trial protocol. After discussion, reviewers agreed that Zhaoke can initiate the related combination trial and should submit the IND application as soon as possible.
INOMAX pre-NDA meeting
On August 20, 2019, a pre-NDA meeting for the inhalated nitric oxide (trade name: INOMAX) was held at the Drug Evaluation Center of the NMPA. Participants at the conference included Minister Ma Yunan, Vice Minister Wang Yamin, Yu Hong (senior reviewer), Liu Fuli (chief reviewer), Shi Jingfen, other reviewers and manufacturer representatives, Callie Gautreaux and Stacy Woeppel, as well as represnetatives from the registered agents of Zhaoke Pharmaceutical (Hefei) Co., Ltd., Dr. Dai Xiangrong, Dr. Huang Sijia, Shi Min, Li Dongmei, Wang Xuyu.
The meeting mainly focused on discussing the production process of and the technical requirements related to the import registration of INOmax. Before the meeting, the participants from both sides were introduced by Dr. Liu Fuli and Dr. Dai Xiangrong. Then, Shi Min, the project manager of Zhaoke Pharmaceutical, briefly introduced the basic information of the product, the summary of the pharmaceutical materials, related questions and answers through the presentation slides. Then, the manufacturer's representative, Callie, introduced the production process, filling system, gas cylinder transportation and recycling management of the product in detail, and gave detailed answers to the questions raised by the reviwers of the Drug Evaluation Center. In the end, both parties reached an agreement on all the issues raised. The communication of this meeting provided a sufficient pharmacy basis for the NDA application of INOmax.
Auransa Enters into Exclusive Licensing Agreement with China Oncology...
PALO ALTO, CA, AND HONG KONG – December 19, 2018 – Auransa, Inc., an artificial intelligence (AI)-driven pharmaceutical company developing precision medicines in areas of significant unmet medical need, and China Oncology Focus Limited (“COF”), an affiliate of Lee’s Pharmaceutical Holdings Ltd. (“Lee’s Pharma”), today announced that the companies have entered into a licensing agreement granting COF exclusive rights to develop and commercialize AU018 in China and other countries of Southeast Asia. Under terms of the agreement, Auransa will receive an upfront payment, potential future milestone payments and high single digit royalties on future net sales. In total, Auransa is eligible to receive up to $22.5 million upon successful attainment of key milestones.