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PHDS Got Ad-p53's Exclusive Global Promotion Authorization


PHDS was exclusively authorized by Sainuosheng(Shenzhen) Gene Industry Development Co. in August, 2021 to launch a global promotion campaign for Recombinant Human Ad-p53 Injection(Gendicine),  a new invention by Sainuosheng, also  the first gene anticancer medicine across the world.  See below:


Background of Authorization

Party A owns drug product "recombinant human adenovirus p53 injection" (Trade name: 今又生®Gendicine , hereinafter referred to as "the product"), which is the first gene therapy drug for cancer approved by the State Food and Drug Administration of China (renamed to the National Medical Products Administration in 2018) in 2003.  Since marketing, it has been used in about 20,000 clinical cases inside and outside China, and its safety and effectiveness have been widely affirmed.  In 2019, after the expansion, renovation and quality upgrade, the manufacturing site was approved for renewal of biological drug. Party A, as the product owner, possesses the exclusive patent right, production right and commercial promotion right of this product.  


Party B is a CRO company with a history of nearly 20 years serving the global pharmaceutical industry. It has established more than 1,900 customer communication channels in more than 50 countries around the world, with excellent global resources and international pharmaceutical marketing channels.  In order to realize the complementary advantages of both parties’ resources and jointly promote the entry of the Product into global pharmaceutical market for the benefit of mankind, Party A hereby authorizes Party B with full and complete authority to the followings:


l      Party B, on behalf of Party A (licensor), promotes and introduce the history, advantages, features and clinical application of the product, as well as Sainuosheng, and effectively communicate with third parties on the marketing of the product based on the written documents and relevant information of the product provided by Party A.


l      Party B has the right to consult, communicate and connect with international health institutions/administrations such as FDA and WHO on regulatory affairs and marketing regulations, so as to obtain support and recognition from international institutions / administrations .  If all conditions permit, Party B shall be responsible for the submission for marketing authorization and handling relevant procedures to the country where the Product is to be entered.


At the meanwhile,


l      Party A is responsible for receiving the third-party partners recommended by Party B and its official institutions/administrations of the country where the  third-party partner is located to visit/audit  Party A's research and development, quality control, manufacturing site and related exhibitions, and Party B will accompany and assist at all times.


l      When Party A enters into business cooperation negotiations with a third party, Party B participates in the whole process, assists and provides necessary support, and actively contributes to the success of the cooperation negotiations.