Eds01 (recombinant human endostatin adenovirus injection), a gene therapy drug for head and neck cancer in Weiyu hospital, was purchased by Guizhou bailing with a price of 50 million yuan

Guizhou bailing (hereinafter referred to as "party a") announced on September 5 that it had signed a technology transfer contract with Chengdu endoshi Bioengineering Technology Co., Ltd (hereinafter referred to as "Party B") to obtain its gene therapy eds01 (recombinant human endostatin adenovirus injection) project Gene therapy gene is the basic functional unit of carrying biological genetic information, which is a specific sequence located on the chromosome Gene therapy refers to the introduction of foreign normal genes into target cells to correct or compensate for diseases caused by gene defects and abnormalities, so as to achieve the purpose of treatment In other words, the exogenous gene is implanted into the patient's appropriate receptor cells through gene transfer technology, so that the products produced by the exogenous gene can treat a certain disease The introduction of foreign genes into biological cells must rely on certain technical methods or vectors Adenovirus vector is one of the most commonly used viral vectors in gene therapy At present, gene therapy is mainly used to treat diseases that pose a serious threat to human health, including genetic diseases (such as hemophilia, cystic fibrosis, family hypercholesterolemia, etc.), malignant tumors, cardiovascular diseases, infectious diseases (such as AIDS, rheumatoid, etc.) As a new biomedical high-tech treatment method, gene therapy is a hot research and development direction in the field of global medicine Compared with the developed countries such as the United States and Europe, the research and clinical trials of gene therapy drugs in China have been carried out earlier with a higher starting point Professor Wei Yuquan, vice president of Sichuan University, director of National Key Laboratory of biotherapy and academician of Chinese Academy of Sciences, is an early scientist engaged in gene drug research and treatment in China, and the only deputy editor in chief of the international authoritative magazine human gene therapy in Asia He and his research and development team enjoy a high reputation and academic success in the field of gene therapy at home and abroad Fruit The project of eds01 eds01 (recombinant human endostatin adenovirus injection) is the research achievement of gene drugs used by Wei Yuquan's team in the treatment of head and neck tumors At present, phase I clinical trials have been completed and phase II clinical trials are being carried out The recombinant adenovirus is independently constructed and has independent intellectual property rights The preclinical study showed that eds01 could inhibit the growth of laryngeal cancer cell Hep2 and human nasopharyngeal carcinoma cell HNE in nude mice; it had obvious therapeutic effect on human lung adenocarcinoma cell SPC-A-1, A549 human non-small cell lung adenocarcinoma cell and mouse Lewis lung cancer cell transplanted subcutaneously in nude mice, and it had enhanced effect when combined with chemotherapy drug carboplatin; the safety evaluation experiment confirmed that it had obvious therapeutic effect in rhesus monkey It is also safe to use 18 times of the clinical dosage The single dose incremental experiment of phase I clinical study showed that the tumor patients were well tolerated, and there was no dose limited toxicity (DLT) and maximum tolerated dose (MTD) The main adverse reactions were fever, local injection site pain, and influenza like symptoms Multi dose administration, twice a week, two consecutive weeks of intratumoral injection, is also safe and tolerable, but the adverse drug reactions increased After single or multiple administration, the initial response of the target focus was seen, and the effective response rate of multiple administration was 16.67% Head and neck tumor is a common disease in China, accounting for 19.9% - 30.2% of the total malignant tumors 60% - 70% of the patients were in advanced stage (Ⅲ - Ⅳ), the five-year survival rate was only 30%, and the local recurrence rate was high (40% - 60%) At present, comprehensive treatment including surgery, radiotherapy, chemotherapy and so on is a common treatment mode for advanced head and neck tumors, which can only improve 5% of the total five-year survival rate Many patients died of tumor recurrence and metastasis due to poor treatment Eds01 is an inhibitor of angiogenesis, endostatin, which is introduced into the body through adenovirus The expressed endostatin can enter the blood and spread to the far end through blood circulation to inhibit the tumor and metastasis at the far end At the same time, the effect of endostatin on tumor blood vessels is irrelevant to the type of tumor, and it is suitable for the treatment of the vast majority of malignant tumors Moreover, eds01 is replication defective adenovirus It can't replicate in the infected cells, it won't spread to the environment, and there is no biosafety problem Eds01 has the world's leading technology and obvious advantages It has the conditions and may become the first gene drug in the world to achieve the purpose of treating malignant tumors by inhibiting the growth of blood vessels The main contents of the contract are as follows: 1 The technology transferred by Party B to Party A: Technical scope: ① all preclinical research data of new drugs declared by eds01, including but not limited to preparation process, process conditions and process parameters, product quality standards, detection methods, pharmacology, etc.; ② clinical research approval document of CFDA (original); ③ phase I clinical research data and phase II clinical research data; ④ existing products have been obtained Related patents Patent No.: zl200510021720.7; patent validity: September 2025; ⑤ the contract signed by Party B and the third party related to the follow-up development of the project; ⑥ other documents related to the follow-up technology development and implementation Technical indicators and parameters: the quality of finished products meets the declared quality standards (Draft) 2、 Party A shall implement the technology in the following scope, manner and time limit: scope of implementation: production of recombinant human endostatin adenovirus injection for the treatment of head and neck tumors Implementation mode: organize and complete phase II and phase III clinical research, apply for new drugs and bear all costs; produce and sell the above drugs Implementation plan: ① accept to launch phase II clinical research immediately after signing the contract; ② produce the new drug within one year after obtaining the new drug certificate and production approval 3、 Party B guarantees the authenticity and legality of the technology, and guarantees that the technology does not infringe the legitimate rights of any third party, and there is no defect in rights If a third party accuses Party A of the establishment of technology infringement, Party B shall compensate Party A for all losses (including legal fees, attorney fees, compensation fees and other costs) and bear relevant legal liabilities 4、 In order to ensure the effective implementation of this technology by Party A, Party B shall provide Party A with the following technical services and technical guidance: Contents of technical service and technical guidance: guide and help Party A to build the production site and complete clinical research samples and three batches of pilot products; assist Party A to carry out phase II and phase III clinical research, but all expenses and technical guidance expenses (to be determined through written consultation) incurred shall be borne by Party A, and both parties shall sign relevant agreements on contents, methods and expenses of technical guidance Discussion Methods of technical service and technical guidance: on site guidance and training of relevant personnel 5、 Party A shall pay Party B the transfer fee (including intellectual property transfer fee) for the transfer of the technology and the payment method: the technology transfer fee is RMB 500000.00 (in words: RMB 50 million only) Among them: the technical service and guidance fee shall be paid after being negotiated and determined in writing according to the actual situation, and shall not be included in the above technology transfer fee The technology transfer fee shall be paid by Party A to Party B or the account designated by Party B in three phases according to the project implementation progress 6、 Both parties confirm that the ownership of the new drug belongs to Party A, but Party B has the right of signature and the right of application of the inventor Scientific research achievements ranking Party B: 1, 3, 5, 7, Party A: 2, 4, 6, 8 Party A has the right to use the technology transferred by Party B for subsequent improvement, and the resulting new technological achievements with the characteristics of substantial change or creative technological progress shall be owned by Party A Party B has the right to make follow-up improvements to the technology transferred to Party A (except for the treatment of head and neck tumors), resulting in new technological achievements with the characteristics of substantial changes or creative technological progress, which shall be owned by Party B, but Party A has the priority right of transfer under the same conditions 7、 After the signing of this contract, Party B shall not transfer the recombinant human endostatin adenovirus injection technology to another person, or permit a third party to use it Otherwise, Party A has the right to unilaterally terminate this contract, and Party B shall return the transfer fee paid by Party A and pay Party A 30% of the total contract amount as liquidated damages If the breach is not enough to make up for the losses suffered by Party A, Party B shall also be responsible for it Compensation 8、 Both parties confirm that "eds01" is a tentative name If the official name of national new drug obtained in the future is inconsistent with it, the rights and obligations of both parties under this contract will not be affected Guizhou bailing believes that the performance of this contract will enrich the company's product structure, improve the company's competitiveness and sustainable profitability, and play a positive role in the company's strategic layout The global leading technology of the eds01 project enables the company to quickly integrate with the world's leading technology in pharmaceutical development and achieve a breakthrough in product technology content.