Saisheng Pharmaceutical Co., Ltd. plans to purchase 50 million yuan of Tianqi pharmaceutical's clinical approval for class 1.1 double target anti-tumor drugs

Beijing saisheng Pharmaceutical Co., Ltd announced on October 27 that the company plans to obtain 50 million yuan for the project of "transfer of clinical approval documents of HM-3 (antiangel peptide) and its preparations" It is worth noting that this product has obtained the clinical approval of a class of new drugs and is expected to become the first dual target anti-tumor drug of neovascular inhibitors and integrin blockers in China According to the announcement, saisheng pharmaceutical and Inner Mongolia Tianqi pharmaceutical recently Investment (Group) Co., Ltd (hereinafter referred to as "Tianqi Pharmaceutical Co., Ltd.") has signed the contract for "HM-3 (antiangel peptide) and its preparation clinical approval transfer" project (hereinafter referred to as "project"), and the transaction amount of technology transfer, patent right transfer and technical service fee for the proposed project "HM-3 (antiangel peptide) and its preparation clinical approval transfer" is RMB 50 million in total
It's worth noting that "HM-3 (antiangel peptide)" product is a synthetic peptide of high-efficiency vascular inhibitor with integrin affinity, which can effectively inhibit the occurrence and development of human lung cancer, liver cancer and gastric cancer when used alone or in combination This product has significant biological activity, can effectively inhibit the proliferation of human non-small cell lung cancer, liver cancer and gastric cancer, and also can significantly inhibit melanoma And metastasis of breast cancer According to saisheng pharmaceutical, the product has obtained the clinical approval of a class of new drugs and is expected to become the first dual target anti-tumor drug of neovascular inhibitors and integrin blockers in China Saisheng pharmaceutical further said that the project is consistent with the strategic R & D direction of the company's new drug reserve, and is also an investment project funded by the company, which is conducive to improving the company's product structure and enriching the company's future product categories At present, the company's main products include anti-tumor and immunomodulators, cardiovascular system drugs, nervous system drugs, and the introduction of "HM-3 (antiangel peptide) and its preparations" is conducive to further forming the market scale About saisheng Pharmaceutical Co., Ltd Beijing saisheng Pharmaceutical Co., Ltd was wholly changed and established by Beijing saisheng Pharmaceutical Co., Ltd on July 28, 2011 It is now located at No 8, Xingsheng street, Beijing Economic and technological development, with a registered capital of 90 million yuan Founded in 1999, saisheng Pharmaceutical Co., Ltd is a high-tech enterprise specializing in research, development, production and sales of biological drugs (active protease, active polypeptide, active polysaccharide, amphoteric lipids) The research and development direction of the products are mainly natural or biotechnological drugs such as cardio cerebrovascular drugs, immune regulation drugs, nervous system drugs, etc After more than ten years of hard work and self-improvement, saisheng pharmaceutical industry has gradually established a high-tech industry integrating technology, innovation, sales and service, and a research and development platform for Biomacromolecule based on affinity chromatography separation and purification technology of antibody and antibody variable region At present, the company has a number of national pharmaceutical quasi brand products with precise clinical efficacy, exclusive or first production, and more than ten national invention patents At the same time, the company is the drafting unit of national standards for a number of drugs Appendix: the announcement of Beijing saisheng Pharmaceutical Co., Ltd on the clinical approval document for the purchase of class 1.1 new drugs, the company and all members of the board of directors guarantee that the content of information disclosure is true, accurate and complete, and there is no false record, misleading statement or major omission Recently, Beijing saisheng Pharmaceutical Co., Ltd (hereinafter referred to as "saisheng pharmaceutical" or "the company") signed a project contract (hereinafter referred to as "the project") for the transfer of HM-3 (antiangel peptide) and its preparation clinical approval This transaction does not constitute a major asset restructuring as stipulated in the measures for the administration of major asset restructuring of listed companies, nor does this transaction constitute a connected transaction I transaction overview: in order to enhance the company's profitability, improve the product structure and promote the company's sustainable long-term development, the company purchased the clinical approval and patent rights of the project through multi-party investigation and demonstration According to the listing rules, the articles of association and other relevant provisions, the amount involved in this exchange does not need to be deliberated and approved by the shareholders' meeting 2 Basic information of counterparties 1 Name of new drug owner: Inner Mongolia Tianqi pharmaceutical investment (Group) Co., Ltd (hereinafter referred to as "Tianqi pharmaceutical") address: Hongshan economic and Technological Development Zone, Chifeng City, Inner Mongolia Autonomous Region legal representative: Han Fengyun 2 New drug patent owner: Inner Mongolia Tianqi pharmaceutical investment (Group) Co., Ltd (hereinafter referred to as "Tianqi pharmaceutical"), Xu Hanmei address: Hongshan economic and Technological Development Zone, Chifeng City, Inner Mongolia Autonomous Region legal representative: Han Fengyun 3 Technical service provider: Nanjing Anji Biotechnology Co., Ltd (hereinafter referred to as "Anji biotechnology") address: room 207, science and technology innovation base, No 8, Hengfei Road, Nanjing Economic and Technological Development Zone legal representative: Kang Zhian III basic information of transaction object 1 Name of new drug project: transfer of HM-3 (antiangel peptide) and its preparation clinical approval 2 Specific situation of transaction object: name of new drug: HM-3 (antiangel peptide) and its preparation clinical approval patent name: HM-3 polypeptide lyophilized powder preparation and its preparation method patent No.: zl2011101220700 Patentee: Inner Mongolia Tianqi pharmaceutical investment (Group) Co., Ltd and Xu Hanmei in accordance with the contract law of the people's Republic of China, the drug administration law of the people's Republic of China and the relevant regulations of the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration" or "CFDA") Saisheng pharmaceutical, the buyer, Tianqi pharmaceutical and Anji biology, the technical service provider, signed a contract for the transfer of HM-3 (antianji peptide) and its preparation clinical approval documents for the transfer of "new drug technology, clinical approval documents and patent rights" and the provision of related services The transaction price is 5, At present, the project has entered the phase I clinical research stage IV main contents and pricing of the transaction agreement 1 Transaction amount: the transaction amount of technology transfer, patent right transfer and technical service fee of the purchase project "HM-3 (antiangel peptide) and its preparation clinical approval transfer" totaled RMB 50 million, with the source of funds raised by the enterprise for purchase 2 Main contents and requirements of the transaction agreement (1) Tianqi pharmaceutical will transfer the project with independent intellectual property rights to saisheng pharmaceutical, and Tianqi pharmaceutical will provide saisheng pharmaceutical with the original clinical approval document, HM-3 raw materials and all materials related to their preparations, as well as the completed clinical trial data of IA and IB; based on Anji biology as the relevant technical service party of the project, Anji Sheng Wu provides technical services and technical guidance to saisheng pharmaceutical; Tianqi pharmaceutical and Anji bio guarantee the authenticity, practicability and reliability of HM-3 related technologies, and ensure that HM-3 related technologies do not infringe the legitimate rights of any third party
(2) saisheng pharmaceutical shall pay the technology transfer fee and technical service fee of the project to Tianqi pharmaceutical and Anji biology in accordance with the terms of the contract, be responsible for the subsequent phase I, phase II and phase III clinical research declaration and registration with CFDA, the organization and sample preparation of clinical trials and clinical research fees; register with CFDA and pay the fees incurred; and Undertake the rights, responsibilities and obligations stipulated in the contract 4 The approval procedures necessary for the effectiveness of the transaction (1) signed and sealed by three parties; (2) approved by the competent approval authority of their respective companies; when the above conditions are established at the same time, the transaction will take effect until the company obtains the production approval of the project V purpose of assets acquisition and its impact on the company 1 Legality: this acquisition complies with the requirements of relevant national laws and regulations and operates in strict accordance with the relevant provisions of assets acquisition and related transactions 2 Necessity (1) "HM-3 (antiangel peptide)" product is a high-efficiency vascular inhibitor peptide with integrin affinity It can effectively inhibit the occurrence and development of human lung cancer, liver cancer and gastric cancer when used alone or in combination The product has significant biological activity, can effectively inhibit the proliferation of human non-small cell lung cancer, liver cancer and gastric cancer, and can also significantly inhibit melanoma And breast cancer metastasis; the product has obtained a class of new drug clinical approval, and is expected to become the first dual target anti-tumor drug of neovascular inhibitors and integrin blockers in China (2) the project is consistent with the strategic R & D direction of the company's new drug reserve, and is also an investment project raised by the company, which is conducive to improving the company's product structure, enriching the company's future product categories, and is necessary for the company's long-term development (3) at present, the company's main products include anti-tumor and immunomodulators, cardiovascular system drugs and nervous system drugs The introduction of "HM-3 (antiangel peptide) and its preparations" is conducive to further forming the market scale (4) the company will have the patent right of "HM-3 (antiangel peptide) and its preparation", which is conducive to strengthening the protection of the company's intellectual property, reasonable planning and improving the internal intellectual property protection system, and maintaining the dominant position of the market 6 Risk Reminder 1 Risks in the application of new drug certificate and production approval document In the process of applying new drug certificate and production approval document, phase IA, phase IB clinical research application, phase II clinical research application and production registration site verification are required to pass The qualified products produced in GMP workshop of the company are required to pass the inspection, and this process may encounter risks in clinical and process amplification 2 Changes in national drug review policies, changes in the development of the pharmaceutical industry, rising energy prices, changes in raw material prices, rising labor costs and other factors may have an impact on product costs and other aspects 3 At present, HM-3 and its preparation clinical approval transfer contract has been signed, but the patentee has not been changed After the patentee changes, the company will announce again, please pay attention to the investment risk VII Reference document 1 Resolution 2 of the fourth meeting of the second board of directors 2 HM-3 and its clinical approval transfer contract are hereby announced Board of directors of Beijing saisheng Pharmaceutical Co., Ltd October 27, 2015