Securities code: 688136 securities abbreviation: Shan Dong Kexing Bioproducts Co.Ltd(688136) Announcement No.: 2022-013 Shan Dong Kexing Bioproducts Co.Ltd(688136)
Voluntary disclosure about the relationship with Shenzhen Antai weishengwu Pharmaceutical Co., Ltd
Announcement on cooperative development of small molecule oral drugs against covid-19 virus
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law. Special tips:
Shenzhen Kexing Pharmaceutical Co., Ltd. (hereinafter referred to as "Shenzhen Kexing"), a wholly-owned subsidiary of Shan Dong Kexing Bioproducts Co.Ltd(688136) (hereinafter referred to as "the company"), signed the shan26 project cooperation agreement (hereinafter referred to as "the cooperation agreement") with Shenzhen antaiwei biopharmaceutical Co., Ltd. (hereinafter referred to as "antaiwei") on February 18, 2022, Aetna will grant the exclusive license of shen26 intellectual property obtained or held by Aetna to Shenzhen Kexing, and transfer the subsequent R & D rights and commercialization rights and interests of products to Shenzhen Kexing.
SHEN26 is an antiviral drug used for the treatment of COVID-19 and other viral infections. It has been included in the 2021 Guangdong provincial New Coronavirus prevention and control technology emergency response special project. It is a special key project of the national science and Technology Ministry's public safety risk prevention and control and emergency technology and equipment.
This cooperation does not constitute a connected transaction, nor does it constitute a major asset reorganization as stipulated in the administrative measures for major asset reorganization of listed companies.
The signing of this Agreement does not have a significant impact on the company's annual operating performance.
R & D risks: (1) shen26 is currently in the preclinical research stage, and there may be risks related to R & D failure and failure to obtain the approval of relevant regulatory authorities. (2) There is uncertainty in the follow-up development of the epidemic in China, and with the improvement of covid-19 vaccination rate, the qualified subjects may be affected by some uncertain factors, which may affect the progress of clinical trials.
Intellectual property risk: (1) the cooperation agreement stipulates the complete rights of antaiway to obtain shen26 itself and relevant intellectual property rights, but there is some uncertainty whether the intellectual property rights can be transferred to antaiway smoothly. (2) Shen26 related patent applications have been accepted by the State Intellectual Property Office, but have not been finally authorized, and there may be a risk of not being authorized in the future.
Market competition risk: at present, many covid-19 therapeutic drugs have been listed outside China. At the same time, there are many covid-19 preventive and therapeutic drugs in different research and development stages. Shan26 has an uncertain market competition pattern after listing
Qualitative.
1、 Signing of cooperation agreement
Shenzhen Kexing Pharmaceutical Co., Ltd. signed the shen26 project cooperation agreement with Shenzhen Antai Weisheng Pharmaceutical Co., Ltd. on February 18, 2022. Antai Weiwei exclusively authorized Shenzhen Kexing to obtain or hold shen26 patents in the global region, transfer the exclusive rights and interests in product development and global commercialization, including the right to use existing and future related patents, product research Rights and interests in registration, clinical and commercial production, distribution and promotion.
The company has no affiliated relationship with Aetna, and the agreement signed this time does not constitute a connected transaction, so it does not need to be submitted to the board of directors and the general meeting of shareholders for deliberation. 2、 Basic information of shen26 and counterparty 1. Shen26
SHEN26 is a New Coronavirus polymerase (RdRp) inhibitor, which can achieve antiviral effect by inhibiting viral nucleic acid synthesis. At present, the laboratory has been developed and is undergoing pre clinical pharmacy and process development, and has submitted relevant patent applications.
The SHEN26 project has been included in the 2021 annual New Coronavirus prevention and control New Coronavirus infection science and technology emergency response special project. It is a special key project of the national science and Technology Department's public safety risk prevention and control and emergency technology and equipment. 2. Counterparty information
Name: Shenzhen Antai weishengwu Pharmaceutical Co., Ltd
Unified social credit Code: 91440300ma5gy7gw98
Legal representative: Li Guanguan
Major shareholders: Li Guanguan (64%), Guo Deyin (36%)
Antai Wei is a biopharmaceutical company engaged in R & D and marketing of antiviral drugs. Its main research areas include related diseases such as coronavirus, human immunodeficiency virus and liver virus, such as new type of coronary disease pneumonia, AIDS, hepatitis B and so on.
The core members of antaiwei are Professor Zhang Xumu and Professor Guo Deyin. Professor Zhang Xumu is currently the president of Pingshan Biomedical Research Institute of Southern University of science and technology. His main research and development directions are pharmaceutical chemistry, research and development of anti-tumor and antiviral small molecule drugs, green synthesis of chiral drugs, etc; Guo Deyin, Professor of Medical School of Sun Yat sen University, is currently the chairman of Virology Professional Committee of Chinese society of microbiology. His main research and development directions are coronavirus infection pathogenesis and immune regulation mechanism, virus gene therapy and antiviral drug screening.
Aetna has no relationship with the company.
3、 Main terms of the cooperation agreement 1. Division of labor and cost bearing
(1) Shenzhen Kexing is responsible for the following work, bear the expenses, and become the holder of the approval / permit of each link: ① be responsible for the clinical application, clinical research and listing application of shen26 in China and other parts of the world;
② Responsible for the commercialization of shen26 in China and other parts of the world, including but not limited to production, sales, distribution and promotion;
③ Responsible for the development of subsequent new indications of shen26;
④ Be responsible for cooperating with Aetna to do a good job in preclinical work.
(2) Aetna is responsible for the following work and bear the cost:
① Be responsible for obtaining the complete rights of shen26 itself and relevant intellectual property rights and exclusive authorization to Shenzhen Kexing;
② Preclinical research and development;
③ Application of shen26 series patents in China, the United States and other parts of the world;
④ Cooperate with Shenzhen Kexing in clinical application (antaiwei and Shenzhen Kexing jointly apply in China), and be responsible for completing the possible supplementary research and promoting it to the stage of clinical development;
⑤ Be responsible for providing necessary support for follow-up clinical trials, registration and application, project development, production, marketing and technology transfer during commercialization; 2. Cooperation cost
The cooperation fee includes the down payment and R & D milestone payment, totaling RMB 100 million, of which the down payment of RMB 20 million is used for the start-up of the project and the acquisition of 10% equity of antaiwei, and the last R & D milestone payment after obtaining China's emergency use authorization or formal approval for listing. 3. Sales commission and commercialization reward
For the annual net sales of shen26 in the global region, Shenzhen Kexing pays a certain proportion of sales commission to Aetna, and pays commercialization rewards after reaching a certain amount.
4、 Impact of this cooperation on the company
Based on the investigation of Aetna's R & D team, shen26 experimental results and intellectual property rights, and considering the follow-up investment, R & D and competitive risks and future business value, the company decided to carry out in-depth strategic cooperation with Aetna. The signing of this cooperation agreement will further accelerate the company's innovative drug layout, thicken the product reserve and enhance the company's core competitiveness, Enrich the company's anti-virus product pipeline, constantly improve the pharmaceutical R & D, production and sales system, and promote the continuous, rapid and healthy development of the company's business. The signing of this agreement will not have a significant impact on the company's recent operating performance. 5、 Risk tip 1. R & D risk
Shen26 project is in the preclinical stage, which may lead to R & D failure or failure to obtain the approval of the drug regulatory department due to various reasons such as uncertain curative effect and safety problems, thus affecting the recovery of the company's early investment and the realization of economic benefits. At the same time, there is uncertainty in the follow-up development of the epidemic in China, and with the improvement of covid-19 vaccination rate, the qualified subjects may be affected by some uncertain factors, which may affect the progress of clinical trials.
Based on the above situation, both parties have agreed on a clear and detailed payment node in the setting of contract terms, so as to effectively prevent and reduce relevant risks. 2. Intellectual property risk
The cooperation agreement stipulates the complete rights of antaiway to obtain shen26 itself and relevant intellectual property rights, but there is some uncertainty whether the intellectual property rights can be smoothly transferred to antaiway.
Shen26 related patent applications have been accepted by the State Intellectual Property Office, but have not been finally authorized, and there may be a risk of not being authorized in the future. 3. Business competition risk
At present, many covid-19 therapeutic drugs have been listed outside China, and there are many covid-19 preventive and therapeutic drugs at different research and development stages. Shan26 has uncertainty in the market competition pattern after listing.
The company will continue to follow up the progress of the matter and fulfill the disclosure obligation in a timely manner in accordance with the Listing Rules of science and Innovation Board of Shanghai Stock Exchange, the articles of association and other regulations.
Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Shan Dong Kexing Bioproducts Co.Ltd(688136) board of directors February 21, 2022
