Zhongsheng Pharmaceutical Co., Ltd. and Wuxi apptec develop new drugs zsym005 for the treatment of influenza A and human avian influenza

Announcement of Guangdong Zhongsheng Pharmaceutical Co., Ltd on the signing of Technology Development (cooperation) contract between the company and Shanghai yaomingkant new drug development Co., Ltd the company and all members of the board of directors guarantee the authenticity, accuracy and integrity of the information disclosed, without false records, misleading statements or major omissions 1 Contract signing Guangdong Zhongsheng Pharmaceutical Co., Ltd (hereinafter referred to as "the company") held the 20th meeting of the 5th board of directors on July 13, 2015, deliberated and passed the proposal on signing the strategic cooperation agreement between Guangdong Zhongsheng Pharmaceutical Co., Ltd and Shanghai yaomingkant new drug development Co., Ltd., and agreed that the company and Shanghai yaomingkant new drug development Co., Ltd (hereinafter referred to as "the drug") Mingkant) signed a strategic cooperation agreement On July 13, 2015, the company and Wuxi apptec signed the strategic cooperation agreement between Guangdong Zhongsheng Pharmaceutical Co., Ltd and Shanghai apptec new drug development Co., Ltd According to the strategic cooperation agreement signed by the company and Wuxi apptec, the two sides will implement and sign more than two cooperation projects in the second half of 2015 The company and Wuxi apptec further promoted the implementation of the strategic cooperation agreement In August and September 2015, they signed the technology development (cooperation) contract of "research and development of a new drug zsym003 for drug-resistant lung cancer" and "research and development of a new drug zsym004 for tumor treatment" For details, see the company's securities times and cninfo.com on August 19, 2015 and October 9, 2015 Relevant announcement of disclosure Recently, the company has signed the zsym005 technology development (cooperation) contract (hereinafter referred to as the "contract") for the treatment of influenza A and human avian influenza 2 Main content of the contract (1) project name: research and development of zsym005 for treatment of influenza A and human avian influenza (II) cooperation content According to the technical requirements of chemical drug registration classification 1.1 in the measures for the administration of drug registration and the guiding principle requirements of the drug evaluation center of the State Food and Drug Administration (CFDA), complete the pre clinical pharmaceutical research, pharmacological and toxicological research, pilot scale-up and production process validation of zsym005, apply to CFDA and obtain the phase I clinical trial approval (III) project equity distribution 1 Both parties agree that the project adopts the mode of risk sharing and revenue sharing for R & D cooperation 2 For the preclinical candidate compounds (PCC) and clinical candidate compounds (ind) finally selected by the project committee, if both parties agree to transfer the project or international rights and interests to a third party in the preclinical phase, the transfer proceeds shall be distributed according to the contract 3 The company has the right to decide whether the project will enter into clinical and later stage research After the project enters into clinical stage, the cooperation mode will be determined separately After the project enters the clinical stage, the research work is led by the company, and the research funds are also provided by the company The rights and interests of Wuxi apptec in the final listed products shall be distributed according to the contract 4 The company has the right to decide to transfer preclinical candidate compounds (PCC) and clinical candidate compounds (ind) designed and mainly researched by Wuxi apptec The transfer proceeds shall be distributed according to the contract 5 The intellectual property rights, application materials and original test records of the project shall be owned by the company, and Wuxi apptec shall enjoy the income right of the research and development achievements of the project in accordance with the proportion agreed in the contract (IV) expenses and payment method: the company shall contribute 25.5 million yuan (excluding clinical research expenses) according to the contract, and pay in installments according to the plan agreed in the contract 3 Overview of zsym005 project: at present, 10% of people in the world are threatened by influenza virus every year According to the World Health Organization, the seasonal influenza epidemic can cause 3 to 5 million severe cases and 250000 to 500000 deaths worldwide every year China is the place where influenza occurs frequently In the past half century (1953 to now), there have been 17 large and medium-sized influenza epidemics in total, and it was the first area to be attacked by influenza pandemic In 1957, 1968 and 1977, the three pandemic strains were all first distributed in China, and the annual incidence of influenza is estimated to reach tens of millions of people Influenza and human suffering from avian influenza not only seriously harm human health, but also easily cause human panic and affect social stability, and also bring great economic burden to the global community In the United States alone, the annual economic loss caused by adult influenza diseases is up to 80 billion US dollars, and the total amount of adult influenza drug market is close to 10 billion US dollars At present, the commonly used anti influenza drugs are mainly divided into two categories The first category is M2 channel blocker (alkanes), and the representative drugs are amantadine and amantadine The second type is neuraminidase inhibitors, including oseltamivir (Tamiflu) and zanamivir Due to the high mutation rate of influenza virus and the occurrence of recombination between viruses, the existing anti influenza drugs are difficult to cope with the changeable influenza virus, which also leads to the escape of influenza virus to the vaccine In recent years, nearly 100% of the seasonal influenza A viruses (H1N1, H3N2) in China and the world and 2009 influenza A viruses were resistant to alkanes The United States, Japan and other countries report that more than 90% of seasonal influenza A virus (H1N1) is resistant to oseltamivir The monitoring data of who in the Western Pacific region also shows that the proportion of oseltamivir resistant strains of seasonal influenza A virus (2008-2009) in China has reached 28% Drug resistance is a major problem in the treatment of influenza virus Secondly, due to the rapid variation of influenza virus, and the reality that the development and production of vaccine are relatively lagging behind, such as the development of H1N1 influenza vaccine, even if the country repeatedly shortens the approval process and time, it is only six months after the outbreak of influenza In addition, the large-scale use of drugs targeting the virus further accelerated the emergence of influenza resistant strains Therefore, it is very urgent to develop new mechanism of action anti influenza drugs To find new mechanism of action anti influenza drugs belongs to "clinical unmet needs" Zsym005 is an innovative anti influenza virus drug with new mechanism and independent intellectual property rights jointly developed by the company and Wuxi apptec The existing research shows that zsym005 has a broad-spectrum anti influenza A virus effect, and also has a strong inhibitory effect on the single drug-resistant strains of alkylamine and neuraminidase, and has a strong inhibitory effect on the current epidemic H1N1 and H5N1, and the anti influenza effect in animals is significantly better than that of Tamiflu On the one hand, zsym005 can solve the problem of Tamiflu resistance, on the other hand, its anti influenza effect is significantly better than Tamiflu Therefore, zsym005 can make up for the deficiency of the current standard treatment plan if its efficacy is confirmed to be on the market through clinical research, which has better treatment effect for influenza and human avian influenza, and will be in a favorable position in the future market competition IV influence on the company after the company and Wuxi apptec cooperated on zsym001, zsym002, zsym003 and zsym004 projects, the signing of this technology development (cooperation) contract is the specific implementation of the strategic cooperation ideas and ideas between the company and Wuxi apptec, and the further promotion and implementation of the strategic cooperation between the two sides At the same time, the implementation of the project will enrich the company's new drug R & D reserves, lay a solid foundation for the company's innovation and development, further enhance the company's overall strength and market competitive advantage, and enhance the company's future profitability, which is in line with the interests of all shareholders and the company's development strategy V risk reminder (I) the technology development (cooperation) contract signed this time involves the development of innovative drugs Based on the characteristics of long cycle, high risk and high investment in new drug development, there is uncertainty in project promotion (II) the signing of this technology development (cooperation) contract does not have a significant impact on the company's short-term financial situation and operating results (III) the company will perform the obligation of information disclosure in accordance with the relevant provisions The information disclosure media designated by the company are securities times and cninfo.com.cn All information of the company is subject to the information published in the above selected media Please pay attention to relevant announcements and investment risks 6 Technical development (cooperation) contract for future reference It is hereby announced The board of directors of Guangdong Zhongsheng Pharmaceutical Co., Ltd February 1, 2016