Zhongsheng Pharmaceutical Co develops a new drug zsym006 for the treatment of liver cancer

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、 Overview of signing the contract 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 "about Guangdong Zhongsheng Pharmaceutical Co., Ltd." The proposal on signing the strategic cooperation agreement between the company and Shanghai Wuxi apptec new drug development Co., Ltd agrees to sign the strategic cooperation agreement between the company and Shanghai Wuxi apptec new drug development Co., Ltd (hereinafter referred to as "Wuxi apptec") 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 between the company and Wuxi Pharmaceutical Co., Ltd., the cooperation period between the company and Wuxi Pharmaceutical Co., Ltd is five years The first stage is from 2015 to 2019 to jointly carry out the research and development of class 1.1 small molecule chemical innovative drugs The company and Wuxi apptec further promoted the implementation of the strategic cooperation agreement In August 2015, September 2015 and January 2016, they respectively signed the technology development (cooperation) contract of "research and development of a new drug zsym003 for the treatment of drug-resistant lung cancer", "research and development of a new drug zsym004 for the treatment of tumor" and "research and development of zsym005 for the treatment of influenza A and human avian influenza" For details, please refer to the relevant announcements disclosed by the company on August 19, 2015, October 9, 2015 and February 2, 2016 in the securities times and cninfo.com Recently, the company has signed the technology development (cooperation) contract (hereinafter referred to as the "contract") for zsym006, a new drug for the treatment of liver cancer 2、 Main content of the contract (I) research and development of a new drug zsym006 for the treatment of liver cancer （2） According to the technical requirements of chemical drug registration classification 1.1 in the measures for the administration of drug registration and the guiding principles of the drug review center of the State Food and Drug Administration (CFDA), the cooperation content completed the preclinical pharmaceutical research, pharmacological and toxicological research, pilot scale-up and production process validation of zsym006, applied to CFDA and obtained the approval document of phase I clinical trial （3） 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 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 developed 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 （4） Expenses and payment method: the company shall contribute 24 million yuan (excluding clinical research expenses) according to the contract, and pay in installments according to the plan agreed in the contract 3、 Zsym006 project overview China is a big country in the incidence of liver cancer According to the statistics of 2012 annual report of China's cancer registration, in 2012, there were 395000 new cases of liver cancer in China, accounting for 52.7% of the global new cases of liver cancer, and in 2015, there were 466000 new cases (from the influencing factors 144, such as Professor Chen Wanqing, academician of Cancer Hospital of Chinese Academy of Medical Sciences, National Cancer Center, director of National Cancer Registration Center, etc.) China's cancer statistics in 2015, published in CA: a cancer journal for clinicians, showed an upward trend Liver cancer patients often have basic liver disease, so the incidence of occult, high degree of malignancy, very prone to infiltration and metastasis and poor prognosis At present, although there are many kinds of comprehensive treatment methods, including surgery, local ablation, hepatic artery intervention, chemotherapy and radiotherapy, but most of the patients have been diagnosed as the middle and late stage, only 15% of the patients are suitable for surgery, and the recurrence and metastasis, postoperative residual cancer are difficult to avoid Therefore, systemic chemotherapy has become the main palliative treatment for liver cancer, which plays an important role in reducing the symptoms, improving the quality of life and possibly prolonging the survival period Sorafenib is the first drug to be found to prolong the survival period of patients with advanced liver cancer It is also the first oral multi-target protein kinase drug approved by the US FDA for the treatment of advanced liver cancer It is the only first-line standard treatment drug recommended by international guidelines for advanced liver cancer Sorafenib has been applied to liver cancer and achieved great success However, sorafenib will lose efficacy after 17.6 weeks on average There is no second-line drug that can remedy sorafenib in patients who cannot tolerate it or resist it The treatment of liver cancer is still in the awkward position of a serious lack of effective treatment drugs, which belongs to the "huge unmet clinical needs" Therefore, the research and development of innovative drugs for the treatment of liver cancer is particularly important Zsym006 is an innovative drug developed by the company and Wuxi apptec, which has a new mechanism of action and independent intellectual property rights The existing studies show that zsym006 has significant anti-tumor cell activity and kinase activity in vitro, and animal experiments show that its therapeutic effect on liver cancer is significantly better than sorafenib Therefore, zsym006 can make up for the deficiency of the current standard treatment plan and have better treatment effect for patients with liver cancer if it is confirmed to be on the market through clinical research 4、 The signing of this technology development (cooperation) contract is the specific implementation of the company's and Wuxi apptec's strategic cooperation ideas and ideas, and the further promotion and implementation of the 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 5、 Risk tip (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 （2） The signing of this technology development (cooperation) contract does not have a significant impact on the company's short-term financial situation and business results （3） The company will perform the obligation of information disclosure in accordance with the relevant regulations 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、 Documents for future reference technical development (cooperation) contract It is hereby announced The board of directors of Guangdong Zhongsheng Pharmaceutical Co., Ltd February 22, 2016