On June 5, Kexing Biopharmaceutical Co., Ltd. (hereinafter referred to as "Kexing Pharmaceutical", 688136) announced that in order to accelerate the company's antiviral drug SHEN26 project for the treatment of new crown and other viral infections, recently, the company's wholly-owned Subsidiary Shenzhen Kexing Pharmaceutical Co., Ltd. (hereinafter referred to as "Shenzhen Kexing") and Shenzhen Xinlitai Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinlitai") and its subsidiary Huizhou Xinlitai signed CDMO technical services and Contract production agreement.
According to the agreement, Shenzhen Kexing entrusts Xinlitai and Huizhou Xinlitai to carry out the SHEN26 project drug CDMO technical services (including but not limited to technology transfer at the drug registration stage, clinical sample production, etc.) and the entrusted processing of APIs and preparations. The total amount of the agreement is RMB 8,882,600, which will be paid by Shenzhen Kexing in seven installments according to the progress of the agreement.
Kexing Pharmaceuticals said that after the signing of this agreement, Xinlitai and Huizhou Xinlitai will provide technical services such as clinical sample production and process verification in the drug registration stage for the SHEN26 project, and provide raw materials and preparations in the commercial production stage. The production capacity support will be conducive to the company's SHEN26 project drug registration and commercialization, and will help the company and Xinlitai to expand cooperation in product research and development, production and other related fields, and enhance the company's business development space, in line with the company's development strategy.
Kexing Pharmaceutical reminds that the relevant production lines of Xinlitai and Huizhou Xinlitai still need to apply for the approval of drug entrusted production registration, and there is certain uncertainty in the relevant registration progress. Previously, SHEN26 was an antiviral drug for the treatment of COVID-19 and other viral infections. So far, all pharmaceutical and non-clinical research work has been completed, but there are uncertainties in the follow-up development of the epidemic. of subjects may be affected, thereby affecting the progress of clinical trials, and there may be risks such as failure of research and development and failure to obtain approval from relevant regulatory authorities.
The announcement also pointed out that there are currently a number of oral anti-new coronavirus drugs in different stages of research and development in China, and there are uncertainties in the market competition after SHEN26 is launched.
Prior to February 20, Kexing Pharmaceutical announced that Shenzhen Kexing signed the "SHEN26 Project Cooperation Agreement" with Shenzhen Antaiwei Biomedical Co., Ltd. (hereinafter referred to as "Antaiwei") on February 18. Novel coronavirus small molecule oral drug. According to the announcement at that time, on a global scale, Antaiwei exclusively licensed the intellectual property rights of SHEN26 it acquired or held to Shenzhen Kexing, and transferred the follow-up research and development rights and commercialization rights of the products to Shenzhen Kexing.
According to reports, SHEN26 is a novel coronavirus polymerase (RdRp) inhibitor, which can achieve antiviral effect by inhibiting viral nucleic acid synthesis. The project has previously been included in the 2021 Guangdong Provincial Emergency Response Project for the Prevention and Control of Novel Coronavirus Infection, and is a key promotion project of the Ministry of Science and Technology of the People's Republic of China on Public Safety Risk Prevention and Control and Emergency Technology Equipment.
According to the agreement, Shenzhen Kexing entrusts Xinlitai and Huizhou Xinlitai to carry out the SHEN26 project drug CDMO technical services (including but not limited to technology transfer at the drug registration stage, clinical sample production, etc.) and the entrusted processing of APIs and preparations. The total amount of the agreement is RMB 8,882,600, which will be paid by Shenzhen Kexing in seven installments according to the progress of the agreement.
Kexing Pharmaceuticals said that after the signing of this agreement, Xinlitai and Huizhou Xinlitai will provide technical services such as clinical sample production and process verification in the drug registration stage for the SHEN26 project, and provide raw materials and preparations in the commercial production stage. The production capacity support will be conducive to the company's SHEN26 project drug registration and commercialization, and will help the company and Xinlitai to expand cooperation in product research and development, production and other related fields, and enhance the company's business development space, in line with the company's development strategy.
Kexing Pharmaceutical reminds that the relevant production lines of Xinlitai and Huizhou Xinlitai still need to apply for the approval of drug entrusted production registration, and there is certain uncertainty in the relevant registration progress. Previously, SHEN26 was an antiviral drug for the treatment of COVID-19 and other viral infections. So far, all pharmaceutical and non-clinical research work has been completed, but there are uncertainties in the follow-up development of the epidemic. of subjects may be affected, thereby affecting the progress of clinical trials, and there may be risks such as failure of research and development and failure to obtain approval from relevant regulatory authorities.
The announcement also pointed out that there are currently a number of oral anti-new coronavirus drugs in different stages of research and development in China, and there are uncertainties in the market competition after SHEN26 is launched.
Prior to February 20, Kexing Pharmaceutical announced that Shenzhen Kexing signed the "SHEN26 Project Cooperation Agreement" with Shenzhen Antaiwei Biomedical Co., Ltd. (hereinafter referred to as "Antaiwei") on February 18. Novel coronavirus small molecule oral drug. According to the announcement at that time, on a global scale, Antaiwei exclusively licensed the intellectual property rights of SHEN26 it acquired or held to Shenzhen Kexing, and transferred the follow-up research and development rights and commercialization rights of the products to Shenzhen Kexing.
According to reports, SHEN26 is a novel coronavirus polymerase (RdRp) inhibitor, which can achieve antiviral effect by inhibiting viral nucleic acid synthesis. The project has previously been included in the 2021 Guangdong Provincial Emergency Response Project for the Prevention and Control of Novel Coronavirus Infection, and is a key promotion project of the Ministry of Science and Technology of the People's Republic of China on Public Safety Risk Prevention and Control and Emergency Technology Equipment.
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