On the evening of June 5, Kexing Pharmaceuticals (688136.SH, closing price: 30.03 yuan/share, market value: 5.97 billion yuan) and Xin Litai (002294.SZ, closing price: 25.85 yuan/share, market value: 28.8 billion yuan) Shuangshuang announced that in order to accelerate the promotion of the new crown oral drug SHEN26 project under Kexing Pharmaceuticals, the two parties signed a cooperation agreement. Xinlitai and its subsidiaries will provide Kexing Pharmaceuticals with CDMO technical services for the SHEN26 project drugs (including but not limited to drug registration). Phased technology transfer, clinical sample production, etc.) and commissioned processing of APIs and preparations. At present, SHEN26 has completed all pharmaceutical and non-clinical research work.
Since the beginning of this year, the new crown epidemic has continued to recur, and domestically produced new crown oral drugs are a key part of epidemic prevention and control. It is worth noting that there are more than ten domestic new crown oral drugs currently under development, and Junshi Bio (688180.SH, closing price: 77 yuan/share, market value: 70.1 billion yuan), Real Biology and Kintor Pharmaceutical (9939 .HK, closing price: HKD 22.50/share, market value: HKD 8.72 billion) The new crown oral drug has entered Phase III clinical trials. In comparison, does Sinovac Pharmaceutical’s SHEN26, which has not yet been approved for clinical use, seems a little late?
The total amount of the agreement is 8.8826 million yuan
Another domestic pharmaceutical company entered the new crown oral drug track. On the evening of June 5, Kexing Pharmaceutical announced that in order to accelerate the SHEN26 project, the company’s wholly-owned subsidiary Shenzhen Kexing Pharmaceutical Co., Ltd. (hereinafter referred to as Shenzhen Kexing), Xinlitai and Huizhou Xinlitai Pharmaceutical Co., Ltd. (hereinafter referred to as Huizhou Xinlitai) signed the CDMO technical service and entrusted production agreement, Shenzhen Kexing entrusted Xinlitai and Huizhou Xinlitai to carry out SHEN26 project drug CDMO technical services (including but not limited to technology transfer in the drug registration stage, clinical Sample production, etc.) and commissioned processing of APIs and preparations.
According to the 2021 annual report of Kexing Pharma, SHEN26 is a novel coronavirus polymerase (RdRp) inhibitor, which can achieve antiviral effect by inhibiting viral nucleic acid synthesis. It was jointly developed by Professor Zhang Xumu and Professor Guo Deyin of Sun Yat-sen University School of Medicine. At present, SHEN26 has completed all pharmaceutical and non-clinical research work.
The announcement shows that the total amount of the CDMO technical service agreement is 8.8826 million yuan, which will be paid by Shenzhen Kexing in seven installments according to the progress of the agreement; Shenzhen Kexing is the holder of the marketing license of the drug and has all the rights to the product. Within the validity period, Xinlitai and Huizhou Xinlitai were respectively entrusted to produce commercial preparations and APIs of SHEN26 according to the order. The announcement also stated that after SHEN26 was approved, Shenzhen Kexing paid commercial batch production and processing fees and post-market management fees based on the actual commissioned processing volume.
It is reported that Kexing Pharma is mainly engaged in the research and development, production and sales of recombinant protein drugs and probiotics. Its core products include human erythropoietin (epudine), human interferon α1b (Serogen), human granulocyte stimulating factor (Bitexi), Clostridium butyricum dual viable bacteria (Changlekang), etc. The company landed on the Science and Technology Innovation Board in December 2020.
The competition in the domestic new crown oral drug track is fierce
Since the beginning of this year, the epidemic situation in various parts of the country has continued to recur. Domestically produced new crown oral drugs are a key part of epidemic prevention and control. Concept stocks related to new crown oral drugs have been highly sought after by the market, and major pharmaceutical companies have also targeted this track. It is worth noting that there are currently more than ten domestic oral drugs for COVID-19 under development. Among them, the oral drugs for COVID-19 from Junshi Bio, Real Bio and Kintor have entered Phase III clinical trials, and most of the rest are in the preclinical research and development stage.
Who will be the first to be approved for the domestic new crown oral drug? Recently, domestic new crown oral drugs have intensively announced research progress. In April, Kintor disclosed key data from a Phase III clinical trial of proclutamide in the treatment of non-hospitalized patients with mild to moderate illness. Symptoms improved significantly compared to previous results that did not reach statistical significance in the interim analysis. In May, Junshi Bio announced that VV116 achieved the primary endpoint in a Phase III clinical trial comparing Pfizer’s PAXLOVID.
In comparison, does Sinovac Pharmaceutical’s SHEN26, which has not yet been approved for clinical use, seems a little late? Today (June 6), a reporter from “Daily Economic News” contacted relevant personnel of Kexing Pharmaceuticals through WeChat. The company replied that the SHEN26 project is a key promotion project of the Ministry of Science and Technology‘s “Public Safety Risk Prevention and Emergency Technical Equipment Special Project”. At present, all pharmaceutical and non-clinical research work has been completed, and it is in close communication with CDE; the company has cooperated with the clinical trial CRO. The company and the Phase I clinical research institutions have carried out comprehensive cooperation in clinical programs and other aspects.
In the future, will SHEN26 conduct international multi-center clinical trials? “The company has plans to conduct international multi-center clinical trials, which will take into account the domestic and foreign epidemics and refer to the “Technical Guidelines for Clinical Trials of New Antiviral Drugs for Novel Coronavirus Pneumonia (Trial)” issued by CDE.” Kexing Pharmaceuticals said.
As of the close on June 6, Kexing Pharmaceuticals reported 30.03 yuan per share, up 6.49% from the previous trading day.
Source of cover image: Photo Network-500668961
