Multiple anti-COVID-19 drugs in China have entered clinical trial stages

　VV116 is an oral nucleoside anti-COVID-19 candidate drug jointly developed by several domestic research institutions including the Shanghai Institute of Materia Medica, Wuhan Institute of Virology, and Xinjiang Institute of Physical and Chemical Technology of the Chinese Academy of Sciences. Preclinical pharmacodynamic studies show that VV116 has significant inhibitory activity in vitro against the original strain and variants of the coronavirus, such as the Delta variant. The research team led by Researcher Shen Jingshan from the Shanghai Institute of Materia Medica and collaborating institutions found through adenovirus mouse model experiments that oral VV116 can reduce the viral titer below the detection limit and significantly improve pathological changes in the lung tissue of experimental model animals. A series of preclinical safety evaluation experiments show that VV116 has good safety and no genotoxicity.

　　Researcher Shen Jingshan from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences: Currently, we call it (VV116) a candidate drug. After completing comprehensive preclinical studies, clinical trials were first approved to be conducted in Uzbekistan, and these clinical trials are Phase I, II, and III phases conducted simultaneously. In China, clinical trials are also underway, and everyone is eagerly awaiting the clinical data.

　　In another laboratory at the Shanghai Institute of Materia Medica, researchers are studying another anti-COVID-19 candidate drug FB2001, jointly developed by the Shanghai Institute of Materia Medica, ShanghaiTech University, and Wuhan Institute of Virology. Researcher Liu Hong, the project leader, told reporters that their main focus is innovative drug research targeting a very important target in the coronavirus replication cycle, the 3CL protease. FB2001 is an active compound they discovered through experiments.

　　Researcher Liu Hong from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences: This compound (FB2001) has very good enzyme inhibitory activity and also shows good antiviral effects against the coronavirus. In March 2021, Phase I clinical research was conducted in the United States. During this process, the related research was published as a cover article in Science.

　　It is understood that regarding the development of anti-COVID-19 drugs, the Shanghai Institute of Materia Medica has made good progress in building screening systems, virtual screening, high-throughput screening, discovery of lead compounds, and subsequent development of small molecule candidate drugs.

　　Director Li Jia of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences: Two new drugs have completed preclinical studies and entered clinical trials, one in the United States and the other conducting clinical trials in China and Uzbekistan. I believe that through continuous validation in Phase I, II, and III clinical trials, if it can be confirmed that our drugs can effectively protect COVID-19 patients, this will be a very important support for COVID-19 patients worldwide.

　　In addition, a new drug with independent intellectual property rights in China, "Pukluren," has successively started three clinical trials in Brazil since September 2020. Results show that the drug has a 92% hospitalization protection rate for male and female mild to moderate non-hospitalized patients and reduces the risk of death in severe patients by 78%. Currently, Pukluren is conducting Phase III global multicenter clinical trials for treating mild to moderate COVID-19 patients in countries including the United States, Brazil, South Africa, Argentina, Malaysia, and the Philippines. It is also conducting Phase III global multicenter clinical trials for treating severe COVID-19 patients in the United States, China, the Philippines, Brazil, and other countries. On October 1 of this year, the first patient was enrolled and dosed at a clinical center in the United States. The clinical trial results are expected to be disclosed in the first half of 2022. September 2020 Pukluren R&D leader Ma Liandong: Pukluren can inhibit two important proteins that allow the coronavirus to enter cells, called ACE2 and TMPRSS2. Pukluren can regulate the levels of these two proteins, lowering them, which prevents the virus from entering cells from outside to replicate. Secondly, it reduces the risk of death by inhibiting the inflammatory molecular storm. These are the two most important mechanisms, developed independently by our team.

　　普克鲁胺研发负责人 马连东：普克鲁胺可以通过抑制新冠病毒进入细胞的两个重要蛋白质，一个叫ACE2，一个叫TMPRSS2。普克鲁胺可以调节这两个蛋白质的水平，让它下降，这样会阻止病毒从细胞外进入到细胞内进行复制，第二个通过抑制的炎症分子风暴来降低死亡风险。这是最重要的两个机制，是我们自主研发和自己团队完成的。