Under the background of covid-19 epidemic, the research and development progress of domestic covid-19 oral drugs has become the focus of attention from all walks of life. At present, the research and development of domestic covid-19 small molecule oral drugs has ushered in a key time point. Azvudine is waiting to be debunked. Vv116 has started the head-to-head phase III clinical trial with Pfizer paxlovid, and the listing process is expected to be accelerated. The phase III clinical trial of AR inhibitor prochloramide is also coming to an end.
During the new release cycle from April 8 to April 14, 20 innovative drug projects from Jiangsu Hengrui Medicine Co.Ltd(600276) , tianzeyuntai, Shanghai affinity biology and Xiantong International were approved for clinical use for the first time. The number of innovative drugs approved for clinical use reached a record high, including products in hot fields such as gene therapy, antibody coupling, bispecific antibodies, oncolytic virus and tcr-t, which were included in the "people's finance · innovative drug index".
In addition, the covid-19 mutant mRNA vaccine sys6006 and synov1, the oncolytic virus product of syngenetic gene of Shijiazhuang Pharmaceutical Group 1. Baiji Shenzhou's Tyk2 inhibitor bgb-23339 and other innovative drugs were registered in China for the first time recently and launched the I clinical trial. Driven by these factors, during the new release cycle, the "people's finance · innovative drug index" Rose 1.29% to 259978.
new progress of domestic covid-19 oral drugs
On the evening of April 20, Shanghai Junshi Biosciences Co.Ltd(688180) covid-19 oral drug vv116 brushed the screen with the news of the new phase III clinical trial.
According to the China clinical trial registration center, this is a multicenter, single-blind, randomized, controlled III clinical study initiated by researchers to evaluate the effectiveness and safety of vv116 compared with Pfizer paxlovid in the early treatment of mild and moderate covid-19 pneumonia. The trial will end on May 31.
In addition to this head-to-head phase III clinical, vv116 is also carrying out a number of international multicenter phase III clinical trials for patients with mild, moderate and severe covid-19 pneumonia. According to the minutes of covid-19 front-line expert exchange meeting in Ruijin Hospital circulated on the Internet, the clinical was approved urgently. At present, it has been about a week (April 14), and about 100 patients have been enrolled. It is planned to complete the enrollment of head-to-head study patients by late April. Industry insiders believe that due to the current covid-19 epidemic in Shanghai, the clinical counterpart with paxlovid will be quickly incorporated into the group. If it shows excellent or non inferior effect, vv116 is expected to apply for emergency use authorization as soon as around June.
It was also the news from a performance exchange meeting of listed companies held by securities companies on the afternoon of April 20 that "the phase III clinical data of azvudine has been summarized, and the CDE verification has been started for several days". At the China Medical Development Conference on April 16, Jiang Jiandong, member of the academic department of the Chinese Academy of Medical Sciences and academician of the Chinese Academy of engineering, said in the report, "at present, the phase III clinical trial of azvudine has been completed, and the results of Russia and Brazil have been submitted for approval." From these two information, azvudine's Unblinding and other work are going on normally.
In addition to vv116 and azvudine, two AR inhibitors, prochloramide and denlumide (hc-1119), also belong to the first echelon of domestic covid-19 oral drug research and development, both of which are in phase III clinical stage.
On April 6, Kaifa pharmaceutical released the key data analysis of phase III global multicenter clinical trial of prochloramide in the treatment of mild and moderate disease non hospitalized covid-19 patients, and the results showed positive. Kaifa said it would actively promote the application of prochloramide to the national drug regulatory authorities of China, the United States and other countries and regions for emergency drug use EUA license.
Hc-1119 is an AR antagonist similar to prochloramide and is the core product of Haichuang pharmaceutical. According to the prospectus of Haichuang pharmaceutical, hc-1119 for the treatment of covid-19 inpatients was approved by Anvisa to enter the phase II / III clinical trial in Brazil in July 2021. It is expected to submit the EUA to Anvisa in Brazil in February 2022 and the NDA in June 2022 However, it is reported that Haichuang pharmaceutical has withdrawn the clinical trial of covid-19 treatment; The company responded that to understand the relevant situation, look at the prospectus.
In addition to the four domestic oral drugs in the phase III clinical stage, good news has also come from a number of covid-19 oral drug candidates in the early clinical stage recently.
On April 20, Wu JINZI, chairman of the board of directors of Geli pharmaceutical, revealed at the online media conference that the covid-19 oral drug 3clpro inhibitor asc11 under development plans to complete the phase I clinical trial by the end of 2022 and start the key phase III clinical trial for about five months at the beginning of next year. It is expected to submit the application for new drug listing to the State Food and drug administration as soon as may and June next year.
The day before that, geley pharmaceutical announced that asc11 was expected to become an effective drug for the treatment of covid-19 pneumonia. The antiviral cell experiment showed that the antiviral activity ec90 of asc11 was 31 times that of Pfizer and 120 times that of yanyeyi s-217622.
The 3CL protease inhibitor sim0417 of Xiansheng pharmaceutical is the fifth domestic covid-19 oral drug entering the clinical stage. On the 2022 research and development day, Xiansheng pharmaceutical revealed that according to the plan, the phase I clinical study of sim0417 will be completed for all subjects by the end of May.
In the 2021 annual report disclosed on the 19th, Shan Dong Kexing Bioproducts Co.Ltd(688136) said that at present, the preclinical work of its covid-19 small molecule candidate shen26 has been basically completed except for some toxicological data reports. Yunding Xinyao said recently that its covid-19 candidate oral drug eddc-2214 is expected to be launched in the second half of this year.
From these developments, domestic covid-19 oral drugs are ready to emerge, and more candidate drugs will enter the clinical stage in the second half of the year. Who can become the first domestic covid-19 oral drug in China depends not only on clinical progress, but also on clinical data.
20 innovative drug projects were approved for clinical use for the first time
Under the pressure of innovative drug policy encouragement and centralized purchase policy, the clinical research and development of innovative drugs in China is advancing rapidly. In the new release cycle, 20 innovative drug projects from Jiangsu Hengrui Medicine Co.Ltd(600276) , Tianze Yuntai, Shanghai Qinli biology, Xiantong international, etc. were approved clinically for the first time, with a record number of approved clinical trials.
In terms of drug categories, many of these varieties belong to products in hot fields such as gene therapy, ADC (antibody coupling), bispecific antibody, oncolytic virus and tcr-t.
Among them, lx101 injection of Langxin biology and vgb-r04 injection of Tianze Yuntai are gene therapy with recombinant adeno-associated virus rAAV as the carrier, aiming at eye disease and hemophilia respectively.
In recent years, major breakthroughs have been made in the field of gene therapy. In 2017, luxturna therapy based on adeno-associated virus (AAV) was approved by FDA for listing, becoming the first "in vivo drug delivery" gene therapy approved in the United States, creating a new chapter of gene therapy. At present, the development of AAV gene therapy in the world is accelerating. There are hundreds of clinical trials of rAAV vector gene therapy. In China, a number of AAV gene therapies such as Wuhan newforth, Faith Medicine and Jinlan gene submitted ind applications last year.
Two oncolytic virus products, vg201 of funuojian biology and vg161 of Zhongsheng funuojian, have also obtained clinical approval recently. Among them, vg201 is a first in class oncolytic virus clinical product based on TTDR (dual regulation of transcription and translation). This is the first time that the project has obtained clinical approval.
As a new method of tumor immunotherapy, oncolytic virus has been approved by regulators in China and many European and American countries. In recent years, it has attracted more and more attention from scientific research and industry. According to our statistics, at present, 15 new oncolytic virus drugs have been approved for clinical use in China, and the highest has progressed to phase 2 clinical practice.
In addition, bl-m02d1 for injection and bat8009 for injection of Bio-Thera Solutions Ltd(688177) are antibody coupled drugs, targeting trop2 and cd276, respectively It is reported that cd276 is one of the most cutting-edge targets in the world. At present, only a few monoclonal antibody drugs targeting cd276 from American companies have entered the clinic. In China, bat8009 is the second clinical cd276 ADC drug. According to the announcement of Bio-Thera Solutions Ltd(688177) , bat8009 shows high antitumor activity in vivo and in vitro pharmacological research, and is a potential "best in class" antibody coupled drug.
In terms of clinical progress, the drug clinical trial registration and information publicity platform. On April 21, Shijiazhuang Pharmaceutical Group registered two phase I clinical trials of its covid-19 mutant mRNA vaccine sys6006, aiming at healthy people aged 18-59 and healthy people aged 60 and above respectively.
Sys6006 obtained clinical approval at the beginning of this month. According to the announcement of stone Pharmaceutical Group, stone Pharmaceutical Group has realized internalized production and domestic substitution of key production raw materials and excipients of mRNA technology, which can meet the demand of large-scale production capacity supply. Based on its advantages in safety, effectiveness and industrialization, and according to the needs of epidemic prevention and control, the product was included in the special approval procedure by the State Food and Drug Administration and quickly approved to enter the clinic.
At the same time, synov1, the oncolytic virus product of syngenetic gene 1. Baiji Shenzhou's Tyk2 inhibitor bgb-23339 and Tali biological Cdk8 / 19 inhibitor tsn084 also registered and started the I clinical trial in China for the first time recently. The promotion of the research and development progress of these innovative drugs is the main reason for the rise of the "people's finance · innovative drug index". (Zhilan)
