Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Favipiravir - Sihuan Pharmaceutical Holdings Group

Drug Profile

Favipiravir - Sihuan Pharmaceutical Holdings Group

Alternative Names: jk 05

Latest Information Update: 12 Mar 2020

At a glance

  • Originator Academy of Military Medical Sciences
  • Developer Sihuan Pharmaceutical Holdings Group
  • Class Small molecules
  • Mechanism of Action RNA inhibitors; RNA replicase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Clinical Phase Unknown COVID 2019 infections
  • No development reported Bunyavirus infections; Ebola virus infections; Influenza virus infections; Viral haemorrhagic fevers; Yellow fever

Most Recent Events

  • 12 Mar 2020 Chemical structure information added
  • 15 Feb 2020 Clinical trials in COVID-2019 infections in China (PO) in early February 2020
  • 28 Nov 2018 No recent reports of development identified for preclinical development in Bunyavirus-infections in China

Development Overview

Introduction

Sihuan Pharmaceutical Holdings Group is developing oral favipiravir (earlier known as jk 05), a small molecule, selective inhibitor of RNA polymerase, for the treatment of COVID-2019 infections. The broad spectrum antiviral was originated by Institute of Microbiology and Epidemiology of the Chinese Academy of Military Medical Sciences and licensed to Sihuan. Chinese media reports state that the government has donated the drug, to fight the 2014 Ebola outbreak in West Africa. After oral absorption, the drug is converted into a bioactive nucleoside triphosphate compound, which is similar to purine, and can compete with purine to inhibit RNA polymerase, inhibiting virus replication. The nucleoside triphosphate compound of Favipiravir can also be inserted into the virus RNA chain and acts as RNA inhibitor by inducing fatal mutation of the virus. Clinical development is underway for COVID-2019 infections in China.

Favipiravir shows anti-Ebola activity and actuivity against other RNA viruses including, influenza, yellow fever, viral haemorrhagic fevers and bunyavirus infections [1] .

Favipiravir was being developed for Ebola virus infections, however as at November 2017, no recent reports of clinical development had been identified for the development in China.

Favipiravir was being developed for Bunyavirus infections, influenza virus infections, viral haemorrhagic fevers and yellow fever, however as at November 2018, no recent reports of development had been identified for preclinical development in China for these indications.

Company Agreements

In October 2014, Beijing Sihuan Pharmaceutical Co Ltd, a subsidiary of the Sihuan Pharmaceutical Holdings Group Ltd, entered into a collaborative development agreement with the Institute of Microbiology and Epidemiology of the Academy of Military Medical Sciences (AMMS), to collaborate for anti-Ebola drug jk-05. Under the terms of the agreement, the Sihuan Pharmaceutical Holdings Group will pay a technology transfer and drug development fee amounting to RMB 10 million to AMMS for the ownership and franchise of the drug. Payment will be settled in installments based on the progress of drug development, until approval for production is received. Sihuan Pharmaceutical Holdings Group and AMMS will support further research and development efforts on jk-05 as a broad-spectrum antiviral drug, and will ensure its manufacture and launch to the market by Beijing Sihuan and addition of the drug to the national reserve. jk-05 is a new drug designated for the treatment of the Ebola virus.

This deal value was converted from RMB at a rate of $US0.163 on 17 October 2014. [1]

Key Development Milestones

In early February 2020, Sihuan Pharmaceutical Holdings Group initiated clinical trials for favipiravir tablet for COVID-2019 infections.The trials were officially initiated by the Ministry of Science and Technology. The Human Genetic Resources Management Office of the PRC urgently reviewed the Trials and the Group obtained the human genetic resources administrative license in only one working day (2020GH0006YJ). The Trials are random, parallel dose exploration studies with three dosage groups (high, middle and low dosage) to explore the best treatment regimen of Favipiravir for COVID-19 patients. A total of 60 cases of regular COVID-19 patients are planned to be recruited for a treatment period of 10 days [2] .

Favipiravir received "Army Special Needs Drug Approval" from the People’s Liberation Army General Medical Department in August 2014 and is available for the emergency treatment of Ebola haemorrhagic fever [3] . Media reports state that doses of the drug have been sent to Africa to fight the 2014 Ebola virus infections, by the Chinese government.

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Tablet, unspecified
  • Class Small molecules
  • Target RNA; RNA replicase
  • Mechanism of Action RNA inhibitors; RNA replicase inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B9 (Antivirals, others)

  • Chemical name 6-Fluoro-3-hydroxy-2-pyrazinecarboxamide
  • Molecular formula C5 H4 F N3 O2
  • Chemical Structure
  • CAS Registry Number 259793-96-9

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Bunyavirus infections - - No development reported (Preclinical) China unspecified / unspecified Sihuan Pharmaceutical Holdings Group 28 Nov 2018
COVID 2019 infections - - Clinical Phase Unknown China PO / Tablet Sihuan Pharmaceutical Holdings Group 15 Feb 2020
Ebola virus infections - - No development reported (Clinical) China unspecified / unspecified Sihuan Pharmaceutical Holdings Group 04 Nov 2017
Influenza virus infections - - No development reported (Preclinical) China unspecified / unspecified Sihuan Pharmaceutical Holdings Group 28 Nov 2018
Viral haemorrhagic fevers - - No development reported (Preclinical) China unspecified / unspecified Sihuan Pharmaceutical Holdings Group 28 Nov 2018
Yellow fever - - No development reported (Preclinical) China unspecified / unspecified Sihuan Pharmaceutical Holdings Group 28 Nov 2018

Commercial Information

Involved Organisations

Organisation Involvement Countries
Academy of Military Medical Sciences Originator China
Sihuan Pharmaceutical Holdings Group Owner Hong-Kong

Development History

Event Date Update Type Comment
12 Mar 2020 Other Chemical structure information added Updated 12 Mar 2020
15 Feb 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in China (PO) in early February 2020 [2] Updated 09 Mar 2020
28 Nov 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Bunyavirus-infections in China Updated 28 Nov 2018
28 Nov 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Influenza-virus-infections in China Updated 28 Nov 2018
28 Nov 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Viral-haemorrhagic-fevers in China Updated 28 Nov 2018
28 Nov 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Yellow-fever in China Updated 28 Nov 2018
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for clinical-Phase-Unknown development in Ebola-virus-infections in China Updated 04 Nov 2017
06 Oct 2014 Licensing Status Sichuan Pharma acquires jk 05 from the Academy of Military Medical Sciences [1] Updated 21 Oct 2014
06 Oct 2014 Phase Change - Preclinical Preclinical trials in Bunyavirus infections, Influenza virus infections, Viral haemorrhagic fevers, Yellow fever in China (unspecified route) Updated 21 Oct 2014
29 Aug 2014 Phase Change - Clinical Clinical trials in Ebola virus infections in China (unspecified route) Updated 21 Oct 2014
29 Aug 2014 Regulatory Status The General Logistics Department of People’s Liberation Army approves jk 05 for the emergency treatment of Ebola virus infections [3] Updated 21 Oct 2014

References

  1. Collaboration Agreement with Academy of Military Medical Sciences for Development of Anti-Ebola Drug jk-05.

    Media Release
  2. Sihuan Pharmaceutical Announces Clinical Research of Favipiravir, A Drug for Coronavirus Disease 2019, Co-Developed with the Academy of Military Medical Sciences of the People's Liberation Army, Has Commenced.

    Media Release
  3. China Approves its First Anti-Ebola Drug.

    Media Release
Back to top