Veća proizvodnja oralnih antivirusnih lijekova i testova za COVID-19

At present, COVID-19 is still in pandemic status around the world. The superposition of Delta and Omicron variants are rampant, resulting in the continuous enhancement of their transmission ability. Amid the repeated waves of COVID-19, in addition to COVID-19 vaccine, the development of effective oral COVID-19 drugs and rapid, simple and innovative testing methods have also become a new demand for current epidemic prevention and control. Viva Biotech Holdings XLement, invested and incubated by Viva BioInnovator, are committed to the production of oral COVID-19 drugs and virus test, contributing to the fight against the COVID-19 pandemic.

Jan 2022, the Medicines Patent Pool (MPP) announced that it has signed agreements with several generic manufacturing companies including Zhejiang Langhua Pharmaceutical Co., Ltd., the subsidiary of Viva biotech holdings for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low-and-middle-income countries (LMICs) to facilitate affordable global access for molnupiravir and support local epidemic prevention & control. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug.

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low-and middle-income countries. MPP and MSD, the tradename of Merck & Co., Inc Kenilworth NJ USA signed a voluntary licencing agreement in Oct 2021. Under the terms of the agreement, MPP, through the license granted by MSD, will be permitted to further license non-exclusive sublicences to manufacturers and diversify the manufacturing base for the supply of quality-assured molnupiravir to countries covered by the MPP Licence, subject to local regulatory authorization.

Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2 (the causative agent of COVID-19). Molnupiravir that MSD is developing in partnership with Ridgeback Biotherapeutics, is the first oral antiviral medicine available for COVID-19 therapy. Data from the Phase 3 MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19.

According to MPP, the companies that were offered the sublicence successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. The authorisation granted to Langhua Pharmaceutical by MPP represents a high affirmation and recognition in its process development and amplification of APIs, supply sustainability, GMP and EHS system.

On March 2nd, 2022, Xlement, a devoted NanoSPR biochip and instruments biotech company that previously invested and incubated by Viva BioInnovator, received the notice of passing the performance evaluation from the Ministry of Science and Technology of the People´s Republic of China. Its project “R&D and Mass Production of NanoSPR COVID-19 Particle Test Kit” is one of the key projects of the “Public Safety Risk Prevention and Control and Emergency Response Technology and Equipment” program which serving an essential part to key COVID-19-related scientific research ongoing in China. With its successful pass to the inspection, Xlement’s COVID-19 Test Kit also has been certified by the European Union CE for future massive production and will be put into use soon.

Leveraged on the unique NanoSPR chip technology, Xlement developed the test kit for COVID-19 particles, which allows one-step test of multiple virus antigens for 96 samples within 15 minutes, and the sensitivity is close to testing a single antigen. This method shows great advantages compared to existing viral nucleic acid testing techniques: it can be used for self-testing at home, it shortens the testing time significantly, thus, significantly reduces the cost of testing reagents and labor. With more adoption of the NanoSPR technology in the COVID-19 testing developed by Xlement, we expect to see more convenient immediate diagnosis of suspected samples and on-site rapid screening at large-scale.