Ascletis Expands Ritonavir Oral Tablet Production and Announces Oral Direct-Acting Antiviral Pipeline Against SARS-CoV-2 Virus

– Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand

– ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection

– ASC11 is an oral direct-acting antiviral drug candidate targeting 3-chymotrypsin like protease (3CLpro), combined with ritonavir oral tablets, to treat SARS-CoV-2 infection

HANGZHOU and SHAOXING, China, Jan. 3, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) today announces the expansion of the production of ritonavir oral tablets and oral direct-acting antiviral R&D pipeline for the treatment of SARS-CoV-2 infection. The Company’s COVID-19 pipeline currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor.

The Company owns the only authorized ritonavir oral tablet in China, which passed bioequivalence study. The Company’s ritonavir oral tablet was approved in September, 2021 by China National Medical Products Administration (NMPA). As a pharmacokinetic booster of multiple antiviral protease inhibitors, a low dose ritonavir oral tablet (100mg) is a component of oral direct-acting antiviral drug Paxlovid (Nirmatrelvir+ritonavir). The Company applied the sophisticated formulation technology to significantly increase the human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the ritonavir oral tablets produced by the Originator, AbbVie. The Company is planning to file generic drug applications for registrations in multiple countries in the world. Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand.

ASC10 is an oral direct-acting antiviral drug candidate targeting RdRp. In vitro data showed significant activity against SARS-CoV-2. ASC10 is an in-house discovered drug candidate with the global intellectual property and commercial rights. Compared to RdRp-targeted Molnupiravir which was approved by US Food and Drug Administration (FDA), ASC10 has a new and differentiated chemical structure. The Company has filed multiple compound and use patent applications. The data from animal studies demonstrated that ASC10 has higher bioavailability when compared to Molnupiravir. The Company plans to submit investigational drug applications (INDs) for clinical trials in China, USA etc. in the first half of 2022.

ASC11 is an oral direct-acting antiviral drug candidate targeting 3CLpro, in combination with the authorized ritonavir oral tablets produced by the Company, to treat SARS-CoV-2 infection. ASC11 is an in-house discovered drug candidate with the global intellectual property and commercial rights. Compared to 3CLpro-targeted Nirmatrelvir which was approved by US FDA, ASC11 has a new and differentiated chemical structure. The Company has filed the compound and use patent applications. The Company plans to submit INDs for clinical trials in China, USA etc. in the second half of 2022. The Company has extensive R&D experience in viral protease inhibitors and successfully developed and commercialized oral HCV protease inhibitor GANOVO® in combination with ritonavir oral tablets for the treatment of chronic hepatitis C.

“At the beginning of COVID-19 in 2020, based on its antiviral platform and R&D experience, the Company made the firm and rapid decision to invest in oral direct-acting antivirals R&D against RdRp and 3CLpro of SARS-CoV-2. Meanwhile, the Company accelerated the development effort to obtain the approval of ritonavir oral tablets in China and successfully achieved the authorization by China NMPA for ritonavir oral tablets,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “The Company has tremendous experience in antiviral oral protease inhibitors and successfully developed the fixed-dose combination ASC09F (ASC09+ritonavir) to treat HIV infection, in addition to launching GANOVO®/Ritonavir combination for chronic hepatits C.”

Fears for Australia’s Famous Migrating Moth

Conservationists are blaming climate change, land clearing and pesticides for the population crash of one of Australia’s most famous insects. Once a common sight, bogong moths have become rare in recent years. They are now recognized as endangered by the world’s leading scientific authority on vulnerable species, the International Union for Conservation of Nature.

The bogong moth is native to Australia. The mass migration of billions of the small insects has long been a spectacular sight in eastern Australia.

Scientists say the moths are guided by the stars and the earth’s magnetic fields.

They fly up to 1,000 kilometers from Queensland to the mountains of Victoria to shelter in caves from the heat of summer. In the caves, it was once estimated there were as many as 17,000 moths per square meter.

But Jess Abrahams, a nature campaigner from the Australian Conservation Foundation says bogong moth numbers have collapsed.

“It is a dramatic decline, and this population crash has been caused by climate change-fueled extreme drought in their breeding grounds in western Queensland. There has also been land clearing over many years, use of pesticides as well and the consequence is a huge crash in numbers and the flow-on affects to other species is of huge concern. This should be an alarm bell because we are in the midst of an extinction crisis. We are seeing (a) million species globally at risk of extinction and literally these things are disappearing before our very eyes,” Abrahams said.

The decline of the bogong moth has a cascading effect on other species. They were a major source of food for another critically endangered animal, the mountain pygmy-possum. Fewer than 2,000 of Australia’s only hibernating marsupials are thought to be left in the wild.

The moth is one of 124 Australian animals and plants that were added in December to the “Red List” of threatened species compiled by the International Union for Conservation of Nature. They include several other types of insects and the grey-headed flying fox, which is Australia’s largest bat.

The Red List classifies how close global animal, plant and fungi species are to dying out, and includes sharks, rays and birds. Many populations are strained by global warming, deforestation, habitat loss and pollution.

Campaigners are urging the Australian government to do more to save the moths that were once in such abundance in cities such as Sydney and Canberra that their vast numbers disrupted sporting events.

Source: Voice of America

Ambulance Service for Poor Helps Residents of Nairobi’s Largest Slum

A community health service in Africa’s largest urban slum is helping poor people get affordable emergency services during the COVID pandemic.

The Kibera community emergency response team in Nairobi is offering a $1 monthly fee for access to emergency services, including an ambulance.

Poor people — like those living in Nairobi’s Kibera slum — find it difficult to access emergency health care.

Even where public services such as clinics and hospitals are provided within slums, the high cost effectively bars most Kibera residents from calling an ambulance.

It’s a challenge Moses Omondi — who was born and brought up in Kibera slum — has undertaken.

He formed a community emergency response team that provides services to slum residents for a fee of $1 a month, including ambulance transport to the hospitals.

“If you have an ambulance, you can easily access a hospital because no hospital should deny you services when you have been taken there by an ambulance, Moses Omondi said. “It means it’s an emergency case that needs emergency attention.”

Annet Okumu is one of about 300 subscribers to the ambulance service. She said she received potentially lifesaving care inside an ambulance after an accident last year.

“The condition I was in wasn’t that good,” Okumu said. “I was really having a very bad headache, I was bleeding. So maybe I could have overbled if I couldn’t have gotten the first aid service.”

Non-profit groups and other benefactors support the service. So far, there is one ambulance for an estimated 250,000 residents in the slum. Officials hope to increase the number to five.

Ambulance services in Kenya ordinarily cost up to $400 depending on the needs of a patient, such as a ventilator and the distance involved.

Officials say arrangements that provide public access to affordable emergency services are especially important during the COVID-19 era. Judith Okech is the head of the Ambulex Kenya service.

“It’s a service people are acknowledging that they very much need, and you’ll realize that people living within such settings, some of them have never called for an ambulance because they know that if you call for an ambulance it’s never going to get there, or you’ll be asked for a lot of money that they are not able to afford,” Judith said.

Residents say the community service emergency response team offers hope they will have better access to the health care they need.

Source: Voice of America