Day: January 3, 2022

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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.”

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Suspect Charged in Connection With Fire at South Africa Parliament

South African investigators say a fire that destroyed significant parts of Cape Town’s historic parliamentary precinct Sunday may have been caused by arson. Police say they have arrested a suspect who was found with stolen goods.

Brigadier Nomthandazo Mbombo, from the Directorate for Priority Crime Investigation in Cape Town also known as The Hawks, listed the charges against the suspect.

“A 49-year-old suspect was arrested and charged with house-breaking and theft, arson and will also be charged under the National Key Points Act. The suspect was allegedly caught with suspected stolen property after he gained entry to the parliament precinct unauthorized. He was spotted by members of the protection and security services when they noticed the building was on fire,” he said.

The National Key Points Act deals with safeguarding certain installations against sabotage or other hostile acts.

Natasha Mazzone, the chief whip of the main opposition Democratic Alliance party, spoke outside the parliament gates.

“We now know that the water sprinkler system was turned off so clearly it was designed for destruction of our parliament, as I look up, I could cry…And what gives me hope is that the statue of Madiba stands strong and was untouched by the fire. And he’s looking on as we rebuild and rebuild we will. And we will be a better parliament than we were before,” said Mazzone.

By Madiba, she was referring to the late South African President Nelson Mandela.

Officials, including Cape Town’s mayor, offered potential meeting sites for parliament.

“Mayor Geordin Hill-Lewis has offered his city council chambers as well as the City Hall which seats over a thousand. We also have the virtual platform which we’ve all become very used to but sit we will and hold the government to account we certainly will,” said Mazzone.

Public Works Minister Patricia De Lille addressed the media at a briefing at parliament Monday afternoon.

“The temperature inside the building is still plus/minus a hundred degrees Celsius, down from what it was yesterday at over 400 degrees Celsius but what they’ve done in the meantime is to use a drone that they are putting inside the building to assess the structure of the building until the temperatures can cool down,” she said.

She said a team of engineers has been brought on board and will focus on the repairs that need to be done, the cost and the time it will take for completion. De Lille said they’ve also brought in a fire expert who will determine exactly where the blaze started, together with a fire forensic team.

“We are being informed by the professional teams that we can expect a preliminary report by Friday morning about their preliminary findings and that report will then be shared also with Madam Speaker and the presiding officers, and we will then decide together what to do, once we’ve seen the full extent of the cost,” she said.

The suspect is due to appear in the Cape Town Magistrate’s Court on Tuesday.

Source: Voice of America

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Fire Reignites at South African Parliament

A fire that severely damaged South Africa’s 130-year-old parliament building complex, including the parliament chamber, Sunday in Cape Town has reignited Monday, officials say.

Police say a man has been charged with setting the fire, which started early in the morning local time on Sunday.

The fire reportedly began in an older part of the complex that was wood-paneled. Some of the country’s most noted artifacts were reportedly on display in the building.

Most firefighters had left the scene but were rushed back once the fire began burning again.

“The wind has been getting steadily stronger and ignited the smoldering wood inside the roof void space, parts of which are not accessible for dousing or dampening,” the Fire and Rescue Service Department said on WhatsApp.

Despite the devastation, no one was reported killed or injured in the blaze.

The suspect, reported to be a 49-year-old man, was set to appear in court Tuesday charged with “housebreaking and arson.”

A full investigation into the fire will be conducted by the Hawks, an elite police unit that investigates major crimes. An initial report is expected on Friday.

“This is an incredibly sad day if you are a normal human being, to stand in front of this building and realize what we’ve lost,” said lawmaker Natasha Mazzone.

Source: Voice of America

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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

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