Distribution of Etesevimab/JS016 in the US Reopened

SHANGHAI, China, Aug. 29, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the United States Food and Drug Administration (the “FDA”), alongside the Office of the Assistant Secretary for Preparedness and Response, has resumed the shipment and distribution of etesevimab and bamlanivimab administered together (the “Therapy”), according to the company’s global partner Eli Lilly and Company (NYSE: LLY). Direct ordering will be available to authorized states in the U.S. effective immediately.

The decision to resume distribution aligns with the FDA’s issuance of an updated fact sheet (the “Fact Sheet”) and a revised letter of authorization for etesevimab and bamlanivimab together. These include a revised limitation of authorized use, only allowing use in the states, territories, and U.S. jurisdictions with a low prevalence of variants that are resistant to treatment with the antibodies.

The Delta variant (the “Delta”) currently accounts for nearly 96 percent of all identified COVID-19 cases in the U.S. As shown in revisions to the Fact Sheet, pseudovirus and authentic virus studies demonstrate that etesevimab and bamlanivimab together retained neutralization activity against the Alpha variant and the Delta.

Over the last several months, prevalence of variants varies by state, region and even country and can change rapidly. As variants continue to evolve and their patterns of transmission and prevalence shift, Eli Lilly and Company (“Lilly”), a partner of the Company, will continue to work with governments and regulators worldwide to ensure the Therapy is available to appropriate patients.

About Etesevimab (JS016/LY-CoV016)
Etesevimab is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from the Company after it was jointly developed by the Company and the Institute of Microbiology of Chinese Academy of Science. The Company leads development in Greater China (including mainland China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the Taiwan region), while Lilly leads development in the rest of the world.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of the Chinese Academy of Sciences and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+86 021-6105 8800

516 more Delta cases detected in PH

MANILA – Health authorities have detected 516 additional cases of the more transmissible Covid-19 Delta variant, increasing the tally of the variant that was first detected in India to 1,789, the Department of Health (DOH) said on Sunday.

In a statement, the DOH said aside from the Delta variant, also detected were cases of Alpha variant (73), Beta variant (81), and Theta variant (41), based on the latest whole-genome sequencing report by the Philippine Genome Center and the UP-National Institutes of Health.

It said 473 of the 516 additional Delta variant cases are local cases, 31 are returning overseas Filipino (ROFs), and 12 cases are currently being verified if these are local or ROF cases.

Of the 473 local cases, 114 cases had an indicated address in the National Capital Region, while 34 cases had been traced to Ilocos Region, 32 cases in Cagayan Valley, 64 cases in Central Luzon, 79 cases in Region 4-A (Calabarzon), 20 cases in Mimaropa, 16 cases in Bicol Region, 13 cases in Western Visayas, 23 cases in Central Visayas, 12 cases in Zamboanga Peninsula, 48 cases in Northern Mindanao, 22 cases in Davao Region, and six cases in Cordillera Administrative Region.

Based on the case line list, six cases are still active, five cases have died while 505 cases have been tagged as recovered.

All other details are being verified by the local and regional health offices.

Meantime, of the new 73 Alpha variant cases detected, about 71 were local cases, two were ROFs while one is being verified as either local or ROF cases. All cases have been tagged as recovered.

To date, the country’s cases of Alpha variant, first detected in the UK, was logged at 2,395.

For the 81 new Beta variant cases that brought the total to 2,699, the DOH said 78 are local cases, two ROFs and one case is being verified if it is local or ROF case.

Based on the case line list, three cases have died and 78 cases have been tagged as recovered.

All the 41 P.3 variant cases are local cases with one died and the remaining 40 cases have been tagged as recovered.

“While the Alpha and Beta variant cases remain the highest in the country, there is a continuous and increasing detection of the Delta variant in communities,” the DOH said.

The DOH added it is closely monitoring with the Centers for Health Development and local government units the implementation of active case finding, aggressive contact tracing, testing and immediate isolation.

The public is urged to continue practicing the minimum public health standards at all times and to be vaccinated to prevent the spread of Covid-19. (PNA)

Source: Philippines News Agency

34 Hospicio Covid-19 patients to transfer to Red Cross facility

MANILA – Responding to the appeal made by Hospicio de San Jose, the Philippine Red Cross (PRC) will transport more than three dozen Covid-19 patients to its isolation facility.

PRC Chairman and CEO Senator Dick Gordon made the decision after Hospicio’s administrator Sr. Maria Soccorro Evidente on Aug. 28 requested the PRC to open its isolation facility in Adamson University Manila to cater to Covid-19 positive individuals of the oldest welfare institution in the country.

As of posting time, the PRC is preparing to transfer 34 Covid-19 patients from Hospicio to the Red Cross isolation facility in Adamson University.

Based on its letter, the Hospicio has at least 108 active Covid-19 cases and 30 more people classified as close contacts.

Gordon immediately mobilized PRC to open the Adamson facility and cater to children and the elderly of Hospicio de San Jose.

“Kailangan natin agad tugunan ang mga matatanda at mga bata ng Hospicio de San Jose dahil isa sila sa mga most vulnerable groups sa ating bansa (We need to immediately help the elderly and children of Hospicio de San Jose because they are the most vulnerable groups in our country),” Gordon said.

“Sa dumarami na kaso ng Covid-19 ay kaagad natin ipinabukas ang isolation facility natin sa Adamson upang mabigyan ng maayos na atensyong medical ang apektado ng Covid-19) Due to the increasing Covid-19 cases, I immediately ordered to open our isolation facility in Adamson to give medical attention to those affected by Covid-19),” he added.

The PRC isolation facility in Adamson University which opens on Saturday will provide a doctor and a nurse to ensure the wellbeing of the patients.

PRC’s Bakuna Bus also recently conducted vaccination at Hospicio de San Jose, inoculating over 150 senior citizens, bed-ridden clients, persons with comorbidities, and health care workers. (PR)

Source: Philippines News Agency

Eleazar orders dismissal of rookie cop facing sexual assault rap

MANILA – Philippine National Police (PNP) chief Gen. Guillermo Eleazar on Sunday ordered the immediate summary dismissal proceedings against a police officer who was accused of raping a quarantine violator in Mariveles, Bataan.

This, after the Mariveles police said sexual assault and acts of lasciviousness complaints were filed against Pat. Elmer Tuazon Jr., 25, and marshal team leader Armando Dimaculangan, 53, before the Office of the Provincial Prosecutor in Balanga City, Bataan.

“Makakatiyak din ng agarang aksyon ang ating mga kababayan laban sa mga tiwali sa aming hanay kaya nakikiusap din ako na huwag sanang lalahatin ang kapulisan dahil iilan lamang ang mga ito at higit na mas nakakarami ang mga pulis na handang tumulong at gumagawa ng tama sa ngalan ng police service (I assure the public of immediate action against the erring cops in our ranks. So I also appeal not to think that all the police officers are like this because there are only a few of them and there are more policemen who are willing to help and do good in the name of police service),” Eleazar said in a statement.

Eleazar apologized to the victim and her family, assuring them that they will get justice.

Based on the investigation, Tuazon and Dimaculangan while on duty at the quarantine control point cited the victim for being an unauthorized person outside residence (APOR) and was subsequently brought to the boarding house of Tuazon for supposed community service.

Brig. General Valeriano T. De Leon, regional director of the Police Regional Office 3 (PRO-3), said on Saturday the 19-year-old quarantine violator accused Tuazon of rape.

De Leon said aside from Tuazon, Dimaculangan was also accused of molesting the victim.

Eleazar urged the public to immediately file complaints against police officers involved in illegal activities. (PNA)

Source: Philippines News Agency

PNP tallies 76 new recoveries, 1 death from Covid-19

MANILA – The Philippine National Police (PNP) tallied 76 new recoveries from Covid-19 on Sunday but an officer with preexisting conditions assigned at the Mimaropa Region also added to the list of fatalities.

Citing reports from the health services department, PNP chief Gen. Guillermo Eleazar said in a statement that the 53-year-old cop died on Aug. 21, just a day after he was taken to a hospital because of high fever and tested positive for Covid-19.

He experienced difficulty in breathing and succumbed while being treated, the 104th fatality in the PNP to date.

The cause of death was severe pneumonia.

Overall, the PNP has 32,295 recoveries out of a total 34,316 infected while there were 43 new cases that jacked up the active tally to 1,917.

A total of 97,184 or 43.61 percent of PNP personnel are already fully vaccinated while 105,016 or 47.12 percent are awaiting the second dose.

Medical records revealed the deceased, a diabetic with hypertension, underwent dialysis for almost three years.

“Ipinaaabot ko sa pamilya ng ating pulis ang aking taos pusong pakikiramay. Patuloy po ang pagsisikap ng PNP upang tugunan ang pangangailangan ng bawat pulis na tinamaan ng naturang virus (I extend my sincerest condolences to the family of our police officer. The PNP continues its efforts to address the needs of every police officer affected by the virus),” Eleazar said in a statement. (PNA)

Source: Philippines News Agency

PH logs nearly 18K new Covid-19 recoveries

MANILA – The country’s total number of recovered coronavirus disease 2019 (Covid-19) cases has reached 1,777,693 after 17,922 new recoveries were reported on Sunday.

In its latest case bulletin, the Department of Health (DOH) noted that recoveries account for 91 percent of the total case count which has reached 1,791,003 since the start of the pandemic last year.

Meanwhile, 18,528 new infections brought the total number of active cases nationwide to 143,221.

About 95.3 percent of these active cases are mild, 2 percent are asymptomatic, 0.6 percent are critical, 1.1 percent are severe, and 1 percent are moderate.

Some 101 new deaths were also reported, pushing the country’s total number of Covid-19 fatalities to 33,109.

According to DOH data on Aug. 27, about 27.9 percent of 66,225 who were tested turned out positive for Covid-19.

“About 285 duplicates were removed from the total case count, and of these, 204 are recoveries. Moreover, 38 cases previously tagged as recoveries were reclassified as deaths after final validation,” it added.

All laboratories were operational Aug. 27 while seven laboratories were not able to submit their data to the Covid-19 Document Repository System.

The DOH noted the seven non-reporting laboratories contribute, on average, 2.7 percent of samples tested, and 2.1 percent of positive individuals based on data in the last 14 days.

To date, 71 percent of 4,100 intensive care unit beds, 64 percent of 20,300 isolation beds, 70 percent of 14,800 ward beds, and 55 percent of 3,100 ventilators are utilized by patients with Covid-19 nationwide.

Meanwhile, 66 percent of 1,400 intensive care unit beds, 63 percent of 4,700 isolation beds, 73 percent of 4,200 ward beds, and 59 percent of 1,100 ventilators dedicated to patients with Covid-19 are in use in the National Capital Region. (PNA)

Source: Philippines News Agency