Daily Archives: September 19, 2021

Junshi Biosciences Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19

SHANGHAI, China, Sept. 19, 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 (FDA) has expanded the emergency use authorization (EUA) for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 mg administered together (the “Therapy”) to include post-exposure prophylaxis in certain individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in institutional settings, including nursing homes and prisons, according to the company’s global partner Eli Lilly and Company (“Lilly”). In February 2021, the FDA granted the Therapy an EUA for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The expanded EUA is based on data from BLAZE-2 (NCT04497987), a study conducted in partnership with the National Institute of Allergy and Infectious Diseases, which is a part of the National Institutes of Health, and the COVID-19 Prevention Network. The study enrolled residents and staff at long-term care facilities in the US.

The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.

Lilly to Supply 388,000 Doses of Etesevimab to US Government
The US Government has made an additional purchase for the Therapy. As part of the agreement between Lilly and the US government. Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the US government, with approximately 200,000 doses expected to be shipped in the third quarter of 2021 and the remaining to be shipped in the fourth quarter of 2021. In February 2021, the US government agreed to purchase a minimum of 100,000 doses of the Therapy from Lilly.

About Etesevimab
Etesevimab is a recombinant fully human neutralizing monoclonal 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 Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Sciences. Junshi Biosciences leads development in Greater China (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. The Therapy has been granted EUAs in more than 12 countries and regions worldwide, and Junshi Biosciences has completed a Phase Ib/II international multi-center clinical study (NCT04780321) of etesevimab for patients with mild to moderate COVID-19 in China.

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 44 drug candidates, 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 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 Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab received an 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 EUA was expanded to include post-exposure prophylaxis for COVID-19 in September 2021. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 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

No entry of foreign workers, including maids, until Dec 31 – Saravanan

PUTRAJAYA, Sept 19 –Private employment agencies that are registered with the Ministry of Human Resources are advised not to make any statements or advertisements that mislead employers on entry of foreign maids into the country.

Human Resources Minister Datuk Seri M. Saravanan said it is generally known that majority of foreign maids in the country are from Indonesia and that the ministry was still in negotiations with the republic to finalise a Memorandum of Understanding (MoU) on the recruitment of Indonesian domestic helpers (PDI) which had expired on May 30, 2016.

He said as of August 2021, there were a total of 92,481 foreign maids in the country and of this number 64,181 were PDI recruitment.

“I would like to remind employers that there is no entry of foreign workers into the country, including foreign maids, from source countries since the implementation of the movement control on March 18, 2020 due to the COVID-19 pandemic.

“Subsequently, tthe government has decided that there will be no entry of both categories of foreign workers until Dec 31, 2021,” he said in a statement here today.

M. Saravanan said any decision to bring in foreign workers, including foreign maids, would be announced by the government after discussions with the National Security Council (MKN), Human Resources Ministry, Home Affairs Ministry, Health Ministry and the relevant ministries.

Source: BERNAMA News Agency

All private kindergartens registered with MOE can resume operations – MOE

KUALA LUMPUR, Sept 19 –The relaxation to allow operation of kindergartens from last Friday includes all private kindergartens and kindergartens at private schools, international schools and expatriate schools that are registered with the Ministry of Education (MOE).

As announced by Prime Minister Datuk Seri Ismail Sabri Yaakob last Wednesday, MOE explained that the relaxation covers states in Phases One and Two of the National Recovery Plan (PPN) and for pupils aged four to six whose parents or guardians are working.

“The operation of these kindergartens is subject to classroom capacity with the required physical distancing,” the ministry said in a statement.

Prior to this, Ismail Sabri when announcing the relaxation of COVID-19 prevention standard operating procedures of the PPN for several sectors also informed that kindergartens, nurseries, day care centres and mental development centres are allowed to reopen in states under Phase One and Two of the PPN.

Source: BERNAMA News Agency

With new sectors reopening, remain vigilant and adhere to SOPs – Tengku Zafrul

KUALA LUMPUR, Sept 19 — The public must remain vigilant and continue to adhere to standard operating procedures (SOP) when the government reopens more sectors once the nation enters the endemic phase, Finance Minister Tengku Datuk Seri Zafrul Tengku Abdul Aziz said.

He said this was important as current developments show there are still new COVID-19 clusters being detected among certain sectors.

These clusters are triggered when certain segments of society become complacent and fail to observe SOPs when more economic sectors reopen, adding that this was quite evident when certain social activities were permitted recently, he said.

“These clusters emerge because we tend to think that things are back to normal and we do not have to comply with the SOPs any longer.

“From social sector activities observed recently, there are many who seem to have forgotten about SOPs,” he said when discussing the National Recovery Plan (PPN) on RTM’s Optik @ Selamat Pagi Malaysia talk show today on how society can contribute towards its success.

At the same time, Tengku Zafrul said the Finance Ministry was open to helping those economically impacted by the COVID-19 pandemic, adding that for the first time in the nation’s history, the ministry had issued a Pre-Budget Statement (PBS) for Budget 2022.

He said the people have also been given the opportunity to engage with ministry officials virtually and in writing, while public consultation papers are issued for experts’ in-depth views.

“Those are our two focuses to help the people and also businesses in the near future and also to make plans for 2022 for the country’s recovery.

“We (Finance Ministry) are quite optimistic, we can see that the IMF (International Monetary Fund) and World Bank’s forecast and projections for Malaysia next year are quite positive,” he said.

Besides this, Tengku Zafrul, who is also PPN Coordinating Minister, said PPN is a dynamic plan that uses current data for decisions to be brought to the National Security Council (MKN) and the pandemic management committee.

He said where decisions are concerned, PPN uses the latest reports not only sourced within Malaysia but also internationally.

“(COVID-19 vaccine) booster shots, for example, the Health Ministry has held discussions and the Health Minister has in fact announced that we will begin booster shots, Insya-Allah, very soon. PPN focuses on both the economic and social sectors,” he said.

Source: BERNAMA News Agency

Nakawan Base Camp offers unique family holiday experience

KANGAR, Sept 19 — The Nakawan Base Camp at the Bukit Ayer Forest Eco Park near here is an ideal destination for a unique family holiday as it offers a refreshing natural landscapes.

Perlis Forestry Department director Awang Shaffie Awang Ahmadni said the campsite was equipped with basic facilities such as electricity supply and bathrooms.

“By paying as low as RM20 for a small site and RM25 for a large site, visitors can use the facilities available at the campsite. Parents will also have the opportunity to expose their children to relaxing outdoor activities.

“The park has 20 spots for camping, we also have a hall, campfire, parking lots and many other facilities,” he told Bernama recently.

The campsite is open daily and visitors are advised to make reservations first.

Meanwhile, Awang Shaffie said the department would introduce firefly-watching activity at Bukit Ayer Forest Eco Park soon.

Source: BERNAMA News Agency

Pulau Bidong remains top destination for history, nature enthusiasts

KUALA NERUS, Sept 19 — After being brought to a standstill by the COVID-19 pandemic for almost two years, Pulau Bidong is starting to ‘breathe’ again after the government allowed Terengganu to move on to Phase Three of the National Recovery Plan from last Friday.

Although not as popular as other resort islands in Terengganu, Pulau Bidong, once called ‘a second life’ island by Vietnam war refugees has remained to be the top choice especially for history and nature lovers.

Bidong Heritage Travel Sdn Bhd managing director Badrol Hisham Zaki said the beauty of its coral reefs, historical relics of Vietnamese refugees, the diversity of flora and fauna that are still ‘untouched’ and the existence of Malaysia’s first underwater gallery have made Pulau Bidong popular among environmentalists as well as snorkelling and scuba diving enthusiasts.

“Pulau Bidong is not for those who want to enjoy a luxurious vacation because it has no fancy restaurants or eateries and luxury facilities like on other islands.

“However, it has always been a dream holiday destination for tranquility and those who want to experience living like an islander,” he told reporters recently.

Badrol Hisham who is also a registered operator of one of the two campsites on the island said he has been receiving encouraging response from the people who want to know more about this historic island since the Terengganu tourism sector was allowed to operate on Sept 1.

In compliance with the standard operating procedure (SOP) set by the government, he said the number of tents is limited to 50 per cent of the usual capacity.

Apart from that, he said only fully-vaccinated individuals were allowed to travel to the island and they are required to comply with the SOP such as using hand sanitisers and wearing face masks.

Pulau Bidong was declared a Vietnamese Boat People settlement centre in August 1978 to November 1991. During that period, a total of 252,390 people took refuge on the island before moving to third countries such as the United States, Canada, Germany and Australia.

It was first opened to tourists in January 2017, but limited to day trips only. Those who want to spend the night need to get prior permission from the Terengganu State Museum Board.

Several tourists who expressed their excitement at the resumption of the tourism sector hoped that the state government would continue with the existing tourism concept in the island to ensure that its invaluable natural treasures remained preserved.

Nurul Ain Norazuan, 31, said Pulau Bidong is different from other resort islands because it has no permanent human settlements and is still free from any form of pollution.

“The beauty of its coral reefs which can be found near the campsite is already mesmerising,” said the private sector worker who was visiting Pulau Bidong with her colleagues.

For Mohd Rushdi Samsudin, 39, those visiting Pulau Bidong must always ensure that cleanliness is maintained continuously and abide by the rules set so that the island’s natural treasures can be enjoyed by future generations.

Meanwhile, state Tourism, Culture and Digital Technology Committee chairman Ariffin Deraman said a a mass gotong-royong programme would be held next week in Pulau Bidong to symbolise the reactivation of tourism activities on the island.

He said the state government would carry out repair works and upgrade public facilities or infrastructure on the island for the convenience of tourists.

“The cleanliness aspect will also be given priority because we do not want the island to be carpeted with garbage. Although Pulau Bidong is open to the public, we will limit the number of tourists because we want to keep it as an exclusive island to preserve its natural beauty and historical value,” he said.

Source: BERNAMA News Agency

Only 1.8 pct left to be vaccinated for adult population 80 pct herd immunity – Dr Adham

JOHOR BAHRU, Sept 19 — Only about 1.8 per cent of the adult population remains to be vaccinated against COVID-19 for Malaysia to achieve the 80 per cent herd immunity for adults, Science, Technology and Innovation Minister Datuk Seri Dr Adham Baba said.

He said as of yesterday, 78.2 per cent of the country’s adult population have been fully vaccinated.

“The focus is currently on all states for at least 60 percent of the adult population to be fully vaccinated by the end of September.

“This month, the vaccination rate was much higher in certain states as efforts are focused on states which still have low (vaccination) rates, namely Kelantan, Pahang, Kedah, Perak and Sabah,” he told reporters here today.

Earlier, Dr Adham visited the OKU Sentral drive-thru vaccination centre (PPV) at the Johor Bahru City Council Aquatic Centre in Arena Larking here today.

Accompanying the minister was OKU Sentral President Senator Datuk Ras Adiba Radzi.

Dr Adham said vaccination coverage in most states is on track, especially in Sarawak, Labuan and in the Klang Valley covering Selangor, Kuala Lumpur and Putrajaya.

However, he said that it did not mean that vaccination efforts were being slowed down, adding that instead, it was merely focused on certain states and areas, including groups inadvertently left out.

“The daily vaccination rate recorded yesterday was 232,559 doses, with the highest number of doses administered in Sabah, Johor and the Klang Valley,” he said.

On vaccinations involving Persons with Disabilities (PwD), Dr Adham said according to data from the COVID-19 Immunisation Task Force (CITF), a total of 517,447 out of 575,564 PwDs, or 89.9 per cent, had received at least one dose.

He said 401,425 of them have been fully vaccinated, covering 69.74 per cent of PwDs registered for the COVID-19 vaccine.

On the OKU Sentral drive-thru PPV at the Aquatic Centre, he said it would be open to the public on a ‘walk-in’ basis from tomorrow until Sept 30.

Source: BERNAMA News Agency