Day: August 29, 2021

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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

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Lajim Ukin contributed significantly in shaping Bersatu direction – Muhyiddin

KUALA LUMPUR, The late Datuk Seri Lajim Ukin was an experienced politician who contributed significantly in shaping the direction of Parti Pribumi Bersatu Malaysia (Bersatu), said party president, Tan Sri Muhyiddin Yassin.

Muhyiddin, in conveying his condolences to the family of Lajim, who died early today, said that the passing of Lajim, 66, who was also a member of the Bersatu Supreme Council, was a great loss for him.

“Lajim was a friend, whom I have known for a long time and we served together in the government before. Representing the party and the Perikatan Nasional, I express my deepest appreciation and thanks for his services.

“Let us recite Al-Fatihah (for the deceased). May his good deeds be rewarded by Allah and his soul be placed among the pious,” said the former Prime Minister in a post on his Facebook today.

Lajim, Amanah Ikhtiar Malaysia (AIM) executive chairman, who was also a former deputy chief minister of Sabah, died of COVID-19 at KPJ Hospital, Kota Kinabalu, Sabah at 6.23 this morning, according to his wife, Datin Seri Normilah Sion.

A former Beaufort Member of Parliament and Klias assemblyman, Lajim had also served as federal deputy minister in the transport, and housing and local government portfolios.

Meanwhile, the sixth Prime Minister Datuk Seri Najib Tun Razak, through his social media account, also conveyed his condolences to Lajim’s family members and prayed that Allah would forgive his sins and place him among the faithful.

Source: BERNAMA News Agency

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Heed Sultan Nazrin’s decree in fight against COVID – Perak PAS

BAGAN SERAI, The Sultan of Perak Sultan Nazrin Shah’s decree during the opening of the Perak State Assembly, in which he called for high-level political maturity and to avoid clashing with one another during the COVID-19 pandemic, should be heeded by all parties, including the opposition.

Perak PAS secretary Mohd Akmal Kamarudin said that in facing the pandemic, all parties should work together to curb the spread of the virus and not make allegations that could trigger misunderstandings.

“Any good proposals for the government are very welcomed in the interest of the people of Perak, especially in efforts to combat COVID-19,” Mohd Akmal, who is also the state Health, Science, Environment and Green Technology Committee chairman, told Bernama.

During the state assembly sitting at Bangunan Perak Darul Ridzuan here on Thursday (Aug 26), Sultan Nazrin said the government should pave the way towards minimising political disputes for the benefit of the state and the people.

Source: BERNAMA News Agency

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MOTAC to focus on upgrading ecotourism infrastructure – Nancy

KUALA LUMPUR, The Ministry of Tourism, Arts and Culture (MOTAC) will focus on efforts to upgrade the infrastructure in ecotourism areas, in preparation to welcome tourists once tourism activities are allowed, said Datuk Seri Nancy Shukri.

“So, when tourists come to the place, the area has been upgraded,” the Batang Sadong MP said in an online interview with Bernama TV tonight.

Nancy is scheduled to take her oath of office as the Tourism, Arts and Culture Minister tomorrow.

On the return of many familiar faces in the new Cabinet line-up, Nancy said it was a strategy to ensure that all of them could focus on their respective tasks to achieve the set results within 100 days.

She was also optimistic that Cabinet members would be able to achieve the 100-day target as set by Prime Minister Datuk Seri Ismail Sabri Yaakob, as a majority of them had the experience of working during the COVID-19 pandemic period.

Commenting on the appointment of 16 ministers and deputy ministers from Sabah and Sarawak, which some parties claimed as insufficient based on the Malaysia Agreement 1963 (MA63), Nancy said she personally viewed the matter as an encouraging situation for leaders from both states to contribute to the country.

“There are many things (regarding MA63) that need to be discussed together and the negotiation should be continued from time to time. That is why the Special Council on MA63 is important,” she said.

Asked about the suggestion to allocate a deputy prime minister post to either Sabah or Sarawak, Nancy said it would be better to take some time to hold a negotiation with the two states that have contributed a lot to the country’s economy.

Source: BERNAMA News Agency

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Public can view EIA Report on KXP, Kedah Aerotropolis Projects

ALOR SETAR, The public can view the Environmental Impact Assessment (EIA) report on the Kulim International Airport (KXP) and Kedah Aerotropolis projects from Aug 16 to Sept 14.

Kedah Menteri Besar Muhammad Sanusi Md Nor said the report had been submitted to the Putrajaya Department of Environment (DOE) for evaluation.

He said the report could be viewed for comments and views on the projects from the public on the DOE and the Sungai Petani Kedah Municipal Council (MPSPk) websites.

“In addition, the EIA report can also be physically checked at Putrajaya DOE, Kedah DOE and MPSPk,” he said in a statement tonight.

Muhammad Sanusi said the report for the project was prepared based on the acts and regulations set by the technical department and supported by the engineering strategic plan.

Muhammad Sanusi was commenting on a statement by the Penang Water Supply Corporation (PBAPP) on Aug 23, which among others mentioned that the proposed KXP project should not jeopardise water supply in Penang.

He said the whole aspect of the environment was carefully studied and various scientific methodologies were used to ensure that all the impacts on the environment were taken into account in the study.

“Based on the environmental impacts that have been identified, mitigation measures have been proposed based on Best Management Practices (BMPs) available in the current industrial sector so that river water and the environment are not affected and the status quo could be maintained,” he said.

He said mitigation measures had been recommended in the report to ensure that the project mover or the contractor did not cause pollution to the nearby river.

Apart from that, he said the water quality of Sungai Muda would not be affected as ponds and silt fences would be built along the bordering area.

“The closest distance between the airport development zone and Sungai Muda is 550 metres compared to the guideline where the minimum buffer zone required is only 50 metres from the river bank,” he said.

Source: BERNAMA News Agency

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Over 235,000 eligible recipients in Pahang have yet to register for vaccination

KUANTAN, More than 235,000 or 20 per cent of Pahang residents who are eligible to receive their COVID-19 vaccination have yet to register through the MySejahtera application.

Pahang Health director Datuk Dr Nor Azimi Yunus has advised this group of people to register on the app immediately to enable herd immunity to be achieved.

She said getting vaccinated is part of the efforts to control the COVID-19 infection, adding that as of today, more than 50 per cent of the adult population in the state have received the two-dose vaccination.

“Today, Pahang reported a total of 839 new cases. This is quite high. However, if we look at the weekly cumulative trend and a weekly average of daily cases, we find them showing a decline.

“It is the first declining trend seen in nine weeks and it happened in line with the increase in vaccinations in Pahang,” she said through a post on her Facebook page.

Pahang aims to inoculate 80 per cent of its population by the end of October, before the start of the monsoon season.

Source: BERNAMA News Agency

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Singapore allows hijab for Muslim nurses in public healthcare

SINGAPORE, Singapore Prime Minister Lee Hsien Loong today announced that starting in November, Muslim nurses in the public healthcare sector in the republic will be allowed to wear a ‘tudung’ (hijab) with their uniforms, if they wish to.

“I hope this decision will be accepted by all parties with the right spirit, in an effort to strengthen our shared commitment to Singapore’s multiracial and multi-religious community,” Lee partly said while delivering his National Day Rally (NDR) English Speech 2021 here today.

“We are making a careful adjustment to keep our racial and religious harmony in good order. This approach has worked well for us for many years.

“And we should celebrate what it has achieved: a truly multiracial, multi-religious nation, where many heart-warming interactions happen every single day,” said Lee.

In 2014, Lee said when there was intense discussion on the ‘tudung’, where he had a closed-door meeting with Muslim leaders.

“We spoke candidly, heart to heart. They explained to me why the ‘tudung’ was important to the community, and what they hoped the Government would allow.

“I told them I understood how strongly they felt, but I also explained the Government’s perspective, and the reasons behind our policies,” said Lee.

Lee noted that the status quo for the Singapore Armed Forces (SAF), Home Team and other uniformed services must be maintained.

“They are impartial and secular arms of the State. They wield armed force, and enforce the laws of Singapore. They must always be seen to be doing so without fear or favour.

“Therefore, everyone wears the same uniform,” he said.

For the nurses in hospitals, Lee said “here, the opposing considerations are more finely balanced.”

“On the one hand, the community’s desires. On the other hand, the government’s concerns – both national and specific.

The prime minister said he told the Muslim leaders in 2014 that government policy in the healthcare sector was not set in stone.

“We would monitor the situation. If and when we changed our position, we would first make sure that everyone – Muslims and non-Muslims – understood and accepted the change.

Since then, Lee said the government has been watching the situation closely.

“We observed that by and large, interactions between the races remain comfortable. Non-Muslims have become more used to seeing Muslim women wear the ‘tudung’.

Furthermore, Lee said younger Singaporeans are more accepting of racial and religious differences.

Source: BERNAMA News Agency