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

Vice President presents pandemic prevention gifts to An Giang

Vice President Vo Thi Anh Xuan on September 19 led a delegation to visit the Mekong Delta province of An Giang and present gifts worth close to 14 billion VND (612,000 USD) to support its fight against the COVID-19 pandemic.

Of the gifts, the Presidential Office and Xuan herself donated 5,000 rapid test kits and five charity houses, and the Vietnam Fatherland Front Central Committee presented 500 million VND. The Vietnam General Confederation of Labour offered local workers with welfare packages valued at 4 billion VND in total, while T&T Group granted 30,000 rapid test kits to An Giang.

At the reception ceremony, Chairman of the provincial People’s Committee Nguyen Thanh Binh briefed on the province’s COVID-19 situation.

Accordingly, from April 15 to 4pm on September 18, An Giang logged a total of 3,608 infections, including 1,077 detected in concentrated quarantine sites, 1,058 in locked-down areas, 1,298 in the community, and 84 imported cases.

There were 1,389 patients undergoing treatment, with the number of recoveries and deaths standing at 1,975 and 29, respectively.

Applying social distancing measures under the Prime Minister’ Directive 16 since July 15, the province is now carrying out the PM’s Directive15 along with some intensified measures.

To date, An Giang has received 161.8 billion VND worth of donations in both cash and kind for COVID-19 prevention and drought impact alleviation.

Binh took the occasion to express his gratitude for the attention of Party, State and Government leaders and the assistance of ministries, sectors, businesses and philanthropists toward the province’s fight against the pandemic.

The visit to An Giang was part of Xuan’s trip to encourage COVID-19 prevention and control activities in An Giang, Dong Thap, Tien Giang, Tay Ninh provinces and Can Tho city, presenting nearly 35 billion VND worth of donations in total.

Source: Vietnam News Agency

UNFPA associated with Vietnam’s achievements in productive health

The United Nations Population Fund (UNFPA) is extremely proud to have been associated with Vietnam’s spectacular achievements in sexual and reproductive health, said Naomi Kitahara, UNFPA Representative in Vietnam.

On the occasion of the 44th anniversary of Vietnam joining the United Nations (September 20), Kitahara granted an exclusive interviewed to the Vietnam News Agency on the cooperation between the UN organisation and Vietnamese partners over the past four decades as well as future development prospect.

Following is the text of the interview.

As the UNFPA Representative for Vietnam, will you share with us your evaluation of Vietnam, your partner, in cooperating and supporting UNFPA to achieve your mission in Vietnam?

I started my position as UNFPA Representative for Vietnam in September 2019, when the UNFPA Country Office was in the midst of implementing its 9th Country Programme of collaboration with the Vietnamese Government. But my experience with Vietnam can be traced back 20 years earlier, when I was covering the Vietnam desk at the UNFPA Headquarter in New York.

In that position, I had a chance to visit Vietnam to provide technical support for the Country Office, and now having returned to Vietnam, I have seen a lot of incredible changes in the country. Vietnam is now a middle-income country with very high development potential that can be tapped into, thanks to its very dynamic and hardworking people and the strong commitment of the Government to uplift the country onto the higher level of socio-economic progress.

UNFPA’s mission in Vietnam is to help the country achieve zero preventable maternal deaths, zero unmet need for family planning, and zero gender-based violence and other harmful practices, within the context of 2030 SDGs agenda. We are here to work closely with Government and key national stakeholders to improve people’s access to quality sexual and reproductive health services, collect and analyse high-quality population data, address gender equality and gender-based violence, promote youth development, and provide social protection for elderly.

The range of our partners is wide, including ministries, mass and civil society organisations, national media, the private sector, and other development partners in and outside the UN system.

We are very thankful to the excellent collaborations that we have enjoyed with all of our partners. And more recently, we have been successful not only to consolidate exiting partnerships but also to explore new partnerships, especially with private sector entities, to achieve common goals for vulnerable populations in Vietnam.

We are privileged to having such solid partnerships and collaboration, without which the delivery of our country programme would not have been as effective as we are seeing.

What are the highlights in the UNFPA projects/ programmes in Vietnam recently?

Having operated in Vietnam for more than 40 years, UNFPA is extremely proud to have been associated with Vietnam’s spectacular achievements in sexual and reproductive health. Maternal mortality has been reduced by 72 percent over the years, and Vietnam was one of the very few countries in the world which have managed to ensure this result. We are continuing with this effort, and introducing telehealth as part of the country’s digital transformation process, so as to ensure people’s access to quality sexual and reproductive health care.

Last year, together with the Ministry of Labour, Invalids and Social Affairs (MoLISA) and General Statistics Office (GSO), and with support from Australia’s Department of Foreign Affairs and Trade (DFAT), we launched the 2019 national survey on violence against women.

Vietnam is the only country in the world so far which managed to conduct such a survey with internationally recognised and credible methodologies for the second time. This allowed for a trend analysis. Through the survey, evidence was provided that still 2 in 3 women in Vietnam experience one or more forms of violence in their life time. In addition, more than 90 percent of them never seek any support services, which means that gender-based violence is hidden in Vietnamese society. And violence against women is costing Vietnam 1.81 percent of GDP, which is alarmingly high. The survey provided pointers for the country’s policy and decision-making, and we are now shifting our gears towards interventions to eliminate violence against women. Together with KOICA, the one stop service centre was established last year in Quang Ninh province for the first time in Vietnam, providing a comprehensive set of services based on victim-centered approach, and our hotline is receiving more than 1,000 calls for help every month.

Lastly, UNFPA was a privileged partner to conduct the 2019 Population and Housing Census. Given a large population size, this was a challenging endeavor in Vietnam, but we helped with the introduction of advanced IT technology to speed up data collection and minimise human errors, and within six months following the Census date, a report was already launched, which is an amazing outcome in the international literature of the Census. And Vietnam’s unique population characteristics emerged from the Census data.

First, Vietnam is experiencing rapid demographic change with nearly 70 percent of the population at working age (15-64), creating a special demographic window to accelerate significant socio-economic growth if appropriate investment is made.

As such, we supported the Government’s effort to get the revised Youth Law approved, as part of promoting the participation of adolescents and youth in the country’s development process and ensuring comprehensive sexuality education also using digital technology. At the same time, the country is facing the challenges of fast population ageing due to fertility decline, and we have supported MoLISA to strengthen social protection for older people, while promoting the development of the private sector for care and services for the elderly population.

Given the fact that Vietnam faced humanitarian challenges last year with floods and landslides, in addition to COVID-19, UNFPA provided emergency support to Vietnam in the areas of ensuring care for pregnant women as well as for women at risk of domestic violence. UNFPA is leading the coordination effort of national and international partners in the areas of gender-based violence in humanitarian settings What will be your recommendations to Vietnam to further promote the efficiency of Vietnam-UNFPA cooperative relations in the coming years, especially in supporting Vietnam to achieve its 2030 sustainable development agenda?

Vietnam, together with countries around the world, is right on the Decade of Action for achieving the 2030 Agenda for Sustainable Development. Vietnam was quick in developing its National Plan of Action to implement the 2030 Agenda, showing unwavering commitments and is steadily moving forward.

As a middle income country, it is critical to look at inequality and disparity issues, which have also been accentuated by COVID-19. For instance, maternal mortality as a national average was reduced significantly as above, but maternal mortality in remote locations, especially among ethnic minorities, is still very high. Likewise, people with disability tend not to have full access to quality sexual and reproductive health care, and also they are often subjected to domestic violence.

Women in Vietnam including elderly women are particularly susceptible to violence, and inclusiveness is critical to ensure social assistance and social protection for the ageing populations. With COVID-19, domestic and international migrant workers are in particular hardships, and special consideration is required to support them, also through income-generation, professional counselling, life skills and comprehensive sexuality education.

As UNFPA, we provide advice to countries in the world in line with the principles of the International Conference on Population and Development. Our mandate as given by the UN member states is to support the country’s effort to ensure that individuals and couples are able to decide freely and responsibly the number, spacing and timing of children.

In demographic analysis, it is clear that population aging occurs not just because mortality declined, and people live longer, but because fertility declined. Also, the sex ratio at birth in Vietnam is the third highest in Asia, following China and India, mostly a result of prenatal sex selection, as fertility limitation and decline exist in the country, coupled with a practice of son preference and the availability of reproductive technology. The ICPD principles are there to promote sexual and reproductive health and rights for all, regardless of age, ethnicity, or gender.

I am confident that the partnership between UNFPA and Vietnam over the four decades will continue to thrive. In any situations, UNFPA reaffirm our continuing commitment to “delivering Vietnam where every pregnancy is wanted, every childbirth is safe and every young person’s potential is fulfilled”, and making sure that “no one is left behind”.

Source: Vietnam News Agency

More religious volunteers support COVID-19 fight in HCM City

The Vietnam Fatherland Front Committee of Ho Chi Minh City on September 18 held a fare-well ceremony, the sixth of its kind, for religious dignitaries, monks, nuns and followers who are voluntarily joining front-liners in the fight against COVID-19 in the city.

This time, four Buddhist followers and 19 Catholic monks and nuns will support medical staff at Trung Vuong COVID-19 treatment hospital and a temporary COVID-19 treatment hospital in Tan Binh district.

Most Venerable Thich Nhat Tu, permanent deputy head of the Vietnam Buddhist Academy in Ho Chi Minh City and head of the Buddhist volunteers coordinating group, said more eligible Buddhist volunteers will also join the effort in the near future,

Since July 22, 567 religious dignitaries, monks, nuns and followers have voluntarily served at intensive care hospitals No. 10, 12, 16, and other temporary COVID-19 treatment hospitals in the city.

Source: Vietnam News Agency

Female migrant workers in Hanoi receive gifts

As many as 480 female migrant workers living in difficult circumstances received gifts worth 500,000 VND each during a programme held in Hanoi on September 18.

They now temporarily reside in 11 wards in the districts of Hoan Kiem, Ba Dinh and Hoang Mai and Hai Ba Trung.

The activity was co-organised by the Hanoi Women’s Union, the Light Community Health Development Institute and Oxfam in Vietnam.

From April 27 to September 15, the Hanoi Women’s Union handed over 7,300 gifts valued at more than 2.2 billion VND to female vulnerable workers.

The same day, the union also held a webinar in response to the 2021 campaign “Make the world cleaner”.

Participants at the event shared creative models regarding waste treatment and recycling in households, as well as ways to raise public awareness of environmental protection.

Source: Vietnam News Agency

Vietnamese consumers’ demand for shopping groceries online soars amid COVID-19

The ranking of e-commerce businesses in Vietnam’s Map of E-commerce changed in the second quarter of 2021, with the volume of searches on Google for essential online stores skyrocketing, according to an iPrice Group study.

The study showed that online grocery was the only category that has maintained steady and consistent growth since the beginning of the pandemic. This also partly explains the strong increase in demand for online stores selling essential products during the months of social distancing.

Google searches related to online grocery stores increased by 223 percent in Q2, 2021. The number of searches increased 11 times in July compared to May and 3.6 times compared to June when the social distancing order under the Directive 16 was implemented in some provinces and cities.

People pay more attention to fresh food, beverages, pre-packaged items, fruits and veggies as the searches of these items surge by 99 percent, 51 percent, 30 percent, and 11 percent, respectively, compared to the previous quarter. Thus, social distancing could be one of the factors driving the surge in demand for online supermarkets. With the growing necessity of purchasing essentials online, retailers are more likely to adapt to the digital platform.

In addition, iPrice discovered that grocery items in Vietnam is among the cheapest in the ASEAN region after comparing the prices of popular offline grocery items in Southeast Asian countries from Numbeo, one of the world’s largest user-contributed databases. According to Numbeo users, the cost of these items in Vietnam is only about 1.2 million VND (54 USD) According to a study conducted by iPrice Group and SimilarWeb, the top 50 shopping sites’ web visits in Vietnam’s Map of E-commerce in the first six months reached more than 1.3 billion, the highest ever and up by 10 percent from the first quarter.

Shopee Vietnam obtained 73 million visits in Q2, which increased by 9.2 million from Q1. Meanwhile, Lazada Vietnam’s average website traffic increased by 14 percent compared to the first three months of the year, reaching 20.4 million visits.

The average visits to the websites of two domestic e-commerce platforms Tiki and Sendo slightly decreased, reaching 17.2 and 7.9 million respectively.

Source: Vietnam News Agency

Experts disagree with coal roadmap in Power Development Plan

The Vietnam Sustainable Energy Alliance (VSEA) raised concerns over the draft of the National Power Development Plan for the 2021 – 2030 period (PDP VIII).

As the draft still includes the use of coal power for 10 years and continues to extend its development to the 2045, VSEA’s representative said: “The option contains many risks and is not feasible.”

Commenting on the draft, the alliance said it was a “setback”, adding about 3,000 MW of coal power and reducing about 8,000 MW of renewable electricity by 2030.

VSEA’s recommendation clearly stated that the concentration of traditional power sources for the current grid was only to ensure the stability of the current power system but would lose the opportunity to catch up and integrate globally, creating impetus for the country’s advanced energy economy and green development.

VSEA said that though draft PDP VIII aimed for the development of power sources in reducing coal power and promoting the exploitation and use of renewable energy sources, the structure and expected development of power sources did not reflect the same idea.

Over the next ten years, there should be no more new renewable energy sources approved, according to the draft.

Though the VSEA recognised the current grid could not yet meet the development of renewable energy sources in Vietnam and managers must reduce capacity in many places, it said suppressing renewable energy was not the optimal solution.

The alliance said with rapid improvements in technology, solar power in Vietnam was able to compete with the cost of coal power production this year, while wind power was forecast to compete with new coal power by 2025.

Regarding concerns about solar power which generates electricity for six hours during the day and causes local overloading of the grid, the alliance said the matter will be overcome with solutions such as selling electricity on-site to factories, applying smart technology in power grid management and administration, upgrading the power grid and letting the private sector take part in public bidding to choose solar power investors.

While the draft PDP VIII increases coal-fired power to about 22,000 MW by 2030 and another 8,000 MW by 2045, VSEA said: “We believe that the feasibility of these projects needs to be re-evaluated based on actual access to capital, the development of these projects in the past and recent major changes in the industry as major financial sources for coal power in Vietnam have all been closed.”

VSEA added there were fluctuations of coal prices. The coal price in the first six months of 2020 was 98.8 USD per tonne but now it increased to 159.7 USD per tonne.

The alliance said: “With coal price increasing to 150-160 USD per tonne at present, electricity price ranged from 10-11 cent/kWh, more expensive than offshore wind power according to FIT at 9.8 US cent/kWh.”

In conclusion, the alliance said PDP VIII should stick to the path of renewable energy development, avoid being hindered by recent renewable energy obstacles, adding instead of cutting clean electricity and avoiding dangerous coal power sources.

The alliance suggested the incentive mechanism has helped the solar power market in Vietnam grow from zero to about 17,000MW in two years, but in the current draft, the solar power industry in Vietnam will be strangled, causing a series of Vietnamese private enterprises in this field to close.

VSEA said, instead the Power Master Plan VIII should introduce solutions to encourage private participation in the grid and immediately consider researching and applying non-storage battery solutions.

On September 16, a seminar on the matter was held online. Nguy Nhu Khanh, Director of GreenID, also suggested reconsidering coal power projects with low feasibility and including solutions to encourage the private sector to invest in the power grid.

With the same view, Assoc. Prof. Dr. Le Anh Tuan, Deputy Director of the Institute of Climate Change Research, Can Tho University, also said the draft Power Plan VIII could “tighten” the green transition roadmap of Vietnam.

He said that Vietnam was trying to reduce greenhouse gas emissions, but the draft would increase coal power capacity and cut green and renewable energy, adding this will cause many impacts and consequences.

Tuan said: “Recently, the European Parliament voted to support the idea of imposing an emission tax on imported goods as the first step in creating a new technical standard that countries exporting goods to Europe, including Vietnam, adding the country must pay attention to or the local goods would be priced too high by a partner for emissions from the use of unfriendly energy.”

Mai Van Trung, Vice President of Nami Energy, said the majority of exporters now face the challenge of using clean electricity in the total electricity usage capacity for export products.

In 2022, Vietnam’s exports will be subject to a certain ceiling, which means that big brands will impose a proportion of renewable energy in export products. Therefore, in Power Plan VIII, priority should be given to the development of renewable and clean energy.

Speaking at the discussion, National Assembly deputy Nguyen Quang Huan, Chairman of the Board of Directors of Halcom Vietnam Joint Stock Company, said even though it was not possible to immediately cut coal power and there must be a gradual reduction plan in the near future, they should find ways to solve the problem as the country still imported coal which was not stable in the long run.

Source: Vietnam News Agency

Quang Ninh grants investment registration certificate to silicon wafer project

Authorities in the northern province of Quang Ninh on September 19 to present an investment registration certificate to a 365.6 million USD project of Jinko Solar Vietnam Co. Ltd., an affiliate of the Jinko Solar Holding Co. Ltd.

Construction of the project will start in late September and it will produce its first silicon wafers in December.

Speaking at the handover ceremony, Chairman of the provincial People’s Committee Nguyen Tuong Van said it is the second project by Jinko Solar in Song Khoai industrial park in Quang Yen township over the past six months.

Covering an area of 20.1 ha, the project is the highest worth in the province with an aim to manufacture, install and sell single-crystal silicon ingots and wafers, as well as study science and develop technologies.

It has a designed capacity of nearly 1.43 million silicon wafers each year. Once operatioal, the project is expected to attract 2,188 workers, including 1,946 domestic workers and 242 foreign experts and technicians.

Van asked the management board of Quang Ninh IPs, authorities of Quang Yen township, departments and agencies concerned to offer all possible support to the investor in line with the law.

Quang Ninh is expected to licence new projects and adjust capital in existing projects at a total value of some 1.2 billion USD by the year-end, more than doubling the figure in 2020. In the first nine months of this year, the province drew 1.067 billion USD in new and existing projects, compared to 398 million USD in the same period last year.

Source: Vietnam News Agency