Junshi Biosciences Announces Lancet Infectious Diseases Publication of Results from the 2nd Phase 3 Study of VV116 for Treating COVID-19

SHANGHAI, China, Nov. 22, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced a new publication in the Lancet Infectious Diseases. The paper presents final analysis results from a multicenter, double-blind, phase 3, randomized controlled study (NCT05582629) evaluating the efficacy and safety of VV116 (mindeudesivir hydrobromide tablets, product code: VV116/JT001) in patients with mild-to-moderate COVID-19. This study demonstrated that VV116 significantly reduced the time to sustained clinical symptom resolution compared to placebo, with no observed safety concerns.

During the study, academician Lanjuan LI, Director of the State Key Laboratory for Diagnosis & Treatment of Infectious Diseases (Zhejiang University), served as the primary investigator and corresponding author. Co-first authors include Prof. Xiaohong FAN and Prof. Yun Ling from Shanghai Public Health Clinical Center, Prof. Xiahong DAI, Prof. Lihua WU and Prof. Lingling TANG from Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan International Medical College.

Efficacy analyses were conducted on 1296 enrolled adult patients (646 in the VV116 group and 650 in the placebo group), with a median age of 35.0 years, of whom about 43.1% carried high-risk factors for progression to severe COVID-19. According to the SARS-CoV-2 genetic variation evaluated at enrollment, BA.5.2.48 and BF.7.14 were the leading subvariants.

At the interim analysis, VV116 was superior to placebo in reducing the time to sustained clinical symptom resolution among 1229 patients (hazard ratio [HR] 1.21, 95% CI 1.04–1.40; p=0.0023). In the final analysis of the study, a substantial reduction in the time to sustained clinical symptom resolution was observed with VV116 compared to placebo (median: 10.9 vs.12.9 days; HR=1.17; 95% CI: 1.04 – 1.33; p=0.0009), consistent with the interim analysis. For the elderly patient subgroup (≥60 years old), the time to sustained clinical symptom resolution was also shorter in the VV116 group compared to the placebo group, with an HR of 1.22 (95% CI: 0.74-2.01), which is consistent with the overall population.

Previously, an active comparator-controlled phase 3 study of VV116 (NCT05341609) published in the New England Journal of Medicine showed that VV116 was non-inferior to nirmatrelvir/ritonavir in reducing the time to sustained clinical symptom resolution among patients with mild-to-moderate COVID-19 at risk for progression (median time: 7 vs. 7 days; HR=1.06; 95% CI: 0.91, 1.22).

By day 5 of the study treatment, compared to the placebo group, a substantial increase in the SARS-CoV-2 Ct value, as well as a more rapid decrease in the viral load, were observed in the VV116 group.

Notably, the efficacy of a 5-day treatment with VV116, including the significant shortening of time to sustained clinical symptom resolution and clinical symptom alleviation in patients, were observed regardless of the presence of high-risk factors for progression to severe COVID-19 or SARS-CoV-2 vaccination status.

VV116 was well-tolerated in patients with mild-to-moderate COVID-19. Among 1347 patients in the safety data set (674 patients in the VV116 group and 673 patients in the placebo group), the incidence of treatment-emergent adverse events (TEAEs) of any grade was similar between groups (35.9% vs. 42.1%). The incidence of treatment-releated adverse events (TRAEs) assessed by the investigator was 17.4% in the VV116 group and 23.2% in the placebo group. Most of the TEAEs were grade 1 or 2. Only 1 patientin the placebo group, progressed to severe COVID-19, and no deaths occurred.

“As of today, more than 3000 patients worldwide are actively participating in our clinical trials for VV116, including several domestic and international phase 3 trials,” said Dr. Jianjun ZOU, Global Research and Development President at Junshi Biosciences, “This extensive participation provides robust data, establishing VV116 as the most evidence-based, domestically-made oral anti-viral medication for COVID-19. Within a single year, VV116 was featured twice in leading international medical journals, which reflected the global recognition of the VV116 R&D team’s research capabilities and R&D quality. We take great pride in these achievements. The rise of innovative domestic COVID-19 treatments stands as a testament to the Chinese pharmaceutical industry’s advancement towards innovation and serves as a commitment to ensuring health and safety for all. Along with our fellow collaborators, Junshi Biosciences will continue onward, propelling further development and benefiting more patients!”

About Mindeudesivir Hydrobromide Tablets (VV116/JT001)

VV116 is an oral nucleoside analog drug that can inhibit the replication of SARS-CoV-2. In preclinical pharmacodynamic studies, VV116 exerted an antiviral effect on the original strain of the novel coronavirus and its known variants in vitro; in the mice model, a low dose of VV116 reduced the virus titers below the detection limit, significantly lowered the risk of lung injury and displayed a strong antiviral effect. Preclinical pharmacokinetics and other research results also show that VV116 has high oral bioavailability. After oral administration, VV116 is rapidly metabolized into parent nucleoside and widely distributed throughout the body.

VV116 was jointly developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences; the Wuhan Institute of Virology, Chinese Academy of Sciences; Xinjiang Technical Institute of Physics and Chemistry, Chinese Academy of Sciences; Central Asian Center of Drug Discovery and Development Chinese Academy of Sciences / China-Uzbekistan Medicine Technical Park (the Joint Laboratory of the Ministry of Science and Technology under the “The Belt and Road Initiative”); Lingang Laboratory; Vigonvita Life Sciences Co., Ltd. (“Vigonvita”); and Junshi Biosciences.

During the pandemic, several multi-center trials were conducted for VV116 in China and abroad. One phase 3 study in patients with mild to moderate COVID-19 at high risk of progression to severe COVID-19 (NCT05341609) published results in the New England Journal of Medicine, and another phase 3 study (NCT05582629) conducted among mild to moderate COVID-19 patients with or without high risk of progression to severe COVID-19 published results in the Lancet Infectious Diseases.

In December 2021, VV116 was approved in Uzbekistan for the treatment of patients diagnosed with moderate to severe COVID-19.

In January 2023, VV116 was approved for marketing in China for the treatment of adult patients with mild to moderate COVID-19.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) 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 over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, first China’s homegrown and self-developed anti-PD-1 monoclonal antibody approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab (JS016), MINDEWEI® (VV116/JT001), and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (California and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
+ 86 021-6105 8800

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Junshi Biosciences
Zhi Li
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Vietnamese, Lao localities tighten cooperation

Dan Hoa commune in Quang Binh province’s Minh Hoa district on November 22 was twinned with Langkhang hamlet cluster in Boualapha district of Laos’s Khammouane province.

This move is hoped to contribute to strengthening special friendship and solidarity between people in border areas.

Accordingly, the two sides are responsible for disseminating and encouraging locals to participate in protecting the status quo of the borderline and border makers; and not committing acts that relocate, destroy or damage border markers, border identification signs and public works, change the borderline or the natural flow of border rivers and streams.

Each party must promptly inform the other when dangerous epidemics occur, and create conditions for and help in emergency care, medical examination and treatment, prevention, support each other in economic development.

Vice Chairman of the Quang Binh People’s Committee Ho An Phong requested authorities of Minh Hoa and Boualapha districts and the twinned localities to continue
encouraging locals to strictly follow legal documents on border management and protection, and join hands in safeguarding border areas and makers, thus contributing to building a borderline of peace, friendship, cooperation and development./.

Source: Vietnam News Agency

HEIs join DepEd Bicol’s learning recovery, remediation program

The Department of Education in Bicol (DepEd-5) has partnered with different higher education institutions (HEIs) and teachers’ education institutions in the region to implement learning recovery programs and remediation activities for basic learners.

This, after more than 60 HEIs and partner non-governmental organizations (NGOs) attended the stakeholder’s convergence and ceremonial signing of a memorandum of agreement (MOA) on Thursday at the University of Santo Tomas (UST) in Rawis here.

In his message, DepEd-5 Regional Director Gilbert Sadsad said the initiative adopts a multistakeholder approach to enhance literacy and numeracy skills among learners from kinder to secondary level.

‘Dubbed as 6Bs: Bawat Batang Bicolano Bihasang Bumasa at Bumilang (each Bicolano child proficient in reading and writing), the initiative is designed to strengthen the coordination and collaboration between schools and communities. It will facilitate the sharing of resources and capacities to uplift the standards in literacy
and numeracy among students,” he said.

Sadsad said the involvement of HEIs and TEIs is a big help in recovering the learning losses incurred by learners during the pandemic.

“We knock on your hearts to help us in solving this problem, to make every Bicolano child a reader and numerate. We can only achieve this if we will help each other,” he said.

in a separate interview, DepEd-5 project development officer Ma. Cristina Barosa said Education students from the different tertiary institutions will serve as volunteer tutors and teaching assistants to all struggling readers.

“We are in the process of identifying our hotspots, the municipalities or provinces where we can find schools with a high number of struggling readers, doon po tayo tutok sa mga bata na nangangailangn ng tulong (we will focus on students who needs help) through our student volunteer teachers,” she said.

At least 60 TEIs and six non-government organizations will work together with the DepEd to make the approach successful.

Barosa said th
e initiative, which is expected to significantly improve the reading proficiency of every learner, will start by January next year.

Source: Philippines News Agency

DOST boosts C. Luzon’s disaster response efforts

The Department of Science and Technology-Central Luzon (DOST-3) will deploy a mobile water treatment system (MWTS) in Tarlac province before the end of this year as part of its continuing efforts to help boost the local government units’ (LGUs) disaster preparedness capabilities.

DOST-3 Regional Director Julius Caesar Sicat said Thursday the deployment of the MWTS is expected to enhance the disaster response capabilities of LGUs in the region by providing a portable water purification system near the evacuation centers in the communities.

‘The MWTS will boost the region’s response capabilities by addressing the concern of lack of safe drinking water during disasters. With its portability, it can move easily to any disaster-affected areas,’ Sicat said in a radio interview.

Funded by the DOST’s Community Empowerment through Science and Technology (CEST) program and developed by Summa Waters Inc., the MWTS has its own generator and has the capacity to produce 500 liters of potable water per hour through ultr
afiltration and reverse osmosis processes.

‘With the MWTS, floodwaters can be transformed into clean water in a matter of hours, and it would keep people safe in the evacuation centers and prevent the spread of diseases like diarrhea,’ he said.

To ensure the efficiency of the MWTS, the DOST official said training of technical personnel who will operate the system will be conducted.

The Office of the Civil Defense-Central Luzon and the provinces of Aurora and Bulacan were the first recipients of the MWTS in the region.

Source: Philippines News Agency

DepEd’s ‘A Million Learners Campaign’ benefits 13 Cabadbaran schools

The ‘PAGBABAGO: A Million Learners Campaign’ of the Department of Education (DepEd) and the Office of Vice President Sara Duterte have reached out to 13 elementary schools in far-flung barangays in Cabadbaran City, Agusan del Norte.

More than 615 elementary learners from the recipient elementary schools received bags and other school supplements during the one-day distribution on Wednesday, in partnership with the Army’s 29th Infantry Battalion (29IB).

‘The support is the contribution of the 29IB to the education sector and to the noble cause of Vice President Sara Duterte, who also serves as DepEd Secretary,’ said 1st Lt. Jade Bryce Bune, civil-military operations officer of the 29IB, in an interview on Thursday.

Bune said the 29IB wants to ensure, with the help of DepEd and the Office of the Vice President, that students in remote villages are provided with the necessary tools to encourage them to strive more in their studies.

In a separate statement on Thursday, Lt. Col. Cresencio Gargar, commander of
29IB, thanked Duterte for the opportunity given to the unit to contribute to the campaign of the DepEd.

‘The access to school supplies and resources will allow the students to fully participate in school activities and lead to the enhancement of the quality of education in the remote areas in Cabadbaran City,’ Gargar said.

He said the DepEd initiative exemplified the strong partnership between the military and civil leadership in fostering social progress and national development.

Source: Philippines News Agency

Power rates up in Negros Occidental

An increase in the price of the Wholesale Electric Spot Market (WESM), the venue for trading electricity in the country, drove residential power rates up in all three distribution utilities in Negros Occidental for November.

Power consumers in the province are served by the Northern Negros Electric Cooperative (Noneco), Central Negros Electric Cooperative (Ceneco), and Negros Occidental Electric Cooperative (Noceco).

In an advisory on Thursday, the Noneco management said this month, the power rate is pegged at PHP13.21 per kilowatt (kWh), higher by PHP1.02 compared to PHP12.18 in October.

The increase has been attributed to the upward adjustment in the WESM market price from PHP6.60 per kWh to PHP7.83.

However, distribution, supply, and metering charges have remained at PHP1.61 per kWh.

Noneco’s coverage area includes the localities from EB Magalona town to San Carlos City.

Ceneco announced a higher rate of PHP11.74 per kWh for November, from the previous month’s PHP11.02, or an increase of PHP0.72 mai
nly due to added generation charges, after an increase in the WESM price.

This year, the decreases in electricity rates have been recorded for eight months while the increase came only in May and November, according to the Ceneco management.

Ceneco serves consumers in the cities of Bacolod, Talisay, Silay, and Bago, as well as the municipalities of Murcia and Don Salvador Benedicto.

Down south, Noceco reported a power rate of PHP12.62 this month, or an increase of about PHP0.61 from the October rate of more than PHP12.

The main factor in the higher generation charge is the increase in the price of WESM as well, its management said.

Noceco consumers are those residing from Pulupandan town to Hinoba-an town in the southern part of the province.

Source: Philippines News Agency