Junshi Biosciences Receives Orphan Medicinal Product Designation from the European Committee for Toripalimab in Treatment of Nasopharyngeal Carcinoma

–6th Orphan Drug Designation granted to toripalimab in the US and EU

SHANGHAI, China, July 21, 2022 (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 today that toripalimab, a PD-1 inhibitor independently developed by Junshi Biosciences is designated as an orphan medicinal product by the European Commission (“EC”) for the treatment of nasopharyngeal carcinoma (“NPC”), following the favorable opinion of the European Medicines Agency (“EMA”). As of now, toripalimab has been granted a total of 6 Orphan Drug Designations (“ODD”) by the regulatory agencies of the European Union and the United States for the treatment of mucosal melanoma, NPC, soft tissue sarcoma, esophageal cancer, and small cell lung cancer (“SCLC”).

“We are encouraged by the ODD granted by the European Committee for toripalimab for the treatment of NPC, especially after being granted the Breakthrough Therapy Designations and ODD by the FDA,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “NPC is an aggressive tumor with higher incidence in Asia, thus the development of novel therapies for NPC has been slower in Europe and America. While emerging immune-oncology drugs have shown clinical efficacy in many types of tumors, none are approved for the treatment of NPC in Europe or the United States. Guided by our strategy of ‘in China, for Global,’ Junshi Biosciences spearheaded the incorporation of immunotherapy into the treatment of patients with advanced NPC in China. Now, we are eager for this innovative therapy to be available to provide benefit to patients in Europe, America, and the rest of the world in the near future!”

According to the EC, orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union (“EU”). The EU Regulation on orphan medicinal products establishes a centralised procedure for the designation of orphan medicinal products and puts in place incentives for their research, development and marketing.

After receiving the designation, Junshi Biosciences will benefit from a number of incentives, including but not limited to: (1) protocol assistance (the EMA provides a form of scientific advice specifically for designated orphan medicines); (2) access to the centralized authorization procedure (companies are allowed to make a single applications for marketing authorization or a conditional approval to the EMA, resulting in a single opinion and a single decision from the EC, valid in all EU Member States); (3) ten years of protection from market competition once approved; (4) fee reduction for regulatory activities (including reduced fees for protocol assistance, marketing-authorization applications, inspections before authorization, application for changes to marketing authorizations made after approval, and reduced annual fees).

In the field of NPC, Junshi Biosciences has completed two pivotal clinical studies—JUPITER-02, a randomized, double blind, placebo-controlled, international multi-center Phase III clinical study, as well as POLARIS-02, a multi-center, open-label, Phase II clinical study. These studies examine first through later lines therapies in the treatment of recurrent/metastatic NPC. The JUPITER-02 results were first presented in the plenary session of the American Society of Clinical Oncology (“ASCO”) annual meeting (#LBA2) in June 2021 and subsequently published in detail as the cover article of the September 2021 issue of Nature Medicine. The POLARIS-02 results were published online in the Journal of Clinical Oncology in January 2021.

Substantiated by the results of POLARIS-02 and JUPITER-02, toripalimab has been recognized by drug regulatory agencies across the world. In 2021, two indications for the treatment of NPC were approved by the National Medical Products Administration (“NMPA”), thereby making toripalimab the world’s first immune checkpoint inhibitor approved for the treatment of NPC. The FDA has accepted for review the resubmission of the Biologics License Application (“BLA”) for toripalimab for the treatment of NPC and set the Prescription Drug User Fee Act (“PDUFA”) action date on December 23, 2022. Toripalimab will be the first and only immuno-oncology agent for NPC in U.S., if approved.

About Nasopharyngeal Carcinoma
NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common head and neck cancers. According to the statistics of the World Health Organization, the number of newly diagnosed NPC cases in 2020 has exceeded 130,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with chemotherapy and radiotherapy. In the United States and Europe, there are presently no immunotherapies approved for the treatment of NPC.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in 2018 (approved in China as TUOYI®). Currently, there are five approved indications for toripalimab in China.

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. 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 monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority.The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

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

EV Technology Group to Hold Virtual Shareholder Conference 25 July 2022

TORONTO, July 21, 2022 (GLOBE NEWSWIRE) — EV Technology Group Ltd. (“EV Technology Group” or the “Company”) (NEO: EVTG, DE: B96A, OTCQB: EVTGF), announces that it will hold a virtual shareholder conference on 25 July, 2022, at 10AM PST, 1PM ET, 6PM BST. The executive team will discuss recent transactions, particularly the recent announcement of the acquisition of a majority of MOKE International. Speaking on the call will be Wouter Witvoet, CEO and Founder of EV Technology Group as well as other members of EV Technology Group’s management team.

Participants can register here, or via the Investor Relations page of EV Technology Group’s website.

An archive of the virtual conference will be available shortly after the call and will remain on the website for six months thereafter.

In addition, EV Technology Group will provide shareholders with the ability to submit questions to management. Management intends to respond to a selection of questions during the Q&A portion of the conference.

About EV Technology Group
EV Technology Group was founded in 2021 with the vision to electrify iconic brands – and the mission to redefine the joy of motoring for the electric age. By acquiring iconic brands and bringing beloved motoring experiences to the electric age, EV Technology Group is driving the EV revolution forward. Backed by a diversified team of passionate entrepreneurs, engineers and driving enthusiasts, EV Technology Group creates value for its customers by owning the total customer experience — acquiring and partnering with iconic brands with significant growth potential in unique markets, and controlling end-to-end capabilities. To learn more visit: https://evtgroup.com/

Media
Rachael D’Amore
rachael@talkshopmedia.com
+1519-564-9850

Investor Relations
Dave Gentry
dave@redchip.com
+14074914498

EV Technology Group
Wouter Witvoet
CEO and Chairman of the Board
wouter@evtgroup.com

Forward-Looking Information

This news release contains forward-looking statements including, but not limited to, the virtual shareholder conference. Often, but not always, these Forward-looking Statements can be identified by the use of words such as “estimated”, “potential”, “open”, “future”, “assumed”, “projected”, “used”, “detailed”, “has been”, “gain”, “planned”, “reflecting”, “will”, “containing”, “remaining”, “to be”, or statements that events, “could” or “should” occur or be achieved and similar expressions, including negative variations.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any results, performance or achievements expressed or implied by the Forward-looking Statements, including those factors discussed under “Risk Factors” in the filing statement and annual information form of the Company. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in Forward-looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this news release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. The forward-looking statements contained herein are made as of the date hereof and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise, except where required by law. There can be no assurance that these forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.

THE NEO STOCK EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE

Darwin Aboriginal Art Fair set to showcase works from over 1,500 First Nations artists, represented by a record 76 community Art Centres from across Australia

DARWIN, Australia, July 21, 2022 (GLOBE NEWSWIRE) — Aboriginal and Torres Strait Islander creatives will be celebrated in Darwin, Australia, from 2-7 August in an unmissable showcase of art, design and culture at Darwin Aboriginal Art Fair (DAAF) Foundation’s series of iconic events.

The Darwin Aboriginal Art Fair (DAAF) is Australia’s largest and most celebrated First Nations visual art event, which will return for the 16th year to run both online and in person this 5-7 August.

The internationally celebrated art fair sits alongside the Foundation’s two Indigenous Fashion Projects events, Country to Couture on the 2 August, and the National Indigenous Fashion Awards on the 3 August, bringing Australia’s most acclaimed and vibrant First Nations artists and designers to the national and global stage.

As the only Australian event of its kind, DAAF has secured a reputation as one of the country’s most significant and internationally recognised arts events, creating a unique opportunity to connect with, and ethically purchase art directly from Art Centres, as well as meeting the artists and learning firsthand about their cultural heritage, stories, history and traditional artistic practices through a range of masterclasses, talks and demonstrations.

DAAF 2022 is on track to be the most successful and widest reaching yet, with a record 76 Art Centres participating in the Foundation’s inaugural hybrid delivery of the event. In 2021, the Fair achieved a record $3.12 million AUD in sales with 100 per cent of profits going back to the Art Centres and their communities. The Fair itself takes no commission from artwork sold.

DAAF Foundation are proud to be part of a collective of organisations championing music, arts, and ideas from the world’s oldest living cultures. Taking place in Australia’s Top End each July-August, alongside DAAF Foundation’s renowned Fair and fashion events, will be:

  • Garma Festival | Yothu Yindi Foundation | 29 July – 1 August
  • Salon des Refusés | Salon Art Projects | 3-13 August
  • Telstra National Aboriginal & Torres Strait Islander Art Awards | Museum and Art Gallery of the Northern Territory | 5 August 2022 – January 2023
  • National Indigenous Music Awards | Music NT | 6 August

The first week of August is predicted to be one of the biggest showcases of First Nations talent in the world. Music, art and culture will collide as The Collective unifies to bring the public a unique experience across the creative industries in the Northern Territory.

For more information about the 16th Darwin Aboriginal Art Fair and for priority access to the digital Art Fair, visit daaf.com.au/register.

Georgina Dawson
georginad@bastionagency.com

 A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Darwin Aboriginal Art Fair: Media Snippet

Ideal Systems Build New TV Studio for SUKE TV Home Shopping Channel in Malaysia

SUKE TV Logo

SUKE TV Logo

KUALA LUMPUR, Malaysia, July 21, 2022 (GLOBE NEWSWIRE) — Ideal Systems today announce they designed and built a new TV studio in Kuala Lumpur for SUKE TV. Launched in April 2022, SUKE TV is a Free-To-Air home shopping and general entertainment channel in Malaysia. The new channel airs 24 hours, 7 days a week on MYTV, the Malaysian national Digital Terrestrial Television (DTT) platform and streams to mobile devices throughout Malaysia.

Malaysian entertainment icon and SUKE TV founder and chairman Dato AC Mizal said, “It’s been my dream as an artist to have my own TV station; I’ve been working on this project for almost seven years. Finally with the help of Ideal Systems, SUKE TV has become a reality for me.”

The new state-of-the-art SUKE TV studio and media production facility was designed to create and produce local programming and entertainment content in its Kuala Lumpur studio and present a unique opportunity for local celebrities, public figures, social influencers, entrepreneurs as well as micro sellers to showcase their products on SUKE TV in a variety of new shows. Viewers will be able to watch the programming via digital and online platforms and make instant purchases via QR code.

SUKE TV awarded the project to Ideal Systems because Ideal could provide a one-stop-shop for the design and build of the TV studio, including the Network’s broadcast and transmission systems as a single turn-key project. The SUKE TV studio uses the latest NDI infrastructure and cameras feeding back to a Tricaster TC1 from NewTek for switching, recording and running the virtual studio, and the latest Kslim LED video wall from Unilumin which is 4mX2.5m. Ideal have deployed Xplayout for playout, Xingest for Ingest and YouPlay for studio playout all from Axel Technology and also uses Aximmetry virtual studio and 3D graphics with an option to run unreal engine which is NDI enabled. For the transmission, encoding and decoding for contribution and streaming, the system will use Kiloview SRT encoding systems.

Sofiyant Neo, Director Media & Creative Content for Ideal Systems, said, “I have been working very closely with our Technology Director Updesh Singh and his team to leverage the latest technologies to help Dato AC Mizal realise their dreams of creating great content and ensuring the market impact and success of SUKE TV.”

“We are honored and delighted to have designed and built these new studio facilities and systems for SUKE TV using the latest NDI technology. As an early adopter of NDI technology for Broadcast and Pro-AV in South East Asia, Ideal Systems are building on our successes as the dominant NDI Systems integrator,” said Fintan Mc Kiernan, CEO of Ideal Systems, South East Asia.

Web: www.idealsys.com

Ideal Systems Media Contact; Melody Bilegt   melody.bilegt@idealsys.com

Related Images

Image 1: SUKE TV Logo

SUKE TV Logo

Image 2: SUKE TV Set

SUKE TV Chroma Key Set

Image 3: Dato AC Mizal

SUKE TV Founder Dato AC Mizal

Image 4: SUKE TV Studio Control

SUKE TV Studio Control Room

This content was issued through the press release distribution service at Newswire.com.

Attachment

Canadian Ambassador Concludes a Successful visit to Vientiane

On July 20, Canadian Ambassador to Laos Sarah Taylor concluded a successful visit to Vientiane, after more than two years’ absence due to the Covid-19 pandemic.

The visit underscored Canada’s ongoing efforts to deepen the relationship between Laos and Canada.

The upcoming ASEAN and APEC ministerial meetings and summits, and how best Canada and the Lao PDR can work shoulder-to-shoulder on behalf of our people.

During her visit, Ambassador Taylor met with Minister of Industry and Commerce, Mr. Malaithong Kommasith, Minister of Health, Dr. Bounfeng Phoummalaysith, and Deputy Minister of Foreign Affairs, Mr. Bounleua Phandanouvon, to deepen collaboration, partnership and dialogue between Canada and Laos, and reinforce Canada’s commitment to supporting the country’s post-pandemic recovery and efforts to respond to the economic crisis.

Supported by the Office of the Embassy of Canada to Laos, Ambassador Taylor also met various local non-profit and community organizations, UN agency and diplomatic representatives, and the Canadian community in Laos.

“As in partnership with Laos for the last 48 years, Canada continues to realize the benefits of our growing relationship. Canada remains keen to further strengthen bilateral and commercial ties, continue moving the dialogue forward on gender equality, inclusive governance, and human rights, elevate our relationship with ASEAN to Strategic Partner, and explore how best to work together to ensure our societies remain resilient in the face of the ongoing Covid-19 challenge and the mounting economic crisis buffeting us all,” stated Ambassador Taylor.

Since the outset of the Covid-19 pandemic, Canada has committed more than C$2.5 billion to support low- and middle-income countries’ Covid-19 response, including the Lao PDR. Earlier this year, Canada donated to the Lao Ministry of Health over 1 million masks valued at C$3.5M, and which followed a donation last August of more than half a million masks from PRIMED Medical Products, a Canadian company soon to be launching their manufacturing operations in Laos later this year. Support was also provided to the Lao Red Cross to assist their efforts with pandemic isolation centres. Canada also donated Personal Protective Equipment worth C$353,000 in late 2020, and C$150,000 to Institut Pasteur du Laos in early 2020 to purchase diagnostic equipment, personal protective equipment and testing supplies.

In 2021, bilateral trade between the two countries was valued at $42 million. Several Canadian firms are active in the Lao PDR, working in the communications, extractives, and manufacturing sectors.

Source: Lao News Agency

Lao Gov’t Urges Dam Operators To Ensure Safety Measures

The Lao Ministry of Energy and Mines, issued a notice, instructing operators of hydro-power dams in Laos, to ensure that safety measures and emergency plans are in place and being complied with.

Safety awareness is especially important during the rainy season, when reservoirs are full to capacity and the most strain is placed on dam walls, local daily Vientiane Times reported today.

The warning was issued after the ministry carried out inspections and found that several hydro-power plants were storing substantial quantities of water, and advised all dam operators to pay extra attention to water management, dam safety, and emergency plans.

Operations managers should monitor the condition of all structures and floodgates, which must be in good working order and ready for use.

Requests for the release of water must be submitted to the Department of Energy Policy and Planning, at least seven days before the discharge is planned.

In addition, emergency plans must be up to date and dam operators should remain in full communication with local authorities and communities living downstream, so that they are aware of, and well prepared for any possible incident.

Furthermore, equipment and vehicles must be included in the emergency plans, so they are ready for use in the event of an unexpected incident. The owners and developers of hydro-power plants have repeatedly been instructed to comply with safety guidelines and monitor the safety of dams, especially through visual inspections and instrument monitoring.

The Ministry of Energy and Mines has been working to strengthen management, to ensure sustainable development of hydro-power, in the wake of the disastrous collapse of a dam in the southern Attapeu province in 2018.

The collapse of the dam at the Xe-Pian Xe-Namnoy hydro-power plant, 560 km south-east of the capital Vientiane, caused a flash flood that wiped out five villages downstream, leaving more than 4,000 people homeless. Several other villages and their inhabitants were also affected.

Earlier this month, the National Assembly approved a new law on dam safety, which sets out specific guidelines and measures, to regulate the construction and operation of hydro-power plants in Laos.

The new law will ensure that dams are built in compliance with strict standards, and that they are closely monitored to maintain safety.–

Source: NAM News Network