Day: September 14, 2021

FRONICS super hearing machine, overcomes microphone limitations to recognize human sound!

SAN FRANCISCO, Sept. 14, 2021 (GLOBE NEWSWIRE) — Fronics Inc., a technology company from South Korea, opens a new horizon for machine learning with the advancement of an artificial ear.

Most people know that various kinds of microphones are used to make voice or sound amplified, recorded or recognized by artificial intelligence. The mechanics of a microphone is vastly different from the human ear. This is why people using hearing aids have many difficulties in hearing from a distance or under noisy situations and why many are less satisfied with AI machines around us.

Fronics Inc. has developed the first and the only voice sensor extracting voice signals from resonance. This sensor works just like the human cochlear, enabling machines to hear like humans. What this means is that, compared to conventional microphones, Fronics’ sensor can detect sounds up to eight times farther away and provide up to 22 times cleaner data. As the market demand grows for smart devices depending on human voice control, a sensor that works just like the human ear is needed to get the precision required to talk to machines like someone would their own family.

To enter into the global market, Fronics Inc. has established an entity named Fronics Technologies Inc. in the U.S. recently. On Sept. 9, seven people gathered in San Francisco to discuss next steps. They are Kisoo Kim, CEO of Fronics Inc.; Yobie Benjamin Franklin, Chairman of Fronics Technologies Inc.; Michelle Kim, board member of Fronics Technologies Inc.; Keonjae Lee, KAIST professor and an inventor; Jounghoon Lee, Vice President of Fronics Inc.; Jeremy McKane, founder of OCN.ai and tech entrepreneur; and Edmond Fong, a senior investment professional at a large institutional investment firm. The group will promote this amazing technology to the media and find companies in need. The group also plans to get a valuation report from a prominent law firm and to list specifications of Fronics on the market in the near future.

We all live in a world where machines can now listen and interact with human voice commands. Fronics is the first company in the world to develop technology that turns the analog process of hearing into the most advanced auditory data for machine learning applications. The team at Fronics believes that this is a new era in machine super hearing.

MEDIA CONTACT:
Kisoo Kim
keith_kim@fronics.com

Related Files

Fronics logo.png

Related Images

Image 1: FRONICS team in San Francisco Sept. 9, 2021

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

Attachment

• FRONICS team in San Francisco Sept. 9, 2021

As new mutations of SARS-CoV-2 keep spreading worldwide, Hyris keeps monitoring its test kits effectiveness, performing routine analysis of SARS-CoV-2 variants to safeguard public health and the product’s quality by assessing the potential impact of new strains on sensitivity and specificity.

LONDON, England, Sept. 14, 2021 (GLOBE NEWSWIRE) — New mutations of SARS-CoV-2 worldwide are causing several concerns regarding further disruption of public safety. Authorities involved in the fight against COVID-19, such as the WHO, the CDC, and the ECDC, identify these mutations as Variants of Concern based on their risk assessment and monitor them, increasing the level of awareness amongst scientific medical communities worldwide.

“In such a fast-evolving scenario, accurate diagnostic data are key to contain and control the pandemic,” says Stefano lo Priore, Founder and CEO at Hyris, an innovation-based biotechnology manufacturer of point-of-care genetic analysis systems. “Therefore, at such a time, a portable yet reliable Diagnostic System capable of detecting Covid-19, including the main known variants, is crucial to any risk-reduction strategy.”

The Hyris System™ confirms its reliability in the fight against Covid-19, after its launch following the authorization by Health Canada in September 2020 and the CE-IVD Mark in November. Deploying PCR (Polymerase Chain Reaction) technology considered the “gold standard” by the CDC and the WHO for COVID-19 testing, Hyris proves to be instrumental in keeping people safe and operations running worldwide.

“Several new ‘variants of concern’ emerged,” recalls Isabella Cavaliere, Quality Manager at Hyris. Cavaliere outlines their codes, and common name, as they are not univocal, such as the ‘Alpha variant’ or  B.1.1.7/501Y.V1, the ‘Beta variant’ or B.1.351/501Y.V2, the ‘Gamma variant’, or P.1/501Y.V3, the ‘Delta variant’, or B.1.617, and the Californian ones known as B.1.429 and B.1.427. She also confirms that Hyris has performed routine in silico analyses of SARS-CoV-2 sequences (from GISAID database: https://www.gisaid.org/). “All the sequences investigated showed no variations from the reference sequence of SARS-CoV-2 in the oligonucleotides annealing sites,” continues Cavaliere. “We can therefore confirm that basing on in silico analysis, the Diagnostical Coverage of the Hyris System™ is confirmed regardless of any of these specific strains“.

“The new SARS-CoV-2 strains just showed that the fight against Coronavirus is far from won yet“, concludes Lo Priore “we need a wider access to diagnostic systems and tests, also to support and validate vaccination campaigns around the world.” In the light of these facts, it is no surprise that many progressive companies and medical practitioners have already chosen the Hyris System™ as the ideal ‘Point of Care’ solution in the fight against Covid-19.

When diagnostic has to be performed under the hardest conditions, Hyris checks all the boxes, consistent with its Vision. Putting Knowledge at the service of Life.

Download the Monitoring Update here

Contact an Hyris expert to discover how Hyris can help you perform beyond the boundaries of your current diagnostic capability. info@hyris.net

____________________________

Business contact: Federico Baldo, federico.baldo@hyris.net

Media Contact: Francesco Rotolo, hyris.media@storyfly.it

Related Files

01_Hyris_monitoring_updater02_2IN1.pdf

Related Images

Image 1: Hyris System™ for Covid-19 diagnostics

Holding the HYRIS bCUBE™

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

Attachment

• Hyris System™ for Covid-19 diagnostics

Anaqua’s AQX platform to provide patent and trademark management with integrated IP analytics

BOSTON, Sept. 14, 2021 (GLOBE NEWSWIRE) — Anaqua, the leading innovation and intellectual property management technology provider, today announced that Bausch Health Companies Inc. has selected Anaqua’s AQX platform to deliver enhanced IP management across the health care products company’s global operations.

Bausch Health will be using Anaqua’s AQX as their primary IP management system – both for patent and trademark management – replacing their previous IP services provider. Bausch Health will take advantage of Anaqua’s broad range of IP offerings including AcclaimIP for patent analytics, Anaqua Services for patent annuities and trademark renewals, as well as AQX modules for IP contract and financial management.

Commented Bob Romeo, CEO of Anaqua: “Bausch Health is an innovative health care company delivering on its commitment to help people around the world. We are proud to be working with them and to better serve their valuable IP assets through Anaqua’s enhanced innovation and IP management solutions.”

About Anaqua
Anaqua, Inc. is a premium provider of integrated intellectual property (IP) management technology solutions and services. Anaqua’s AQX platform combines best practice workflows with big data analytics and tech-enabled services to create an intelligent environment designed to inform IP strategy, enable IP decision-making, and streamline IP operations. Today, nearly half of the top 100 U.S. patent filers and global brands, as well as a growing number of law firms worldwide use Anaqua’s solutions. Over one million IP executives, attorneys, paralegals, administrators, and innovators use the platform for their IP management needs. The company’s global operations are headquartered in Boston, with offices across the U.S., Europe, and Asia. For additional information, please visit anaqua.com, or on LinkedIn.

Company Contact: Amanda Hollis Associate Director, Communications Anaqua 617-375-2626 ahollis@Anaqua.com

New Topaz sensors are ideal for mobile applications, offering an attractive price point with no-compromise performance.

GRENOBLE, France, Sept. 14, 2021 (GLOBE NEWSWIRE) — Teledyne e2v, a part of Teledyne Technologies [NYSE: TDY], has introduced its Topaz series of industrial CMOS sensors with new 2MP and 1.5MP resolution devices. These new 1920 x 1080 and 1920 x 800-pixel format sensors use state-of-the-art low noise, global-shutter pixel technology to offer powerful solutions and enable compact mobile designs for many applications.

Housed in a tiny 4.45 mm wide Chip Scale Package (CSP), the Topaz sensors have an optical array centre which precisely matches the mechanical centre of the package, allowing for a slim camera design. This makes them particularly suitable for miniature OEM barcode engine designs, mobile terminals and sleds, IoT, contactless authentication systems, wearable devices, drones and robotics. Their 1/3” optical format is made possible due to the small 2.5µm global shutter pixel that employs in-pixel CDS (correlated double sampling) and advanced dual light-guides to achieve good SNR at low-light, with low crosstalk for crisp images.

Gareth Powell, Marketing Manager for CMOS Sensors at Teledyne e2v, said, “Modern logistics, retail, and manufacturing applications all require enhanced productivity and throughput, with longer working ranges. The new Topaz sensors were developed with this in mind, offering an excellent cost/performance ratio for high volume adoption. They also have a tiny footprint making them ideal to drive the world’s smallest barcode OEM engines and thinnest mobile platforms.”

Key Features

• Advanced 2.5µm x 2.5µm global shutter pixel
• Low readout noise of typically 3.3 electrons
• Excellent low light SNR performance with short exposure times
• Ultra-low dark signal for exceptionally good high temp performance
• Frame rate of >100 frames per second in 8 bit output mode
• 2 lane MIPI outputs (1.2Gpix/sec each) for seamless connection with CPU, ISP and other application processors
• Fast Wake Up mode – decode within 10 milliseconds after power up and other useful application features

Samples and evaluation kits are available now. Please contact us for more information.

Find out more about Topaz at VISION, 5-7 October 2021 in Stuttgart, Germany, Teledyne booth 8B10.

For media enquiries, please contact:
Jessica.Broom@teledyne.com

Notes to Editors:
Teledyne e2v’s innovations lead developments in healthcare, life sciences, space, transportation, defense and security and industrial markets. Teledyne e2v’s unique approach involves listening to the market and application challenges of customers and partnering with them to provide innovative standard, semi-custom or fully custom imaging solutions, bringing increased value to their systems.

For more information, visit imaging.teledyne-e2v.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/413bf4a5-a6ae-4be4-bea1-d5b5a1a12ac2

INSIDE INFORMATION
REGULATED INFORMATION

Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Mont-Saint-Guibert (Belgium), September 14, 2021, 8:00 am CET / 2:00 am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate.

The FDA’s Breakthrough Designation Program was created to help patients and healthcare providers receive faster access to innovative technologies that hold the potential to provide more effective treatment of irreversibly debilitating diseases or conditions. According to the FDA, OSA is an irreversibly debilitating human disease for patients with sleep apnea. Under the Program, the FDA will provide the Genio® system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the US.

“We are pleased to have received Breakthrough Device Designation for our proprietary Genio® system for OSA patients with CCC, recognizing that Obstructive Sleep Apnea is an irreversibly debilitating condition.” said Olivier Taelman, CEO of Nyxoah. “This Breakthrough Designation accelerates our market authorization process in the US and expands our total addressable market to include CCC patients currently contraindicated for hypoglossal nerve stimulation.”

The Breakthrough Designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and performance of the Genio® system in adult OSA patients with and without CCC.

About BETTER SLEEP Trial
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea, or BETTER SLEEP, is a multicenter, prospective, open-label, two-group clinical trial, designed to assess the safety and performance of the Genio® system for the treatment of OSA in adult patients with and without CCC. Top-line BETTER SLEEP results showed primary safety and performance endpoints were met, with statistically significant mean reduction in the AHI score in full patient population including CCC patients. Nyxoah will submit full BETTER SLEEP study data to a medical journal for publication and announce results following further analyses.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah is seeking for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

Contacts:
Nyxoah
Fabian Suarez, Chief Financial Officer
corporate@nyxoah.com
+32 10 22 24 55

Gilmartin Group
Vivian Cervantes
IR@nyxoah.com

Attachment

• ENGLISH – NYXH FDA BTD CCC FINAL

London, September 14, 2021

CNH Industrial (NYSE: CNHI / MI: CNHI) announces an important appointment to the future Senior Leadership Team of Iveco Group, the Company previously referred to as the “On-Highway” business of CNH Industrial, which will begin independent operations in early 2022.

Effective January 1, 2022, Francesco Tanzi will join the Company and will serve as Chief Financial Officer of Iveco Group once the spin-off is achieved. Mr. Tanzi is a seasoned professional in the world of corporate finance with leadership experience in international strategies that generate dynamic financial results. He is stepping down from his current role as Chief Financial Officer at the multinational tire manufacturer Pirelli & C. S.p.A., a position he has held for 12 years, to accept this new role. Tanzi began his finance career at Pirelli in 1989, rising through the ranks before departing to serve as Finance Director at TIM Group, Italy’s largest telecommunications provider, for eight years prior to rejoining Pirelli as their CFO.

“Building this new senior management team for Iveco Group is an exciting task as we work to form the very best team to ensure the success of our independent group. We are delighted to have found our CFO in Francesco Tanzi, whose experience and expertise will bring great value to our business activities from the outset. I want to take this opportunity to thank Damiano Cretarola, who has been supporting me as Finance leader for the Commercial & Specialty Vehicles segment within CNH Industrial and will continue serving with a prominent role in Francesco Tanzi’s team once it is formed,” said Gerrit Marx, current President Commercial & Specialty Vehicles at CNH Industrial and designated Chief Executive Officer of Iveco Group.

“On behalf of the Board of Directors of CNH Industrial, we wish to welcome Francesco Tanzi to the new Iveco Group organization. Having overseen this spin-off from its inception and the design of the On-Highway Senior Leadership Team, we have long identified the CFO role as one requiring a very specific and seasoned profile, and I am certain we have found it in Francesco Tanzi. Oddone Incisa, who will continue serving as CFO for CNH Industrial, will ensure a smooth transition and make sure that Francesco is ideally poised to embark on Iveco Group’s journey,” said Suzanne Heywood, Chair of CNH Industrial.

CNH Industrial N.V. (NYSE: CNHI / MI: CNHI) is a global leader in the capital goods sector with established industrial experience, a wide range of products and a worldwide presence. Each of the individual brands belonging to the Company is a major international force in its specific industrial sector: Case IH, New Holland Agriculture and Steyr for tractors and agricultural machinery; Case and New Holland Construction for earth moving equipment; Iveco for commercial vehicles; Iveco Bus and Heuliez Bus for buses and coaches; Iveco Astra for quarry and construction vehicles; Magirus for firefighting vehicles; Iveco Defence Vehicles for defence and civil protection; and FPT Industrial for engines and transmissions. More information can be found on the corporate website: www.cnhindustrial.com

Contacts:

Corporate Communications

Email: mediarelations@cnhind.com

Investor Relations

Email: investor.relations@cnhind.com

Attachments

• 20210914_PR_CNH_Industrial_CFO_Iveco_Group
• CNH INDUSTRIAL N.V.

PORT MELBOURNE, Australia, Sept. 14, 2021 (GLOBE NEWSWIRE) — Knosys today announced that its knowledge management solution, KnowledgeIQ (www.knoiq.co) has launched a new integration with Salesforce. With KnowledgeIQ and Salesforce, your customer-facing teams can effortlessly access the right information and answers sourced from their entire business to make sales, drive exceptional customer experiences and improve agent experience.KnowledgeIQ can now seamlessly integrate with Salesforce allowing users to maximize the use of two powerful solutions – KnowledgeIQ’s knowledge management software and Salesforce.

Knosys’ Managing Director, John Thompson, said, “KnowledgeIQ gives agents access to organization-wide knowledge from within their Salesforce interface making it easier and faster to address customer issues.”

“Organisations are now looking for effective ways to improve agent productivity, reach their customers, and build brand loyalty. KnowledgeIQ has developed a platform that provides enhanced and quick integration, and we are excited to provide our customers with the tools they need to deliver exceptional experiences to both agents and customers. Furthermore, having an externalized knowledge system means those employees who do not have access to Salesforce and also benefit from direct access to the knowledge company-wide,” added John.

Key benefits of Salesforce Integration with KnowledgeIQ

Integrating Salesforce with a powerful knowledge management platform provides organizations the competitive advantage they need with advancing accuracy, speed, and consistency of the service delivery. With this integration, organizations will get to experience:

• Proactive agent assistance
• Predictive Search
• Realtime alerts of changes
• Collaboration with Governance
• Higher agent confidence
• Contextual knowledge and agents’ fingertips
• Establish a single source of truth

About KnowledgeIQ

KnowledgeIQ, A solution by Knosys – unlocking knowledge to help employees and customers find answers and information quickly when they need it with a trusted ‘single source of truth’ for everyone. We believe knowledge management should bring business advantage and should not be over complicated, unwieldy, or an expensive solution.

Contact

For further information about KnowledgeIQ’s integration with Salesforce or other product features, please contact:

Melissa Mercer
VP Sales & Marketing
mmercer@knosys.it

[End]

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

SHANGHAI, China and REDWOOD CITY, Calif., Sept. 14, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (Nasdaq: CHRS) announced the presentation today of positive interim results from the pivotal study “CHOICE-01” (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as the first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) without driver mutations. The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone.

The interim results were summarized on September 13 in a presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract detailing the interim results was first made available on the WCLC website on August 18.

“The addition of toripalimab to standard 1st-line chemotherapy in patients with advanced non-small cell lung cancer showed superior progression free survival, overall response rate and duration of response over chemotherapy alone, with a safety profile consistent with the PD-1 inhibitor class of drugs,” said Dr. Wang. “Overall survival data are still maturing, with a notable emerging trend favoring the toripalimab-chemotherapy combination. We look forward to additional data from this study and believe CHOICE-01 results will provide strong evidence to support the use of toripalimab with chemotherapy as a 1st-line therapeutic option for NSCLC.”

A final analysis of progression free survival and an additional interim overall survival analysis are expected later this year. Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission to the pending biologics license application of an efficacy supplement for toripalimab for the first line treatment, in combination with platinum-based chemotherapy, of advanced, unresectable NSCLC without driver mutations.

“CHOICE-01 is the first of four pivotal clinical trials evaluating toripalimab for the treatment of lung cancer to have clinical data presented, and its positive results are a promising start for toripalimab in lung cancer. Lung cancer is the most common form of cancer worldwide and the leading cause of death due to cancer, so there is a clear need to develop complementary approaches to standard chemotherapy to improve patient outcomes, maintain quality of life, and seek to improve survival for patients diagnosed with this deadly disease. We will work closely with Coherus and the regulatory authorities to bring this new therapy to patients in the United States,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences.

“The CHOICE-01 interim data presented at WCLC are encouraging early evidence for toripalimab’s clinical benefit in the first line setting in non-small cell lung cancer,” said Denny Lanfear, CEO of Coherus. “We eagerly anticipate additional results from this study and the potential to advance toripalimab toward registration for this indication in the United States.”

Toripalimab Phase 3 clinical trials in lung cancer
Junshi Biosciences and Coherus are currently evaluating toripalimab in four pivotal Phase 3 clinical trials in lung cancer.

• CHOICE-01, with 465 patients enrolled, is comparing toripalimab in combination with chemotherapy to chemotherapy alone as first-line treatment of advanced NSCLC. The study met the primary endpoint of progression free survival (PFS) at the interim analysis (data cut-off date: November 17, 2020). Patients receiving the placebo-chemotherapy combination were allowed to actively cross over to toripalimab treatment at the time of disease progression. Overall survival (OS) data are still maturing and exhibiting a trend favoring the toripalimab-chemotherapy arm as of a March 2021 observation. Final PFS and additional interim OS analyses are expected later in 2021.
• Toripalimab is also being evaluated in combination with standard platinum-based chemotherapy in patients with NSCLC harboring EGFR mutations whose tumors are no longer responding to EGFR TKI therapy. Enrollment of 410 subjects in this Phase 3 study is on track to be completed by the end of 2021. The primary endpoint of the study is PFS. Initial results are expected in 2022.
• In the neoadjuvant setting, toripalimab is being evaluated in combination with chemotherapy in a Phase 3 study with 406 patients with NSCLC scheduled to undergo surgical resection of their lung cancer. Enrollment is on track to be completed by the end of 2021. The primary endpoints of the study are major pathological response and event free survival. Initial results are expected in 2022.
• Toripalimab is being evaluated in combination with standard chemotherapy in a Phase 3 study with 442 patients with extensive stage small cell lung cancer. Enrollment is complete. PFS and OS are the co-primary endpoints. Results are expected by the first half of 2022.

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 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials evaluate the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

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 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 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 Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. 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.

About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

Coherus markets UDENYCA^® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis^®, Humira^®, and Avastin^®, if approved.

UDENYCA^® is a trademark of Coherus BioSciences, Inc.

Avastin^® and Lucentis^® are registered trademarks of Genentech, Inc.

Humira^® is a registered trademark of AbbVie Inc.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA^® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus’ and Junshi Biosciences’ plans to file additional toripalimab BLAs with the FDA over the next three years for lung cancer or other clinical indications; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira^®, Avastin^® and Lucentis^®, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences 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

Coherus Contact Information:
IR Contact:
McDavid Stilwell
Coherus BioSciences, Inc.
mstilwell@coherus.com
+1 (650) 395-0152

Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
+1 (949) 903-4750