Antengene Corporation Limited | September 19, 2022
Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.
At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.
Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.
Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.
ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.
"We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene's first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world."
Dr. Bo Shan, Antengene's Chief Scientific Officer
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® already approved in mainland China, South Korea, Singapore and Australia.
Tivic Health | October 18, 2022
Tivic Health® Systems, Inc. a commercial-phase health technology company focused on bioelectronic medicine, announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and all related assets from Reliefband Technologies, LLC.
Reliefband has been an innovator in wearable, FDA-cleared electronic therapeutics for treatment of nausea and vomiting. Reliefband has multiple products available both over-the-counter and by prescription.
“We are incredibly excited to add the full suite of Reliefband products to our commercial portfolio. The Reliefband team successfully pioneered a direct-to-consumer business model for medical products. This acquisition, when combined with our growing direct-to-consumer sales of ClearUP, will significantly accelerate Tivic’s revenue opportunities.”
Jennifer Ernst, CEO of Tivic Health
Recurring nausea impacts approximately 1 in 6 US adults. According to QY Research, nausea treatment is a $2.4B market in the US and $5.5B globally, growing at 6.5% CAGR.
Reliefband’s wrist-worn electronic nerve stimulators have been FDA-cleared for treatment of nausea associated with seven independent clinical indications, including nausea from motion sickness, pregnancy, migraines, anxiety, chemotherapy, various medications and hangovers.
The patented products are backed by 40 peer-reviewed clinical studies and have generated over 3500 Amazon reviews averaging 4+ stars.
Both Reliefband and ClearUP products offer consumers ways to manage health-related conditions without the issues and side effects often associated with medication use. Both are FDA-cleared, highly effective, fast-acting, convenient, and drug-free. Both currently are sold primarily online, and both have received CE Marks allowing international expansion.
In addition to the Reliefband direct-to-consumer branded products, Tivic will also acquire Reliefband’s Reletex-branded prescription nausea treatments. Reletex products are currently distributed by hospitals and medical professionals and are reimbursed under HCPCS code E0765 for certain conditions.
“We look forward to growing Tivic with the addition of clinically proven, revenue-producing bioelectronic products that have seen strong customer adoption and growth,” continued Ernst.
Consideration to be provided by Tivic consists of up to $33.5 million, of which up to $1.5 million can be paid, at the election of Tivic, in restricted common stock of Tivic. Consideration is subject to working capital adjustments, less Reliefband transaction expenses and any indebtedness of Reliefband at closing.
The transaction is expected to be consummated in the fourth quarter of 2022 or first quarter of 2023 after the satisfaction of certain customary closing conditions, including but not limited to securing the financing necessary to pay the purchase price. Additional information on the transaction can be found in a Current Report on Form 8-K filed by Tivic with the Securities and Exchange Commission (SEC).
IMPLANET | November 23, 2022
IMPLANET a medical technology company specializing in vertebral implants, announces the signing of an agreement with SMTP Technology Co., a high-tech medical device company specialized in the manufacturing and marketing of ultrasonic medical equipment, for the exclusive distribution of its latest generation ultrasonic surgical scalpel in France.
Adam Li, GMA & International Business Manager at SMTP Technology Co., stated: “We are delighted with the signing of this contract tying us to IMPLANET, which will henceforth ensure the distribution of our latest generation ultrasonic surgical scalpel. This innovative solution will increase surgical efficiency while ensuring greater patient safety. Thanks to this collaboration with IMPLANET, a company recognized for its expertise in the field of spine surgery and its foothold in French medical centers, we are strengthening the credibility of our solutions for their international deployment”.
“This latest contract, which comes close on the heels of the commercial and technological partnership signed with Sanyou Medical, further emphasizes the pertinence of our repositioning on the spine market. The surgical scalpel developed by SMTP, through its innovation and ease of use, should meet the needs of surgeons and patients alike. IMPLANET is proud to be able to work with one of the only players in the world capable of developing this type of product based on ultrasound”.
Ludovic Lastennet, IMPLANET’s Chief Executive Officer
The ultrasonic surgical scalpel developed by SMTP Technology Co. can support both open surgery, minimally invasive surgery and endoscopic intervertebral spine surgery. This product, which has been granted marketing clearance in China, the European Union and the United States, stands out through its innovative design, guaranteeing enhanced surgical safety. Thanks to the smaller amplitude of its cutting tip, the scalpel cuts bone tissue by the acceleration of hundreds of thousands of mechanical vibrations per second while sparing soft tissue.
The agreement signed today between IMPLANET and SMTP Technology Co. follows the signing of the distribution contract and technological partnership with Sanyou Medical, of which SMTP Technology Co. is a subsidiary. This new agreement gives IMPLANET exclusive rights to distribute the scalpel on the French market.
SMTP Technology Co., founded in 2010, is a high-tech medical device company focusing on the innovative research and development, manufacturing and marketing of ultrasonic surgical equipment. The ultrasonic osteotomy surgical system manufactured by SMTP Technology, which supports both open surgery and minimally invasive surgery under the channel and intervertebral endoscope, has been granted marketing approval in China, the European Union and the United States. Based in the Zhangjiagang free trade zone in Jiangsu province, SMTP is a subsidiary of the Sanyou group with 100 employees and revenue of 14 million euro.
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its activity revolves around a comprehensive innovative solution for improving the treatment of spinal pathologies complemented by the product range offered by Orthopaedic & Spine Development (OSD), acquired in May 2022. Implanet’s tried-and-tested orthopedic platform is based on the traceability of its products. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration in the United States, the CE mark in Europe and ANVISA approval in Brazil. IMPLANET employs 39 staff and recorded a consolidated revenue of €6.1 million in 2021. Based near Bordeaux in France, IMPLANET opened a US subsidiary in Boston in 2013. IMPLANET is listed on the Euronext Growth market in Paris.
Royal Philips | November 28, 2022
Royal Philips a global leader in health technology announced its portfolio of smart diagnostic systems and transformative workflow solutions featured at the Radiological Society of North America annual meeting. Powered by AI, the company will showcase its latest systems and informatics solutions designed for providers to efficiently deliver patient-centric, high-quality imaging services.
Overwhelming volume of radiology data compounding staff shortages and burnout
Radiology plays a critical role in diagnosing and guiding patients into the right treatment plans. However, with increasing staff shortages and workloads, radiologists and staff continue to struggle to manage and interpret the huge volume of data captured to provide quality care for each patient. In the recent Future Health Index 2022 report commissioned by Philips, 24% of radiology leaders surveyed stated that managing the sheer volume of data available to them is their top data-related issue, with nearly two-thirds (65%) indicating their staff are overwhelmed by data overload.
“With 47% of radiologists experiencing burnout , our customers are looking for innovations to help reduce their workloads and seamlessly integrate into their day-to-day operations. With smart intelligence built into imaging systems and informatics across the radiology workflow, Philips’ integrated solutions condense large volumes of data into patient-centric actionable insights for earlier and more definitive diagnosis and treatment.”
Kees Wesdorp, Chief Business Leader of Precision Diagnosis at Philips
AI-powered solutions enhance operational efficiencies and simplify complex workflows
Some of the biggest challenges facing radiology leaders today are driven by managing complex, disconnected workflows which can negatively impact patient care, staff experience, outcomes, and cost. Visitors to the Philips booth at RSNA will see how the company’s latest interoperable and vendor-neutral operational solutions and strong portfolio of smart connected imaging systems help streamline and transform the radiology workflow to improve patient and staff experience; advance clinical and diagnostic confidence for better health outcomes; and drive a sustainable, resilient diagnostic infrastructure to help lower the cost of care. Featured at RSNA will be Philips’ AI-enabled technology  that automates and accelerates routine and repetitive tasks to generate patient-centric insights from large volumes of data to help improve productivity.
Solutions include Philips Imaging Orchestrator – ROCC and Philips Ultrasound Collaboration Live, both pioneering the virtualization of radiology, extending care and collaboration beyond traditional models. Philips Imaging Orchestrator – ROCC, a vendor-neutral, multi-modality, multi-site telepresence solution provides advanced tele-acquisition capabilities and seamlessly connects imaging experts at a command center with technologists at scanning locations across an organization. Philips Ultrasound Collaboration Live tele-ultrasound, available on Philips ultrasound systems – EPIQ Elite and Affiniti – allows teams to securely video stream from their ultrasound system to a PC or mobile device for remote, on-demand access to clinical expertise regardless of location.
Philips will also introduce the latest in AI-enabled image interpretation to help prioritize patient worklists based on clinical outcomes and expand diagnostic capabilities with its new Philips Advanced Visualization Workspace, with enhanced features to automate reporting and help drive earlier and more definitive diagnosis. Also featured is Philips Enterprise Performance Analytics – PerformanceBridge – to enhance operational decision-making through a vendor-neutral, real-time data analysis solution to help improve productivity and reduce costs.
Smart connected imaging systems advance clinical and diagnostic confidence
New at RSNA, Philips’ AI-powered MR SmartSpeed is designed to increase speed, image quality, and productivity and drive diagnostic confidence with improved image resolution via the AI reconstruction algorithm. It utilizes Philips’ state-of-the-art speed engine and an award-winning  AI reconstruction technology delivered at the source of the MR signal to ensure no data loss. SmartSpeed joins the company’s expanding portfolio of AI-driven MR solutions which includes AI-based touchless patient sensing, SmartExam, and MR Workspace. Philips will also showcase MR 5300, Philips’ newest BlueSeal Magnet, and industry-first wide bore helium-free operations system design for sustainable imaging at lower site costs without image quality or clinical compromises.
Philips will spotlight its award-winning Spectral CT 7500, the company’s latest dual-detector CT system helping radiologists better characterize disease and reduce scan times at the same dose levels as conventional scans. Used in oncology imaging, cardiac imaging, and interventional radiology, the system has demonstrated a 34% reduction in time to diagnosis, a 25% reduction in repeat scans and a 30% reduction in follow-up scans . Philips will also demonstrate its latest innovations in minimally-invasive care with the company’s SmartCT 3D suite of interventional tools including its Azurion 7 C20 with FlexArm Image-Guided Therapy System and Zenition 70 Mobile C-arm with Flat Detector.
Philips will also introduce the Ultrasound Compact 5000 Series system and the Philips Lumify Handheld Ultrasound, now featuring pulse wave Doppler for all physicians – from cardiologists and radiologists to emergency care – to quickly assess hemodynamics in cardiac function anytime, anywhere. Also making its first appearance at RSNA is Philips Fluoroscopy 7000 N – ProxiDiagnost N90, combining digital radiography and high-end nearby fluoroscopy to help enhance clinical confidence and improve patient and staff satisfaction.
About Royal Philips
Royal Philips is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries.