• Lancet Digital Health study highlights Lunit INSIGHT CXR as top performer in TB screening, showing promise for improving detection in high-burden settings

SEOUL, South Korea, Aug. 6, 2024 /PRNewswire/ — Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that its AI-powered chest X-ray analysis software, Lunit INSIGHT CXR, has demonstrated superior performance in tuberculosis (TB) detection in a large-scale, independent study published in The Lancet Digital Health.

Despite being a curable disease, TB remains the world’s second leading cause of death from a single infectious agent, with an estimated 10.6 million new cases in 2022. A major challenge in TB control is underdiagnosis, with 3.1 million cases going undetected that year. While chest X-rays are more sensitive than symptom screening, their effectiveness is often limited by variability in human interpretation and a shortage of radiologists in high-burden countries. This context underscores the critical importance of advanced AI assistance.

The study, conducted by Dr. Zhi Zhen Qin and a team of researchers from the Stop TB Partnership at UNOPS and Heidelberg University Hospital, evaluated 12 commercially available AI products for TB detection using data from South Africa’s national TB prevalence survey. Lunit INSIGHT CXR achieved the highest area under the receiver operating characteristic curve (AUC) of 0.902, significantly outperforming other products.

Key findings for Lunit INSIGHT CXR include:

• Highest AUC (0.902) among all tested products
• 89.9% sensitivity at 67.7% specificity, meeting WHO target product profile
• 89.5% sensitivity at 70.2% specificity, meeting WHO target product profile
• Ability to maintain high sensitivity (>90%) across a wide range of thresholds

The study, which included 774 participants (258 bacteriologically confirmed TB cases), is the first to comprehensively evaluate multiple AI products in a high TB setting.

“This landmark study not only showcases our AI’s superior accuracy but also demonstrates its alignment with WHO standards,” said Brandon Suh, CEO of Lunit. “Lunit INSIGHT CXR’s ability to maintain high sensitivity across diverse populations and thresholds is particularly crucial in resource-limited settings, where every undetected case can have far-reaching consequences. By bridging the gap in TB diagnosis, we are contributing to a future where no case goes undetected, especially in regions where it matters most.”

The study’s findings have significant implications for TB screening in high-burden settings. Lunit INSIGHT CXR’s robust performance, particularly its ability to maintain high sensitivity across various thresholds, allows for tailored screening strategies. This adaptability enables healthcare systems to optimize detection rates while managing available resources for confirmatory testing, potentially leading to more accessible and cost-effective TB programs in diverse healthcare settings.

About Lunit

Founded in 2013, Lunit is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,500 hospitals and medical institutions across 50+ countries.

Our clinical findings are featured in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA.

In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies.

Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer. Discover more at lunit.io.

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BEIJING, Aug. 6, 2024 /PRNewswire/ — Paper-cutting, a delicate art representative of China, has become a typical driver for rural vitalization in Shizhong District of Zaozhuang City in east China’s Shandong Province amid the increasing lovers of traditional Chinese culture.

For years, the district delved into intangible cultural heritage (ICH) protection and inheritance to pool resources to grow the ICH-based economy for local rural areas.

Taking the paper-cut of Diao’s family as an example, Shizhong District facilitated related business-starting, cultivated lead enterprises and organized local businesses to participate in various exhibitions and marketing activities to expand the local paper-cutting industry.

Through more paper-cutting-themed cultural activities in local schools, scenic zones, communities and villages, the district improved the influences of paper-cutting and crafted a unique regional cultural brand that brought lots of economic benefits to local villagers.

Apart from paper-cutting, walnut carving, sugar painting, dough figurine, gourd pyrography, and straw weaving thrive in Shizhong District where there are altogether 149 ICH programs and 83 ICH inheritors.

In the future, the district planned to better leverage the local ICH resources to integrate related industry development with rural vitalization to bring more business-starting and employment chances for local farmers.

See the original link: https://en.imsilkroad.com/p/341457.html

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TOKYO, Aug. 6, 2024 /PRNewswire/ — Terumo Corporation (TSE: 4543) today announced that it has established “Terumo Ventures,” a Corporate Venture Capital (CVC) organization responsible for leading the Group’s venture investments, as a department within Terumo Americas Holding, Inc.

Terumo Ventures operates in global innovation hubs around the world, such as Massachusetts and California in the United States, and invests US$ 75 million over the next five years in early-stage companies primarily in the fields of cardiovascular disease treatment, chronic disease treatment, and digital technologies. This will enable Terumo to enhance its access to innovative technologies and business ideas from start-ups, promote open innovation, and pursue synergies with its internal R&D efforts.

Terumo has been building relationships with medtech start-ups by investing in venture capital funds in the United States and China since 2013. With the establishment of the CVC, the company will further increase its agility in identifying, evaluating, and executing venture investments, while accelerating the speed of acquiring cutting-edge technologies and developing a robust M&A target pipeline for future growth.

With the 5-Year Growth Strategy “GS26” and its long-term vision of “From Devices to Solutions,” Terumo is committed to delivering innovative and comprehensive solutions to various medical challenges and unmet needs.

As part of this effort, the company has been working to strengthen its innovation capabilities. This includes the introduction of the new director position in charge of innovation in April 2024. The position centrally manages innovation-related functions across the company, such as R&D, intellectual property, clinical development, digital transformation, and venture investment, and facilitates cross-functional collaboration.

Going forward, Terumo will continue to enhance its ability to create innovation through a combination of internal development and partnerships with external parties to further expand the value it provides to society.

For more information on Terumo Ventures, please visit https://www.terumo.com/terumo-ventures.

About Terumo

Terumo (TSE:4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

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HONG KONG, Aug. 5, 2024 /PRNewswire/ — META Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investigational new drug META-001-PH for the treatment of primary hyperoxaluria (PH). Primary hyperoxaluria is a rare genetic disorder that can lead to kidney stone formation, renal failure, and can be life-threatening in severe cases. The RPDD is intended to facilitate the development of drugs and biologics for serious and life-threatening rare pediatric diseases that affect fewer than 200,000 people in the U.S. and predominantly occur in patients aged 18 years and younger. This designation is pursuant to section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ff(a)(3)).

About Primary Hyperoxaluria (PH)

Primary Hyperoxaluria (PH) is an autosomal recessive metabolic disorder in which oxalate is overproduced and deposited in the body due to defects in enzymes responsible for oxalate metabolism in the liver and other organs. Patients typically present with kidney stones, nephrocalcinosis, renal failure, and oxalate deposition in other organs. Severe cases can lead to end-stage renal disease (ESRD) requiring dialysis, kidney transplantation, or combined liver-kidney transplantation. Symptoms of the disease usually appear at the age of 0 to 3. Without intervention, most patients will develop end-stage renal disease during adolescence, which severely threatens their lives. The incidence of PH is estimated to be 1/58,000, affecting more than 10,000 people in the United States and the European Union, and more than 20,000 people in China. Currently, there is no cure for primary hyperoxaluria. Existing treatments are primarily supportive care, including increased fluid intake to dilute oxalate in the urine, and medications such as pyridoxine (vitamin B6) to reduce oxalate production. However, patients’ symptoms and disease progression cannot be effectively controlled.

About META-001-PH

META-001-PH is a groundbreaking small molecule drug developed by META for the treatment of primary hyperoxaluria. This innovative molecule is the product of a collaborative effort between META’s chemistry team and XtalPi’s (2228.HK) AI drug discovery team, who worked together from the initial scaffold screening to the preclinical compound nomination. XtalPi’s automated robotic chemical synthesis lab was responsible for the chemical synthesis of the related molecule series, ensuring a precise and efficient production process. Preclinical experiments in animal disease models have shown that META-001-PH can significantly reduce urinary oxalate excretion by up to 80%. While existing therapeutic agents are unable to effectively control urinary oxalate levels in the long term, META-001-PH, administered orally daily, can maintain oxalate at normal levels, thus demonstrating the potential for better long-term control of kidney stone formation in patients with PH. META-001-PH has also demonstrated good tolerability and safety in preclinical animal models and is undergoing IND-enabling toxicology studies with a clinical Phase I safety assessment on healthy subjects planned for 2025H1 in Australia. This collaboration between META and XtalPi marks a significant advancement in the development of effective treatments for primary hyperoxaluria.

About Rare Pediatric Disease Designation (RPDD)

The Rare Pediatric Disease Designation (RPDD) is an eligibility determination for rare pediatric diseases that affect fewer than 200,000 patients and pose a serious life-threatening risk to children under the age of 18. The RPDD and Priority Review Voucher (PRV) program aims to recognize the significant need for therapies for rare pediatric diseases and to encourage the development of new treatments for these serious or life-threatening conditions. Under the program, sponsors will be eligible to receive a PRV upon approval of a New Drug Application (NDA) or Biologics License Application (BLA) for a rare pediatric disease. PRVs can be used for any subsequent product approval application, reducing the review time by 4-6 months, or can be traded with an average transfer price of more than $100 million in recent years.

About META Pharmaceuticals Inc.

META Pharmaceuticals Inc. (META) is an innovative biopharmaceutical company dedicated to discovering and developing urgently needed breakthrough treatments for a broad range of autoimmune disorders, metabolic diseases, and cancer. As the only company in the Asia Pacific Region leveraging the groundbreaking theory of immuno-metabolism, META leads the way in creating safer and more effective therapies that modulate cellular metabolism to regulate immune system function and other pathways. META has developed two distinct chemical series targeting META-001 for the treatment of autoimmune diseases and primary hyperoxaluria, respectively, which hold the potential to become the next-generation oral treatments for these conditions, addressing significant unmet clinical needs. META Pharmaceuticals Inc. is jointly incubated by XtalPi (2228.HK), the leader in the AI-pharmaceutical industry, Forcefield Ventures, and IMO Ventures, with investments from Tiantu Capital (1973.HK), Yael Capital, Fangyuan Capital, Lead Rich International, Decent Capital, and Bopu Capital. For more information, please visit http://en.metabiopharma.com/ and follow us on LinkedIn. 

Contact: contact@metabiopharma.com

Source: Meta Pharmaceuticals Inc.

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TAIPEI, Aug. 5, 2024 /PRNewswire/ — Taiwan-based Formosa Pharmaceuticals (“Formosa“, 6838.TWO) announced today that the company has entered into an exclusive licensing agreement with Apotex Inc. (“Apotex”), for exclusive rights in Canada to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing deal will include certain payments, including an upfront payment and milestone payments upon achievement of certain regulatory and sales milestones. APP13007’s active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma’s proprietary APNT^® nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). APP13007 will enter a ~$C50M market for topical ophthalmic steroids and steroid combinations, growing at around 5% annually, driven by an estimated ~500,000 ocular surgeries annually in Canada.

“Formosa Pharma is honored to partner with Apotex, with its storied history and reputation for success,” said Erick Co, President and CEO of Formosa Pharmaceuticals. “Their commitment to branded ophthalmology products gives us full confidence that APP13007 will flourish in the Canadian market. We look forward to working with the Apotex team in providing this differentiated therapy to Canadian physicians and patients.”

“We are pleased to provide Canadian patients with APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery,” said Allan Oberman, President & CEO, Apotex. “Expanding our portfolio of innovative medicines, including our ophthalmic portfolio, along with our commercial infrastructure, enables us to support more patients along their journey to health.”

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company’s proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues. For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for consumers worldwide, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceutical products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.

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