Netupitant/Palonosetron Hydrochloride

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- On November 5, the 7th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center in Shanghai. As a seven-time attendee of the CIIE, Fosun showcased the latest achievements in innovation and global operations at its Fosun Pharma booth in Hall 7.1, featuring cutting-edge medical devices and innovative pharmaceuticals that made their debut in China. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past seven years, CIIE has improved every year, becoming a window for China to build a new development framework, a platform for high-level openness, and an international public product for global sharing. Fosun has been a participant, witness, and beneficiary of the CIIE. Leveraging the CIIE platform, our long-term innovations have continually been put into practice, transforming many 'exhibits' into 'products', and converting many overseas partners from 'exhibitors' into 'investors'. This year, we continue to showcase our latest achievements in integrated innovation in the medical device and health sector, including several 'world's firsts' and 'China's firsts'. We firmly believe that China remains a significant opportunity for global development. Together with more overseas companies and global partners, we will promote more cutting-edge innovations to take root in China, moving forward and achieving mutual success on the grand stage of the CIIE." Stars of CIIE Taking Root, Transforming Ion from "Exhibit" to "Product" Healthcare is one of Fosun's main businesses. With CIIE's "spillover effect," several star products from Fosun, supported by the CIIE "accelerator" effect, have successfully entered the market to serve Chinese patients, transforming from "exhibits" into "products". This year, following the popular da Vinci Surgical System, the Ion Robotic Bronchoscopy made its CIIE debut after receiving domestic approval. Since its first appearance at the CIIE in 2019, Ion caught the attention of visitors. By the end of 2022, Ion entered the National Medical Products Administration's 'Green Channel' for innovative products and gained approval in March 2024, with the first commercial application completed in September. Lung cancer is considered the leading cause of cancer deaths, with 1.06 million new cases in China in 2022. The five-year survival rate is only 19.7%, and bronchoscopy is a key diagnostic tool for early lung cancer detection. The Ion bronchoscopy navigation control system offers innovative features for precise, convenient clinical diagnosis, providing new options for patients. By the third quarter of this year, 736 Ion systems had been installed globally, with over 150,000 Ion procedures performed. Outside the CIIE exhibition hall, Fosun is accelerating the localization of advanced medical devices. In June this year, Intuitive Fosun's headquarter industrial base was launched in Shanghai, marking Intuitive's largest R&D, production, and training center in the Asia-Pacific region. At this base, in addition to the Ion shape-sensing bronchoscopy control system, advanced products and core components, including the da Vinci surgical robot, are gradually achieving "Made in China, joint R&D, and global sales." Accelerating Integrated Innovation to Lead in Neurological Disease Treatment Transformation Fosun has long committed to investing in cutting-edge areas of healthcare, fostering a continuous stream of breakthrough "solid achievements" through an open innovation ecosystem involving independent R&D, collaborative development, licensing, and industry investment. These innovations are continually transformed into new drivers of growth. At this year's CIIE, Fosun introduced several latest products that are leading industry transformation. In the field of neurological disease treatment, especially for conditions like essential tremor and Parkinson's disease, patients have long faced challenges with unmet clinical needs. Traditional drug and surgical treatments often have limitations, but advancements in non-invasive treatment technologies have brought new hope to these patients. Fosun has actively responded to this unmet clinical need. At this year's CIIE, the new V2 model of the CNS (Central Nervous System) innovative treatment technology, the V2 model of "Exablate Neuro FUS system" made its debut in China, generating high expectations within the industry. This new model has already received CE certification in Europe and FDA approval in the United States and submitted a registration application to China's National Medical Products Administration in 2024. The V2 model's innovation lies in providing a non-invasive surgical solution for clinically drug-resistant essential tremor and tremor-dominant Parkinson's disease, while also being compatible with a broader range of MRI models, further enhancing the accessibility of this technology. Last year, Fosun, in partnership with Insightec, showcased the "Exablate Neuro" at CIIE, drawing much attention and continuous interest in collaboration. Leveraging the CIIE's "spillover effect", Fosun Pharma and Insightec established a joint venture, Fosun-Insightec, in February this year. The venture is focused on the marketing and developing clinical efforts of Exablate Neuro FUS system in improving the lives of patient living with essential tremor and Parkinson's disease, working to help them regain their quality life and wellbeing. Focusing on innovating to meet real customer needs is a core methodology for Fosun. Data shows that Fosun has made long-term investments in technological innovation, with an investment of RMB 3.5 billion in the first half of this year. Connecting Globally to Enhance Accessibility of Innovative Drugs, Benefiting more Patients Leveraging the CIIE's openness, Fosun also presented innovative products focused on solid tumors, hematological tumors, and immune-inflammatory conditions. Fosun's seven-year journey at CIIE has facilitated the introductions of global products and enabled the export of local innovations to benefit more patients worldwide. In 2017, Fosun introduced China's first CAR-T cell therapy product, Yi Kai Da (ejilunsai injection). Since then, by continuously participating in the CIIE, Fosun has enabled the public to gain an in-depth understanding of this advanced therapy. At this year's CIIE, Fosun highlighted Yi Kai Da's latest developments in the "accessibility and treatability" in lymphoma treatment. Yi Kai Da is now included in over 110 urban customized commercial health insurances and more than 80 commercial insurances, created a new path of payment mode for patients; and over 170 high-standard treatment centers across 28 regions in China providing treatments for over 900 lymphoma patients, achieving revolutionary innovative breakthroughs for cancer care. As a global company rooted in China, Fosun has an extensive industrial presence in over 35 countries and regions worldwide, with robust global R&D capabilities and impressive progress. This year, Fosun also showcased several innovative products, including the world's first and only dual-channel fixed-dose combination oral formulation, Akynzeo® oral (Netupitant and Palonosetron hydrochloride), which blocks both NK-1 and 5-HT3 receptors; the immunoglobulin Thymoglobulin® for improving transplant patient outcomes; the world's first oral targeted medication for psoriasis, Otezla® (apremilast tablets); a new third-generation COMT inhibitor Ongentys® (Opicapone) for managing symptom fluctuations in adult Parkinson's disease patients; and Parsabiv® (Etelcalcetide Hydrochloride Injection), the only peptide-based calcimimetic for treating secondary hyperparathyroidism in adult dialysis patients with chronic kidney disease. Guo Guangchang concluded, "Participating in CIIE has been a top priority for Fosun for seven consecutive years. We have witnessed CIIE become a crucial platform for global companies to share in China's development opportunities and deepened our global partnerships through this platform. We believe the CIIE stage will continue to expand, and Fosun's journey of innovation and globalization will grow broader." SOURCE Fosun WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com