Exploratory Clinical Study on the Dexamethasone-Free, Optimized Antiemetic Regimen with NEPA (Netupitant-Palonosetron) Capsules for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately to Highly Emetogenic Chemotherapy

Start Date04 Feb 2026

Sponsor / Collaborator

Zhongshan Hospital Xiamen University

ChiCTR2600116296

/ SuspendedPhase 4IIT

To evaluate the efficacy and safety of NEPA combined with Megestrol Acetate versus NEPA combined with Dexamethasone in preventing nausea and vomiting caused by T-Dxd in breast cancer patients

Start Date30 Jan 2026

Sponsor / Collaborator-

NCT07254416

/ Not yet recruitingPhase 4IIT

To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis.
The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.

Start Date15 Dec 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

[+1]

100 Clinical Results associated with Netupitant/Palonosetron Hydrochloride

100 Translational Medicine associated with Netupitant/Palonosetron Hydrochloride

100 Patents (Medical) associated with Netupitant/Palonosetron Hydrochloride

128

Literatures (Medical) associated with Netupitant/Palonosetron Hydrochloride

01 Feb 2026·SUPPORTIVE CARE IN CANCER

Bioequivalence of netupitant and palonosetron (NEPA) oral suspension and hard capsules in healthy individuals: results from an open-label, randomized, two-treatment, four-period, two-sequence replicative design trial

Article

Author: Bezzo, Riccardo ; Seitz, Friedeborg ; Gasanin, Edis ; Spinelli, Tulla

PURPOSE:

NEPA, a fixed-antiemetic combination of netupitant and palonosetron, is available via two administration routes (oral and intravenous). A new oral suspension was developed to offer a more convenient option for patients. This study evaluated the bioequivalence between the oral capsule and the oral suspension.

METHODS:

Open-label, randomized, single-center phase I trial conducted according to a two-treatment, four-period, two-sequence replicative design. Two treatments were investigated for bioequivalence: a 10-mL oral suspension (Test [T]) and the hard capsule (Reference [R]), both containing 300 mg netupitant/0.5 mg palonosetron. Healthy individuals were randomized (1:1) to receive two doses of both Test and Reference formulations, in either T-R-T-R or R-T-R-T sequence. The primary objective was to demonstrate AUC_0-t bioequivalence of netupitant and palonosetron after a single dose of Test and Reference formulations.

RESULTS:

In total, 72 participants were included. The geometric mean plasma concentration-time profiles of netupitant and palonosetron were similar for the Test and Reference formulations. The AUC_0-t geometric means of both analytes were similar for the Test and Reference formulations. The 90% confidence interval of the Test/Reference ratios for AUC_0-t of netupitant and palonosetron were within the acceptance range for bioequivalence of 80-125%. The AUC_0-t variability was moderate for netupitant and low for palonosetron. Both formulations were well tolerated.

CONCLUSION:

The NEPA oral suspension is pharmacokinetically bioequivalent to the capsule formulation in healthy individuals, with no new safety concerns. These findings support NEPA oral suspension as a potentially beneficial option for patients who prefer an oral suspension over a hard capsule and for those with swallowing difficulties. EUCT Number: 2023-504355-28-00 (25/08/2023).

01 Feb 2026·ANNALS OF ONCOLOGY

Personalised antiemetic prophylaxis with NEPA for patients at high risk of chemotherapy-induced nausea and vomiting receiving moderately emetogenic chemotherapy: results from the randomised, multinational MyRisk trial

Article

Author: Stimamiglio, V ; Tomlins, E ; Cheng, Y ; Roeland, E J ; Brozos Vázquez, E ; Syrigos, K ; Dranitsaris, G ; Zhou, Z ; Aapro, M ; Mavroudis, D ; Schwartzberg, L ; Christoph, D C ; García Alfonso, P ; Majem, M ; Molassiotis, A ; Zimovjanová, M ; Olivari Tilola, S ; Karthaus, M ; Jordan, K ; Alonzi, A ; Bonizzoni, E ; Lu, X ; Buchler, T

BACKGROUND:

Patients receiving moderately emetogenic chemotherapy (MEC) are commonly prescribed a 5-hydroxytryptamine-3 (5-HT₃) receptor antagonist (RA) and dexamethasone (DEX) as standard-of-care (SOC) antiemetic prophylaxis. However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK₁) RA-containing regimen may optimise their antiemetic prevention. To address this unmet need for a more personalised antiemetic strategy, the MyRisk trial incorporated a predictive risk factor algorithm to select patients at increased risk of CINV who may benefit from enhanced antiemetic prophylaxis.

PATIENTS AND METHODS:

MyRisk was a phase IV, randomised, open-label, multicentre, multinational trial. Adult patients scheduled to receive three cycles of MEC with a high-risk CINV score were randomly assigned to NEPA (a fixed combination of an NK₁ RA, netupitant, and 5-HT₃ RA, palonosetron) + DEX or SOC. The CINV risk score was calculated based on an algorithm that considered seven risk factors. The primary endpoint was complete response (CR: no emesis/no rescue medication) during the overall phase (0-120 h) across three consecutive cycles.

RESULTS:

Of 401 randomly allocated patients, 388 were included in the efficacy analysis. The most common cancers were colorectal and lung; oxaliplatin and carboplatin were the most common MECs. Patients randomly assigned to NEPA were significantly more likely to experience a CR compared with SOC (odds ratio 1.67, 95% confidence interval 1.12-2.49, P = 0.012). The NEPA group had a significantly higher probability of CR, no nausea, no emesis, and complete protection (81.0%, 63.7%, 95.4%, and 71.8%, respectively) compared with the SOC arm (71.8%, 54.9%, 86.7%, and 62.4%, respectively) across three cycles of chemotherapy.

CONCLUSIONS:

When individual risk factors are considered before MEC, a three-drug regimen including NEPA provides superior CINV prevention across multiple cycles compared with the standard two-drug approach. These findings underscore the value of personalised risk-adapted antiemetic strategies and have practice-changing potential for optimising antiemetic control.

01 Dec 2025·Asia-Pacific Journal of Clinical Oncology

The Double‐Blind Placebo‐Controlled Study Comparing Upfront and Subsequent Netupitant in Addition to Olanzapine‐Containing Regimen for Prevention of High‐Dose Cisplatin‐Induced Nausea/Vomiting

Article

Author: Sitthideatphaiboon, Piyada ; Chotirut, Attapol ; Mahaparn, Wasamol ; Zungsontiporn, Nicha ; Tanasanvimon, Suebpong ; Lertanansit, Chalermchai ; Uttamapinan, Suleepon ; Vinayanuwattikun, Chanida ; Sintawichai, Nattaya ; Sriuranpong, Virote

ABSTRACT:

Background:

Addition of olanzapine to NK‐1 receptor antagonist regimen improves chemotherapy‐induced nausea and vomiting (CINV) prevention for highly emetogenic chemotherapies (HECs). However, the benefit of addition of NK‐1 receptor antagonist to olanzapine regimen has not been demonstrated. This study compared the efficacy of upfront and subsequent addition of netupitant‐ to olanzapine‐containing regimen for preventing CINV from high‐dose cisplatin (≥ 75 mg/m 2 ).

Patient and Methods:

The double‐blind placebo‐controlled trial randomized patients receiving high‐dose cisplatin to upfront and subsequent netupitant arms. In upfront netupitant arm, patients received NEPA (a combination of netupitant and palonosetron), dexamethasone, and olanzapine since first cycle. In subsequent netupitant arm, patients received olanzapine, dexamethasone, and ondansetron in first cycle but received NEPA, dexamethasone, and olanzapine in second cycle if no complete response (CR). After preplanned analysis, the initial dexamethasone dose in netupitant regimen was modified from 4 to 8 mg on Days 2–4. The primary endpoint was the overall CR rate of two cycles.

Results:

Between January 2019 and December 2020, 51 and 49 patients were randomly assigned to upfront and subsequent netupitant arms, respectively. CR rates in acute (0–24 h), delayed (> 24–120 h), and overall periods were 93.0% versus 77.4% ( p = 0.003), 75.5% versus 68.8% ( p = 0.31), and 73.3% and 67.7% ( p = 0.34) in upfront and subsequent netupitant arms, respectively. After amendment to increase dexamethasone in netupitant regimen, first‐cycle CR rates in acute, delayed, and overall periods were 95.2% versus 87.7% ( p = 0.34), 85.7% versus 73.5% ( p = 0.26), and 85.7% and 69.4% ( p = 0.26) in 4‐drug and 3‐drug groups, respectively. Among 15 patients crossing over to receive netupitant regimen in second cycle, CR was 46.6%.

Conclusion:

In this Phase II trial, there was no significant improvement in overall CR when patients received upfront netupitant compared to subsequent addition of netupitant to an olanzapine regimen in patients receiving high‐dose cisplatin chemotherapy.

News (Medical) associated with Netupitant/Palonosetron Hydrochloride

24 Mar 2026

·www.prnewswire.com

Fosun Pharma Announces 2025 Annual Results

Innovation and Globalization Propel Fosun Pharma's High-Quality Growth SHANGHAI, March 24, 2026 /PRNewswire/ -- On 24 March, 2026, Fosun Pharma ("the company", stock code: 600196.SH; 02196.HK), an innovation-driven global pharmaceutical and healthcare group, announced its 2025 annual operating results (the reporting period). Powered by the dual engines of innovation and globalization, Fosun Pharma achieved total operating revenue of RMB 41.662 billion, up 1.45% year-on-year. Of this, revenue from innovative drugs reached RMB 9.893 billion, rising 29.59% year-on-year; overseas revenue amounted to RMB 12.977 billion, growing 14.87% year-on-year. Net profit attributable to shareholders of the parent company was RMB 3.371 billion, up 21.69% year-on-year; recurring net profit attributable to shareholders of the parent company amounted to RMB 2.34 billion, increasing 1.12% year-on-year; and net cash flow generated from operating activities reached RMB 5.213 billion, up 16.45% year-on-year, further consolidating the foundation for high-quality development. Innovative Drugs Emerge as Core Growth Engine Revenue from innovative drugs hit RMB 9.893 billion, accounting for 33.16% of pharmaceutical business revenue, becoming the core engine of performance growth. Total R&D investment for the year amounted to RMB 5.913 billion, up 6.46% year-on-year, of which R&D investment related to innovative pharmaceuticals reached RMB 4.303 billion, a year-on-year increase of 15.98%, accounting for 80.26% of pharmaceutical business R&D investment. High-intensity R&D investment has been translated into fruitful results. During the reporting period, 16 indications of 7 innovative drugs were approved for marketing in China and overseas markets; marketing applications for 6 innovative drug candidates were accepted, and nearly 40 innovative drug clinical trials received approval from China and overseas regulatory authorities; and multiple core products entered key clinical phases, laying a solid pipeline foundation for subsequent commercial growth. Additionally, 5 new innovative drugs were included in the 2025 National Reimbursement Drug List (NRDL), and the CAR-T therapy Yikaida (axicabtagene ciloleucel injection) was successfully listed in the first edition of the Commercial Insurance Innovative Drug Catalog. This not only improves patient access to innovative drugs but also further unlocks the volume potential of commercialization. Building Differentiated Clinical Pipeline Advantages Fosun Pharma focuses on innovative drugs as its development priority. Centering on the three core therapeutic areas of oncology (solid tumors, hematologic tumors), immune inflammation and neurodegenerative diseases, the Company continuously strengthens its pipeline construction through in-house R&D, collaborative development and licensing-in. Oncology: In 2025, Fosun Pharma further strengthened the layout of its innovative pipeline around key indications such as breast cancer and lung cancer. The company's self-developed small-molecule innovative drug Fumaining® (luvometinib Tablet) received approval for two indications, filling the gap in the treatment of rare tumors in China; the innovative small-molecule CDK4/6 inhibitor Futuoning® (fovinaciclib citrate capsules) was launched for two indications in China, bringing a brand-new treatment option for breast cancer patients; the anti-PD-1 monoclonal antibody Serplulimab Injection was approved in Europe and multiple emerging markets for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody to receive such approval in the EU and accelerating the company's globalization pace; antibody and ADC drugs such as HLX43 and HLX22 entered key clinical phases, continuously improving the echelon of the oncology pipeline. The marketing application for the second CAR-T product Brexucabtagene Autoleucel was accepted. Immune Inflammation and Chronic Diseases: The licensed-in first-in-class innovative drug Wantile (Tenapanor Hydrochloride Tablets) was successfully approved, providing a new treatment option for chronic kidney disease patients on dialysis in China. Steady clinical progress was made for core products such as FXS7553. Neurodegenerative diseases: Opicapone Capsules, a treatment for Parkinson's disease, was launched in the Boao Pilot Zone for innovative drugs. Fosun Insightech accelerated product upgrading and indication expansion for its Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system. Sodium Oligomannate Capsule was incorporated into the Company's Alzheimer's disease innovative drug pipeline, with post-marketing confirmatory clinical trials underway. AR1001, an in-licensed asset, has advanced into global multi-center Phase 3 clinical trials. These initiatives further enriched the Company's product pipeline in the neurodegenerative disease sector. Breakthroughs in Cutting-Edge Technologies and Two-way Licensing On the basis of consolidating core technology platforms including antibodies, ADCs, small molecules, and cell therapy, Fosun Pharma is strategically investing in advanced fields such as radiopharmaceuticals and small interfering RNA (siRNA). The radiopharmaceutical project SRT-007 successfully initiated Phase I clinical trials, establishing a preliminary "imaging diagnosis - targeted therapy" integrated R&D pathway; in cell therapy, the autologous dual-target CAR-T product FKC289 had its clinical trial application accepted by the NMPA, continuously empowering the reserve of follow-on innovative products. In 2025, Fosun Pharma's global resource integration capability has been significantly enhanced. The total upfront payment from out-licensing reached over US$260 million in the whole year, with potential milestone payments exceeding US$ 3.8 billion. Among them, the global licensing project of the GLP-1 target YP05002 garnered an upfront payment of US$150 million and potential total payments of US$2.085 billion, fully confirming the global competitiveness of the company's innovative R&D. In terms of collaborative development, Fosun Pharma entered into a joint development agreement with Teva for FXB0871 and established original innovation cooperation with a fund under Aditum Bio. Meanwhile, Fosun Pharma introduced multiple overseas original drugs, including Akynzeo (netupitant and palonosetron hydrochloride capsules), Pu Rui Ni (pretomanid tablets) , and Daxxify (botulinum toxin type A for injection), through licensing-in, achieving marketing approval for them in China. Globalization Moves Towards "System-centric Globalization" In 2025, Fosun Pharma's international development achieved a strategic upgrade from "product-centric going global" to "system-centric globalization", making comprehensive breakthroughs in innovative R&D, production quality, registration and access, commercialization and academic influence, and building a global operation network covering markets such as China, the United States, Europe, Africa, India and Southeast Asia. In 2025, the company's overseas revenue reached RMB 12.977 billion, accounting for 31.15% of the total revenue, increased by 3.64 percentage points year-on-year. Fosun Pharma has built a global R&D and production synergy registration capability featuring "leading breakthroughs in Europe and the US, and in-depth cultivation in emerging markets". The core innovative drug Serplulimab Injection has been approved for marketing in more than 40 countries and regions worldwide. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. Biosimilars such as Denosumab have successively obtained approvals from the FDA and the EU, marking that the quality system and registration capability of the biologic drug platform have been certified to international standards; the small-molecule innovative drug Fumaining® received Priority Review status from the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, becoming an important fulcrum to leverage the Middle East and global markets. Seventeen of Fosun Pharma's workshops/production lines in China have passed GMP certifications of mainstream regulatory markets such as the US, the EU and the WHO. The relevant biologic drug production lines have realized regular supply to the global market, covering China, Europe, Latin America, Southeast Asia, India and other markets. Multiple injection production lines of India's Gland Pharma have passed certifications in Europe, the US, Japan and Australia, providing a solid guarantee for the stability and quality controllability of the global supply chain. Fosun Pharma has formed a mature overseas go-global model of "independent operation + licensing authorization" running in parallel, with over 6,000 commercial personnel worldwide and established a marketing network covering over 40 countries and regions in Africa; the controlling subsidiary Sisram's marketing network covers over 110 countries and regions, while Breas covers over 50 countries and regions. ESG Governance Recognized by Global Authorities While achieving high-quality development of its core business, in 2025, Fosun Pharma's MSCI ESG rates were upgraded to "AA", retained its Hang Seng ESG rating of "A-" and was selected into the 2025 Fortune China ESG Influence List, being the only Chinese pharmaceutical enterprise on the list. "In 2025, Fosun Pharma firmly implemented its corporate strategy of Innovation Driven, Deep Globalization and AI Embracement, achieving high-quality growth powered by innovative drugs and globalization." Chen Yuqing, Chairman of Fosun Pharma said, "Looking ahead, Fosun Pharma will always focus on unmet clinical needs, continue to innovate, and further deepen its layout in core therapeutic areas such as oncology, immune inflammation and neurodegenerative diseases. It will integrate innovative resources from a global perspective, drive operational upgrading with digital intelligence, and strive to become a world-leading integrator of medical innovation, creating long-term value for shareholders and providing more high-quality and accessible medicines and healthcare solutions for patients." About Fosun Pharma Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem. Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia. Looking ahead, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health. For more information, please visit the company website: SOURCE Fosun Pharma 21% more press release views with Request a Demo

Phase 1Drug ApprovalLicense out/in

09 Feb 2026

·www.biospace.com

Helsinn and ESTEVE expand their partnership extending the Distribution and Licence Agreement for AKYNZEO® and ALOXI® to Austria

Helsinn and ESTEVE expand their partnership extending the Distribution and Licence Agreement for AKYNZEO ® and ALOXI ® to Austria Lugano, Switzerland – February 9th, 2026 – Helsinn Healthcare SA (“Helsinn”), a global pharmaceutical group focused on supporting patients with cancer and chronic diseases, and ESTEVE, an international pharma company with a focus on highly specialized treatments that address significant unmet medical needs, today announced that they have expanded their relationship by extending the Distribution and Licence Agreement for AKYNZEO ® (combination of netupitant-palonosetron) and ALOXI ® (palonosetron) to Austria. Both products are indicated for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. 1 2 Helsinn and ESTEVE previously entered into a Distribution and Licence Agreement for ALOXI ® and AKYNZEO ® in Germany, in November 2007 and September 2011, respectively. Riccardo Braglia, Chairman and CEO of Helsinn, commented: “We are delighted to further strengthen our long-standing collaboration with ESTEVE, a trusted partner for more than 15 years. This enduring relationship is built on a deep alignment of values and a shared commitment to delivering the highest standards of supportive care to patients. Together, we strive to continuously innovate and provide solutions that make a meaningful difference in the lives of those undergoing cancer treatment.” Klaus Schwarz, Managing Director DACH of ESTEVE, added: “With the expansion of our collaboration to Austria, we are transferring our long-standing experience with AKYNZEO® and ALOXI® to another market within the German-speaking region, while strategically expanding our business activities and strengthening our presence in this country. As a company with a clear focus on highly specialized solutions, our ambition goes beyond individual products: we aim to contribute sustainably to patient care, improve access to treatments, and create long-term value by serving people with unmet medical needs.” About AKYNZEO ® AKYNZEO ® is a 5-HT3 and NK1 receptor antagonist fixed combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics 1 . About ALOXI ® ALOXI® is approved in Europe in adults for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. ALOXI® is also indicated in pediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. For additional information please see the EU Summary of Product Characteristics 2 . 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 diseases, with a focus on supportive care, oncology and dermato-oncology. Headquartered in Lugano, Switzerland, Helsinn has direct commercial operations in the U.S., manufacturing operations in Ireland, offices in China, and a network of trusted partners enabling a commercial presence in 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. For half a century, Helsinn has been operating with integrity, passion, and quality. The company continuously fosters innovation for its patients and embraces sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit or follow us on LinkedIn and X . About ESTEVE ESTEVE ( esteve.com ) is a global pharmaceutical company with a clear purpose: to improve people's lives. Founded in 1929 and headquartered in Barcelona, ESTEVE has a strong international presence with pharmaceutical affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA.   ESTEVE is focused on delivering highly specialized treatments that address significant unmet medical needs in several therapeutic areas. In addition, to our innovative pharma business, we offer comprehensive Contract Manufacturing and Development services (CDMO), specializing in the production of Active Pharmaceutical Ingredients (APIs) through world-class facilities in Spain, Mexico, China and the USA. ESTEVE's strong commitment to its core values—people matter, transparency, and accountability—remains at the heart of everything it does.   For more information: Helsinn Media Contact Sabrina Perucchi Group Communication Manager Tel: +41 (0) 91 985 21 21 Email: communications@helsinn.com ESTEVE / Local PR agency: Verena van Elst VAN ELST healthcare Berlin, Deutschland Tel. +49 30 58 75 75 78 Email: vve@vanelst-healthcare.de

License out/inDrug Approval

06 Nov 2025

·www.prnewswire.com

Fosun Marks Eighth Year at CIIE, Guo Guangchang Calls for More Cutting-Edge Innovation

HONG KONG, Nov. 6, 2025 /PRNewswire/ -- On 5 November 2025, the 8th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center (Shanghai). As a "full-attendance" exhibitor for eight consecutive years, Fosun, together with its overseas member companies and global partners, is showcasing a range of world-leading innovative drugs, advanced medical devices, and achievements in international collaboration at the Fosun Pharma booth in the Medical Equipment and Healthcare Products Exhibition Area. The exhibits focus on core therapeutic areas including oncology, immune-inflammatory disorders, central nervous system, and kidney diseases, highlighting holistic breakthroughs in medical technology, from diagnosis and treatment to recovery. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past eight years, the CIIE has continued to grow in influence and innovate, serving as a key window into China's new development paradigm, a platform for advancing high-level opening-up, and a global public good that benefits the international community. We have witnessed and benefited from this 'everlasting' showcase. The CIIE has enabled Fosun's global innovations to continuously transform from 'exhibits' into 'products', while many overseas partners have changed their roles from 'exhibitors' to 'investors'. Fosun believes that healthcare innovation should address unmet clinical needs and bring hope of cure to patients. This year, our showcases in the Medical Equipment and Healthcare Products Exhibition Area center on the latest advancements addressing global clinical needs, with several new products making their debut. We firmly believe that China's high-level opening-up will remain a source of certainty and opportunity for global development. Looking ahead, Fosun will further capitalize on its global industrial advantages to foster more cutting-edge innovations in China, contributing the 'power of Fosun' to fulfill people's aspirations for a better life." Focusing on oncology: advancing from "treatment" to "cure" Fosun is presenting a series of cutting-edge innovative products aimed at advancing oncology from "treatment" to "cure" at this year's CIIE. Among them, the debut product, the Marie Upright Particle Therapy System, has attracted significant attention. As a revolutionary breakthrough in cancer treatment, the Marie Upright Particle Therapy System eliminates the cumbersome structure of conventional particle therapy system, enabling rapid deployment within existing medical facilities. Studies show that the upright positioning enhances precision in tumors located in the lung, breast, abdomen, and other areas. The system supports multiple advanced particle therapy modalities including proton therapy, heavy ion therapy, boron neutron capture therapy (BNCT), and FLASH radiotherapy, offering patients more precise, comfortable, and flexible treatment options. The Marie Upright Particle Therapy System, which received U.S. Food and Drug Administration (FDA) approval in July 2025, is making its debut in China at this year's CIIE. In the field of hematologic oncology, Fosun's Yi Kai Da (ejilunsai injection), China's first CAR-T cell therapy product, continues to share the latest developments in making lymphoma treatment both accessible and curative at the CIIE. This year, Yi Kai Da has made multiple major advances: inclusion in over 110 urban customized commercial health insurances and over 80 commercial insurances; establishment of over 190 high-standard treatment centers across 29 provinces and cities nationwide, benefiting more than 1,000 lymphoma patients; successful first-ever cross-border shipping and usage in Hong Kong SAR and Macau SAR; and a remarkable case of the first patient treated with Yi Kai Da in the Chinese mainland achieving over seven years of high-quality survival. Notably, following Yi Kai Da, the drug registration application of Fosun's second CAR-T product, brexucabtagene autoleucel injection, was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Regarding supportive care in cancer, Fosun is showcasing several innovative drugs that fill treatment gaps in the domestic market. These include the world's first and currently only dual-channel antiemetic, Akynzeo (netupitant and palonosetron hydrochloride capsules); China's first oral thrombopoietin receptor agonist with dual indications for chronic liver disease-associated thrombocytopenia and immune thrombocytopenia, Su Ke Xin (avatrombopag maleate tablets); and the long-acting recombinant human granulocyte colony-stimulating factor, Pei Jin (telpegfilgrastim injection). Additionally, Wan Ti Le (tenapanor hydrochloride tablets), a "CIIE baby" introduced to China through the CIIE, received approval from the NMPA in February 2025. It is indicated for the control of serum phosphorus levels in dialysis patients with chronic kidney disease. This groundbreaking innovation has also been shortlisted as a candidate for Best Pharmaceutical Product at the Prix Galien 2025. Addressing neurological disorders with innovative drugs and devices In recent years, the number of patients with neurological disorders has rapidly increased, with a notable trend toward younger patients. Disorders such as Parkinson's disease, brain tumors, and epilepsy have attracted growing attention. Focusing on unmet clinical needs, Fosun is actively exploring world-leading innovative solutions. In advanced medical devices, Fosun is once again featuring cutting-edge non-invasive treatments, the magnetic resonance image guided focused ultrasound brain therapy system (MRgFUS brain therapy system) and the world's first 128-channel helium-free Marvel magnetoencephalography (MEG), at the CIIE, providing integrated solutions from precise localization to non-invasive treatment for common neurological disorders such as Parkinson's disease, brain tumors, and epilepsy. To date, more than 25,000 patients worldwide have benefited from the MRgFUS brain therapy system. Its new V2 model, featuring enhanced device compatibility and easier operation, has obtained CE marking in the European Union and U.S. FDA approval. Since its debut at the last CIIE, the MRgFUS brain therapy system has been deployed in over 10 medical institutions in the Chinese mainland, benefiting nearly 1,000 patients. In the field of innovative drugs, Fosun has introduced a world-leading combination therapy for Parkinson's disease, contributing to the continuous improvement of diagnosis and treatment in China. The oral COMT inhibitor, Ongentys (opicapone) is currently the only once-daily COMT inhibitor approved globally, offering convenient dosing that significantly enhances treatment adherence and long-term disease management. Ongentys is already in clinical use in pilot zones such as Boao Lecheng, leveraging special access policies for clinical prescriptions and paving the way for broader national adoption. Integrating global resources to drive local innovation, embracing AI to accelerate breakthroughs Fosun continues to integrate global resources to advance cutting-edge medical technologies in China. Leveraging CIIE's support in transforming "exhibits" into "products", Intuitive Fosun's surgical system has been gradually launched, contributing to the development of a high-quality healthcare system in China. The Da Vinci surgical system, a popular exhibit at the CIIE for eight consecutive years, has witnessed the rapid development of minimally invasive surgery in China. By the end of September 2025, over 480 Da Vinci surgical systems had been installed in more than 370 hospitals across the Chinese mainland, Hong Kong SAR, and Macau SAR, collectively serving over 810,000 patients. This year, Intuitive Fosun is showcasing several surgical systems, including the domestically produced multiport Da Vinci Xi surgical system, the single-port Da Vinci SP surgical system designed for single-incision or natural orifice surgeries, and the Ion Robotic Bronchoscopy that brings breakthrough innovations in lung cancer diagnosis and treatment. To better meet China's clinical needs, Intuitive Fosun Innovation Center has partnered with over 20 grade 3A hospitals accredited by the National Health Commission of the People's Republic of China to establish Da Vinci Surgical System Training Centers, creating an integrated training system that combines clinical practice with education. To date, Intuitive Fosun has established 7 regional training centers across China and trained more than 15,000 medical professionals, promoting the standardized and sustainable development of surgical systems nationwide. In digital transformation, Fosun actively embraces AI and has gradually built a comprehensive digital and intelligent system covering research and development, operations, and product applications. At this year's CIIE, Fosun Pharma is showcasing its PharmAID decision intelligence platform, which deeply integrates leading large model technologies such as DeepSeek, achieving intelligent leaps in drug commercial decision-making, clinical trial prediction, and toxicology optimization. In medical aesthetics, Sisram is presenting revolutionary solutions including Alma IQ, an intelligent skin analysis and consultation solution, and Universkin, the world's first AI-assisted medical-grade skincare line launched in North America, setting new standards for personalized treatment. In healthcare services, Fosun Health continues to explore deep AI applications in assisted diagnosis, treatment quality control, and proactive health management. Leveraging four core hospitals in the Greater Bay Area including Foshan Fosun Chancheng Hospital, Fosun Health has established an internationalized service platform integrating online and offline resources, providing one-stop services from remote consultation to full patient care for individuals from Japan, Bangladesh, Indonesia, Peru, and other countries. Guo Guangchang said, "Looking ahead, Fosun will leverage its long-established innovation and globalization capabilities, collaborating with global partners to continuously drive high-quality development of the pharmaceutical industry and help realize the ambitious vision of 'Healthy China 2030'." SOURCE Fosun 21% more press release views with Request a Demo

Drug Approval

100 Deals associated with Netupitant/Palonosetron Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Netupitant/Palonosetron Hydrochloride	A04AA	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Nausea	Canada	Knight Therapeutics, Inc.	20 Nov 2017
Vomiting	Canada	Knight Therapeutics, Inc.	20 Nov 2017
Chemotherapy-induced nausea and vomiting	United States	Helsinn Healthcare SA	10 Oct 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	United States	Helsinn Healthcare SA	16 Mar 2018
Brain Cancer	Phase 2	Greece	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Poland	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Romania	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Turkey	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Greece	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Poland	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Romania	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Turkey	Helsinn Healthcare SA	07 Jul 2025
Neoplasms	Phase 2	United States	Helsinn Therapeutics (U.S.), Inc.	27 Apr 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2025	Not Applicable	Chemotherapy-induced nausea and vomiting	22	Oral NEPA (netupitant and palonosetron) (highly emetogenic chemotherapy)	zaabklrxcw(qbqpwvcxzh) = dtkgaznprh bdkffcvmqp (usfxbvzeal ) View more	Positive	05 Dec 2025
				Oral NEPA (netupitant and palonosetron) (moderately emetogenic chemotherapy)	zaabklrxcw(qbqpwvcxzh) = gxmyjhuwaz bdkffcvmqp (usfxbvzeal ) View more
NCT04817189 (CINV \| MyRisk, CTgov)	Phase 4	Chemotherapy-induced nausea and vomiting	414	Dexamethasone+NEPA (300mg netupitant/0.5mg palonosetron) (NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg)	zmvhnomgcv = pksfhchbrf xunimxjkpl (uzjpehsrsl, nzlilkguxs - ckwzahgxzd) View more	-	29 Oct 2025
				Granisetron+Tropisetron+Dolasetron+Dexamethasone+Palonosetron+Ondansetron (Standard of care + Dexamethasone 8 mg)	zmvhnomgcv = wcbwdrlwfh xunimxjkpl (uzjpehsrsl, opgqlvuqxb - toakwalxqh) View more
NCT03367572 (CTgov)	Phase 3	Nausea \| Breast Cancer \| Vomiting	1,363	Quality-of-Life Assessment+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone)	bkskmrsalq(yuexxweotw) = tnrunyhcdp yujfsyffgn (cizlrdlfpy, 0.155) View more	-	25 Sep 2025
				Quality-of-Life Assessment+Prochlorperazine+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo))	bkskmrsalq(yuexxweotw) = vrvzrpwipf yujfsyffgn (cizlrdlfpy, 0.141) View more
ChiCTR2400089311 (ASCO2025)	Phase 3	Chemotherapy-induced nausea and vomiting	164	Dexamethasone 5mg	pjwgtkppia(qlelloagxj) = obhrnxgmyz eyangvplqx (hmeohrjimz ) View more	Positive	30 May 2025
				Dexamethasone 8mg	pjwgtkppia(qlelloagxj) = pnrkdhpeqf eyangvplqx (hmeohrjimz ) View more
ASCO2025	Not Applicable	Nasopharyngeal Carcinoma	312	Oral NEPA	dbjxbivxin(rzpldssjlv) = kdnywlivmb ulizognkfb (hzicotktvr ) View more	Positive	30 May 2025
				Fosaprepitant + Palonosetron	dbjxbivxin(rzpldssjlv) = grcutscvft ulizognkfb (hzicotktvr ) View more
NCT06065722 (Pubmed \| Cancer Med)	Phase 2	Chemotherapy-induced nausea and vomiting	227	NEPA (Netupitant/Palonosetron) plus dexamethasone with olanzapine	upwiomujso(vdahmbfvgg) = knqpzfgagk byjmdtwdln (stsjsmamjb, 59 - 88)	Positive	01 Apr 2025
				NEPA (Netupitant/Palonosetron) plus dexamethasone	upwiomujso(vdahmbfvgg) = qpyzunbpke byjmdtwdln (stsjsmamjb, 67 - 89)
ESMO_ASIA2024	Not Applicable	Neoplasms	164	NEPA	qnwfpsgynr(ohofdwyvxw) = wmpqzruogx hlfewgofqz (upzvtaxvfv ) View more	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	-	-	NEPA 300mg on day 1,5	sqttezrqcq(gbadnfvvyq) = jhesobjkpq xegdneqfhs (anqcbqiurf ) View more	Positive	07 Dec 2024
				NEPA 300mg on day 1	sqttezrqcq(gbadnfvvyq) = pkjwkpexug xegdneqfhs (anqcbqiurf ) View more
CTRI/2023/04/051951 (ASCO2024) Manual	Phase 4	Chemotherapy-induced nausea and vomiting	178	IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (HEC)	dlfrijemqz(qfamosgkpb) = qsieobpuas fplrejonuo (dnghquezhu ) View more	Positive	24 May 2024
				IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (MEC)	dlfrijemqz(qfamosgkpb) = ezaitjnzsw fplrejonuo (dnghquezhu ) View more
EHA2023	Not Applicable	Hematopoietic stem cell transplantation \| Lymphoma	76	NEPA	kptfultsot(qvrqjrergl) = yfbwvdfkkq uvqpxqqydy (gbqlxdczcw ) View more	-	08 Jun 2023
				Ondansetron	kptfultsot(qvrqjrergl) = npbbfotqoz uvqpxqqydy (gbqlxdczcw ) View more

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Netupitant/Palonosetron Hydrochloride

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