A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital

This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm.
The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.

Start Date01 Aug 2026

Sponsor / Collaborator

Ottawa Hospital Research Institute

CTR20262093

/ Active, not recruitingNot Applicable

奈妥匹坦帕洛诺司琼胶囊空腹状态下在健康试验参与者中的生物等效性试验

[Translation] Bioequivalence study of netupitant palonosetron capsules in healthy trial participants under fasting conditions

主要目的：在健康男性与女性试验参与者中于空腹条件下，评价受试制剂奈妥匹坦帕洛诺司琼胶囊【规格：每粒硬胶囊含奈妥匹坦0.3 g（0.1 g/片×3片）和盐酸帕洛诺司琼0.5 mg（以C19H24N2O计，软胶囊1粒），生产商：浙江华海制药科技有限公司】和Helsinn Healthcare SA为持证商的参比制剂奈妥匹坦帕洛诺司琼胶囊【奥康泽（Akynzeo），规格：每粒硬胶囊含奈妥匹坦0.3 g（0.1 g/片×3片）和盐酸帕洛诺司琼0.5 mg（以C19H24N2O计，软胶囊1粒）】的生物等效性。次要目的：观察受试制剂奈妥匹坦帕洛诺司琼胶囊与参比制剂奈妥匹坦帕洛诺司琼胶囊【奥康泽（Akynzeo）】在健康试验参与者中的安全性。

[Translation]

Primary Objective: To evaluate the bioequivalence of the investigational formulation, netupitant-palonosetron capsules [specification: each hard capsule contains 0.3 g netupitant (0.1 g/tablet × 3 tablets) and 0.5 mg palonosetron hydrochloride (calculated as C19H24N2O, 1 soft capsule), manufactured by Zhejiang Huahai Pharmaceutical Technology Co., Ltd.], and the reference formulation, netupitant-palonosetron capsules [Akynzeo, specification: each hard capsule contains 0.3 g netupitant (0.1 g/tablet × 3 tablets) and 0.5 mg palonosetron hydrochloride (calculated as C19H24N2O, 1 soft capsule), manufactured by Helsinn Healthcare SA], under fasting conditions in healthy male and female participants. Secondary objective: To observe the safety of the investigational formulation, netupitant-palonosetron capsules, compared with the reference formulation, netupitant-palonosetron capsules [Akynzeo], in healthy trial participants.

Start Date24 Jun 2026

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Technology Co., Ltd.

ACTRN12626001076369

/ RecruitingPhase 4IIT

A randomised, open-label controlled trial of oral Akynzeo (netupitant/palonosetron) versus standard anaesthesia care for post-operative nausea, vomiting and pain in adults undergoing metabolic bariatric surgery

Start Date06 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Netupitant/Palonosetron Hydrochloride

100 Translational Medicine associated with Netupitant/Palonosetron Hydrochloride

100 Patents (Medical) associated with Netupitant/Palonosetron Hydrochloride

132

Literatures (Medical) associated with Netupitant/Palonosetron Hydrochloride

01 Oct 2026·SUPPORTIVE CARE IN CANCER

A phase 2 pharmacokinetic and pharmacodynamic dose-finding study of oral NEPA for chemotherapy-induced nausea and vomiting in pediatric patients with cancer

Article

Author: Patel, Priya ; Spinelli, Tulla ; Chaleff, Stanley ; Dementieva, Nataliia ; Bernareggi, Alberto ; Melnikov, Mikhail ; Chen, Tingchao ; Arakaev, Oleg

PURPOSE:

Chemotherapy-induced nausea and vomiting (CINV) remains a significant challenge in pediatric oncology, with limited data guiding optimal antiemetic regimens. This phase 2 study evaluated pharmacokinetics (PK), pharmacodynamics, efficacy, and safety of oral netupitant combined with oral palonosetron (NEPA) in pediatric patients receiving highly or moderately emetogenic chemotherapy.

METHODS:

In this multicenter, randomized, double-blind, dose-finding study, pediatric patients (< 18 years) were stratified by age, chemotherapy emetogenicity, and schedule. Patients received one of two netupitant doses (1.33 or 4 mg/kg) with palonosetron (20 µg/kg). Efficacy was assessed via complete response (CR; no emesis and no rescue medication) during acute (0-24h), delayed (> 24-120h), and overall (0-120h) phases. PK parameters were derived from plasma concentrations of netupitant, its metabolites, and palonosetron. Safety was monitored through adverse events and clinical assessments.

RESULTS:

Among 65 evaluable patients, CR rates were 85.3%, 70.6%, and 70.6% in the lower netupitant dose group, and 87.1%, 71.0%, and 67.7% in the higher dose group, for the acute, delayed, and overall phases, respectively. CR was mostly consistent across age groups and chemotherapy emetogenicity. A trend toward increased CR with higher netupitant exposure (AUC_0-inf) was observed in the delayed phase. The safety profile was consistent with expectations for cytotoxic chemotherapy, and no new safety signals were observed.

CONCLUSION:

A single dose of 4 mg/kg oral netupitant with oral palonosetron was effective and well-tolerated for CINV prevention in pediatric patients, supporting further investigation of NEPA in this population.

TRIAL REGISTRATION:

NCT03204279 [2 July 2017 registration date].

01 Sep 2026·JOURNAL OF CLINICAL ONCOLOGY

Reduced/No Dexamethasone With Netupitant/Palonosetron and Olanzapine for Chemotherapy‑Induced Nausea/Vomiting in Highly Emetogenic Chemotherapy: Phase III Noninferiority Trial

Article

Author: Yan, Fei ; Zhou, Qin ; Weng, Jie ; Yang, Ling ; Wu, Hao ; Fang, Shencun ; Mu, Yuxin ; Fan, Weifei ; Zhao, Jianhua ; Meng, Yanchun ; Liu, Jinsong ; Zhang, Ling ; Du, Yiqun ; Liu, Xiaojun ; Liu, Yingying ; Li, Zikang ; Zhang, Jian ; Lin, Mingxi ; Mao, Yu ; Zhou, Jianbo ; Chen, Yong ; Wang, Lili ; Tian, Shaodong ; Zhuang, Xiaojie ; Long, Xiangyu ; Liu, Lianfang

PURPOSE:

Guideline-recommended 4-day dexamethasone (DEX) for highly emetogenic chemotherapy (HEC) raises toxicity and immunotherapy interference concerns. We tested whether DEX reduction or omission with netupitant/palonosetron (NEPA) plus olanzapine (OLZ) is noninferior to standard DEX.

PATIENTS AND METHODS:

In this open-label, randomized phase III noninferiority trial across 28 Chinese centers, adults receiving HEC received NEPA (day 1) plus OLZ (days 1-4) and were randomly assigned to standard DEX (12 mg day 1, 8 mg days 2-4), DEX-sparing (6 mg day 1 only), or DEX-free (no DEX). The primary end point was complete response (CR; no emesis/no rescue medication) from 0 to 120 h. Noninferiority margin was –12% (one-sided α = .025).

RESULTS:

Of 644 randomly assigned patients (median age 54.9 years; 66.0% female), stratified analysis showed overall CR rates of 72.4% for standard, 72.2% for DEX-sparing (stratified risk difference [RD], –0.2% [95% CI, –8.7 to 8.5]; Pnoninferiority = .005), and 70.1% for DEX-free (stratified RD, –2.2% [95% CI, –10.7 to 6.4]; Pnoninferiority = .014). Both met noninferiority, confirmed in per-protocol analysis. Steroid-related toxicities were significantly lower with DEX-sparing and DEX-free regimens versus standard.

CONCLUSION:

NEPA plus OLZ with reduced (6 mg day 1 only) or no DEX is noninferior to standard 4-day DEX for chemotherapy-induced nausea and vomiting prevention in HEC, supporting steroid-sparing strategies particularly relevant in the chemo-immunotherapy era.

01 Sep 2026·Drug information journal

Pharmacoeconomic Evaluation of Netupitant Palonosetron for Chemotherapy-Induced Nausea and Vomiting: Evidence from Economic Analyses

Article

Author: Tian, Chen ; Zhang, Fan ; Zhang, Yunjin ; Zhang, Meiyan ; Wang, Chenghui ; Zhang, Lei ; Zhang, Hongnan

INTRODUCTION:

This study was conducted to systematically evaluate the economic profile of netupitant palonosetron(NEPA) for the prevention of chemotherapy-induced nausea and vomiting(CINV)in patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC). The goal is to provide evidence-based support for optimizing clinical medication decisions and standardizing future pharmacoeconomic research.

METHODS:

Literature was searched through different Chinese and English databases from database inception to March 16, 2025, with study quality assessed using the CHEERS checklist. Most evaluations utilized cost-utility analysis via Markov or decision tree models, primarily focusing on direct medical costs from healthcare payer or system perspectives.

RESULTS:

Nine studies meeting the inclusion criteria were analyzed. The results confirm the economic advantages of NEPA for CINV prophylaxis. In Western healthcare systems (UK, Spain, Italy, and the US), NEPA was frequently identified as a dominant strategy, providing greater health benefits (QALYs) at lower total costs. In China, NEPA was shown to be cost-effective at a willingness-to-pay (WTP) threshold equivalent to one times the national GDP per capita. Sensitivity analyses revealed that the cost-effectiveness of NEPA is highly sensitive to local drug pricing and variations in clinical practice.

CONCLUSION:

NEPA is a cost-effective or even dominant strategy for CINV prophylaxis in both HEC and MEC populations. These findings provide a scientific basis for drug reimbursement negotiations and clinical pathway optimization. Future research should utilize real-world evidence across multiple chemotherapy cycles to further validate its long-term economic value and support value-based healthcare decisions.

News (Medical) associated with Netupitant/Palonosetron Hydrochloride

25 Aug 2026

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Fosun Pharma Announces 2026 Interim Results

Globalization Accelerates Value Realization of Innovative Drugs SHANGHAI, Aug. 25, 2026 /PRNewswire/ -- On August 25, Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) announced its interim results for 2026. In the first half of 2026 ("the Reporting Period", or 1H2026), the Company recorded revenue of RMB 20.442 billion, a year-on-year increase of 4.75%, or 7.17% at constant exchange rates. Profit attributable to shareholders of the listed company, net of non-recurring gains and losses, stood at RMB 1.144 billion, up 19.09% year-on-year. Profit growth outpaced revenue growth, reflecting sustained improvement in earnings quality. Net cash generated from operating activities reached RMB 2.424 billion, rising 13.59% year-on-year. Innovation and globalization stand as the dual core engines driving business performance. Revenue from Innovative Drugs hit RMB 4.911 billion, representing a 13.84% year-on-year increase and accounting for 33.21% of pharmaceutical segment revenue, 2.17 percentage points higher than the same period last year. Business revenue from regions outside Chinese mainland and other countries totaled RMB 6.379 billion, growing 16.45% year-on-year and making up 31.21% of total revenue, a year-on-year uplift of 3.14 percentage points. The Group's revenue mix continues to improve. Focusing on Core Therapeutic Areas and Accelerating Clinical Translation of Innovative Drugs Guided by clinical-value-driven innovation, Fosun Pharma prioritises three core therapeutic areas: oncology, immunology and inflammation, and neurodegenerative diseases. It also expands into CVRM (cardiovascular, renal and metabolic), anti-infectives, rare diseases and other segments. Leveraging an open-innovation framework that combines in-house R&D, two-way licensing and fund-incubation models, the Company accelerates clinical translation and pushes forward its innovation-led transformation. In 1H2026, Fosun Pharma's total R&D investment amounted to RMB 3.247 billion, up 25.66% year-on-year. Among this, R&D investment related to Innovative Drugs accounted for 81.61% of total R&D investment, primarily directed towards pipelines such as HLX43, HLX22, GR1803, FXR0906, as well as next-generation small molecule drugs, radiopharmaceuticals, and other cutting-edge technology platforms. During the reporting period, Fosun Pharma's Innovative Drugs entered a period of intensive approvals and value realization, with a total of 20 indications of 7 Innovative Drugs were approved for launch both domestically and overseas. In solid tumor areas including lung cancer, breast cancer, and gastrointestinal tumors, the Company has established differentiated competitive advantages through multi-product synergy and global commercialization. Han Li Kang (Rituximab), Han Qu You (trastuzumab), and Akynzeo® continue to maintain leading positions in their respective market segments, consistently contributing stable cash flow. During H1 2026, Han Si Zhuang (Serplulimab) gained approval in China for the perioperative treatment of gastric cancer, filling a global unmet clinical need. In the EU, it obtained three additional first-line approvals for squamous non-small-cell lung cancer, esophageal squamous-cell carcinoma and non-squamous non-small-cell lung cancer. To date, serplulimab has been launched in approximately 50 countries and regions worldwide and is reimbursed under national health-insurance or public-reimbursement schemes in 12 markets including the United Kingdom, Germany, Italy, Spain and Sweden. Han Bei You (Pertuzumab) received successive marketing approvals in the EU and China. It works in synergy with breast-cancer portfolio assets including Han Qu You, Han Nai Jia and Fu Tuo Ning to drive commercial uptake. Fu Mai Ning (luvometinib tablets) secured a new indication for pediatric and adolescent patients aged two years and older with relapsed/refractory Langerhans-cell histiocytosis (LCH) following systemic therapy, addressing an unmet clinical need in China. With regulatory applications accepted for multiple innovative drugs and international multi-center clinical trials for key pipelines moving forward efficiently, Fosun Pharma continues to fuel its long-term commercial growth. - The NDA for SAF-189 (foritinib succinate capsules), an ALK inhibitor for non-small-cell lung cancer, has been accepted by the NMPA. - The NDA of Fu Mai Ning for adult patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) has been accepted and granted priority review by the NMPA. - The NDA for Velinotamig (GR1803), a BCMA × CD3 bispecific antibody for multiple myeloma, has been accepted. Lead pipeline candidates HLX43 and HLX22 are progressing in international multi-center trials across China, the US, Europe, Australia, Japan and other geographies. As a potential best-in-class pan-tumor PD-L1-targeting ADC, HLX43 has demonstrated promising preliminary clinical efficacy featuring high potency and favorable safety profiles across multiple solid tumors types including non-small-cell lung cancer. In the immunology and inflammation field, the Company strengthened its in-house R&D while continuously enriching its pipeline through BD collaborations, obtaining the rights to develop, manufacture, and commercialize roconkibart (anti-IL-17A monoclonal antibody) in Chinese mainland, Hong Kong SAR, Macau SAR, and Taiwan region. The complement inhibitor FXS6837 for the treatment of IgA nephropathy and other glomerular diseases associated with complement dysregulation initiated Phase 2b clinical trials in Chinese mainland. The DPP1 inhibitor FXS7553 is in Phase 2 clinical stage in Chinese mainland for two indications: non-cystic fibrosis bronchiectasis and COPD. In the neurodegenerative diseases field, the integrated diagnosis and treatment layout continues to strengthen. The post-marketing confirmatory clinical trial for Sodium Oligomannate Capsules in Chinese mainland is progressing steadily; as of July 31, 2026, cumulative enrollment exceeded 1,000 cases, reaching over 50% of the planned enrollment target. HT001, an investigational drug for Parkinson's disease, has initiated Phase 1 clinical trials in Australia. Parallel work is underway on the clinical deployment of magnetic-resonance-guided focused-ultrasound therapy and the R&D of companion diagnostic reagents. Rooted in evidence-based medicine, Fosun Pharma presented three oral abstracts at the 2026 ASCO Annual Meeting, including the Phase 3 study of Fu Mai Ning in adult NF1 patients, the Phase 3 study of serplulimab injection in the perioperative setting for gastric cancer, and the clinical study of HLX43 in non-small cell lung cancer. 10 studies were selected for poster presentations at the 2026 ASCO Annual Meeting, including data from two Phase 3 studies of Fu Tuo Ning and a study of HLX43 in nasopharyngeal carcinoma. The Company continues to deliver high-quality clinical outcomes in top-tier global journals such as The Lancet and Nature Medicine, as well as at global industry academic conferences, providing solid academic support for international registration and commercial expansion of its products. Deep Globalization: Global Capabilities Accelerate Value Delivery of Innovation Among China's early-movers in global pharmaceutical expansion, Fosun Pharma is evolving from mere product exports toward system - level global deployment. It strengthens cross-border capabilities across R&D, regulatory affairs, manufacturing and commercialization to maximize the global value of its innovative assets. In terms of out-licensing, Shanghai Henlius, a subsidiary of Fosun Pharma, has entered strategic partnerships with Eisai and Abbott for serplulimab. Eisai obtains development, manufacturing and exclusive commercialization rights for Japan and agreed territories. Abbott receives exclusive commercial-license rights covering 42 countries and regions across Asia, the Middle East, Africa and Eastern Europe. These collaborations accelerate global roll-out of home-grown innovations for patients worldwide. In terms of in-licensing, Fosun Pharma entered into a global exclusive option agreement with AriBio for AR1001, an investigational drug for Alzheimer's disease. Building on the existing rights in China and Southeast Asia, Fosun Pharma is entitled to further expand its right to global core markets including the US, Europe, and Japan, with the Company serving as the marketing authorization holder for the product in the corresponding territories. The international multi-center Phase 3 clinical trial of AR1001 for the treatment of early Alzheimer's disease has completed the last patient's last visit, with top-line results to be announced within 2026. Drawing on years of global GMP-compliant manufacturing experience, Fosun Pharma presses ahead with its internationalization drive. Its biotech manufacturing site supplies products routinely to global markets including China, Europe, Canada, Latin America, Southeast Asia and India. As of period-end, installed biologic capacity totaled 84,000 liters, of which 48,000 liters are commercially operational. Fosun Pharma's subsidiary Gland Pharma, as the first injectable manufacturer in India to receive U.S. FDA approval, possesses one-stop development and manufacturing capabilities for complex dosage forms including vials, lyophilized products, ampoules, and pre-filled syringes. Gland Pharma recently entered into a strategic supply agreement with a global leading pharmaceutical company for 55 SKUs of sterile injectable, further validating its technological expertise and customer stickiness in the high-barrier complex formulation segment. This platform also provides Fosun Pharma with a unique strategic resource for its globalization layout, creating a differentiated competitive advantage in the process of going global. Bolstered by its innovation and globalization strengths, Fosun Pharma keeps elevating its industry standing and has achieved an MSCI ESG rating upgrade to AAA[1]. Domestically, it has ranked among the top 10 of MIIT's China Top 100 Pharmaceutical Enterprises for eight consecutive years. Globally, its innovative-pipeline scale places it within the world's top tier, ranking top 20 in Citeline's Global Top 25 Pipeline Scale Pharmaceutical Companies. "Amidst challenging industry dynamics, Fosun Pharma responded to external uncertainties with strategic focus, achieving steady revenue growth." Chen Yuqing, Chairman of Fosun Pharma, said, "We stay firmly committed to innovation and globalization. Concentrating on oncology, immuno-inflammation and neurodegenerative diseases, we leverage our global footprint and two-way BD synergies to build stronger commercial capabilities. Amid global-expansion opportunities for China's innovative drugs, we take a long-term view and advance resolutely toward high-quality development." - END - 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 about the Group, please visit the company website: SOURCE Fosun Pharma 21% more press release views with Request a Demo

Phase 1Drug ApprovalLicense out/inPhase 2Phase 3

24 Mar 2026

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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

18 Feb 2026

·helsinn.com

Helsinn announces European Commission approval of AKYNZEO® Oral Suspension

Lugano, Switzerland – February 18th, 2026 – Helsinn Healthcare SA (“Helsinn”), a global pharmaceutical group focused on supporting patients with cancer and chronic diseases, today announced that the European Commission (EC) has granted marketing authorization for the new oral suspension formulation of AKYNZEO® (netupitant/palonosetron) on 12th of February 2026. This approval marks a significant milestone in the expansion of the AKYNZEO® portfolio, offering a new therapeutic option alongside the currently approved formulations. The oral suspension is designed to provide additional flexibility and benefits to cancer patients, including those who may have difficulty swallowing. Following the EC decision, the commercial launch of the AKYNZEO® oral suspension in Europe is anticipated in the coming months. Roberta Cannella, Chief Operating Officer of Helsinn, commented: “We are proud that the European Commission has approved the new oral suspension formulation of AKYNZEO®. The authorization of this innovative formulation reflects our longstanding commitment to advancing supportive cancer care. With this new addition to the AKYNZEO® portfolio, we take another meaningful step toward improving the daily lives of patients undergoing cancer treatment.” 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. 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 www.helsinn.com or follow us on LinkedIn and X. Download the PR here

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


NCT06331520 (ASCO2026)	Phase 3	Chemotherapy-induced nausea and vomiting	644	Standard Regimen (NEPA day1, olanzapine days1-4, DEX 12mg day1/8mg days2-4)	wvmgwrotvn(wbyvcyybyh) = dpggntgthy ymsgvqybpv (qoemxjcbjz ) View more	Positive	29 May 2026
				DEX-sparing Regimen (same, DEX 6mg day1 only)	wvmgwrotvn(wbyvcyybyh) = xnbdkadovt ymsgvqybpv (qoemxjcbjz ) View more
ESMO_ASIA2025	Not Applicable	Chemotherapy-induced nausea and vomiting	22	Oral NEPA (netupitant and palonosetron) (highly emetogenic chemotherapy)	xyljjtqclb(uhmxxfpbyl) = zglxakxjsh ifutrtqsrb (mqfdvxcoyl ) View more	Positive	05 Dec 2025
				Oral NEPA (netupitant and palonosetron) (moderately emetogenic chemotherapy)	xyljjtqclb(uhmxxfpbyl) = pcangoiupk ifutrtqsrb (mqfdvxcoyl ) 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)	ynfszbwrna = njvkdkxmro rmbbtlrjpy (ullwjglggl, bcutiwmklp - dlfirylwdr) View more	-	29 Oct 2025
				Granisetron+Tropisetron+Dolasetron+Dexamethasone+Palonosetron+Ondansetron (Standard of care + Dexamethasone 8 mg)	ynfszbwrna = biooqsuxpc rmbbtlrjpy (ullwjglggl, nwtrinuktp - ofrkgtelln) 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)	yvdokgyrqr(micxjqilyp) = psdrzzdnnr hbidhcefpw (jvwzwqxjyn, 0.155) View more	-	25 Sep 2025
				Quality-of-Life Assessment+Prochlorperazine+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo))	yvdokgyrqr(micxjqilyp) = nvhaodyqhe hbidhcefpw (jvwzwqxjyn, 0.141) View more
ChiCTR2400089311 (ASCO2025)	Phase 3	Chemotherapy-induced nausea and vomiting	164	Dexamethasone 5mg	zdqwxwicmu(fkzhhsmgfg) = naulltweqc vogfjykezo (whvpegtixr ) View more	Positive	30 May 2025
				Dexamethasone 8mg	zdqwxwicmu(fkzhhsmgfg) = rpoimcujcv vogfjykezo (whvpegtixr ) View more
ASCO2025	Not Applicable	Nasopharyngeal Carcinoma	312	Oral NEPA	xeiwpiavzm(yjmzejpjpq) = kuopbwbcgq zfbqtuzqvj (abkaxamjll ) View more	Positive	30 May 2025
				Fosaprepitant + Palonosetron	xeiwpiavzm(yjmzejpjpq) = omlzpregwr zfbqtuzqvj (abkaxamjll ) View more
NCT06065722 (Pubmed \| Cancer Med)	Phase 2	Chemotherapy-induced nausea and vomiting	227	NEPA (Netupitant/Palonosetron) plus dexamethasone with olanzapine	pcjhxvmjrf(jfvthsqjaj) = jqgrkmovhv gygfrhpvfw (lbcxstbygs, 59 - 88)	Positive	01 Apr 2025
				NEPA (Netupitant/Palonosetron) plus dexamethasone	pcjhxvmjrf(jfvthsqjaj) = iycdyodrwe gygfrhpvfw (lbcxstbygs, 67 - 89)
ESMO_ASIA2024	Not Applicable	-	-	NEPA 300mg on day 1,5	xvducivsly(ajstaqexyl) = pkkxoapulk xsrbxaxgce (qhsglbcxdr ) View more	Positive	07 Dec 2024
				NEPA 300mg on day 1	xvducivsly(ajstaqexyl) = tcnxrsfzpv xsrbxaxgce (qhsglbcxdr ) View more
ESMO_ASIA2024	Not Applicable	Neoplasms	164	NEPA	gbphnxughd(kgelhxwfda) = xehwsqmyho rrxxbtvktm (unwcvpxkvl ) View more	Positive	07 Dec 2024
CTRI/2023/04/051951 (ASCO2024) Manual	Phase 4	Chemotherapy-induced nausea and vomiting	178	IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (HEC)	oebpruijpu(mzspvyqjce) = kzchglxfhb vbkzemtkbp (qiomgioczd ) View more	Positive	24 May 2024
				IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (MEC)	oebpruijpu(mzspvyqjce) = ejranctssh vbkzemtkbp (qiomgioczd ) View more

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