RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Mexico), Orphan Drug (Switzerland)

Structure/Sequence

Sequence Code 431576801L

Source: *****

Sequence Code 431576802H

Source: *****

180

Clinical Trials associated with Serplulimab

NCT07527520

/ Not yet recruitingPhase 2IIT

Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial

This study aims to observe and evaluate the efficacy and safety of moderately hypofractionated radiotherapy combined with chemotherapy and immunotherapy, compared with conventional neoadjuvant chemoradiotherapy, in patients with high-risk locally advanced colorectal cancer.

Start Date01 Jun 2026

Sponsor / Collaborator

Fudan University

NCT07113275

/ RecruitingPhase 3IIT

A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer

This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.

Start Date15 May 2026

Sponsor / Collaborator-

NCT07543848

/ Not yet recruitingPhase 2IIT

A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)

This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).
In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.
The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.

Start Date01 May 2026

Sponsor / Collaborator

Chongqing University Cancer Hospital

100 Clinical Results associated with Serplulimab

100 Translational Medicine associated with Serplulimab

100 Patents (Medical) associated with Serplulimab

Literatures (Medical) associated with Serplulimab

01 Apr 2026·CPT-Pharmacometrics & Systems Pharmacology

Population Pharmacokinetics of Serplulimab and Quantitative Assessment of Transitioning From Weight‐Based to Flat‐Dosing Strategy

Article

Author: Kwok, Zhihao ; Hu, Chen ; Xu, Fengyan ; Lin, Yaqi ; Gao, Yuying ; Wang, Kun ; Wang, Qingyu ; Shen, Yuanyuan ; Zhou, Liang

ABSTRACT:

Serplulimab is a fully humanized anti–PD‐1 monoclonal antibody approved for small‐cell lung cancer and other malignancies. The initial dosing strategy was based on body weight (WT‐based); however, flat‐dosing offers greater convenience and reduced variability. This study characterized the population pharmacokinetics (PopPK) of serplulimab using data from 11 clinical trials and quantitatively evaluated the appropriateness of transitioning from WT‐based to flat‐dose regimens. Serplulimab concentration–time data from 2110 patients were analyzed using nonlinear mixed‐effects modeling. A previously developed two‐compartment model with time‐varying clearance best described the pharmacokinetic (PK) profile. A stepwise forward‐addition and backward‐elimination procedure was used to evaluate covariate effects on PK parameters. Model adequacy was confirmed by diagnostic plots, prediction‐corrected visual predictive checks (pcVPCs), and bootstrap analysis. Simulations compared exposures between 3 mg/kg every 2 weeks (Q2W), 4.5 mg/kg every 3 weeks (Q3W), 200 mg Q2W, and 300 mg Q3W regimens. Body weight and albumin were the main predictors of exposure. Although statistically significant, covariate effects were modest (≤ 20%) and not clinically meaningful, supporting a unified dosing strategy. Simulations showed that flat‐dose regimens achieved exposure comparable to WT‐based dosing, with < 25% differences in median Cavg and Cmax across body‐weight ranges. Exposure–response (E–R) analyses revealed no meaningful association between exposure and outcomes. The PopPK model adequately described serplulimab PK and supports transitioning from WT‐based to flat‐dosing, demonstrating comparable exposure, efficacy, and safety across regimens.

16 Mar 2026·Cureus Journal of Medical Science

Incidence and Comparative Risk of Hematological Adverse Events Across Different Immune Checkpoint Inhibitors: A Network Meta-Analysis of Randomized Controlled Trials

Review

Author: Chaudhari, Sandipkumar S ; Jabeen, Sidra ; Muneeb Ullah, Muhammad ; Amin, Adil ; Wei, Calvin R ; Reyaz, Nafisa ; Vajje, Jaahnavi ; Gillani, Iman

Cancer immunotherapy with immune checkpoint inhibitors (ICIs) has transformed oncologic treatment, yet hematological adverse events (HAEs) remain incompletely characterized across different agents. We conducted a systematic review and network meta-analysis to compare the incidence and risk of hematological toxicities (all grades) among various ICIs. A comprehensive literature search was performed across PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science through January 2026. Phase II and III randomized controlled trials (RCTs) evaluating ICIs and reporting HAEs were included. Frequentist network meta-analysis was performed to estimate odds ratios and rankings using surface under the cumulative ranking curve values for anemia, neutropenia, and thrombocytopenia. Thirty-seven RCTs encompassing diverse malignancies were included in the network meta-analysis. For anemia, ipilimumab demonstrated the most favorable safety profile, followed by toripalimab and pembrolizumab, while serplulimab and nivolumab ranked lowest. Regarding neutropenia, ipilimumab again showed the best safety ranking, followed by avelumab and pembrolizumab, whereas toripalimab and serplulimab exhibited less favorable profiles. For thrombocytopenia, ipilimumab ranked highest, followed by sintilimab and nivolumab, while toripalimab showed the least favorable ranking. No significant global inconsistency was detected across networks. Publication bias was identified for neutropenia but not for anemia or thrombocytopenia. This network meta-analysis reveals substantial heterogeneity in hematological safety profiles across ICIs, with ipilimumab consistently demonstrating favorable rankings across all HAEs. These findings suggest potential differences in hematologic safety profiles across treatments. However, given the star-shaped network structure, reliance on indirect comparisons, and observed heterogeneity, the results should be interpreted cautiously. While not definitive, the analysis may still offer preliminary insights to inform treatment selection, particularly for patients with baseline hematological vulnerabilities or those receiving concurrent myelosuppressive therapies, and may help guide the development of risk-stratified monitoring strategies in clinical practice.

01 Mar 2026·BIODRUGS

Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors

Article

Author: Zhang, Jian ; Chen, Cong ; Cao, Xubo ; Chen, Yang ; Liu, Rujiao ; Gao, Shuiping ; Jing, Hui ; Zhang, Jinghao ; Li, Ke ; Li, Jing ; Liu, Yuanyuan ; Wang, Qingyu ; Yu, Haoyu ; Sun, Ci ; Meng, Meng ; Wu, Yanmin

BACKGROUND:

HLX26 is a novel, recombinant humanized anti-LAG-3 IgG4 monoclonal antibody that exhibits high affinity for LAG-3 and demonstrates that it can block LAG-3 and its ligand interaction and activate T cells in preclinical in vitro studies.

OBJECTIVE:

These two phase I, dose-escalation studies evaluated the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of HLX26 monotherapy, or in combination with serplulimab (PD-1 inhibitor), in patients with advanced/metastatic solid tumors or lymphomas.

PATIENTS AND METHODS:

Adult patients with advanced/metastatic solid tumors that have failed or deemed clinically unsuitable for standard therapy, or lymphoma received different doses of HLX26 alone (at 60, 150, 300, 500, and 800 mg administered every 3 weeks [Q3W]) in the HLX26-001 study, or HLX26 plus serplulimab (HLX26 at 500, 800, and 1600 mg plus serplulimab (300 mg) administered Q3W) in the HLX26-002 study, respectively. The primary end points for both studies were the dose-limiting toxicities (DLT) and maximum tolerable dose (MTD).

RESULTS:

As of 18 August 2023, with a median follow-up duration of 12.8 months, 26 patients were screened for the HLX26-001 study, 18 of whom were enrolled. As of 31 August 2023, with a median follow up duration of 6.0 months, 14 patients were screened for the HLX26-002 study, 9 of whom received HLX26 plus serplulimab. No DLT was observed, and the MTD was not reached for both studies. In the HLX26-001 study, 17 (94.4%) patients experienced at least one treatment-emergent adverse event (TEAE), most commonly proteinuria (n = 6, 33.3%) and hypercholesterolemia (n = 5, 27.8%). In the HLX26-002 study, all nine (100.0%) patients experienced TEAEs that were all treatment-related and predominantly mild in severity.

CONCLUSIONS:

HLX26 was well-tolerated and safe at various doses as a single agent, and in combination with serplulimab for patients with advanced solid tumors and warrants further investigation.

TRIAL REGISTRATION:

HLX26-001-ClinicalTrials.gov: NCT05078593; HLX26-002-ClinicalTrials.gov: NCT05400265.

104

News (Medical) associated with Serplulimab

06 May 2026

·allsci.com

Fosun/Teva’s anti-PD-1/IL-2 fusion protein to enter the clinic in China for PD-(L)1-resistant solid tumors

A first-in-human (FIH) clinical trial of FXB0871 (TEV-56278), an anti-PD-1/IL-2 antibody-cytokine fusion protein, has been registered in China, with HKEX- and SSE-listed Fosun Pharma serving as the regional developer under an exclusive license from Israel-based Teva Pharmaceutical Industries. The Phase Ia/Ib study targets adults with locally advanced or metastatic solid tumors, with a specific focus in the expansion phase on patients whose disease has progressed on or become resistant to PD-(L)1 checkpoint inhibitors — a population for whom few mechanistically distinct options currently exist. The open-label, multicenter trial (NCT07558200) will enroll approximately 138 participants across two sequential parts. Part Ia is a dose-escalation phase enrolling adults with selected solid tumors that have progressed on, are intolerant to, or are otherwise unsuitable for standard therapy; it uses a Bayesian optimal interval design to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D). Part Ib is a dose-expansion phase restricted to patients with PD-(L)1-resistant non-small cell lung cancer (NSCLC) or hepatocellular carcinoma (HCC), with NSCLC participants randomized 1:1 between the RP2D and a lower dose selected from Part Ia data. FXB0871 is administered by intravenous infusion every two weeks, with schedule optimization to every three or four weeks permitted based on pharmacokinetic, pharmacodynamic, and safety data. Treatment may continue for up to 12 months. The trial is set to begin enrolling in May 2026, with primary completion anticipated in April 2030. Participants must have ECOG performance status 0 or 1 and at least one measurable lesion per RECIST v1.1. The primary endpoints are the incidence and severity of adverse events and dose-limiting toxicities in Part Ia, and objective response rate in Part Ib; secondary endpoints include pharmacokinetic parameters, duration of response, progression-free survival, and overall survival. FXB0871 belongs to a class of molecules designed to address a long-standing tension in cytokine-based immunotherapy: IL-2 has potent T-cell stimulatory activity but, at systemic doses, produces severe toxicity including vascular leak syndrome, which has constrained its clinical use for decades. The molecule pairs a non-blocking anti-PD-1 antibody — one that binds PD-1 at an epitope distinct from the PD-L1 binding site, thereby preserving checkpoint receptor function — with a highly attenuated IL-2 variant. The intent is to deliver the IL-2 payload selectively to PD-1-expressing tumor-infiltrating T cells, where it can drive CD8+ effector T-cell proliferation and activation within the tumor microenvironment while limiting systemic cytokine exposure. Preclinical data presented at ASCO 2025 indicated preferential engagement of effector CD8+ T cells over regulatory T cells, which is mechanistically relevant given that unmodified IL-2 expands Tregs via the high-affinity IL-2Rα (CD25) receptor, potentially counteracting anti-tumor immunity. The Teva–Fosun partnership announcement from June 2025 describes the molecule as a product of Teva’s internally developed ATTENUKINE platform. The most directly comparable clinical-stage program is M89 (Merck KGaA / Jiangsu Hengrui, Phase I/II), an anti-PD-1/IL-2 fusion protein also targeting PD-(L)1-resistant tumors, though the precise IL-2 attenuation strategy and PD-1 binding epitope differ from FXB0871’s non-blocking design. Within the same mechanistic class, Synaffix-derived and other IL-2 conjugate formats have been explored, but FXB0871’s explicit non-blocking PD-1 arm — intended to preserve compatibility with conventional checkpoint inhibitors — represents a design distinction that the current trial will begin to test clinically for the first time in this regional program. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

License out/inPhase 1ImmunotherapyIND

29 Apr 2026

·www.biospace.com

European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY ® (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product. 1 “As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon. 2,3 “Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines.” 3,4 “Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system.” In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence. POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response). 5 In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China. 6 About POHERDY ® (pertuzumab) in the E.U. Early breast cancer Poherdy is indicated for use in combination with trastuzumab and chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) Metastatic breast cancer Poherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. For more information please visit: Poherdy | European Medicines Agency (EMA) About Henlius Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards. Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly ® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem. To learn more about Henlius, visit and connect with us on LinkedIn at . About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about POHERDY treatment goals and Organon’s ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicine. Forward-looking statements may be identified by words such as “will,” “plan,” “ongoing,” “commitment to supporting,” “may,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. PERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG; Organon is not associated with this trademark owner. 1. PERJETA. Product Information. Genentech, Inc.; 2025. 2. Breast cancer in the EU. European Commission, Joint Research Centre. October 2023. Accessed April 14, 2026. 3. European Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency (EMA). Last Updated October 29, 2019. Accessed April 14, 2026. 4. Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; January 2025. Accessed April 14, 2026. 5. Biosimilar medicines: overview. European Medicines Agency (EMA). April 2, 2025. Accessed April 14, 2026. 6. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed April 14, 2026. Contacts Organon Media Contacts: Karissa Peer (614) 314 8094 Selena Dhanak +44 (7919) 914475 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Henlius Media Contacts: Janice Han jiayi_han@henlius.com Bella Zhou wenting_zhou@henlius.com Henlius Investor Contact: Venus Hu junyan_Hu@henlius.com

Drug ApprovalLicense out/in

28 Apr 2026

·www.prnewswire.com

Fosun Pharma Announces Q1 2026 Results: Net Profit Attributable to Shareholders After Deducting Non-Recurring Gains and Losses Increased by 21.96% YoY, With Strong Pipeline Execution

SHANGHAI, April 28, 2026 /PRNewswire/ -- On 28 April, Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) announced its results for the first quarter of 2026 (the reporting period). During the reporting period, the Company achieved a total revenue of RMB 10,073 million, representing a year-on-year increase of 6.93%. Regarding R&D investment, the Company firmly implemented its innovation transformation strategy. During the reporting period, the R&D expenditure increased to RMB 897 million, increased by 1.59% YoY. While increasing the R&D intensity, the Company maintained a positive growth trend in profit. Net profit attributable to shareholders of the list company after deducting extraordinary gain or loss was RMB 501 million, up 21.96% year-on-year. Net profit attributable to shareholders of the listed company was RMB 871 million, increased by 13.87% YoY. Net cash flows generated from operating activities was RMB 1,149 million, up 8.8% YoY. In the first quarter of 2026, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma firmly continued to advance its innovation transformation, promoted the deep synergy between innovation and R&D and global operations, and further enhanced the foundation for high-quality development. Driven by the continuous increase in R&D investment, the Company's transformation of innovative achievements continues to materialize. During the reporting period, the NDA for 4 Innovative Drugs were accepted by the NMPA or the U.S. FDA, and 14 clinical trials for Innovative Drugs (calculated by approval) were approved by domestic and overseas regulatory authorities, covering core therapeutic areas such as oncology. In the Pharma R&D Annual Review 2026 white paper released by the world-known consulting firm Citeline, Fosun Pharma ranked among the global top 20, gained international professional recognition for its innovative R&D strength and pipeline quality. Deepening Core Technology Platforms to Consolidate Advantages in Oncology and Other Fields Fosun Pharma has established an open-ended R&D system that combines in-house R&D, co-development, licensing, fund incubation, and industrial investment, also focused on strengthening core technology platforms such as antibodies/ADC, small molecules, and cell therapy, continuously consolidating its innovation moat in core therapeutic areas including oncology. In the field of antibody/ADC technology platform, Shanghai Henlius, a subsidiary of Fosun Pharma, has steadily advanced the approvals and clinical progress of several self-developed biological drugs. Notably, denosumab injection (HLX14) secured approval in Canada in March 2026, covering all indications of the reference product approved locally, achieving a global commercialization breakthrough in areas such as osteoporosis, bone metastasis from tumors, and giant cell tumor of bone. The NDA for bevacizumab injection (HLX04) was accepted in the U.S., marking a new milestone in the Company's international registration capabilities for biosimilars. HLX43, an antibody-drug conjugate targeting PD-L1, is expected to create synergy with HLX07 or serplulimab injection for the treatment of advanced colorectal cancer and other solid tumors. HLX3901, a tetraspecific antibody of DLL3×DLL3×CD3×CD28, received approval for clinical trial, demonstrating significant potential in refractory solid tumors through multi-target synergistic activation of immune cells. In the field of small molecule innovative drug platform, in January 2026, the NDA for foritinib succinate capsules (SAF-189), Fosun Pharma's Class 1 innovative drug, was accepted by the NMPA, intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), expected to provide a new option for precision treatment of lung cancer. In February 2026, the NDA for the self-developed MEK 1/2 inhibitor luvometinib tablets (Trade name in Chinese mainland: Fu Mai Ning) for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) have been accepted and granted in the priority review by the NMPA. This marks a critical step toward full-age coverage following its approval for pediatric and adolescent NF1 patients in May 2025, also brings new hope to a large number of adult NF1 patients in China who lack effective drug treatments. Additionally, the NDA for methoxyetomidate hydrochloride injection (ET-26), a Class 1 innovative drug self-developed by the subsidiary Avanc Pharma for anesthesia induction and short-term surgical anesthesia, was also accepted. In the field of prospective layout of early-stage pipeline, several new molecules have been approved for the clinical trials: FXB0871, a PD-1-targeted IL-2 fusion protein, was approved for clinical trials in locally advanced or metastatic solid tumors. Based on the ATTENUKINE™ platform, FXB0871 is expected to achieve high efficacy and low toxicity. FXS0683, a next-generation Bcl-2 inhibitor, was approved for Phase I clinical trials in hematological malignancies. Innovative molecule including HLX97 (a KAT6A/B small molecule inhibitor) and HLX3901 (tetra specific antibody of DLL3×DLL3×CD3×CD28) were approved for clinical trials, widely covering refractory solid tumors such as breast cancer and small cell lung cancer. Meanwhile, HLX22 (anti-HER2 monoclonal antibody) entered phase II clinical trials for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in combination with HLX87. HLX43 (PD-L1 ADC) in combination with HLX07 or serplulimab injection, and HLX701 (CD47 fusion protein), among others, have entered Phase I clinical trials, further enhancing the Company's layout in the fields of tumor immunology and targeted therapy. Expanding Global Commercialization Network and Enhancing Academic Influence During the reporting period, Fosun Pharma's global registration and commercialization network continued to expand. The overseas registration of products like denosumab and bevacizumab progressed steadily. The Company reached deep collaborations with global partners such as Eisai and Abbott to accelerate the market coverage of innovative products in Japan, Asia-Pacific, Middle East, Africa, and Eastern Europe. In the academic field, several innovation achievements were presented at top international conferences such as AACR and ASCO. The Phase III study data of luvometinib tablets for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) was selected for a rapid oral abstract session at 2026 ASCO, the study results will be released for the first time during the meeting. At the 2026 AACR Annual Meeting, Shanghai Henlius, a Fosun Pharma's subsidiary, presented preclinical data for the novel trispecific T-cell engager HLX3902 and the tetraspecific antibody HLX3901, demonstrating best-in-class treatment potential, building a solid foundation for the future clinical development. AI Embracement: Driving Digital Transformation via FoSTRAID Fosun Pharma continues to deepen its digitalization and AI strategic layout, and systematically advances the platformisation, engineering and scaled implementation of AI capabilities focusing on core aspects such as new drug R&D, clinical research, products and services, and operation management. On this basis, the fully AI- embracing strategy centered on FoSTRAID (Fosun Pharma Strategic Transformation via AI & Data science) was further defined and steadily advanced. By integrating resources, a digital-intelligence architecture that promotes synergistic development across "foundation — platform — data — agent — scenario — mechanism" has been established. The self-developed PharmAID® Pharmaceutical Intelligence Platform deeply applies large language models, fine-tuned with professional medical corpora and R&D data. It integrates full-cycle of decision-making tools including competitor analysis, clinical competitive performance evaluation, NDA approval prediction, and peak sales estimation, comprehensively applied in key scenarios such as target discovery, molecular optimization, clinical writing, intelligence retrieval, and literature interpretation, providing systematic and data-driven support for drug R&D decision-making. Looking ahead, Fosun Pharma will continue to adhere to the dual drivers of innovation and globalization, deepen its core technology platforms, promote the implementation of AI strategy and accelerate the transformation of its pipeline and global market access. The Company remains committed to providing high-quality healthcare products and services to patients worldwide, striving to become a leading global healthcare innovation integrator. - 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 ApprovalPhase 2Clinical ResultPhase 3

100 Deals associated with Serplulimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Serplulimab	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	European Union	Accord Healthcare SL	13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma	Iceland	Accord Healthcare SL	13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	Accord Healthcare SL	13 May 2026
Locally Advanced Lung Non-Small Cell Carcinoma	Norway	Accord Healthcare SL	13 May 2026
metastatic non-small cell lung cancer	European Union	Accord Healthcare SL	13 May 2026
metastatic non-small cell lung cancer	Iceland	Accord Healthcare SL	13 May 2026
metastatic non-small cell lung cancer	Liechtenstein	Accord Healthcare SL	13 May 2026
metastatic non-small cell lung cancer	Norway	Accord Healthcare SL	13 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	European Union	Shanghai Henlius Biotech, Inc.	10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Iceland	Shanghai Henlius Biotech, Inc.	10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Liechtenstein	Shanghai Henlius Biotech, Inc.	10 May 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Norway	Shanghai Henlius Biotech, Inc.	10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	European Union	Shanghai Henlius Biotech, Inc.	10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Iceland	Shanghai Henlius Biotech, Inc.	10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Liechtenstein	Shanghai Henlius Biotech, Inc.	10 May 2026
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Norway	Shanghai Henlius Biotech, Inc.	10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma	European Union	Shanghai Henlius Biotech, Inc.	10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma	Iceland	Shanghai Henlius Biotech, Inc.	10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma	Liechtenstein	Shanghai Henlius Biotech, Inc.	10 May 2026
PD-L1 positive Esophageal Squamous Cell Carcinoma	Norway	Shanghai Henlius Biotech, Inc.	10 May 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	NDA/BLA	European Union	Accord Healthcare SL	26 Mar 2026
Small Cell Lung Cancer	NDA/BLA	European Union	Accord Healthcare SL	26 Mar 2026
PD-L1 positive Stomach Cancer	NDA/BLA	China	Shanghai Fuhong Ruilin Biotechnology Co., Ltd.	12 Dec 2025
PD-L1 positive Stomach Cancer	NDA/BLA	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	12 Dec 2025
Esophageal Carcinoma	NDA/BLA	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	26 Aug 2022
MSS/MSI-L/pMMR cancer	NDA/BLA	China	Shanghai Henlius Biotech, Inc.	23 Apr 2021
Non-small cell lung cancer stage IIIB	Phase 3	China	Shanghai Henlius Biotech, Inc.	31 Dec 2025
Stomach Cancer	Phase 3	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Advanced Cervical Carcinoma	Phase 3	China	Shanghai Henlius Biotech, Inc.	30 Sep 2022
Small cell lung cancer limited stage	Phase 3	United States	Shanghai Henlius Biotech, Inc.	17 May 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05443646 (ASTRUM-LC01, ESMO_ELCC2026)	Phase 2	Small cell lung cancer limited stage Consolidation	296	Serplulimab consolidation	qzcmbrjatf(ecooeqhzee) = foznvmyugi eibsjkbpxs (ptvxtvgycs ) View more	Positive	25 Mar 2026
				Hypo-cCRT alone	-
ASTRUM-004R (ESMO_ELCC2026)	Not Applicable	Squamous non-small cell lung cancer First line	132	Serplulimab plus platinum-based therapy	pxqhnobatu(vtilhuqfba) = ikbwslquuf upfmufqpur (aarpxhqncp ) View more	Positive	25 Mar 2026
				Serplulimab plus platinum-based therapy	xwquujagnv(elfdodmtgh) = ivhvlpkscg bbeitxakzn (jdqiovpiiv )
ESMO_ELCC2026	Not Applicable	Non-small cell lung cancer stage IIIB Neoadjuvant	82	Serplulimab plus platinum-doublet chemotherapy	suvbwompuu(mjlrikidii) = yqcnjikmhb gbmibdwils (almccchdsk ) View more	Positive	25 Mar 2026
NCT06461910 (Pubmed \| BMC Med)	Phase 2	Locally Advanced Gastric Adenocarcinoma Neoadjuvant	30	Serplulimab (anti-PD-1) + SOX (S-1 and oxaliplatin) + Thymalfasin	gjhlhzzobp(szcwteeqti) = pxonfqqlgo zxuzzuceym (cgvntkesxu ) View more	Positive	26 Feb 2026
NCT06688786 (FIRM, ASCO_GI2026 \| NEWS) Manual	Phase 2	Rectal Cancer Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	28	mFOLFOX6 +serplulimab	scwsspnntx(yfsijhlkof) = qnpotwzeqb tvzyqkjsuo (amzzvnpjcv ) View more	Positive	12 Jan 2026
				mFOLFOX6 +serplulimab (high LARC (>10 cm from anal verge, ineligible for nCRT))	scwsspnntx(yfsijhlkof) = ngwyygygsq tvzyqkjsuo (amzzvnpjcv ) View more
NCT05732493 (TORCH-C, ASCO_GI2026 \| NEWS) Manual	Phase 2	Colonic Cancer Neoadjuvant Microsatellite Stable (MSS) \| Proficient DNA Mismatch Repair (pMMR)	79	SCRT+serplulimab+CAPOX (radiotherapy group)	devyugqojx(zqmdpvacjp) = txygzfncdd hxyqzfshxk (wdbkdlfrxl ) View more	Positive	12 Jan 2026
				CAPOX (chemotherapy group)	devyugqojx(zqmdpvacjp) = pcrvzhjxnz hxyqzfshxk (wdbkdlfrxl ) View more
NCT05659251 (Nat Commun) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Neoadjuvant	45	Serplulimab + Carboplatin + Albumin Paclitaxel	ztwuxmwbrd(rdxxvoxxwh) = tpdyrygjnn vchtkzxaex (yrivqfxkfm, 18.2 - 46.6) View more	Positive	21 Dec 2025
NCT04063163 (ASTRUM-005, CTgov)	Phase 3	Extensive stage Small Cell Lung Cancer	585	HLX10+Etoposide+Carboplatin (A Groups)	ohorehxqxr(fhjkdfyixt) = zzbkldhzze lwxgreseig (yugjzmvfxj, wckoeikogi - uvygultljv) View more	-	09 Dec 2025
				Placebo+Etoposide+Carboplatin (B Groups)	ohorehxqxr(fhjkdfyixt) = kafndjaqly lwxgreseig (yugjzmvfxj, rvaxzxenjl - wlbzdxjreh) View more
ESMO_ASIA2025	Not Applicable	Squamous non-small cell lung cancer First line	46	Serplulimab	hkgiikqgju(goslcvwwcz) = sskkusdbfr jxowkdwhgv (cuiwfeoaot, 33.66 - 69.06) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Locally Advanced Lung Carcinoma Neoadjuvant driver gene-negative	27	Serplulimab plus platinum-based chemotherapy	hrchqtynce(mwgksklqra) = wmlujztgci opwwqipeua (nuceogkabn ) View more	Positive	05 Dec 2025

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