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

Structure/Sequence

Sequence Code 431576801L

Source: *****

Sequence Code 431576802H

Source: *****

115

Clinical Trials associated with Serplulimab

NCT06812260

/ RecruitingPhase 2

A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Start Date24 Jun 2025

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT06860529

/ RecruitingPhase 2IIT

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

Start Date15 Apr 2025

Sponsor / Collaborator

Henan Cancer Hospital

NCT06850103

/ Not yet recruitingPhase 2IIT

A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases

Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.

Start Date28 Mar 2025

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

100 Clinical Results associated with Serplulimab

100 Translational Medicine associated with Serplulimab

100 Patents (Medical) associated with Serplulimab

Literatures (Medical) associated with Serplulimab

31 Dec 2025·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

Author: Xu, Kai ; Zhang, Lingli ; Yu, Man ; Lin, Yingtao ; Su, Dan ; Li, Xin ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

01 May 2025·Journal of Thoracic Disease

First-line serplulimab-based immunochemotherapy in elderly patients with extensive-stage small cell lung cancer: a multicenter, real-world study

Article

Author: Yang, Wenyue ; Zhou, Yun ; Wang, Jialei ; Zhou, Xinli ; Xia, Xiaodong ; Zhou, Min ; Shi, Meiqi

Background:

While immune checkpoint inhibitors (ICIs) in combination with chemotherapy have improved outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC), elderly patients (≥70 years) are often underrepresented in clinical trials, and real-world evidence on their efficacy and safety remains scarce. We conducted a real-world study to supplement data on using serplulimab [a programmed cell death protein 1 (PD-1) inhibitor] with chemotherapy as first-line treatment for elderly (≥70 years) ES-SCLC patients.

Methods:

We gathered data on ES-SCLC patients aged 70 and above treated with first-line serplulimab, focusing on progression-free survival (PFS) as the primary endpoint. Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Kaplan-Meier survival curves were used for PFS and OS, and Cox proportional hazards models and accelerated failure time (AFT) models were used for the subgroup analyses. The baseline and post-4-cycle neutrophil-to-lymphocyte ratio (NLR) levels were also collected as exploratory endpoints.

Results:

Forty-three ES-SCLC patients with a median age of 73 years were included. Median PFS was 7.0 months [95% confidence interval (CI): 6.1-12.5]. Subgroup analysis indicated a significantly higher risk of disease progression in female patients (P=0.04) and those who had brain radiotherapy (P<0.001). OS rate was 94.7% (95% CI: 87.9-100.0%) at 6 months and 65.8% (95% CI: 50.0-86.5%) at 1 year. The ORR was 65.12% (95% CI: 49.07-78.99%), and the DCR was 97.67% (95% CI: 87.71-99.94%). AEs occurred in 19 patients (44.19%), mostly grade 1-2 (14 patients, 32.56%), with grade ≥3 AEs in 11.63% (5 patients). There was no significant difference in NLR levels before and after patient treatment.

Conclusions:

This study showed that combining serplulimab with chemotherapy improved survival and reduced toxicity in elderly ES-SCLC patients. Additionally, NLR may not be suitable as a biomarker for the elderly ES-SCLC population.

01 May 2025·BMJ Open

Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol

Article

Author: Bi, Nan ; Cao, Jianzhong ; Deng, Lei ; Wang, Jianyang ; Duan, Jianchun ; Wu, Yuqi ; Zhou, Xiaohong ; Zhang, Tao

Introduction:

With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.

Methods and analysis:

We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.

Ethics and dissemination:

Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).

Trial registration number:

NCT05443646.

News (Medical) associated with Serplulimab

01 Jul 2025

·www.prnewswire.com

HanchorBio and Henlius Sign Major Licensing Deal for HCB101 to Expand Global Immuno-Oncology Reach

TAIPEI and SHANGHAI and SAN FRANCISCO, July 1, 2025 /PRNewswire/ -- HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announces the signing of a major out-licensing agreement with Shanghai Henlius Biotech, Inc. (hereafter "Henlius"). The deal grants Henlius exclusive development and commercialization rights to HCB101 across Greater China (including Mainland China, Hong Kong, and Macau), key Southeast Asian countries, as well as all countries in the Middle East and North Africa (MENA). Continue Reading HanchorBio and Henlius Sign Licensing Deal for HCB101 HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein Under the terms of the agreement, HanchorBio will receive an upfront payment of USD 10 million, with additional payments tied to development and regulatory milestones of up to USD 192 million. Henlius will also pay tiered royalties and assume full responsibility for development, manufacturing, and commercialization in the licensed territories. HanchorBio retains all rights outside the licensed regions. HCB101 is a novel engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio's proprietary Fc-Based Designer Biologics (FBDB™) platform. It is designed to selectively block the CD47 "don't eat me" signal and activate macrophage-mediated anti-tumor immunity. Compared to earlier CD47-targeted agents, HCB101 reduces hematologic toxicity while maintaining strong efficacy, as demonstrated in over 80 CDX and PDX tumor models, and exhibits durable pharmacokinetics. Its binding affinity to CD47 is 100-fold higher than that of wild-type SIRPα-Fc fusions, and its signal-blocking potency exceeds 1,000-fold that of earlier versions. In a global Phase 1 dose-escalation study (NCT05892718), HCB101 monotherapy demonstrated a favorable safety profile, high CD47 receptor occupancy (saturating RO levels across multiple doses), and early signs of anti-tumor activity. Two patients achieved confirmed partial responses (PRs): one with head and neck squamous cell carcinoma and another with marginal zone lymphoma confirmed by both PET imaging and CT, as reported at ASCO 2025. Both tumors continued to shrink with ongoing weekly dosing. Additionally, six patients achieved stable disease at low to mid dose levels, including one ovarian cancer patient who maintained disease control for over 40 weeks. Following regulatory clearance from the U.S. FDA, Mainland China's NMPA, and Taiwan's TFDA, HCB101 has advanced into multi-regional Phase 2 trials in patients with solid tumors and hematologic malignancies, including head and neck, gastric, colorectal, and breast cancers. "This agreement positions HCB101 as a key asset in Greater China and reinforces HanchorBio's scientific strength and global partnering strategy," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "It also marks a critical milestone for HanchorBio's biopharmaceutical innovation as we pursue our mission to deliver globally accessible, next-generation cancer immunotherapies, and as Taiwan continues to gain global recognition." About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWO), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: About Henlius. Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. SOURCE HanchorBio Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inImmunotherapyPhase 1Drug ApprovalClinical Result

26 Jun 2025

·pmlive.com

MHRA approves Accord Healthcare’s Hetronifly to treat aggressive form of lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Accord Healthcare’s Henlius-partnered Hetronifly (serplulimab) as the first anti-PD-1 monoclonal antibody for an aggressive form of lung cancer. The drug has been authorised to treat adults with extensive-stage small cell lung cancer (SCLC) that has not previously been treated and has spread within the lungs or to other parts of the body. SCLC, a fast-growing cancer that typically develops in the airways of the lungs, accounts for up to 15% of all lung cancer cases and is often diagnosed at a late stage. Administered as an intravenous infusion, Hetronifly is designed to block the PD-1 protein to help immune cells recognise and destroy cancer cells more effectively. The approval was supported by positive results from the phase 3 ASTRUM-005 trial of 585 adults, who were randomised to receive either Hetronifly or placebo, alongside chemotherapy. Hetronifly-treated patients lived on average for 15.4 months, compared with 10.9 months for those receiving chemotherapy and placebo. Julian Beach, interim executive director of healthcare quality and access at the MHRA, said: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for SCLC, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis. “We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this medicine have been met. As with all products, we will keep its safety under close review.” Serplulimab was originally developed by Henlius Biotech, which has granted Accord’s parent company Intas Pharmaceuticals exclusive rights to develop and commercialise the drug in over 50 countries across Europe and India. The MHRA’s decision comes just under six months after it approved Amgen’s antineoplastic agent Imdylltra (tarlatamab) to treat SCLC in adults whose disease has spread throughout the lungs, to other parts of the body, or both, and who have failed two other types of treatments.

Clinical ResultPhase 3Drug ApprovalLicense out/in

24 Jun 2025

·www.prnewswire.com

Accord Healthcare receives approval for Hetronifly® (Serplulimab), from the Medicines and Healthcare Regulatory Agency (MHRA) for first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Intas and its subsidiary Accord Healthcare lead commercialisation in Europe and India. In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. ESMO has scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. Serplulimab is the only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has now reached over 110,000 patients. It has been approved in nearly 40 countries, including China, Europe, India and multiple Southeast Asian countries. LONDON, June 24, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is delighted to announce that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly®, has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body. This approval comes in the same week as the announcement in India, bringing the total number of countries and regions in which the medicine is approved to over 40 — including Europe, China, Indonesia, and Singapore. Accord Healthcare will lead commercialisation in both the UK and India on behalf of its parent company, Intas, and its commercial partner, Henlius. Lung cancer remains the leading cause of cancer-related death globally. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options[1]. Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK's Medicines and Healthcare products Regulatory Agency (MHRA), commented: "As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis."[2] Henlius Biotech originally developed Serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise the medicine in over 50 countries across Europe and India. Welcoming the news, Paul Tredwell, Executive Vice-President EMENA, Accord Healthcare, said: "At Accord, we are dedicated to supporting patients with cancer. The MHRA's approval of Hetronifly® provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions." Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius said: "The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world." In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. ESMO has also scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. About Serplulimab Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is an anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC. About Lung Cancer Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.[1] Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in an extensive stage. Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.[3] References Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 MHRA approves the UK's first anti-PD-1 monoclonal antibody for the treatment of an aggressive form of lung cancer. last accessed June 2025 Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical ResultASCOImmunotherapyOrphan Drug

100 Deals associated with Serplulimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Serplulimab	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	01 Dec 2024
Esophageal Squamous Cell Carcinoma	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	19 Sep 2023
Extensive stage Small Cell Lung Cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	16 Jan 2023
Squamous non-small cell lung cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	25 Oct 2022
Advanced gastric carcinoma	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022
Colorectal Cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022
Microsatellite Instability-high Solid Tumors	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Esophageal Carcinoma	NDA/BLA	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	26 Aug 2022
Microsatellite Instability cancer	NDA/BLA	China	Shanghai Henlius Biotech, Inc.	23 Apr 2021
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
Small cell lung cancer limited stage	Phase 3	China	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Austria	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Czechia	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Germany	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Greece	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


NCT04063163 (ASTRUM-005, ASCO2025 \| Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	585	Serplulimab plus chemotherapy	xarlhvvekc(qfydhyryfz) = ksowzexypa cfymzeqmhq (wsqticdcsg ) View more	Positive	30 May 2025
				Placebo plus chemotherapy	xarlhvvekc(qfydhyryfz) = kemacrdddy cfymzeqmhq (wsqticdcsg ) View more
NCT03468751 (Phase 1 study of fixed-dose regimens of serplulimab, ASCO2025)	Phase 1	Advanced Malignant Solid Neoplasm	37	Serplulimab 200 mg Q2W	zicnaldjvu(nfknvvldnw) = Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE gzhdvfuain (mksksxuzso )	Positive	30 May 2025
				Serplulimab 300 mg Q3W
NCT06099951 (PANFORTE, ASCO2025)	Phase 2	Mismatch repair-deficient Rectal Cancer Adjuvant proficient mismatch repair	53	FOLFOXIRI plus serplulimab (200 mg)	fvxeaantwl(hghrclmxmg) = npphrnzmra sbnqbglgny (cipaxjvpuz ) View more	Positive	30 May 2025
				Long-course radiotherapy + capecitabine + serplulimab (200 mg)	eynrobihho(wzchdccrsw) = mrhovkcjgg ewonbbqjmr (chjtithiti ) View more
ChiCTR2300073237 (ASCO2025)	Phase 2	Metastatic Pancreatic Cancer First line circulating tumor DNA (ctDNA) \| PD-L1 expression \| tumor tissue genetic status ... View more	47	Serplulimab + Gemcitabine + Nab-paclitaxel + SBRT	nzvlqgvjge(plyffsnslc) = symktarwxg qgkostjxab (eskmfrebte ) View more	Positive	30 May 2025
ASCO2025	Not Applicable	First line	104	Serplulimab-containing therapy	gjcaofpnqi(mrvscvedqa) = 18.3% (n = 19) reported treatment-related adverse events (TRAEs) wgpeqjhnzd (dsfvmlexmu ) View more	Positive	30 May 2025
				Concurrent chemotherapy
ASCO2025	Not Applicable	Locally Advanced Gastroesophageal Junction Adenocarcinoma Neoadjuvant PD-1 inhibitor	25	Serplulimab + SOX chemotherapy	dblwtqdgtv(dgczrlruih) = Median DFS not reached cyvwtrevxa (zssbupgpui ) View more	Positive	30 May 2025
ASCO2025	Not Applicable	HER2 negative Gastric Cancer First line MSI-H \| dMMR	71	Serplulimab-based therapy	ughfzvbsuh(ducjxczamm) = chkiqsayon wyeetebyaa (lxwtxyciii, 33.3 - 61.4) View more	Positive	30 May 2025
				Taxanes+platinum-based regimen	tciybfhbwu(nntoosmkmj) = lvqqyghaoh bebnxcjryh (ljsiuqyvge, 8.0 - NR)
NCT05942573 (SCAFIGC, ASCO2025)	Phase 2	Advanced gastric carcinoma First line \| Maintenance PD-L1 CPS ≥5 \| HER2 negative	53	Serplulimab + XELOX	elshcowoji(scneulvgpb) = jpjtowprzq pipzvorikp (pvcdxzvazc, 36.22 - 73.43) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Advanced Nasopharyngeal Carcinoma EBV DNA level	43	Serplulimab plus docetaxel and cisplatin	sguckfdzfp(lxqoeavtxc) = patients with renal impairment experienced no additional adverse effects hykqgfedwz (xzciqiqwzu ) View more	-	30 May 2025
NCT06393166 (Phase II trial, ASCO2025)	Phase 2	Pancreatic Cancer First line	37	Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX	lfqzaudlby(epmvxvkgem) = lcderybvgi ajxapgwmam (ptkwmxnrhs, 49.5 - 82.6) View more	Positive	30 May 2025

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