Delving into the Latest Updates on Camrelizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

AiRuiKa, Carrelizumab, Karelizumab

+ [7]

Target

PD-1

Action

inhibitors, stimulants

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), T lymphocytes stimulants

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [8]

Active Indication

Metastatic Cervical CarcinomaRecurrent Cervical CancerAdvanced Hepatocellular Carcinoma+ [51]

Inactive Indication

Adenocarcinoma of EsophagusAdvanced biliary tract cancerAdvanced Cervical Carcinoma+ [48]

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Ruijin Hospital

+ [6]

Inactive Organization

Atridia Pty Ltd.

HRYZ (Shanghai) Biotech Co., Ltd.

License Organization

Incyte Corp.

Elevar Therapeutics, Inc.

Crystal Genomics, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (29 May 2019),

Hodgkin's Lymphoma

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

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Structure/Sequence

Sequence Code 9905931L

Source: *****

Sequence Code 13337117H

Source: *****

This is a prospective, multicenter, multi-cohort, Phase II clinical trial enrolling patients with unresectable, recurrent, or metastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland malignancies (excluding adenoid cystic carcinoma) who have not previously received PD-1 inhibitor therapy. The planned sample size is 10 subjects per cohort, for a total of 40 subjects. Investigators may adjust the cohort sample sizes based on actual enrollment. Potentially eligible subjects will be screened within 4 weeks prior to the first dose to assess their eligibility for study entry. Subjects confirmed by the investigator to meet all inclusion criteria and none of the exclusion criteria will receive the investigational medicinal products as per the study design and undergo efficacy and safety assessments. This trial will consist of three periods: Screening/Baseline Period, Treatment Period, and Follow-up Period. The study procedures include: Screening Period: From the signing of the informed consent form up to 28 days prior to the first dose; Treatment Period: Treatment discontinuation is defined as the cessation of treatment for any reason, such as disease progression or intolerance, or premature withdrawal for any reason; Follow-up Period: Following the subject's last dose, safety follow-up will be initiated to monitor the resolution of adverse events. The first safety follow-up visit will occur 30 ± 7 days after the last study dose (calculated based on the later date of 30 days post the last dose of either camrelizumab or famitinib). Subjects are required to return to the study center for this safety follow-up, regardless of whether they have initiated new antineoplastic therapy. The subsequent two safety visits (60 ± 7 days and 90 ± 7 days after the last dose) may be conducted via telephone. After study discontinuation, survival follow-up will be conducted every 3 months to monitor survival status and subsequent antineoplastic treatments. The dosing regimen is as follows: camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle. Study drugs should be administered at approximately the same time each day. If a patient vomits or misses a dose, no replacement dose should be taken on that day, and the next scheduled dose should be taken as usual. Subjects will continue treatment with camrelizumab and famitinib until discontinuation criteria are met. Clinical tumor imaging assessments will be performed every 2 cycles according to RECIST v1.1 (Appendix IV). Additionally, on Day 1 of each treatment cycle, clinically required assessments must be completed, including vital signs, physical examination, complete blood count, urinalysis, fecal occult blood test, hepatic and renal function tests, serum electrolytes, serum proteins, coagulation profile, serum tumor markers, thyroid function, electrocardiogram (ECG), and ECOG performance status score (specific assessments for each visit are detailed in the Schedule of Assessments). Hepatitis virus carriers will also require viral load monitoring every 2 to 4 treatment cycles.

Start Date01 Jul 2026

Sponsor / Collaborator

The Ninth People's Hospital of Shanghai Jiaotong University Medical College

NCT07653451

/ Not yet recruitingPhase 2/3IIT

Precision Medicine Strategies for Advanced Esophageal Cancer Refractory to Immune Checkpoint Inhibitors

This study is an open-label, biomarker-integrated umbrella trial designed to evaluate the clinical efficacy of molecular subtype- and genomic biomarker-guided precision therapies in patients with advanced esophageal cancer refractory to prior immunotherapy. Conducted in a two-step process, the study first enrolls patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed on prior immunotherapy, performing circulating tumor DNA (ctDNA) sequencing to stratify them into three distinct treatment cohorts, after which patients receive tailored combination regimens matched to their specific molecular profiling in the second step. Specifically, Cohort 1 includes patients with high EGFR expression or activation of EGFR-related signaling pathways, who will receive Afatinib (40 mg, p.o., Q.D.) combined with Toripalimab (240 mg, i.v., Q21D) in a 21-day treatment cycle, continuing until radiographic disease progression (PD), unacceptable toxicity, loss to follow-up, death, or other investigator-determined criteria for discontinuation, with a maximum toripalimab treatment duration of 24 months. Cohort 2 comprises patients harboring genomic alterations directly associated with cell cycle regulation or activation of cell cycle signaling pathways, who will be treated with Dalpiciclib (125 mg, p.o., Q.D. for 21 consecutive days followed by a 7-day off period in a 28-day cycle [Q4W]) combined with Pyrotinib maleate (320 mg, p.o., Q.D., administered within 30 minutes post-meal, Q4W) until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of consent, or investigator's decision for treatment discontinuation. Cohort 3 includes patients with other molecular profiles who do not fit Cohorts 1 or 2, who will receive Camrelizumab (200 mg, i.v., Q3W) and Apatinib (250 mg, p.o., Q.D.), with clinical efficacy evaluations performed every 6 weeks, continuing until radiographic PD, unacceptable toxicity, death, or treatment discontinuation, whichever occurs first. The study aims to recruit an estimated maximum of 90 subjects, enrolling up to 30 subjects per cohort, with the final sample size dependent on the observed toxicities and the prevalence of each molecular cohort within the screened population.

Start Date01 Jul 2026

Sponsor / Collaborator-

NCT07627620

/ Not yet recruitingPhase 2IIT

A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer

This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.

Start Date30 Jun 2026

Sponsor / Collaborator

Hunan Cancer Hospital

100 Clinical Results associated with Camrelizumab

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100 Translational Medicine associated with Camrelizumab

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100 Patents (Medical) associated with Camrelizumab

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978

Literatures (Medical) associated with Camrelizumab

31 Dec 2026·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

Author: Wang, Ting ; Chen, Jinyun ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

31 Dec 2026·ANNALS OF MEDICINE

Cost-effectiveness of adjuvant therapy with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma: from the perspective of the Chinese healthcare system

Article

Author: Shen, Liangfang ; Feng, Yuxin ; Wang, Rui ; Zhou, Qin ; Long, Rong

OBJECTIVE:

Immune checkpoint inhibitors, particularly programmed cell death 1 inhibitors, have shown promising clinical outcomes in the adjuvant treatment of locoregionally advanced nasopharyngeal carcinoma (LA-NPC), offering a more effective and less toxic treatment option. This study aimed to explore the cost-effectiveness of adjuvant immunotherapy with camrelizumab for patients with LA-NPC from the perspective of the Chinese healthcare system.

METHODS:

A Markov model was developed to evaluate the health and economic outcomes of adjuvant camrelizumab versus standard therapy (observation) in high-risk LA-NPC. Clinical efficacy and safety data were derived from the phase 3 DIPPER trial. The model incorporated three distinct health states and simulated the outcomes over a lifetime horizon. Key endpoints included overall cost, quality-adjusted life year (QALY), incremental cost-effectiveness ratio (ICER), and incremental net health benefit (INHB), assessed at a predefined willingness-to-pay (WTP) threshold of $39,613 per QALY. One-way and probabilistic sensitivity analyses were conducted to assess the robustness of the model.

RESULTS:

Compared with standard therapy, adjuvant camrelizumab for high-risk patients with LA-NPC resulted in an added 4.39 QALYs at an incremental cost of $21,539, yielding an ICER of $4,910/QALY and an INHB of 3.85 QALYs. At the predefined WTP, camrelizumab demonstrated a 98.6% probability of being a cost-effective adjuvant treatment for LA-NPC in China. The health utility value of event-free survival was the most significant parameter influencing the model results. Sensitivity analysis results supported the robustness of the model.

CONCLUSIONS:

In China, adjuvant immunotherapy with camrelizumab following induction-concurrent chemoradiotherapy offers a potentially cost-effective approach for the management of patients with high-risk LA-NPC, yielding an ICER significantly below the predefined WTP threshold.

01 Aug 2026·BREAST

Tumor flare-like response: A novel imaging phenomenon with predictive significance in triple negative breast cancer patients undergoing neoadjuvant immuno-chemotherapy

Article

Author: Zheng, Bing Jie ; Song, Ho-Young ; Xu, Wen Juan ; Wang, Cheng Zheng ; Yue, Xia Yu ; Chen, Ya Fei ; Li, Cong Yu ; Chen, Yu ; Qu, Jin Rong ; Gao, Quan Li ; Liu, Ming Ge ; Li, Xiang ; Xu, Chun Miao ; Wang, Jia Yu ; Zhang, Ren Zhi ; Chen, Xue Jun ; Liu, Zhen Zhen

BACKGROUND:

Preoperative immuno-chemotherapy improves outcomes in triple-negative breast cancer, but associated imaging response patterns remain poorly characterized. This study aimed to describe a novel MRI phenomenon, tumor flare-like response (TFLR), and evaluate its association with pathological complete response (pCR).

METHODS:

Ad hoc imaging analysis of a prospective phase II trial (NCT04213898; n = 39). Breast MRI was performed at baseline and after every two cycles. TFLR was defined a priori as new enhancing nodules (≥5 mm) separate from the index tumor on DCE-MRI, appearing during neoadjuvant therapy with subsequent regression. Inter-reader agreement was assessed with Cohen's kappa and intraclass correlation coefficient. Univariate logistic regression and ROC analysis (Youden index) with 1000-bootstrap resampling identified the optimal largest-nodule size cut-off for pCR prediction. Two multivariable logistic regression models (continuous-size and binary-size) evaluated independence after adjustment for PD-L1 status, FGT category, baseline tumor size, and clinical stage; multicollinearity was assessed by variance inflation factor.

RESULTS:

TFLR occurred in 74.4% (29/39) of patients and was significantly associated with higher FGT density (P = .03). Among the 29 patients with TFLR, nodules were predominantly oval (93.1%) with circumscribed margins, homogeneous enhancement. Distribution was bilateral (72.5%), ipsilateral (17.2%), or contralateral (10.3%) relative to the primary tumor, with consistently asymmetric counts between breasts. Kinetic curves were persistent (31.0%), plateau (27.6%), or washout (41.4%). TFLR first appeared after cycle 2 in all cases and completely resolved in 75.9% (22/29) by treatment completion; median persistence was 152 days (95% CI 145-159). Presence of TFLR alone did not predict pCR (P = .72). Patients with largest nodule ≥9 mm had significantly higher pCR rate (77.8% vs. 36.4%, P = .048). ROC analysis identified 9 mm as the optimal cut-off. In multivariable analysis, largest nodule diameter remained independently predictive whether analyzed continuously (OR = 2.965, 95% CI 1.298-6.772, P = .01) or dichotomized at ≥9 mm (OR = 7.833, 95% CI 1.260-48.701, P = .027). Model AUCs were 0.904 (95% CI 0.797-1.00) and 0.727 (95% CI 0.519-0.936), respectively.

CONCLUSIONS:

TFLR is a frequent, reversible MRI finding in TNBC treated with camrelizumab-based neoadjuvant immuno-chemotherapy. Largest nodule diameter ≥9 mm is a strong, independent predictor of pathological complete response and represents a promising early, non-invasive imaging biomarker of immunotherapeutic efficacy.

101

News (Medical) associated with Camrelizumab

17 Jul 2026

·www.fiercepharma.com

Fierce Pharma Asia—GSK, Merck ADCs’ trial wins; AZ’s $1.5B EGFR buy; Biotechs’ new patent tricks

Antibody-drug conjugates from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck & Co. and GSK, delivered positive phase 3 readouts in China. AstraZeneca reached out to its spinout, Dizal Pharma, for an EGFR lung cancer med. Biotechs are growing protective of their intellectual property and business intelligence. And more. 1. Kelun scores sac-TMT win in first-line NSCLC population missing from Merck’s massive phase 3 program Kelun-Biotech reported a positive phase 3 readout for its Merck & Co.-partnered TROP2 ADC, sac-TMT, as a first-line treatment for PD-L1-negative nonsquamous non-small cell lung cancer in China. The readout offers the first, direct proof for an ADC replacing chemo in the lucrative first-line NSCLC setting and could inspire Merck to fill a gap in its global phase 3 program, analysts argued. 2. GSK sees phase 3 win for Hansoh-partnered ADC in China as validating its ‘priority asset’ Also in China, GSK’s partner Hansoh Pharma said a phase 3 study of its ris-rez, a B7-H3-targeted ADC, has hit its primary endpoint in small cell lung cancer. It marks the first positive phase 3 overall survival readout from a B7-H3 ADC. The asset, along with a B7-H4 ADC from Hansoh, are among GSK’s priority assets. 3. AstraZeneca pays up to $1.5B for EGFR lung cancer drug Zegfrovy from its spinoff Dizal AstraZeneca has signed another China deal, this time tapping into its own spinout, Dizal Pharma. With $600 million upfront and up to $900 million in milestones, AZ is buying Dizal’s EGFR inhibitor Zegfrovy, which just reported confirmatory phase 3 data in first-line NSCLC with EGFR exon 20 insertion mutations. Dizal was formed in 2017 based on AZ’s China innovation center. 4. ‘How did they get there first?’ Biotechs forced to learn new patent tricks to protect pipelines As competition with Chinese companies grows, U.S. biotechs have become more secretive about their research. Besides building a robust patent package, biotechs are advised to exercise caution with their public communications or use public statements to highlight lower-priority candidates to throw off competitors. 5. Insilico signs on with CDMO Bora in $2.5B AI drug discovery deal Insilico’s Chinese partner returns for $177M pact to explore ‘mass market’ CNS indication On a dealmaking spree, AI drug discovery outfit Insilico Medicine has teamed up with Bora Pharmaceuticals in a deal potentially worth $2.5 billion. Insilico’s proprietary Pharma.AI platform will be paired with Bora’s CDMO capabilities to enable drug innovation. Meanwhile, China Medical System has tapped Insilico’s PandaOmics in a $177 million collaboration aimed at a large central nervous system indication. 6. FDA rejects Hengrui, Elevar’s PD-1 liver cancer combo for a 3rd time The FDA has declined to approve Hengrui Pharma and Elevar Therapeutics’ camrelizumab and rivoceranib for a third time in first-line liver cancer. While the previous two rejections cited problems at Hengrui’s camrelizumab plant, the latest complete response letter cited the plant making rivoceranib. The FDA didn’t raise any issues with clinical data. 7. Avere goes public via NextCure reverse merger, secures Hansoh IL-23 drug with $2.3B deal 8. Braveheart aims for freedom with IPO to support Hengrui-licensed cardio asset 9. FDA's latest onshoring move homes in on streamlined facility registration, foreign plant scrutiny 10. Bipartisan Senate bill seeks to build vigilance around foreign companies making drugs in US 11. Star Padcev-Keytruda combo expands bladder cancer reach with FDA approval, pressuring AstraZeneca 12. Eisai, Biogen scoop up subQ Leqembi starter dose nod (Regulatory tracker) 13. Huyabio scores with Opdivo combo in 'milestone' skin cancer trial 14. Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial

Phase 3Drug ApprovalClinical ResultPhase 2IPO

16 Jul 2026

·www.fiercepharma.com

Huahai poaches quality chief from Hengrui amid FDA manufacturing citations

Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility. Xuejian Xu, who most recently served as chief quality officer at Hengrui Pharma, joined Huahai under the same title in June, the Zhejiang Province, China-headquartered generics giant said in a July 15 securities disclosure (Chinese, PDF). Before his two-year stint at Hengrui, Xu was chief quality officer at WuXi Biologics and held similar responsibilities at WuXi AppTec after some time as a manufacturing reviewer at the U.S. FDA’s Office of Generic Drugs. The appointment comes as Huahai works through a scathing citation the FDA slapped on its manufacturing facility in Linhai, China. Following an inspection in April, the agency issued the site a 24-page Form 483 (PDF) with 13 observations, some of which repeated deficiencies identified in a June 2025 FDA warning letter . For example, the first issue the FDA flagged in the 2025 warning letter centered on the site’s failure to clean equipment and utensils at appropriate intervals to prevent malfunctions or contamination of the drug product. The same language appeared in the eighth observation of the newly published Form 483. In addition, the FDA cited deficiencies in the cleaning and disinfection of equipment in aseptic processing areas. The plant failed to prevent potential carryover of contamination from one area to another by allowing for a single clean cloth to wipe multiple surfaces, according to the letter. In one of the longest observations, detailed over four pages, the FDA said the Linhai facility’s procedures for preventing microbiological contamination of sterile drug products were inadequate. Huahai was at the center of the infamous 2018 valsartan contamination crisis involving nitrosamine impurities classified as probable human carcinogens. Despite this legacy issue, the Linhai plant lacked a risk analysis to determine how substances the FDA described as “potential genotoxic and suspected human carcinogenic” came to be present in certain tablets, according to the first observation in the agency’s new Form 483. The agency criticized the plant for using an API that had not been tested for the impurities by either the supplier or Huahai before the company shipped bulk tablets containing the API to the U.S. Xu came to Hengrui’s rescue in 2024 after a series of manufacturing missteps drew the FDA’s attention. Manufacturing deficiencies at a plant operated by Hengrui's subsidiary, Suzhou Suncadia Biopharmaceutical, led the FDA to reject Hengrui and Elevar Therapeutics’ PD-1 inhibitor, camrelizumab, used in combination with the companies’ VEGFR inhibitor, rivoceranib, as a first-line treatment for liver cancer. Around the same time, the FDA escalated a prior Form 483 to a warning letter for Hengrui’s small-molecule finished drugs facility in Lianyungang, China. Following the initial 2024 rejection, the FDA declined to approve the camrelizumab-rivoceranib combo again last year after spotting new issues during a reinspection of the Suncadia plant. Last week, Hengrui said the FDA turned down its application for the third time, citing deficiencies at the rivoceranib plant.

Drug ApprovalExecutive Change

15 Jul 2026

·www.biospace.com

Manufacturing issues prompt FDA to reject Hengrui-Elevar filings for third time

iStock, DoggieMonkey An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo. The FDA has again rejected a request for approval of Hengrui Pharma and Elevar Therapeutics’ oncology drug combination over manufacturing issues. Hengrui and Elevar, a majority-owned subsidiary of South Korea’s HLB, are developing a combination of the oral tyrosine kinase inhibitor (TKI) rivoceranib and anti-PD-1 antibody camrelizumab. A Phase 3 trial linked the first-line use of the combination to longer overall survival than sorafenib, which Bayer sells as Nexavar, in people with unresectable or metastatic hepatocellular carcinoma. But manufacturing issues have plagued the companies’ attempts to bring the two drugs to market. In 2024, the FDA rejected camrelizumab over deficiencies seen during a preapproval inspection (PAI) of a plant listed in the application for the anti-PD-1 antibody. The camrelizumab rejection, plus the FDA’s inability to complete clinical inspections amid travel restrictions, triggered the 2024 complete response letter (CRL) for rivoceranib. In 2025, the FDA rejected camrelizumab after finding deficiencies during a reinspection of a plant listed in the application for the anti-PD-1 antibody. The camrelizumab rejection led the FDA to issue the 2025 CRL for rivoceranib. Manufacturing FDA proposes streamlined requirements for ‘hub-and-spoke’ manufacturing models Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience. July 14, 2026 · 2 min read · Nick Paul Taylor Read more The roles were reversed in the latest setback, with deficiencies at a rivoceranib plant leading the FDA to issue a CRL for camrelizumab. The problems arose at a rivoceranib production plant. The FDA issued a Form 483 listing deficiencies after inspecting the rivoceranib facility. The agency wants the facility team to provide satisfactory responses to the deficiencies before Elevar resubmits. Once it receives the responses, the FDA may reinspect the facility to confirm compliance with current good manufacturing practices (cGMP). A PAI could follow the confirmation of cGMP compliance. Satisfactory outcomes from the cGMP and PAI assessments will be needed before the FDA is willing to approve rivoceranib and, by extension, camrelizumab. Elevar is reviewing the FDA’s CRL and plans to work closely with the agency to find the right path forward, CEO Dong-Gun Kim said in a statement. The biotech remains committed to advancing rivoceranib and camrelizumab and “will engage with the FDA promptly,” Kim said.

Phase 3NDAClinical ResultDrug ApprovalAccelerated Approval

100 Deals associated with Camrelizumab

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KEGG	Wiki	ATC	Drug Bank
-	Camrelizumab	L01XC	DB14776

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	13 May 2025
Recurrent Cervical Cancer	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	13 May 2025
Advanced Hepatocellular Carcinoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	31 Jan 2023
Advanced Nasopharyngeal Carcinoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	27 Apr 2021
Esophageal Squamous Cell Carcinoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	17 Jun 2020
Non-Small Cell Lung Cancer	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	17 Jun 2020
Hepatocellular Carcinoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	05 Mar 2020
Hodgkin's Lymphoma	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	29 May 2019
Hodgkin's Lymphoma	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	29 May 2019
Non-squamous non-small cell lung cancer	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic hepatocellular carcinoma	NDA/BLA	United States	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	02 Nov 2023
Unresectable Hepatocellular Carcinoma	NDA/BLA	United States	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	02 Nov 2023
Nasopharyngeal Carcinoma	NDA/BLA	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	12 Nov 2020
Metastatic Pancreatic Cancer	Phase 3	China	HUTCHMED (China) Ltd.	08 May 2024
Squamous cell carcinoma of the oral cavity	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	21 Nov 2023
Metastatic Triple-Negative Breast Carcinoma	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	11 Jan 2022
Metastatic Cervical Squamous Cell Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	23 Jul 2021
Locally Advanced Rectal Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	20 Jul 2021
Triple Negative Breast Cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	09 Dec 2020
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	21 Sep 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_GCC2026 \| ESMO_GI2026	Not Applicable	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	197	Neoadjuvant chemotherapy combined with camrelizumab	embkqycchj(otwvtrvlxr) = plcgooczze zhsnwmvlop (prwzfaslld ) View more	Positive	02 Jul 2026
NCT05475678 (HELEN-Trio 011, ASCO2026)	Phase 3	Triple Negative Breast Cancer Neoadjuvant	369	Camrelizumab+chemotherapy	wbcqtmhcrd(tlfkrynayq) = hszdgaryxs gwuzmpubfd (hmizcutzir, 27.4 - 48.2) View more	Positive	29 May 2026
				Chemotherapy alone	wbcqtmhcrd(tlfkrynayq) = wwunsnyktw gwuzmpubfd (hmizcutzir, 12.5 - 43.7) View more
NCT05512481 (CAP 03-NEO, ASCO2026)	Phase 2	Acral Lentiginous Malignant Melanoma Neoadjuvant	60	Neoadjuvant camrelizumab + apatinib + temozolomide	tydmxvijxi(fxozdebsmw) = vvywbsiijz uozckeaish (umyfkzkkhq ) View more	Positive	29 May 2026
				Adjuvant PD-1 inhibitor	-
NCT05320692 (ASCO2026)	Phase 3	Unresectable Hepatocellular Carcinoma First line	423	Camrelizumab (C) + Rivoceranib (R) + TACE	ckevuyirhn(ljzsszjncc) = venbzzyfro jcpfqurush (pdlyjnihca, 7.8 - 14.0) View more	Positive	29 May 2026
				TACE	ckevuyirhn(ljzsszjncc) = iabtqqukfe jcpfqurush (pdlyjnihca, 6.9 - 9.5) View more
NCT06345300 (ASCO2026)	Phase 2	Pancreatic Cancer	21	Liposomal irinotecan + oxaliplatin + 5-FU/LV + camrelizumab	vukfhgaafb(zjeubrcroh) = Cohort 1: most common all-grade AEs were nausea (69.2%), diarrhea (50.0%), neutropenia (41.7%), constipation (33.3%); Grade ≥3 AEs included neutropenia (25.0%), malnutrition (16.7%), leukopenia (8.3%), hypoalbuminemia (8.3%). Cohort 2: most common all-grade AEs were nausea (44.4%), diarrhea (22.2%), leukopenia (22.2%); only Grade ≥3 diarrhea (11.1%) was severe. qoihckztcs (kmwiikuoeo )	Positive	29 May 2026
				Liposomal irinotecan + oxaliplatin + 5-FU/LV
ChiCTR2500111883 (ASCO2026)	Phase 2	Nasopharyngeal Carcinoma Maintenance	20	Camrelizumab + Capecitabine (Metastatic Nasopharyngeal Carcinoma)	ypmdovgfco(iqxqfqzknl) = vbghnkaoek ojymmtssne (bgbzvcklhk ) View more	Positive	29 May 2026
NCT07314372 (FAD-HCC-01, ASCO2026)	Phase 2	Unresectable Hepatocellular Carcinoma FAD subtypes (F1, F2, or F3)	86	camrelizumab+rivoceranib (F1 or F2 subtype)	apwhamzjlq(ddgwwmclwt) = The most common treatment-related adverse events were Grade 2-3 hypertension (camrelizumab, 53.8%; TACE, 39.7%) and Grade 1-2 diarrhea (rivoceranib, 47.6%). bkwrsltudq (dqqluhnwsd )	Positive	29 May 2026
				camrelizumab+rivoceranib+TACE (F3 subtype)
ASCO2026	Not Applicable	Advanced Nasopharyngeal Carcinoma	103	Camrelizumab + Concurrent Chemoradiotherapy	tmskvzxikn(zyjwlrntzg) = lqaedsechr ovedoxsuau (jgftammfls ) View more	Positive	29 May 2026
				Concurrent Chemoradiotherapy	tmskvzxikn(zyjwlrntzg) = znmfbdyidt ovedoxsuau (jgftammfls ) View more
NCT06061276 (TALEM-H, ASCO2026)	Phase 2	Hepatocellular Carcinoma First line	40	bTAE + FOLFOX-HAIC + lenvatinib + camrelizumab	rajeggjxjd(fgzditccnk) = yepbzmeaxo ejlauxwwwo (fkunyubtob ) View more	Positive	29 May 2026
NCT04889768 (ASCO2026)	Phase 2	Advanced gastric carcinoma HER2-negative	46	HIPEC combined with camrelizumab, paclitaxel, and S-1	xopancenok(srwwiwilzm) = ymbjpfbawl uytmcoofnh (xqrycngmjo ) View more	Positive	29 May 2026

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Core Patent

Boost your research with our Core Patent data.

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Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

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Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

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Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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