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: *****

184

Clinical Trials associated with Serplulimab

NCT07622550

/ Not yet recruitingPhase 2IIT

A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance

This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.

Start Date15 Jun 2026

Sponsor / Collaborator

Jiangsu Cancer Hospital

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-

100 Clinical Results associated with Serplulimab

100 Translational Medicine associated with Serplulimab

100 Patents (Medical) associated with Serplulimab

102

Literatures (Medical) associated with Serplulimab

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.

02 Jun 2026·Cancer Immunology Research

Induction Serplulimab and Chemotherapy Followed by Chemoradiotherapy for Bulky Unresectable Stage III NSCLC: A Phase II Study (SUCCEED-01)

Article

Author: Liu, Xiaomeng ; Fan, Bingjie ; Du, Yang ; Liu, Chengxin ; Sun, Hongfu ; Fu, Chengrui ; Xu, Longyu ; Li, Baosheng ; Dai, Tianyuan ; Han, Dan ; Huang, Wei

Abstract:

Patients with bulky, unresectable stage III non–small cell lung cancer (NSCLC) face poor outcomes with standard concurrent chemoradiotherapy (cCRT) due to large radiation fields and toxicity risks. We evaluated the feasibility and efficacy of induction immunochemotherapy to downstage tumors prior to cCRT. In this single-arm, phase II study, eligible patients received two cycles of induction serplulimab plus chemotherapy. Patients without progression underwent multidisciplinary restaging to receive either cCRT with serplulimab consolidation or surgery. The primary endpoints were objective response rate (ORR) after cCRT and changes in lung volume receiving ≥20 Gy (V20). Forty-nine patients were enrolled (75.5% stage IIIB/IIIC). Following induction, the V20 value was significantly reduced by 11.41% (P < 0.001). The ORR following cCRT was 77.14% (95% confidence interval, 59.86%–89.58%). The 12-month progression-free survival and overall survival rates were 76.15% and 90.54%, respectively. Notably, six patients successfully underwent R0 resection, with five achieving a pathologic complete response. Grade 3 adverse events occurred in 14.29% of patients, and toxicities were manageable. Induction serplulimab–chemotherapy prior to cCRT is a promising strategy for bulky, stage III NSCLC. This approach significantly reduced radiation volumes, achieved high response rates, and enabled curative surgery in selected patients with manageable toxicity.

01 Jun 2026·LANCET

Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study

Article

Author: Yuan, Xianglin ; Hu, Jiankun ; Liang, Jun ; Shen, Bo ; Chen, Xiaolei ; Sun, Meili ; Deng, Yanhong ; Bi, Tienan ; Chen, Zihua ; Li, Jingzhang ; Li, Yong ; Wang, Quan ; Xu, Zekuan ; Li, Junhe ; Pan, Wensheng ; You, Tao ; Yang, Yan ; Yin, Xianli ; Huo, Zhibin ; Yang, Chunkang ; Wang, Gang ; Li, Zhen ; Li, Xiaorong ; Lu, Linzhi ; Hu, Xuhui ; Ji, Jiafu ; Zhang, Jingdong ; Zhu, Zhiqiang ; Zhou, Yanbing ; Jie, Zhigang ; Ba, Yi ; Luo, Suxia ; Wang, Xiaoqiang ; Cao, Baoshan ; Ji, Ke ; Li, Jing ; Wang, Haijiang ; Xue, Yingwei ; Yu, Haoyu ; Wang, Ziwei ; Liu, Funan ; Wu, Dan ; Cao, Peiguo ; Cao, Zhixin ; Mou, Yiping ; Guan, Quanlin ; Yang, Xiaojun ; Ye, Yingjiang ; Ge, Jie ; Yan, Su ; Zhu, Jun ; Yu, Nanrong ; Chen, Shaojun ; Yang, Futang ; Yuan, Ying ; Pan, Hongming ; Teng, Lisong ; Huang, Changming ; Zhang, Xiaotian ; Tao, Guoquan ; You, Jun ; Bo, Yuankai ; Shen, Lin ; Wang, Zhenning ; Wang, Shubin ; Tao, Kaixiong ; Tan, Yunbo ; Lv, Guoqing ; Tang, Yun ; Wang, Qingyu ; Zhang, Yongchang ; Sun, Guoping ; Chen, Ye ; Jiang, Congqiao ; Bi, Xiaogang

BACKGROUND:

Perioperative chemo-immunotherapy shows variable outcomes in resectable gastric or gastro-oesophageal junction adenocarcinoma. We evaluated the efficacy and safety of neoadjuvant serplulimab with S-1 plus oxaliplatin (SOX) chemotherapy followed by adjuvant serplulimab versus neoadjuvant placebo plus SOX followed by adjuvant SOX in patients with PD-L1-positive, locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma.

METHODS:

In this randomised, double-blind, multicentre phase 3 ASTRUM-006 study, patients were screened at 75 hospitals in China and Thailand. Eligible patients aged 18-70 years with PD-L1 combined positive score (CPS) ≥5, resectable gastric or gastro-oesophageal junction adenocarcinoma were randomly assigned 1:1 to neoadjuvant serplulimab or placebo (intravenous; 4·5 mg/kg) plus SOX chemotherapy (intravenous oxaliplatin 130 mg/m² on day 1, and oral S1 40-60 mg twice daily on days 1-14) for three cycles (cycle length 21 days), followed by adjuvant serplulimab (up to 17 cycles; serplulimab group) or SOX (five cycles; placebo group). The primary endpoint was investigator-assessed event-free survival (defined as the time from randomisation to the occurrence of progressive disease or local or distant recurrence, other new malignancies, or death), with efficacy first evaluated in PD-L1 CPS ≥10, then in the intention-to-treat (CPS ≥5) population. This study is registered with ClinicalTrials.gov, NCT04139135, and is ongoing.

FINDINGS:

Between Nov 26, 2019, and April 19, 2024, 1646 patients were screened, of whom 588 patients (median age 61·0 years [IQR 55-66]; 124 [21%] female and 464 [79%] male) at 57 hospitals in China were randomly assigned to the serplulimab group (n=292) or placebo group (n=296). With a median follow-up duration of 42·7 months (IQR 24·3-53·6), median event-free survival was significantly longer with serplulimab than with placebo in the PD-L1 CPS ≥10 population (not reached [NR] vs 42·0 months; hazard ratio 0·65 [95% CI 0·47-0·90]; p=0·0082). With a median follow-up of 35·9 months (IQR 23·5-49·4), median event-free survival was also significantly longer with serplulimab than with placebo in the intention-to-treat population (NR vs 35·9 months; 0·73 [95% CI 0·56-0·94]; p=0·015). Grade 3 or worse treatment-related adverse events occurred in 136 (47%) patients in the serplulimab group and 172 (59%) patients in the placebo group; 19 (7%) and 31 (11%) patients in the respective groups discontinued treatment due to treatment-related adverse events.

INTERPRETATION:

Neoadjuvant serplulimab plus SOX followed by adjuvant serplulimab significantly improved event-free survival and demonstrated a better safety profile compared with neoadjuvant and adjuvant SOX in PD-L1-positive, resectable gastric or gastro-oesophageal junction adenocarcinoma. Extended follow-up for the overall survival data is warranted to confirm a survival advantage of this perioperative strategy with a chemotherapy-sparing adjuvant component for this indication.

FUNDING:

Shanghai Henlius Biotech.

106

News (Medical) associated with Serplulimab

09 Jun 2026

·www.biospace.com

Burning Rock Reports First Quarter 2026 Financial Results

GUANGZHOU, China, June 09, 2026 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next-generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended March 31, 2026. Recent Business Updates Early Detection, Therapy Selection & MRD Presented multiple study results at the 2026 AACR in April, showcasing validation data on MMcall, CanCatch Surf, 25-plex ddPCR, and SPIRAL. Presented study results at Journal for ImmunoTherapy of Cancer in April 2026. “A four-cycle perioperative regimen of serplulimab combined with taxane-carboplatin demonstrated promising MPR and pCR rates with an acceptable safety pro patients with resectable sq-NSCLC.” First Quarter 2026 Financial Results Revenues were RMB107.9 million (US$15.6 million) for the three months ended March 31, 2026, representing an 18.9% decrease from RMB133.1 million for the same period in 2025. Revenue generated from central laboratory business was RMB32.3 million (US$4.7 million) for the three months ended March 31, 2026, representing a 15.3% decrease from RMB38.3 million for the same period in 2025, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing. Revenue generated from in-hospital business was RMB52.8 million (US$7.6 million) for the three months ended March 31, 2026, representing an 8.5% decrease from RMB57.7 million for the same period in 2025, primarily attributable to a decrease in revenue from two hospitals due to one-off issue. Excluding such two, in-hospital revenue for the three months ended March 31, 2026 would have increased by 2% year-over-year. Revenue generated from pharma research and development services was RMB22.8 million (US$3.3 million) for the three months ended March 31, 2026, representing a 38.6% decrease from RMB37.1 million for the same period in 2025, primarily attributable to decreased testing services performed for our pharma customers and lower milestone progress of our pharma programs achieved due to timing of the projects. Cost of revenues was RMB29.9 million (US$4.3 million) for the three months ended March 31, 2026, representing a 16.1% decrease from RMB35.7 million for the same period in 2025. Gross profit was RMB78.0 million (US$11.3 million) for the three months ended March 31, 2026, representing a 19.9% decrease from RMB97.4 million for the same period in 2025. Gross margin was 72.3% for the three months ended March 31, 2026, compared to 73.2% for the same period in 2025. By channel, gross margin of central laboratory business was 88.7% for the three months ended March 31, 2026, compared to 84.1% during the same period in 2025, primarily driven by a reduction in inventory write-downs; gross margin of in-hospital business was 72.9% for the three months ended March 31, 2026, compared to 76.1% during the same period in 2025, primarily attributable to a decrease in sales volume to high margin products; gross margin of pharma research and development services was 47.4% for the three months ended March 31, 2026, compared to 57.5% during the same period of 2025, primarily due to a decrease in test volume of higher-margin projects. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB80.5 million (US$11.7 million) for the three months ended March 31, 2026, representing a 20.0% decrease from RMB100.7 million for the same period in 2025. Non-GAAP gross margin was 74.6% for the three months ended March 31, 2026, compared to 75.6% for the same period in 2025. For more details on these non-GAAP financial measures, please see the table captioned “Reconciliations of GAAP and Non-GAAP Results” set forth at the end of this press release. Operating expenses were RMB96.9 million (US$14.1 million) for the three months ended March 31, 2026, representing a 14.0% decrease from RMB112.6 million for the same period in 2025. The decrease was primarily driven by business cost and payment collection control to improve operating efficiency. Research and development expenses were RMB27.6 million (US$4.0 million) for the three months ended March 31, 2026, representing a 31.8% decrease from RMB40.4 million for the same period in 2025, primarily due to (i) a temporary decrease across different research phases, and (ii) a decrease in amortized expense on share-based compensation. Selling and marketing expenses were RMB41.2 million (US$6.0 million) for the three months ended March 31, 2026, remaining relatively stable as compared with RMB40.9 million for the same period in 2025. General and administrative expenses were RMB28.1 million (US$4.1 million) for the three months ended March 31, 2026, representing a 10.3% decrease from RMB31.3 million for the same period in 2025, primarily due to a decrease in impairment expenses for accounts receivables and contract assets. Net loss was RMB17.5 million (US$2.5 million) for the three months ended March 31, 2026, compared to RMB13.5 million for the same period in 2025. Cash, cash equivalents and restricted cash were RMB448.7 million (US$65.1 million) as of March 31, 2026. Exchange Rate Information This press release contains translations of certain Renminbi amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars and from U.S. dollars to Renminbi are made at a rate of RMB6.8980 to US$1.00, the exchange rate on March 31, 2026, set forth in the H.10 statistical release of the Federal Reserve Board. The Company makes no representation that the Renminbi or U.S. dollars amounts referred could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all. About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. For more information about Burning Rock, please visit: ir.brbiotech.com. Safe Harbor Statement This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. Non-GAAP Measures In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance and formulate business plans. However, the presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). These non-GAAP financial measures may be different from non-GAAP methods of accounting and reporting used by other companies, including peer companies, and therefore their comparability may be limited. The Company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The Company defines non-GAAP gross margin as non-GAAP gross profit divided by its revenue. The Company believes presenting non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization, in addition to the Company’s GAAP gross profit and gross margin, provides a better understanding of the underlying trends in the Company’s operating business performance. Reconciliation of these non-GAAP financial measures to the most directly comparable U.S. GAAP measures are set forth at the end of this press release, all of which should be considered when evaluating the Company’s performance. Contact: IR@brbiotech.com Selected Operating Data As of March 31, June 30, September December March 31, 2025 2025 30, 2025 31, 2025 2026 In-hospital channel: Pipeline partner hospitals (1) 30 30 31 30 30 Contracted partner hospitals (2) 63 63 63 64 64 Total number of partner hospitals 93 93 94 94 94 (1) Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company’s products. (2) Refers to hospitals that have entered into contracts to purchase the Company’s products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals. Selected Financial Data For the three months ended March 31, June 30, September December March 31, Revenues 2025 2025 30, 2025 31, 2025 2026 (RMB in thousands) Central laboratory channel 38,296 40,861 36,811 44,025 32,420 In-hospital channel 57,687 62,496 52,847 51,005 52,761 Pharma research and development channel 37,099 45,197 41,959 31,285 22,762 Total revenues 133,082 148,554 131,617 126,315 107,943 For the three months ended March 31, June 30, September December March 31, Revenues by location of contracting customer 2025 2025 30, 2025 31, 2025 2026 (RMB in thousands) Overseas 24,407 37,458 17,214 21,849 8,544 Chinese mainland 108,675 111,096 114,403 104,466 99,399 Total revenues 133,082 148,554 131,617 126,315 107,943 For the three months ended March 31, June 30, September December March 31, Gross profit 2025 2025 30, 2025 31, 2025 2026 (RMB in thousands) Central laboratory channel 32,191 35,937 30,126 39,322 28,761 In-hospital channel 43,895 46,490 37,925 38,388 38,458 Pharma research and development channel 21,315 25,676 30,793 20,856 10,789 Total gross profit 97,401 108,103 98,844 98,566 78,008 For the three months ended March 31, June 30, September December March 31, Share-based compensation expenses 2025 2025 30, 2025 31, 2025 2026 (RMB in thousands) Cost of revenues 308 280 301 300 82 Research and development expenses 1,800 (270 ) 73 259 (345 ) Selling and marketing expenses 1,025 364 624 748 164 General and administrative expenses 1,413 2,005 2,831 1,815 1,907 Total share-based compensation expenses 4,546 2,379 3,829 3,122 1,808 Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the three months ended March 31, June 30, September December March 31, March 31, 2025 2025 30, 2025 31, 2025 2026 2026 RMB RMB RMB RMB RMB US$ Revenues 133,082 148,554 131,617 126,315 107,943 15,649 Cost of revenues (35,681 ) (40,451 ) (32,773 ) (27,749 ) (29,935 ) (4,339 ) Gross profit 97,401 108,103 98,844 98,566 78,008 11,310 Operating expenses: Research and development expenses (40,389 ) (49,770 ) (41,469 ) (34,866 ) (27,559 ) (3,995 ) Selling and marketing expenses (40,888 ) (38,413 ) (41,808 ) (44,066 ) (41,206 ) (5,974 ) General and administrative expenses (31,303 ) (31,417 ) (31,698 ) (31,672 ) (28,088 ) (4,072 ) Total operating expenses (112,580 ) (119,600 ) (114,975 ) (110,604 ) (96,853 ) (14,041 ) Loss from operations (15,179 ) (11,497 ) (16,131 ) (12,038 ) (18,845 ) (2,731 ) Interest income 2,581 2,226 1,744 1,502 1,261 183 Interest expense - - (15 ) (15 ) (15 ) (2 ) Other (expense) income, net (652 ) 387 7 1 294 43 Foreign exchange (loss) gain, net (26 ) (574 ) (2,151 ) (3,960 ) 65 9 Loss before income tax (13,276 ) (9,458 ) (16,546 ) (14,510 ) (17,240 ) (2,498 ) Income tax expenses (224 ) (244 ) (212 ) (876 ) (232 ) (34 ) Net loss (13,500 ) (9,702 ) (16,758 ) (15,386 ) (17,472 ) (2,532 ) Net loss attributable to Burning Rock Biotech Limited’s shareholders (13,500 ) (9,702 ) (16,758 ) (15,386 ) (17,472 ) (2,532 ) Net loss attributable to ordinary shareholders (13,500 ) (9,702 ) (16,758 ) (15,386 ) (17,472 ) (2,532 ) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted (0.13 ) (0.09 ) (0.16 ) (0.15 ) (0.17 ) (0.02 ) Class B ordinary shares - basic and diluted (0.13 ) (0.09 ) (0.16 ) (0.15 ) (0.17 ) (0.02 ) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted 90,291,658 90,357,970 90,416,619 87,444,109 87,871,026 87,871,026 Class B ordinary shares - basic and diluted 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustments (72 ) (243 ) (1,724 ) (2,050 ) (3,143 ) (456 ) Total comprehensive loss (13,572 ) (9,945 ) (18,482 ) (17,436 ) (20,615 ) (2,988 ) Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders (13,572 ) (9,945 ) (18,482 ) (17,436 ) (20,615 ) (2,988 ) Burning Rock Biotech Limited Unaudited Condensed Consolidated Balance Sheets (in thousands) As of December 31, March 31, March 31, 2025 2026 2026 RMB RMB US$ ASSETS Current assets: Cash and cash equivalents 478,392 446,002 64,657 Restricted cash 2,696 2,728 395 Accounts receivable, net 169,611 164,497 23,847 Contract assets, net 12,301 12,715 1,843 Inventories, net 56,975 54,294 7,871 Prepayments and other current assets 18,611 20,759 3,010 Total current assets 738,586 700,995 101,623 Non-current assets: Property and equipment, net 31,099 26,997 3,914 Operating right-of-use assets 42,774 51,931 7,528 Intangible assets, net 284 258 37 Other non-current assets 7,632 7,603 1,102 Total non-current assets 81,789 86,789 12,581 TOTAL ASSETS 820,375 787,784 114,204 Burning Rock Biotech Limited Unaudited Condensed Consolidated Balance Sheets (Continued) (in thousands) As of December 31, March 31, March 31, 2025 2026 2026 RMB RMB US$ LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable 40,744 18,043 2,616 Deferred revenue 107,819 114,487 16,597 Accrued liabilities and other current liabilities 80,861 75,381 10,928 Customer deposits 592 592 86 Current portion of long-term borrowings 200 200 29 Current portion of operating lease liabilities 16,762 21,113 3,061 Total current liabilities 246,978 229,816 33,317 Non-current liabilities: Long-term borrowings 1,700 1,700 246 Non-current portion of operating lease liabilities 24,458 27,850 4,037 Other non-current liabilities 11,975 11,961 1,734 Total non-current liabilities 38,133 41,511 6,017 TOTAL LIABILITIES 285,111 271,327 39,334 Shareholders’ equity: Class A ordinary shares 120 120 17 Class B ordinary shares 21 21 3 Additional paid-in capital 5,010,060 5,011,868 (8,291 ) Treasury stock (57,193 ) (57,193 ) 726,568 Accumulated deficits (4,255,607 ) (4,273,079 ) (619,466 ) Accumulated other comprehensive loss (162,137 ) (165,280 ) (23,961 ) Total shareholders’ equity 535,264 516,457 74,870 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 820,375 787,784 114,204 Burning Rock Biotech Limited Unaudited Condensed Statements of Cash Flows (in thousands) For the three months e nded March 31, March 31, March 31, 2025 2026 2026 RMB RMB US$ Net cash used in operating activities (23,527 ) (29,304 ) (4,248 ) Net cash used in investing activities (1,531 ) (364 ) (53 ) Net cash generated from financing activities - - - Effect of exchange rate on cash, cash equivalents and restricted cash 302 (2,690 ) (390 ) Net decrease in cash, cash equivalents and restricted cash (24,756 ) (32,358 ) (4,691 ) Cash, cash equivalents and restricted cash at the beginning of period 522,162 481,088 69,743 Cash, cash equivalents and restricted cash at the end of period 497,406 448,730 65,052 Burning Rock Biotech Limited Reconciliations of GAAP and Non-GAAP Results For the three months ended March 31, June 30, September December March 31, 2025 2025 30, 2025 31, 2025 2026 (RMB in thousands) Gross profit: Central laboratory channel 32,191 35,937 30,126 39,322 28,761 In-hospital channel 43,895 46,490 37,925 38,388 38,458 Pharma research and development channel 21,315 25,676 30,793 20,856 10,789 Total gross profit 97,401 108,103 98,844 98,566 78,008 Add: depreciation and amortization: Central laboratory channel 562 456 231 490 412 In-hospital channel 290 389 372 308 228 Pharma research and development channel 2,412 1,528 1,491 2,057 1,885 Total depreciation and amortization included in cost of revenues 3,264 2,373 2,094 2,855 2,525 Non-GAAP gross profit: Central laboratory channel 32,753 36,393 30,357 39,812 29,173 In-hospital channel 44,185 46,879 38,297 38,696 38,686 Pharma research and development channel 23,727 27,204 32,284 22,913 12,674 Total non-GAAP gross profit 100,665 110,476 100,938 101,421 80,533 Non-GAAP gross margin: Central laboratory channel 85.5% 89.1% 82.5% 90.4% 90.0% In-hospital channel 76.6% 75.0% 72.5% 75.9% 73.3% Pharma research and development channel 64.0% 60.2% 76.9% 73.2% 55.7% Total non-GAAP gross margin 75.6 % 74.4 % 76.7 % 80.3 % 74.6 %

Financial StatementClinical Result

22 May 2026

·www.biospace.com

HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting

HONG KONG and FLORHAM PARK, N.J., May 22, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA. Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025. Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead Author Presentation details SPONSORED STUDIES A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011 Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 1, 2026 1:15 PM CDT Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531 Poster Session: Genitourinary Cancer – Kidney and Bladder Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533 Poster Session: Genitourinary Cancer – Kidney and Bladder Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612 Publication Only: Gynecologic Cancer INVESTIGATOR-INITIATED STUDIES Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563 Poster Session: Gastrointestinal Cancer – Colorectal and Anal CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631 Poster Session: Developmental Therapeutics – Immunotherapy Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579 Poster Session: Gynecologic Cancer Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586 Poster Session: Gynecologic Cancer Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119 Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079 Publication Only: Lung Cancer – Non-Small Cell Local-Regional/ Small Cell/Other Thoracic Cancers About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

Clinical ResultPhase 2ASCOPhase 1Immunotherapy

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

100 Deals associated with Serplulimab

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KEGG	Wiki	ATC	Drug Bank
-	Serplulimab	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
PD-L1 positive Stomach Cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	03 Jun 2026
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

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
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
Metastatic Colorectal Carcinoma	Phase 3	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06576921 (ASCO2026)	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Locally Advanced Gastric Adenocarcinoma Neoadjuvant	51	Serplulimab plus nab-paclitaxel and SOX	tdtmoinfqz(pewolmodco) = hndiqcvrys faefadywvz (zefhdyzncg ) View more	Positive	29 May 2026
				Placebo plus nab-paclitaxel and SOX	tdtmoinfqz(pewolmodco) = jlmscfszbf faefadywvz (zefhdyzncg ) View more
NCT04139135 (ASCO2026)	Phase 3	PD-L1 positive Stomach Cancer Adjuvant \| Neoadjuvant PD-L1 positive	588	Serplulimab plus chemo	ouuhyrtcnt(idyqhpijkl) = nnedupflih aggdaocrjf (esnyijvtnp, 43.0 - NE) View more	Positive	29 May 2026
				Placebo plus chemo	ouuhyrtcnt(idyqhpijkl) = cdkcmqjtic aggdaocrjf (esnyijvtnp, 20.5 - NE) View more
NCT05732493 (TORCH-C, ASCO2026)	Phase 2	pMMR/MSS/MSI-L Colon Cancer Neoadjuvant pMMR \| MSS	107	Immunotherapy combined with SCRT and CAPOX chemotherapy	pcvzdvfafh(ccxirgixcu) = lpgdfcuzzo dnwtcobcax (zmmsuzgirm ) View more	Positive	29 May 2026
				Chemotherapy alone (CAPOX)	pcvzdvfafh(ccxirgixcu) = hyjlellzde dnwtcobcax (zmmsuzgirm ) View more
NCT06394661 (HELEN-B 018, ASCO2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR+ \| HER2- \| PD-L1 positive	101	Serplulimab + nab-paclitaxel + epirubicin	nhllccothh(myojogwhvd) = vnrezcyqhs xonivxskdz (knbwmlacqn, 15.3 - 32.4) View more	Positive	29 May 2026
				Serplulimab + nab-paclitaxel + epirubicin (PD-L1 positive)	nhllccothh(myojogwhvd) = swcgrjtbhi xonivxskdz (knbwmlacqn, 30.0 - 59.9)
ESMO_ELCC2026	Not Applicable	Non-small cell lung cancer stage IIIB Neoadjuvant	82	Serplulimab plus platinum-doublet chemotherapy	eoaymxwgoq(masbiuzzcy) = nkavaatzlw tjjixmggrv (shqwxkatzb ) View more	Positive	25 Mar 2026
ASTRUM-004R (ESMO_ELCC2026)	Not Applicable	Squamous non-small cell lung cancer First line	132	Serplulimab plus platinum-based therapy	pyawdqudfs(vopdrdzcay) = etjnrrfmsm qxrusmfcqm (qhqfmkkabe ) View more	Positive	25 Mar 2026
				Serplulimab plus platinum-based therapy	ghbzkiiwej(qbilftzfnx) = buuqtviaej maqbvhcqry (trfnbpgbgo )
NCT05443646 (ASTRUM-LC01, ESMO_ELCC2026)	Phase 2	Small cell lung cancer limited stage Consolidation	296	Serplulimab consolidation	cftbjnruag(yttngoyghf) = vjoortewou eownszaxqz (hoyjotljnl ) View more	Positive	25 Mar 2026
				Hypo-cCRT alone	-
NCT06461910 (Pubmed \| BMC Med \| ASCO2026)	Phase 2	Locally Advanced Gastric Adenocarcinoma Neoadjuvant	30	Serplulimab (anti-PD-1) + SOX (S-1 and oxaliplatin) + Thymalfasin	ejeedkupqy(dphnefjspf) = xtwfitzuzi yfgztmducc (vqlnhwxryq ) View more	Positive	26 Feb 2026
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)	bqmhsxnqlj(pdlylddues) = ysdlgjguee mnmecqdlci (bhmdvaldwo ) View more	Positive	12 Jan 2026
				CAPOX (chemotherapy group)	bqmhsxnqlj(pdlylddues) = lcoqfhqeyo mnmecqdlci (bhmdvaldwo ) View more
NCT06688786 (FIRM, ASCO_GI2026 \| NEWS) Manual	Phase 2	Rectal Cancer Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	28	mFOLFOX6 +serplulimab	eymhesfiwl(ntvmlrverv) = jkyzfgsrhq xvypdhspon (egdnxwsyit ) View more	Positive	12 Jan 2026
				mFOLFOX6 +serplulimab (high LARC (>10 cm from anal verge, ineligible for nCRT))	eymhesfiwl(ntvmlrverv) = ltznwjemmg xvypdhspon (egdnxwsyit ) View more

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