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

Structure/Sequence

Sequence Code 13029014H

Source: *****

Sequence Code 13029039L

Source: *****

655

Clinical Trials associated with Sintilimab

NCT06900218

/ Not yet recruitingPhase 3IIT

A Multicenter, Randomized Controlled Phase III Trial of Sintilimab Combined With Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for High-Risk Locoregionally-advanced Nasopharyngeal Carcinoma

This study will enroll 664 patients who had completed induction chemotherapy combined with the PD-1 antibody sintilimab treatment followed by concurrent cisplatin-based chemoradiotherapy (no concurrent sintiliamb). Patients will be randomly divided into two groups. One group will receive 9 cycles of sintilimab therapy, while the other group will receive an additional year of capecitabine chemotherapy on top of the sintilimab treatment. The primary endpoints will be event-free survival and overall survival.

Start Date01 May 2025

Sponsor / Collaborator

Sun Yat-Sen University

NCT06608537

/ RecruitingPhase 2IIT

A Single-center, Single-arm Phase II Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer

The combination of short course radiotherapy and immunotherapy helps to increase the proportion of pathological complete response after neoadjuvant therapy, providing more patients with the opportunity for organ preservation. However, there is no accurate and unified cCR diagnostic standard in the world. As a new radiotracer, 68Ga-FAPI has been developed and used to target fibroblast activating protein and tumor matrix visualization, which has the advantages of low background uptake, high contrast, few preparation requirements, short post-injection interval, and no influence on blood glucose. Therefore, we will invite you to participate in a clinical study to explore whether the PET parameters of 18F-FDG and 68Ga-FAPI-42 PET/CT can be used to predict pathological responses after neoadjuvant therapy for locally advanced rectal cancer (LARC). The findings will help improve future treatment stratification of LARC, help patients preserve organs and improve quality of life.

Start Date07 Apr 2025

Sponsor / Collaborator

Sun Yat-Sen University

NCT06888648

/ Not yet recruitingPhase 1/2IIT

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

Start Date01 Apr 2025

Sponsor / Collaborator

Zhejiang University

[+1]

100 Clinical Results associated with Sintilimab

100 Translational Medicine associated with Sintilimab

100 Patents (Medical) associated with Sintilimab

1,434

Literatures (Medical) associated with Sintilimab

31 Dec 2025·Hematology

Sintilimab for treating progressive multifocal leukoencephalopathy caused by human polyomavirus 2 virus infection following allogeneic hematopoietic cell transplantation: a case report

Article

Author: Zhong, Xushu ; Liu, Qinyu ; Jin, Xuelian ; Chen, Xinchuan

BACKGROUND:

Progressive multifocal leukoencephalopathy (PML) is characterized by demyelination in the central nervous system. It is caused by infection with human polyomavirus 2 and has a poor prognosis. Therapeutic strategies involve restoring immune function and/or discontinuing immunosuppressive treatment. Immune checkpoint inhibitors such as those targeting programmed death receptor-1 (PD-1) can alleviate PML by restoring T cell function. There are no case reports on the use of the PD-1 inhibitor, Sintilimab, for treating PML. Here, we report a case of successful treatment of PML with sintilimab following allogeneic hematopoietic stem cell transplantation.

CASE PRESENTATION:

A 35-year-old woman with high-risk acute myeloid leukemia underwent allogeneic hematopoietic stem cell transplantation after induced remission and developed PML 12 months after transplantation. She received five courses of 100 mg every 4 weeks with monitoring by magnetic resonance imaging (MRI) and viral load in the cerebrospinal fluid, showing clinical improvement, resolution of neurological symptoms, and reduced viral load. MRI showed initial exacerbation of lesions but significant improvement after five courses of treatment. No graft-versus-host disease occurred, but manageable immune reconstitution inflammatory syndrome was observed.

CONCLUSION:

Sintilimab, a PD-1 inhibitor, might be used to treat PML in patients with hematologic malignancies undergoing allo-HSCT, which needs further investigation.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Hedgehog pathway inhibitors (HHI) combined with radiotherapy and immunotherapy for advanced basal cell carcinoma: a case report

Article

Author: Wei, Gao ; Yao, Zhijian ; Li, Longshan ; Zhao, Chen ; Li, Xianghui ; Ruan, Zhuren

PURPOSE:

Basal cell carcinoma (BCC) is one of the most common skin cancers. Most BCCs can be treated with surgery excision. For advanced BCC unsuitable for curative surgery, the combination of radiotherapy and Hedgehog pathway inhibitors (HHI) are effective systemic treatment options. However, there is a scarcity of evidence-based guidelines for the management of patients with advanced or metastatic BCC, particularly those who develop resistance to HHI therapy.

MATERIALS AND METHODS:

We report the case of a patient with advanced BCC of the head and neck, which originated from a nevus sebaceous.

RESULTS:

The patient initially responded well to sonidegib, an HHI, but resistance emerged within a month. We then modified the systemic therapy to include a combination of radiotherapy and the anti-PD-1 agent sintilimab.

CONCLUSIONS:

This adjusted treatment regimen led to effective long-term clinical responses without significant adverse events.

31 Dec 2025·ANNALS OF MEDICINE

Effect of cold atmospheric plasma on common oral pathogenic microorganisms: a narrative review

Review

Author: Zhang, Hao ; Xin, Jiajun ; Zou, Jiatong ; Dai, Yifei ; Li, Yushen ; Wang, Rui ; Chen, Xiantao ; Wang, Bowei ; Liu, Zhihui

BACKGROUND:

The oral microbiota is a diverse and complex community that maintains a delicate balance. When this balance is disturbed, it can lead to acute and chronic infectious diseases such as dental caries and periodontitis, significantly affecting people's quality of life. Developing a new antimicrobial strategy to deal with the increasing microbial variability and resistance is important. Cold atmospheric plasma (CAP), as the fourth state of matter, has gradually become a hot topic in the field of biomedicine due to its good antibacterial, anti-inflammatory, and anti-tumor capabilities. It is expected to become a major asset in the regulation of oral microbiota.

METHODS:

We conducted a search in PubMed, Medline, and Wiley databases, focusing on studies related to CAP and oral pathogenic microorganisms. We explored the biological effects of CAP and summarized the antimicrobial mechanisms behind it.

RESULTS:

Numerous articles have shown that CAP has a potent antimicrobial effect against common oral pathogens, including bacteria, fungi, and viruses, primarily due to the synergy of various factors, especially reactive oxygen and nitrogen species.

CONCLUSIONS:

CAP is effective against various oral pathogenic microorganisms, and it is anticipated to offer a new approach to treating oral infectious diseases. The future objective is to precisely adjust the parameters of CAP to ensure safety and efficacy, and subsequently develop a comprehensive CAP treatment protocol. Achieving this objective is crucial for the clinical application of CAP, and further research is necessary.

252

News (Medical) associated with Sintilimab

25 Mar 2025

·www.globenewswire.com

Burning Rock Reports Unaudited Fourth Quarter and Full Year 2024 Financial Results

GUANGZHOU, China, March 25, 2025 (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 unaudited financial results for the three months and the year ended December 31, 2024. 2024 Business Overview and Recent Updates Corporate Updates Completed profitability-driven organizational optimization, execution towards profitability well underway Early Detection THUNDER study for 6-cancer test was included in the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition) and the Expert Consensus on Detection and Clinical Application of Tumor DNA Methylation Markers (2024 Edition), showing an impressive performance of ELSA-seq using cfDNA in cancer detection and origin prediction. Therapy Selection Presented study results on small-cell lung cancer and colorectal cancer at the ASCO in June 2024. “The efficacy and safety of high dose Almonertinib in untreated EGFR-mutated NSCLC with brain metastases, including biomarker analysis” and “Individualized tumor-informed circulating tumor DNA analysis for molecular residual disease detection in predicting recurrence and efficacy of adjuvant chemotherapy in colorectal cancer.”Presented study results at the 2024 World Conference on Lung Cancer in September 2024. “Neoadjuvant sintilimab plus chemotherapy could be an optional treatment modality in selected EGFR-mutant NSCLC” and “Distinct Genomic and Immune Microenvironment Features of Solid or Micropapillary Predominant Subtype in Stage I Lung Adenocarcinomas.” Pharma Services New companion diagnostics (CDx) collaboration announced with Bayer in China in May 2024.The companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through the collaboration of Burning Rock and Dizal, has been approved by the National Medical Products Administration (NMPA) of China in October 2024, which marks the first co-developed NGS-based CDx for lung cancer approved by NMPA since the release of the CDx guideline in China. Fourth Quarter 2024 Financial Results Revenues were RMB126.0 million (US$17.3 million) for the three months ended December 31, 2024, representing a 4.1% increase from RMB121.1 million for the same period in 2023. Revenue generated from central laboratory business was RMB39.3 million (US$5.4 million) for the three months ended December 31, 2024, representing a 23.4% decrease from RMB51.3 million for the same period in 2023, 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 RMB43.5 million (US$6.0 million) for the three months ended December 31, 2024, representing a 50.9% increase from RMB28.8 million for the same period in 2024, driven by an increase in sales volume from existing hospitals and new contracted partner hospitals.Revenue generated from pharma research and development services was RMB43.3 million (US$5.9 million) for the three months ended December 31, 2024, representing a 5.6% increase from RMB41.0 million for the same period in 2023, primarily attributable to increased development and testing services performed for our pharma customers. Cost of revenues was RMB36.6 million (US$5.0 million) for the three months ended December 31, 2024, representing a 14.8% decrease from RMB43.0 million for the same period in 2023, primarily due to (i) a decrease in cost of central laboratory business, which was in line with the decrease in revenue generated from this business; and (ii) a decrease in amortization expense for all kinds of business. Gross profit was RMB89.4 million (US$12.3 million) for the three months ended December 31, 2024, representing a 14.5% increase from RMB78.1 million for the same period in 2023. Gross margin was 71.0% for the three months ended December 31, 2024, compared to 64.5% for the same period in 2023. By channel, gross margin of central laboratory business was 84.4% for the three months ended December 31, 2024, compared to 81.7% during the same period in 2023, primarily due to the decreased depreciation; gross margin of in-hospital business was 68.0% for the three months ended December 31, 2024, compared to 44.8% during the same period in 2023, and such increase was primarily due to an increase in sales volume to high margin hospitals and decreased depreciation and rental cost in relation to our laboratory of Guangzhou headquarters; gross margin of pharma research and development services was 61.7% for the three months ended December 31, 2024, compared to 56.9% during the same period of 2023, primarily due to an increase in test volume of higher margin projects. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB93.6 million (US$12.8 million) for the three months ended December 31, 2024, representing a 7.5% increase from RMB87.1 million for the same period in 2023. Non-GAAP gross margin was 74.3% for the three months ended December 31, 2024, compared to 71.9% for the same period in 2023. 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 RMB171.3 million (US$23.5 million) for the three months ended December 31, 2024, representing a 29.9% decrease from RMB244.4 million for the same period in 2023. The decrease was primarily driven by budget control measures, including headcount reduction, to improve our operating efficiency. Research and development expenses were RMB52.2 million (US$7.2 million) for the three months ended December 31, 2024, representing a 28.6% decrease from RMB73.1 million for the same period in 2023, primarily due to (i) a decrease in the expenditure for detection research, and (ii) a decrease in amortized expense on share-based compensation; and (iii) a decrease in amortized expenses for office building decoration.Selling and marketing expenses were RMB46.7 million (US$6.4 million) for the three months ended December 31, 2024, representing a 6.1% decrease from RMB49.8 million for the same period in 2023, primarily due to a decrease in staff cost resulted from the reorganization of our sales department to improve operating efficiency.General and administrative expenses were RMB37.3 million (US$5.1 million) for the three months ended December 31, 2024, representing a 69.3% decrease from RMB121.5 million for the same period in 2023, primarily due to (i) a decrease in amortized expense on share-based compensation; (ii) a decrease in amortized expenses for office building decoration; and (iii) a decrease in impairment expenses for accounts receivables and contract assets resulting from accelerated settlement with customers with long accounts receivable. Net loss was RMB81.3 million (US$11.1 million) for the three months ended December 31, 2024, compared to RMB162.2 million for the same period in 2023. Cash, cash equivalents, restricted cash were RMB522.2 million (US$71.5 million) as of December 31, 2024. Full Year 2024 Financial Results Revenues were RMB515.8 million (US$70.7 million) for 2024, representing a 4.0% decrease from RMB537.4 million for 2023. Revenue generated from central laboratory business was RMB175.6 million (US$24.1 million) for 2024, representing a 24.6% decrease from RMB232.8 million for 2023, 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 RMB224.5 million (US$30.8 million) for 2024, representing an 19.0% increase from RMB188.7 million for 2023, driven by an increase in sales volume from existing hospitals and new contracted partner hospitals.Revenue generated from pharma research and development services was RMB115.7 million (US$15.8 million) for 2024, remaining relatively stable (decreasing by 0.2%) from RMB115.9 million for 2023. Cost of revenues was RMB153.4 million (US$21.0 million) for 2024, representing a 11.9% decrease from RMB174.2 million for 2023, primarily due to a decrease in cost of revenues for our central laboratory business, as we continued our transition towards in-hospital testing. Gross profit remained relatively stable at RMB362.4 million (US$49.6 million) for 2024, compared to RMB363.2 million for the same period in 2023. Gross margin increased to 70.3% for 2024 from 67.6% for 2023. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB386.3 million (US$52.9 million) for 2024, representing a 3.3% decrease from RMB399.4 million for 2023. Non-GAAP gross margin was 74.9% for 2024, compared to 74.3% for 2023. 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 RMB720.0 million (US$98.6 million) for 2024, representing a 30.3% decrease from RMB1,032.5 million for 2023. Research and development expenses were RMB232.3 million (US$31.8 million) for 2024, representing a 33.1% decrease from RMB347.0 million for 2023, primarily due to (i) a decrease in the expenditure for detection research; (ii) a decrease in amortized expense on share-based compensation; (iii) a decrease in staff cost resulted from the reorganization of our research and development department to improve operating efficiency; and (iv) a decrease in amortized expenses for office building.Selling and marketing expenses were RMB190.9 million (US$26.2 million) for 2024, representing a 22.9% decrease from RMB247.7 million for 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of our sales department to improve operating efficiency; (ii) a decrease in marketing and conference fee; (iii) a decrease in amortized expense on share-based compensation; and (iv) a decrease in travel expense.General and administrative expenses were RMB261.6 million (US$35.8 million) for 2024, representing a 40.2% decrease from RMB437.8 million for 2023, primarily due to (i) a decrease in amortized expense on share-based compensation; (ii) a decrease in amortized expenses for office building; (iii) a decrease in staff cost resulted from the reorganization of our general and administrative department to improve operating efficiency; and (iv) a decrease in operating lease.Impairment loss on long-lived assets were RMB35.1 million (US$4.8 million) for the year ended December 31, 2024 as a result of the long-lived assets impairment test conducted by the management. Net loss was RMB346.6 million (US$47.5 million) for 2024, compared to RMB653.7 million for 2023. 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 RMB7.2993 to US$1.00, the exchange rate on December 31, 2024, 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 March31, 2023 June30, 2023 September30, 2023 December31, 2023 March31, 2024 June 30,2024 September30, 2024 December31, 2024In-hospital channel: Pipeline partner hospitals(1)29 30 29 28 28 29 30 29Contracted partner hospitals(2)49 50 55 59 59 59 61 63Total number of partner hospitals 78 80 84 87 87 88 91 92 (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 RevenuesMarch 31,2023 June 30,2023 September 30,2023 December 31,2023 March 31,2024 June 30,2024 September 30,2024 December 31,2024 (RMB in thousands) Central laboratory channel61,804 66,239 53,481 51,288 47,614 48,773 39,984 39,278In-hospital channel51,561 53,835 54,496 28,809 57,387 59,872 63,769 43,464Pharma research and development channel29,151 26,194 19,589 40,988 20,622 26,888 24,891 43,280Total revenues142,516 146,268 127,566 121,085 125,623 135,533 128,644 126,022 For the three months ended Gross profitMarch 31,2023 June 30,2023 September 30,2023 December 31,2023 March 31,2024 June 30,2024 September 30,2024 December 31,2024 (RMB in thousands) Central laboratory channel48,090 51,876 41,487 41,886 37,002 38,424 33,262 33,153In-hospital channel34,409 33,353 35,459 12,910 39,192 44,058 46,580 29,563Pharma research and development channel16,273 15,193 8,974 23,317 9,500 12,956 12,004 26,706Total gross profit98,772 100,422 85,920 78,113 85,694 95,438 91,846 89,422 For the three months ended Share-based compensation expensesMarch 31,2023 June 30,2023 September 30,2023 December 31,2023 March 31,2024 June 30,2024 September 30,2024 December 31,2024 (RMB in thousands) Cost of revenues353 627 680 654 596 464 289 520Research and development expenses13,612 15,301 12,161 12,401 12,287 12,008 3,180 3,202Selling and marketing expenses1,606 3,389 2,848 1,816 508 1,232 1,917 1,353General and administrative expenses62,595 18,502 57,704 56,472 55,990 54,407 4,732 2,937Total share-based compensation expenses78,166 37,819 73,393 71,343 69,381 68,111 10,118 8,012 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 March31, 2023 June30, 2023 September30, 2023 December31, 2023 March31, 2024 June30, 2024 September30, 2024 December31, 2024 December31, 2024 RMBRMBRMBRMBRMBRMBRMBRMBUS$Revenues142,516 146,268 127,566 121,085 125,623 135,533 128,644 126,022 17,265 Cost of revenues(43,744) (45,846) (41,646) (42,972) (39,929) (40,095) (36,798) (36,600) (5,014)Gross profit98,772 100,422 85,920 78,113 85,694 95,438 91,846 89,422 12,251 Operating expenses: Research and development expenses(94,417) (95,779) (83,701) (73,119) (65,985) (64,952) (49,150) (52,203) (7,152)Selling and marketing expenses(64,774) (70,842) (62,310) (49,785) (46,856) (48,907) (48,411) (46,730) (6,402)General and administrative expenses(128,039) (69,525) (118,724) (121,533) (98,681) (92,794) (32,874) (37,289) (5,109)Impairment loss on long-lived assets- - - - - - - (35,127) (4,812)Total operating expenses(287,230) (236,146) (264,735) (244,437) (211,522) (206,653) (130,435) (171,349) (23,475)Loss from operations (188,458) (135,724) (178,815) (166,324) (125,828) (111,215) (38,589) (81,927) (11,224)Interest income3,144 5,255 4,018 5,539 4,038 3,187 3,173 1,814 249 Other income (expense), net599 (118) (157) 160 434 (82) 1 4,353 596 Foreign exchange (loss) gain, net(116) （210) 423 (517) (13) 262 (129) (220) (30)Loss before income tax(184,831) (130,797) (174,531) (161,142) (121,369) (107,848) (35,544) (75,980) (10,409)Income tax expenses(422) (445) (450) (1,071) (180) (190) (201) (5,314) (728)Net loss(185,253) (131,242) (174,981) (162,213) (121,549) (108,038) (35,745) (81,294) (11,137)Net loss attributable to Burning Rock Biotech Limited’s shareholders(185,253) (131,242) (174,981) (162,213) (121,549) (108,038) (35,745) (81,294) (11,137)Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(1.81) (1.28) (1.71) (1.58) (1.19) (1.05) (0.35) (0.79) (0.11)Class B ordinary shares - basic and diluted(1.81) (1.28) (1.71) (1.58) (1.19) (1.05) (0.35) (0.79) (0.11)Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,065,585 85,151,052 85,000,869 85,071,360 85,219,188 85,271,858 85,902,670 86,036,286 86,036,286 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive (loss) income, net of tax of nil: Foreign currency translation adjustments(5,659) 14,829 (1,955) (3,026) 590 940 (4,054) 6,009 823 Total comprehensive loss(190,912) (116,413) (176,936) (165,239) (120,959) (107,098) (39,799) (75,285) (10,314)Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(190,912) (116,413) (176,936) (165,239) (120,959) (107,098) (39,799) (75,285) (10,314) Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the year ended December 31,2023 December 31,2024 December 31,2024 RMB RMB US$Revenues537,435 515,822 70,667 Cost of revenues(174,208) (153,422) (21,020)Gross profit363,227 362,400 49,647 Operating expenses: Research and development expenses(347,016) (232,290) (31,824)Selling and marketing expenses(247,711) (190,904) (26,154)General and administrative expenses(437,821) (261,638) (35,844)Impairment loss on long-lived assets- (35,127) (4,812)Total operating expenses(1,032,548) (719,959) (98,634)Loss from operations (669,321) (357,559) (48,987)Interest income17,956 12,212 1,673 Other income, net484 4,706 645 Foreign exchange loss, net(420) (100) (14)Loss before income tax(651,301) (340,741) (46,683)Income tax expenses(2,388) (5,885) (806)Net loss(653,689) (346,626) (47,489)Net loss attributable to Burning Rock Biotech Limited’s shareholders(653,689) (346,626) (47,489)Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(6.38) (3.37) (0.46)Class B ordinary shares - basic and diluted(6.38) (3.37) (0.46)Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,071,691 85,610,197 85,610,197 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 Other comprehensive income, net of tax of nil: Foreign currency translation adjustments4,189 3,485 477 Total comprehensive loss(649,500) (343,141) (47,012)Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(649,500) (343,141) (47,012) Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets(In thousands) As of December 31, 2023 December 31, 2024 December 31, 2024 RMB RMB US$ASSETS Current assets: Cash and cash equivalents615,096 519,849 71,219Restricted cash120 2,313 317Accounts receivable, net126,858 152,013 20,826Contract assets, net22,748 13,855 1,898Inventories, net69,020 62,625 8,580Prepayments and other current assets50,254 25,963 3,557Total current assets884,096 776,618 106,397Non-current assets: Equity method investment337 - -Convertible note receivable5,320 - -Property and equipment, net131,912 47,152 6,460Operating right-of-use assets12,284 53,188 7,287Intangible assets, net964 421 58Other non-current assets5,088 7,926 1,086Total non-current assets155,905 108,687 14,891TOTAL ASSETS 1,040,001 885,305 121,288 Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets (Continued)(in thousands) As of December 31, 2023 December 31, 2024 December 31, 2024 RMB RMB US$LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable18,061 33,747 4,623 Deferred revenue130,537 117,895 16,152 Accrued liabilities and other current liabilities104,935 89,498 12,262 Customer deposits1,197 592 81 Current portion of operating lease liabilities8,634 24,567 3,366 Total current liabilities263,364 266,299 36,484 Non-current liabilities: Non-current portion of operating lease liabilities3,690 27,754 3,802 Other non-current liabilities4,537 10,425 1,428 Total non-current liabilities8,227 38,179 5,230 TOTAL LIABILITIES271,591 304,478 41,714 Shareholders’ equity: Class A ordinary shares116 124 17 Class B ordinary shares21 21 3 Additional paid-in capital4,849,337 5,002,255 685,306 Treasury stock(65,896) (63,264) (8,667)Accumulated deficits(3,853,635) (4,200,261) (575,433)Accumulated other comprehensive loss(161,533) (158,048) (21,652)Total shareholders’ equity768,410 580,827 79,574 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY1,040,001 885,305 121,288 Burning Rock Biotech LimitedUnaudited Condensed Statements of Cash Flows(in thousands) For the three months ended December 31,2023 December 31,2024 December 31,2024 RMB RMB US$ Net cash (used in) generated from operating activities(16,019) 19,062 2,611 Net cash used in investing activities(328) (812) (111)Net cash used in financing activities(1,909) (74) (10)Effect of exchange rate on cash, cash equivalents and restricted cash(3,277) 5,739 787 Net (decrease) increase in cash, cash equivalents and restricted cash (21,533) 23,915 3,277 Cash, cash equivalents and restricted cash at the beginning of period636,749 498,247 68,259 Cash, cash equivalents and restricted cash at the end of period615,216 522,162 71,536 For the year ended December 31,2023 December 31,2024 December 31,2024 RMB RMB US$Net cash used in operating activities(255,783) (92,261) (12,640)Net cash used in investing activities(9,300) (4,412) (604)Net cash used in financing activities(48,832) (72) (10)Effect of exchange rate on cash, cash equivalents and restricted cash3,863 3,691 506 Net decrease in cash, cash equivalents and restricted cash (310,052) (93,054) (12,748)Cash, cash equivalents and restricted cash at the beginning of period925,268 615,216 84,284 Cash, cash equivalents and restricted cash at the end of period615,216 522,162 71,536 Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the three months ended March 31,2023 June 30, 2023 September 30, 2023 December 31, 2023 March 31,2024 June 30,2024 September 30, 2024 December 31,2024 (RMB in thousands) Gross profit: Central laboratory channel48,090 51,876 41,487 41,886 37,002 38,424 33,262 33,153 In-hospital channel34,409 33,353 35,459 12,910 39,192 44,058 46,580 29,563 Pharma research and development channel16,273 15,193 8,974 23,317 9,500 12,956 12,004 26,706 Total gross profit98,772 100,422 85,920 78,113 85,694 95,438 91,846 89,422 Add: depreciation and amortization: Central laboratory channel2,567 2,645 2,550 2,414 1,919 1,226 1,277 1,010 In-hospital channel2,582 2,637 2,751 2,728 1,524 824 798 623 Pharma research and development channel3,974 3,665 3,863 3,808 3,856 4,417 3,846 2,534 Total depreciation and amortization included in cost of revenues9,123 8,947 9,164 8,950 7,299 6,467 5,921 4,167 Non-GAAP gross profit： Central laboratory channel50,657 54,521 44,037 44,300 38,921 39,650 34,539 34,163 In-hospital channel36,991 35,990 38,210 15,638 40,716 44,882 47,378 30,186 Pharma research and development channel20,247 18,858 12,837 27,125 13,356 17,373 15,850 29,240 Total non-GAAP gross profit107,895 109,369 95,084 87,063 92,993 101,905 97,767 93,589 Non-GAAP gross margin： Central laboratory channel82.0% 82.3% 82.3% 86.4% 81.7% 81.3% 86.4% 87.0% In-hospital channel71.7% 66.9% 70.1% 54.3% 70.9% 75.0% 74.3% 69.5% Pharma research and development channel69.5% 72.0% 65.5% 66.2% 64.8% 64.6% 63.7% 67.6% Total non-GAAP gross margin75.7% 74.8% 74.5% 71.9% 74.0% 75.2% 76.0% 74.3% Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the year ended December 31,2023 December 31,2024 (RMB in thousands)Gross profit: Central laboratory channel183,339 141,841In-hospital channel116,131 159,393Pharma research and development channel63,757 61,166Total gross profit363,227 362,400Add: depreciation and amortization: Central laboratory channel10,176 5,432In-hospital channel10,699 3,769Pharma research and development channel15,310 14,653Total depreciation and amortization included in cost of revenues36,185 23,854Non-GAAP gross profit： Central laboratory channel193,515 147,273In-hospital channel126,830 163,162Pharma research and development channel79,067 75,819Total non-GAAP gross profit399,412 386,254Non-GAAP gross margin： Central laboratory channel83.1% 83.8%In-hospital channel67.2% 72.7%Pharma research and development channel68.2% 65.5%Total non-GAAP gross margin74.3% 74.9%

Financial StatementPhase 1Clinical Result

19 Mar 2025

·pipelinereview.com

Innovent and HUTCHMED Jointly Announce that the FRUSICA-2 Phase 2/3 Study of Sintilimab and Fruquintinib Combination Has Met Its Primary Endpoint in Advanced Renal Cell Carcinoma in China

SAN FRANCISCO, CA, USA and SUZHOU, China I March 18, 2025 I Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR). The combination of sintilimab and fruquintinib received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study ( NCT03903705 ). The FRUSICA-2 study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC ( NCT05522231 ). In addition to the primary endpoint PFS, the combination also demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). Full results will be submitted for presentation at an upcoming scientific conference. Prof Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study , said: “The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Targeted therapy remains an indispensable and crucial component in systemic treatment of advanced RCC in China. Optimizing the selection of targeted therapy, either as monotherapy or in combination with immunotherapy, for individual patients is a key focus of clinical interest. The results from the FRUSICA 2 study underscore the potential of the sintilimab and fruquintinib combination to address the pressing medical needs of patients with this challenging disease.” Prof Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study , said: “The positive results from this Phase 3 study of the sintilimab and fruquintinib combination represent a significant advancement in the treatment of advanced renal cell carcinoma. We are optimistic about the clinical implications of the findings as we strive to provide more effective treatment options for patients who may not have had adequate responses to previous therapies.” Dr Hui Zhou, Senior Vice President of Innovent , stated: “We are encouraged by the positive results in the FRUSICA-2 clinical trial. These outcomes not only underscore the great potential of the combination therapy of sintilimab and fruquintinib but also bring new hope to previously treated patients with advanced renal cell carcinoma. We look forward to working closely with HUTCHMED to jointly advance the registrational communication of this innovative combo therapy and make it available to patients as soon as possible.” Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: “The encouraging results from our study provide clear evidence for the combination of fruquintinib and sintilimab as a viable new treatment option for advanced renal cell carcinoma patients who have progressed on previous therapy. This not only reaffirms our commitment to advancing cancer therapies but also represents an important step forward in addressing unmet medical needs within this patient population. I extend my heartfelt gratitude to the patients and investigators who participated in this research; their contributions have been vital to our success. We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months.” About Kidney Cancer and RCC It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022. [i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022. [ii] Approximately 90% of kidney tumors are RCC. About Sintilimab Sintilimab, marketed as TYVYT ® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. [iii] In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT ® (sintilimab injection) includes: Furthermore, sintilimab’s eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. And the NDA for sintilimab in combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation. In addition, three clinical studies of sintilimab have met their primary endpoints: About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor (VEGF) receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. [iv] About Fruquintinib Approvals Fruquintinib is co-developed and co-marketed in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE ® . It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. The combination of ELUNATE ® (fruquintinib) and TYVYT ® (sintilimab injection) has conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA ® . Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US in November 2023, in the EU in June 2024, in Switzerland and Argentina in August 2024, in Canada, Japan and the United Kingdom in September 2024, in Australia and Singapore in October 2024 and in Israel and the United Arab Emirates in December 2024. Regulatory applications are progressing in many other jurisdictions. The global regulatory submissions are based on data from two large, randomized, controlled Phase III trials in colorectal cancer, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 metastatic colorectal cancer patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023, [v] while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA . [vi] The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated: About Fruquintinib for Second-line Treatment of RCC The U.S. Food and Drug Administration (FDA) has approved five immune-oncology combination therapies for the first-line treatment of advanced RCC. However, only one immune-oncology combination therapy has been approved in China for advanced RCC patients classified as having intermediate or poor risk by the International mRCC Database Consortium (IMDC). Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced RCC in China. Notably, advanced RCC patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need. Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination demonstrated promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival (“OS”) was not reached, and the 36-month OS rate was 58.3%. [vii] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com , or follow Innovent on Facebook and LinkedIn. Statement: （ 1 ） Innovent does not recommend the use of any unapproved drug (s)/indication (s). （ 2 ） Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED 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 www.hutch‑med.com or follow us on LinkedIn . Reference: [i] The Global Cancer Observatory, kidney cancer fact sheet. https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf. Accessed February 19, 2025. [ii] The Global Cancer Observatory, China fact sheet. https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed February 19, 2025. [iii] Wang J, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303. [iv] Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther. 2014 [v] Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO‑2): an international, multicentre, randomised, double‑blind, Phase III study. Lancet. 2023;402(10395):41‑53. doi:10.1016/S0140‑6736(23)00772‑9. [vi] Li J, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855. [vii] Xu H, et al. Fruquintinib Plus Sintilimab in Patients with Treatment‑Naïve and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Targeted Oncology. 2025; 20:113–125. doi.org/10.1007/s11523-024-01120-6. SOURCE: Innovent Biologics

Phase 3Drug ApprovalImmunotherapyClinical ResultPriority Review

19 Mar 2025

·www.prnewswire.com

Innovent and HUTCHMED Jointly Announce that the FRUSICA-2 Phase 2/3 Study of Sintilimab and Fruquintinib Combination Has Met Its Primary Endpoint in Advanced Renal Cell Carcinoma in China

SAN FRANCISCO and SUZHOU, China, March 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR). The combination of sintilimab and fruquintinib received conditional approval from China's National Medical Products Administration (NMPA) for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705). The FRUSICA-2 study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC (NCT05522231). In addition to the primary endpoint PFS, the combination also demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). Full results will be submitted for presentation at an upcoming scientific conference. Prof Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study, said: "The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Targeted therapy remains an indispensable and crucial component in systemic treatment of advanced RCC in China. Optimizing the selection of targeted therapy, either as monotherapy or in combination with immunotherapy, for individual patients is a key focus of clinical interest. The results from the FRUSICA 2 study underscore the potential of the sintilimab and fruquintinib combination to address the pressing medical needs of patients with this challenging disease." Prof Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study, said: "The positive results from this Phase 3 study of the sintilimab and fruquintinib combination represent a significant advancement in the treatment of advanced renal cell carcinoma. We are optimistic about the clinical implications of the findings as we strive to provide more effective treatment options for patients who may not have had adequate responses to previous therapies." Dr Hui Zhou, Senior Vice President of Innovent, stated: "We are encouraged by the positive results in the FRUSICA-2 clinical trial. These outcomes not only underscore the great potential of the combination therapy of sintilimab and fruquintinib but also bring new hope to previously treated patients with advanced renal cell carcinoma. We look forward to working closely with HUTCHMED to jointly advance the registrational communication of this innovative combo therapy and make it available to patients as soon as possible." Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: "The encouraging results from our study provide clear evidence for the combination of fruquintinib and sintilimab as a viable new treatment option for advanced renal cell carcinoma patients who have progressed on previous therapy. This not only reaffirms our commitment to advancing cancer therapies but also represents an important step forward in addressing unmet medical needs within this patient population. I extend my heartfelt gratitude to the patients and investigators who participated in this research; their contributions have been vital to our success. We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months." About Kidney Cancer and RCC It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[ii] Approximately 90% of kidney tumors are RCC. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[iii] In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. And the NDA for sintilimab in combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation. In addition, three clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy; Phase 2/3 study of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor (VEGF) receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.[iv] About Fruquintinib Approvals Fruquintinib is co-developed and co-marketed in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US in November 2023, in the EU in June 2024, in Switzerland and Argentina in August 2024, in Canada, Japan and the United Kingdom in September 2024, in Australia and Singapore in October 2024 and in Israel and the United Arab Emirates in December 2024. Regulatory applications are progressing in many other jurisdictions. The global regulatory submissions are based on data from two large, randomized, controlled Phase III trials in colorectal cancer, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 metastatic colorectal cancer patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023,[v] while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA.[vi] The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated: About Fruquintinib for Second-line Treatment of RCC The U.S. Food and Drug Administration (FDA) has approved five immune-oncology combination therapies for the first-line treatment of advanced RCC. However, only one immune-oncology combination therapy has been approved in China for advanced RCC patients classified as having intermediate or poor risk by the International mRCC Database Consortium (IMDC). Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced RCC in China. Notably, advanced RCC patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need. Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination demonstrated promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival ("OS") was not reached, and the 36-month OS rate was 58.3%.[vii] About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED 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 ‑med.com or follow us on LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultImmunotherapyDrug ApprovalLicense out/in

100 Deals associated with Sintilimab

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KEGG	Wiki	ATC	Drug Bank
-	Sintilimab	L01XC	DB15765

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Dec 2024
Classical Hodgkin's Lymphoma	Macao	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
Non-Small Cell Lung Cancer	Macao	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
EGFR positive Non-squamous non-small cell lung cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	06 May 2023
Gastroesophageal junction adenocarcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Jun 2022
Stomach Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Jun 2022
Esophageal Squamous Cell Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	16 Jun 2022
Hepatocellular Carcinoma	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Jun 2021
Non-squamous non-small cell lung cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	03 Feb 2021
Hodgkin's Lymphoma	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Dec 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2025
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Esophageal Carcinoma	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Sep 2021
Colorectal Cancer	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	27 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Resectable Lung Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	15 Mar 2024
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Advanced Renal Cell Carcinoma	Phase 3	China	HUTCHMED (China) Ltd.	27 Oct 2022
Liver Cancer	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Advanced Gastric Adenocarcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	10 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05522231 (FRUSICA-2, GlobeNewswire) Manual	Phase 2/3	Advanced Renal Cell Carcinoma Second line	-	fruquintinib + sintilimab	uvfawreabv(qlniqwtcaf) = met its primary endpoint of progression free survival. kvpdjipupf (iclmstpaku ) Met View more	Positive	18 Mar 2025
NCT04745130 (Pubmed) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	-	Regorafenib plus Sintilimab	njgjcgipxm(dyivpueiua) = yziehbzgmx xhzvyfcyoc (ebavjicxrb, 10.5 - 17.7) View more	Positive	10 Feb 2025
NCT04745130 (Pubmed) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	-	Regorafenib plus Sintilimab (RAS/RAF wild-type)	njgjcgipxm(dyivpueiua) = zpnfwnzgpl xhzvyfcyoc (ebavjicxrb, 10.0 - 36.6)	Positive	10 Feb 2025
NCT04722718 (NeoSAC, Signal Transduct Target Ther) Manual	Phase 2	Triple Negative Breast Cancer Neoadjuvant HER2 Negative \| PR Negative \| ER Negative	34	Apatinib + sintilimab + nab-paclitaxel + carboplatin	tjmimxuddn(mzirmljhec) = woqcphlala mhlvwrvtpg (zutqhbjktv, 53.0 - 85.3) View more	Positive	07 Feb 2025
NCT05244798 (SCIENCE, ASCO_GI2025) Manual	Phase 3	Esophageal Squamous Cell Carcinoma Neoadjuvant	146	Sintilimab combined with nCT (nab-paclitaxel plus carboplatin) for two cycles	crcpnswdxx(demvkxozbf) = xcgpbyrzps jolrogmgtp (jyscabumrp ) Met View more	Positive	27 Jan 2025
NCT05244798 (SCIENCE, ASCO_GI2025) Manual	Phase 3	Esophageal Squamous Cell Carcinoma Neoadjuvant	146	Sintilimab combined with concurrent nCRT (nab-paclitaxel plus carboplatin chemotherapy and radiotherapy using IMRT/IGRT totaling 41.4 Gy)	crcpnswdxx(demvkxozbf) = akzmigjcny jolrogmgtp (jyscabumrp ) Met View more	Positive	27 Jan 2025
NCT05024968 (ASCO_GI2025) Manual	Phase 2	Unknown Primary Neoplasms	10	Sintilimab 200 mg IV every 3 weeks	jshhtdpvbr(wnqcowlepe) = pczgyhumdu etngwzikyd (byhlvbnvki, 12.2 - 73.8) View more	Positive	23 Jan 2025
ESMO_ASIA2024 Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Anlotinib + Sintilimab	aykygzlubq(grdxhujvvt) = hkdomjurvv wxrefnmfqs (cbvkpjxegx ) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Chemotherapy + Immunotherapy	aykygzlubq(grdxhujvvt) = chljbjcoeg wxrefnmfqs (cbvkpjxegx ) View more	Positive	07 Dec 2024
NCT04271813 (ESMO_ASIA2024) Manual	Phase 2	Colorectal Cancer First line	29	Sintilimab plus Anlotinib	rdujpubpul(agoinsflvd) = ytjoaevsnl fdfuvdqodu (ldgmmwfbyn, 28.3–65.7) View more	Positive	07 Dec 2024
NCT05017103 (CTgov)	Phase 2	Malignant Fibrous Histiocytoma	6	sintilimab	lnuswcspby = gmunlyanjq qvprekubdh (fmakonytec, gnbymqqykf - dzpgifscyp) View more	-	12 Nov 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (ITT)	cegcvwzyxa(efzpinbjul) = okmlirqfva eprctdxvnf (hjocgsotfd ) View more	Positive	28 Oct 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (per-protocol set)	cegcvwzyxa(efzpinbjul) = pmivbmlkxd eprctdxvnf (hjocgsotfd ) View more	Positive	28 Oct 2024
NEWS Manual	Phase 2	Primary Central Nervous System Lymphoma	27	信迪利单抗+甲氨蝶呤+替莫唑胺+利妥昔单抗	oyatwsdjpv(jlsglnpdja) = msxiigevct nzbldmvhyw (qrbazfxiaj ) View more	Positive	19 Sep 2024

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