EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), HER4 antagonists(Receptor tyrosine-protein kinase erbB-4 antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [1]

Active Indication

Advanced HER2-Positive Breast CarcinomaHER2 Positive Breast CancerHER2-Low Breast Carcinoma+ [16]

Inactive Indication

Adenocarcinoma of LungAdvanced biliary tract cancerAdvanced Malignant Solid Neoplasm+ [7]

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Dr. Reddy's Laboratories Ltd.

Inactive Organization

Hengrui Therapeutics, Inc.

License Organization

Dr. Reddy's Laboratories Ltd.

HLB Life Science Co., Ltd.

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

China (12 Aug 2018),

HER2 Positive Breast Cancer

RegulationBreakthrough Therapy (China), Special Review Project (China), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC36H35ClN6O7

InChIKeyZUZJPRMSUMMELD-ZLWATVBPSA-N

CAS Registry1397922-61-0

302

Clinical Trials associated with Pyrotinib Maleate

ChiCTR2500111744

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Paclitaxel Oral Solution in Combination with Trastuzumab for Subcutaneous Injection and Pyrotinib as First-line Treatment for HER2-positive Recurrent/Metastatic Breast Cancer

Start Date31 Oct 2025

Sponsor / Collaborator

Beijing Institute for Cancer Research

NCT07189884

/ Not yet recruitingPhase 1/2IIT

A Single-arm, Exploratory Clinical Study of Pyrotinib in Combination With Darcilib and Standard Endocrine Neoadjuvant Therapy for the Treatment of HR+HER2 Low-expression Breast Cancer

This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.

Start Date23 Sep 2025

Sponsor / Collaborator

The First Affiliated Hospital of Xiamen University

NCT07179939

/ Not yet recruitingPhase 2IIT

A Multicenter, Open-Label, Phase II Trial of Exploring the Maintenance of Trastuzumab Plus Pyrotinib or Trastuzumab Plus Dalpiciclib and Endocrine Therapy Based on HR Status Following Trastuzumab Rezetecan as Induction Treatment for HER2 Positive Unresectable Locally Recurrent or Metastatic Breast Cancer

This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.

Start Date10 Sep 2025

Sponsor / Collaborator

Fudan University

[+2]

100 Clinical Results associated with Pyrotinib Maleate

100 Translational Medicine associated with Pyrotinib Maleate

100 Patents (Medical) associated with Pyrotinib Maleate

409

Literatures (Medical) associated with Pyrotinib Maleate

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of trastuzumab deruxtecan as a second-line treatment for HER2-mutant advanced non-small cell lung cancer

Article

Author: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Zhang, Wen ; Huang, Jinglong ; Zhou, Aiping

The study of DESTINY-Lung01 and DESTINY-Lung02 demonstrated the favorable efficacy and optimal dosage of trastuzumab deruxtecan (T-DXd) in managing the human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) patients who had received previous treatment. The study sought to assess the cost-effectiveness of T-DXd in both the United States (US) and Chinese healthcare systems. Markov models were developed to evaluate the overall cost, incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and life years (LYs) of treatment with T-DXd compared with docetaxel, nivolumab, and pyrotinib for patients in the US and China. The level of willingness-to-pay (WTP) in the US and China is 150,000/QALYs and 32,517/QALYs, respectively. Sensitivity analyses were carried out to ensure the precision of the model. T-DXd yielded additional QALYs of 0.63 and 0.06 with an ICER of $338997.84 and $1437258.33 per QALY, respectively, in the US compared to the docetaxel and nivolumab regimens. And T-DXd yielded additional QALYs of 0.63, 0.06, and 0.13 with an ICER of $137959.45, $623805.93, and $515447.12 per QALY, respectively, in China compared to the docetaxel, nivolumab, and pyrotinib regimens. Sensitivity analysis showed that the cost of drugs is the most influential factor. T-DXd provides substantial therapeutic benefit for NSCLC patients with HER2 mutations who have had previous treatment but is not deemed cost-effective in either the US or China when compared to docetaxel, nivolumab, and pyrotinib. Price reduction is perhaps the main way to make T-DXd cost-effective.

01 Oct 2025·ONCOLOGIST

Survival analysis of pyrotinib in HER2-positive metastatic breast cancer: a multicenter real-world study

Article

Author: Wu, Xiaohong ; Zhu, Chengjun ; Xu, Hong ; Zhang, Yusong ; Yang, Lei ; Yi, Tongbo ; Zhou, Jun ; Yuan, Yuan ; Shan, Haixia ; Xie, Li ; Li, Shiyi ; Zhang, Lili ; Xu, Ting

Abstract:

Background:

In previous clinical trials, pyrotinib has shown good antitumor activity and manageable toxicity in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). However, real-world data on pyrotinib remain limited. In this study, we reported the latest real-world data on the efficacy and safety of pyrotinib in HER2-positive MBC.

Methods:

This multicenter retrospective study included 337 HER2-positive MBC patients treated with pyrotinib between October 2016 and October 2024. We reported the analysis of the efficacy and safety of pyrotinib in HER2-positive MBC. The primary endpoints were progression-free survival (PFS) and overall survival (OS).

Results:

As of April 1, 2025, the median follow-up duration was 42.6 months (range, 2.0-92.7). The median line of treatment was two. The median PFS was 15.3 months (95% CI, 12.9-17.6). By treatment line, the median PFS was 21.4 months (95% CI, 10.1-32.6) for first-line treatment, 14.8 months (95% CI, 11.4-18.1), and 10.9 months (95% CI, 8.1-13.7) for second-line and third-line or above treatment. The 3-year OS rate was 54.6% overall, with 63.2%, 61.1%, and 37.7% for first-line, second-line, and third-line or above treatment. The ORR, DCR, and CBR were 41.5%, 91.2%, and 80.0%. We further analyzed 57 patients with brain metastases (BM). The result showed that the median duration of response (DoR) and time to response (IQR) of radiotherapy-naïve ones were 12.6 months (95% CI, 6.8-18.4) and 1.7 months (95% CI, 1.3-2.2), respectively. The most frequent grade 3 or 4 adverse event was diarrhea. No treatment-related deaths were reported.

Conclusion:

The updated analysis demonstrated that pyrotinib could be a promising treatment option in HER2-positive MBC with acceptable toxicity in the real world. Survival is still under assessment with longer follow-up.

01 Oct 2025·ONCOLOGIST

Pyrotinib versus pertuzumab with trastuzumab and taxane in HER2-positive metastatic breast cancer: a Chinese multicenter real-world study

Article

Author: Feng, Ronghua ; Deng, Jian ; Ouyang, Quchang ; Li, Yongxin ; Hu, Zhe-Yu ; Wu, Tao ; Zhao, Jiuda ; Yi, Zongbi ; Xie, Ning ; Tian, Can ; Liu, Binliang

Abstract:

Importance:

THP (trastuzumab + paclitaxel + pertuzumab) and THPy (trastuzumab + paclitaxel + pyrotinib) are widely used as first-line regimens for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in China. However, direct comparative data on their efficacy and safety remain scarce.

Objective:

To evaluate and compare the clinical outcomes of THPy and THP in the first-line treatment of HER2-positive MBC to guide clinical decision-making.

Design:

Real-world, multicenter retrospective study conducted from 2020 to 2024.

Setting:

Five large breast cancer centers in China.

Participants:

A total of 145 patients with HER2-positive MBC were included before propensity score matching (PSM). After PSM, 76 patients (38 in each group) were analyzed.

Intervention(s) or Exposure(s):

Patients received either THP (trastuzumab + paclitaxel + pertuzumab) or THPy (trastuzumab + paclitaxel + pyrotinib) as first-line treatment.

Main Outcome(s) and Measure(s):

The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate, and safety profile.

Results:

Before PSM, 145 patients were included, with the median follow-up of 9.4 months. The ORR was significantly higher in the THPy group (75.0%) compared to the THP group (56.8%; P = .023). Median PFS showed a trend favoring THPy (19.80 months vs 15.57 months; Log-rank P = .343). After PSM, 76 patients were matched, with the median PFS of 24.33 months versus 14.50 months for THPy and THP groups, respectively. Though the difference in PFS was not statistically significant (Log-rank P = .309), THPy demonstrated a higher ORR compared to THP (78.9% vs 57.9%; P = .048). Further subgroup analysis revealed greater benefits of THPy, particularly in patients with prior neoadjuvant therapy (hazard ratio [HR] = 0.261; 95% CI: 0.072-0.940). Regarding safety, THPy was associated with a higher incidence of grade 3/4 diarrhea (26.6% vs 3.1%) as well as increased rates of neutropenia, anemia, alanine aminotransferase elevation, fatigue, and peripheral neuropathy compared to THP.

Conclusion and Relevance:

Both THP and THPy are effective first-line options for HER2-positive MBC. While THPy demonstrates a higher ORR and a trend toward longer PFS, it also carries a higher incidence of adverse events, particularly diarrhea. These findings offer preliminary insights that may help inform treatment decisions, pending further validation in prospective studies.

News (Medical) associated with Pyrotinib Maleate

20 Oct 2025

·www.prnewswire.com

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma's Emerging Innovation Power

BERLIN, Oct. 20, 2025 /PRNewswire/ -- From October 17 to 21, the European Society for Medical Oncology (ESMO) Annual Congress convened in Berlin, bringing together global leaders in oncology and pharmaceutical innovation. Representing China's advancing biopharmaceutical landscape, Hengrui Pharma not only returned with a comprehensive portfolio of oncology research but also debuted as an exhibitor, marking a new milestone in its global academic engagement. Since 2016, Hengrui has presented pioneering research at the ESMO Annual Congress for ten consecutive years. This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology. In parallel, Hengrui scheduled a series of academic events, fostering in-depth dialogue with leading global experts and clinical researchers on cutting-edge topics in oncology. These initiatives established a dynamic platform for international academic exchange and infused Chinese innovation into the global landscape of cancer diagnosis and treatment – marking a new chapter in Hengrui's journey of international scientific engagement. As one of the world's premier oncology platforms, the ESMO Annual Congress attracts more than ten thousand experts and hundreds of leading international pharmaceutical companies each year. The meeting showcases the latest advances in cancer research and therapeutics, serving as a high-level hub for academic exchange and collaboration. It continues to catalyze innovation and clinical translation across the oncology community, aligning with the 2025 Congress vision: "Standing by those who care about cancer." Global Vision: China Innovation Going Global At the ESMO 2025 Annual Congress, Hengrui co-hosted the roundtable "China Innovation Going Global," bringing together leading Chinese and international experts to discuss strategic pathways and future prospects for the globalization of China-origin innovations. During the global launch of the CARES-009 study, featuring Hengrui's innovative therapeutic combination of camrelizumab and rivoceranib, Academician Jia Fan of the Chinese Academy of Sciences and Professor Jian Zhou of Zhongshan Hospital, Fudan University, jointly presented the latest global data from the study, garnering widespread attention from the international oncology community. Ms. Jo Feng, President and Chief Operating Officer of Hengrui Pharma, led the company's delegation at this year's Congress. She stated, "ESMO serves as a premier global platform for oncology exchange, and this year, Hengrui proudly presented 46 research achievements – highlighting our growing academic presence on the world stage. As an innovation-driven global pharmaceutical company, Hengrui places medical innovation at the heart of its strategic vision, with a steadfast commitment to addressing unmet clinical needs. Looking ahead, we remain firmly patient-centric, continuing to advance groundbreaking therapies to improve the lives of patients worldwide." Breakthroughs Across Multiple Cancer Types At this year's ESMO Annual Congress, Hengrui had 46 oncology research projects accepted, including four LBAs, spanning 14 innovative therapeutic programs. Among these, nine were selected for oral presentations, two for mini oral sessions, 32 as posters, and three as e-posters. Collectively, these studies encompass more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, pancreatic cancer, lung cancer, sarcoma, biliary tract cancer, head and neck squamous cell carcinoma, prostate cancer, and thyroid cancer. In breast cancer, Hengrui had 11 research studies accepted, comprising one oral presentation, one mini oral, eight posters, and one e-poster. Notably, an LBA featuring Hengrui's antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) compared with pyrotinib plus capecitabine for patients with HER2-positive advanced or metastatic breast cancer was selected for presentation. Multiple studies highlighting both established and emerging therapies, including pyrotinib, dalpiciclib, and adebrelimab, demonstrate Hengrui's deep and sustained commitment to advancing breast cancer research. In gastrointestinal cancers, 14 studies were accepted, including two oral presentations, 11 posters, and one e-poster. Alongside flagship therapies such as camrelizumab and rivoceranib, four studies on adebrelimab in the gastrointestinal field were featured. In addition, investigational agents including HRS-4642 (a KRAS G12D inhibitor) and SHR-1701 (a PD-L1/TGF-β bifunctional antibody) were also presented, reflecting the strong momentum of both Hengrui's established portfolio and emerging pipeline in advancing care for patients with gastrointestinal malignancies. In lung cancer, six poster presentations featuring camrelizumab and adebrelimab were accepted, underscoring Hengrui's expanding footprint in this therapeutic area. These studies covered both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), further validating the clinical potential and versatility of these regimens. Across additional disease areas, including gynecologic tumors, thymic epithelial tumors, head and neck squamous cell carcinoma, sarcoma, prostate cancer, and thyroid cancer, Hengrui had 13 studies accepted, featuring a diverse range of innovative therapies such as camrelizumab, fuzuloparib, rivoceranib, rezvilutamide, adebrelimab, famitinib, HRS-7058, and HRS-4642. These included six oral presentations, one mini oral, five posters, and one e-poster, highlighting Hengrui's robust and broad-based R&D capabilities. In addition, two posters were accepted on hetrombopag and ondansetron oral soluble films, focusing on the prevention and management of chemotherapy-induced thrombocytopenia, nausea, and vomiting. Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, stated: "At this year's ESMO Annual Congress, we unveiled a broader and more impactful portfolio of research findings. The concentrated release of these breakthrough data not only reflects Hengrui's robust R&D capabilities, but also highlights the results of our science-driven, globally oriented innovation R&D strategy. Our pipeline is both deep and forward-looking – while reinforcing our existing product portfolio, we are also actively expanding into cutting-edge therapeutic areas. We firmly believe that through this in-depth engagement with the global oncology community, we can better enable our breakthroughs to benefit more patients worldwide." A Decade of ESMO Participation: China Innovation Going Global Since 2016, Hengrui Oncology has participated in the ESMO Annual Congress for 10 consecutive years, consistently setting new benchmarks for Chinese pharmaceutical companies. Between 2023 and 2025, Hengrui presented a total of 119 research achievements: 2023: 36 studies accepted, including two preferred oral presentations, six mini oral presentations, and 28 posters, covering multiple therapeutic areas such as gastrointestinal cancers, breast cancer, cervical cancer, pancreatic cancer, and melanoma. 2024: 37 studies accepted, spanning 13 innovative therapies and more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, and lung cancer. 2025: Marking its first-ever exhibition booth at ESMO, Hengrui presented 46 studies across 14 innovative medicines. This milestone represents a significant step forward in Hengrui's internationalization strategy and its commitment to advancing global cancer care. Commitment to Global Impact with the Promise of Patient Focus Hengrui remains steadfast in its commitment to science and innovation driven by the goal of addressing unmet patient needs. Leveraging a global R&D network, the company is advancing innovative medicines onto the international stage. Through a strategically structured pipeline, continuous breakthroughs across multiple cancer types, and active participation in global academic exchange, Hengrui Oncology is accelerating the internationalization and bringing new hope and broader treatment options to patients worldwide. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Hengrui Oncology Hengrui Oncology specializes in the development, production, and global commercialization of innovative cancer therapies. It is the first business unit within Hengrui to achieve technological breakthroughs and successfully enter international markets. Hengrui Oncology has established a robust and diversified oncology pipeline encompassing multiple tumor types, with a comprehensive portfolio that includes immunotherapies, targeted therapies, and ADCs. In key areas such as breast cancer, Hengrui Oncology provides full-course treatment solutions that span multiple lines of therapy. To date, 14 novel oncology agents developed by Hengrui have been approved for marketing in China. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOImmunotherapyDrug Approval

17 Oct 2025

·www.prnewswire.com

Kelun-Biotech's Core product Trastuzumab Botidotin Approved for Marketing by NMPA for HER2-positive BC

CHENGDU, China, Oct. 17, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (also known as A166) was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have received one or more prior anti-HER2 therapy. The approval is based on a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study that evaluates the efficacy and safety profile of trastuzumab botidotin versus T-DM1 in patients with HER2-positive unresectable or metastatic BC who have received prior trastuzumab and taxane-containing regimens. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM1; the beneficial trend for overall survival (OS) of trastuzumab botidotin was also observed. Results from this study will be presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany (Presentation # LBA24, Proffered paper session 1: Breast cancer, metastatic). The Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC. Dr. Michael Ge, CEO of Kelun-Biotech said, "We are thrilled to see our first HER2 ADC drug, trastuzumab botidotin, successfully approved for market. This marks a significant advancement in the treatment of HER2-positive breast cancer. As China's first domestically developed HER2 ADC capable of broadly covering 2L+ HER2 BC patients, trastuzumab botidotin leverages its differentiated structural design to deliver superior efficacy while addressing unmet clinical needs in this population." About HER2+ BC Breast cancer, as the most common malignant tumor, poses a serious threat to women's health. Among its subtypes, HER2-positive breast cancer accounts for approximately 15%–20% of all breast cancer cases[1], and is characterized by its aggressiveness and high malignancy. According to the 2025 CSCO guidelines, first-line treatment for HER2-positive breast cancer primarily consists of trastuzumab and pertuzumab in combination with taxane-based chemotherapeutic agents. Second-line treatment regimens comprise tyrosine kinase inhibitors (TKIs, such as pyrotinib) and antibody-drug conjugates (ADCs, such as T-DM1 and T-DXd). Following disease progression on second-line therapy, subsequent treatment strategies are determined based on prior second-line regimens, the patient's tolerance to therapy, tumor burden, and other relevant factors. Despite recent advances in anti-HER2 therapeutics, a significant number of patients still experience drug resistance or severe adverse effects, highlighting an urgent need for agents with improved safety profiles to address the treatment requirements of patients with recurrent or drug-resistant HER2-positive breast cancer. A bout trastuzumab botidotin Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (DAR) of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalADCPhase 3Phase 2Clinical Result

05 Jun 2025

·www.prnewswire.com

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

SHANGHAI, June 5, 2025 /PRNewswire/ -- The 2025 ASCO Annual Meeting successfully concluded in Chicago on June 3 (local time). Hengrui Pharma delivered a strong international presence, featuring 15 innovative drugs and 72 research outcomes. These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts. In the field of breast cancer, results from 19 studies evaluating the company's innovative drugs—pyrotinib, dalpiciclib, camrelizumab, apatinib, adebrelimab, Trastuzumab rezetecan (SHR-A1811), and SHR-2017, either in combination with each other or with chemotherapies, were presented at ASCO 2025. Notably, 7 studies involving pyrotinib and 6 studies involving dalpiciclib were selected, with both agents consistently demonstrating promising efficacy, reinforcing their established roles in breast cancer treatment. Furthermore, studies evaluating SHR-A1811 and adebrelimab were selected for rapid oral presentations, attracting considerable attention from the industry. In the field of gastrointestinal cancers, drugs such as camrelizumab, apatinib, adebrelimab, and SHR-8068 were featured in a total of 30 accepted studies. Notably, camrelizumab was included in 21 of these studies, demonstrating its broad therapeutic profile and potential while reinforcing its position as a key focus at ASCO. This further solidifies the achievements of China-developed PD-1 inhibitors on the global stage. Additionally, adebrelimab, which has achieved significant breakthroughs in lung cancer in recent years, is actively expanding into new indications. At this year's ASCO, five related studies exploring adebrelimab's efficacy in indications such as hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA) , and pancreatic cancer were presented. The ongoing emergence of cutting-edge research on both established and emerging agents holds promise for improving clinical outcomes for patients with gastrointestinal tumors. Across a wide range of disease areas—including lung cancer, gynecologic cancers, lymphoma, bladder cancer, head and neck cancer, melanoma, sarcoma, nasopharyngeal carcinoma, chordoma, salivary gland cancer, thymic cancer, desmoid tumors, and salivary duct carcinoma—Hengrui Pharma's innovative oncology portfolio (camrelizumab, apatinib, adebrelimab, pyrotinib, dalpiciclib, fluzoparib, famitinib, SHR-A1811, SHR-1501, SHR-1701, SHR-1826, SHR-A1912, and SHR-A2102) was featured in 22 research presentations at ASCO 2025. These comprised 4 oral presentations, 2 rapid oral presentations, 12 poster presentations, and 4 online publications, collectively demonstrating the company's robust R&D capabilities. Additionally, one online publication highlighted ondansetron oral soluble film, underscoring its favorable efficacy in preventing and treating chemotherapy-induced nausea and vomiting (CINV). For 15 consecutive years, Hengrui Pharma has consistently presented its cutting-edge research at the ASCO Annual Meeting, highlighting the company's global leadership in oncology drug research and development while showcasing China's robust pharmaceutical innovation capabilities to the international academic community. The inclusion of 70 Hengrui-sponsored studies at this year's meeting reflects the strong foundation laid by the company's portfolio of 23 marketed innovative drugs and a robust pipeline of over 90 candidates currently in development. Looking ahead, Hengrui will remain committed to its patient-centric approach, striving to develop advanced therapeutics that support the "Healthy China" initiative and enhance clinical outcomes for patients globally. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOClinical ResultCSCO

100 Deals associated with Pyrotinib Maleate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB14993

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced HER2-Positive Breast Carcinoma	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Apr 2023
HER2 Positive Breast Cancer	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	12 Aug 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HER2-Low Breast Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Jan 2024
Hormone receptor positive breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Jan 2024
HR-positive/HER2-low Breast Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Jan 2024
Invasive Mammary Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Jan 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Sep 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05292742 (KATHERINE, SABCS2025)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2-positive	102	CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumabe (HER2-positive early breast cancer + Non-pCR)	hqeopthndt(mzhnfkchcp) = uicdhybhxq bdkztnuvuo (eoyxxtmnax, 83.3 - 95.6) View more	Positive	11 Dec 2025
ESMO_ASIA2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	411	Docetaxel+Trastuzumab+Pyrotinib	fmvcglkmze(umxbquqvtg) = wqrzgsnqui ojgslssrwv (tjeqiakewy, 21.2 - 30.4) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable		411	Taxane+Trastuzumab+Pertuzumab	fmvcglkmze(umxbquqvtg) = pttxsltbhq ojgslssrwv (tjeqiakewy, 13.2 - 23.3) View more	Positive	05 Dec 2025
ESMO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2+	301	Inetetamab + Pyrotinib + Chemotherapy	guajlecewd(bwcevxhxbz) = bkxzwavalh asqwahjlcm (khoiqvbtwi, 9.8 - 14.2) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable		301	Inetetamab + Pyrotinib + Chemotherapy (1st line)	guajlecewd(bwcevxhxbz) = cmulwmbdkh asqwahjlcm (khoiqvbtwi )	Positive	17 Oct 2025
NCT04486911 (MUKDEN 01, ESMO2025)	Phase 2	ER positive, PR positive, HER2 positive breast cancer First line \| Neoadjuvant ER Positive \| PR Positive \| HER2 Positive	81	Pyrotinib+Letrozole+Dalpiciclib	hhvlauvsch(nwbekccawx) = hpvzaxktpx mtzpwabcbd (ogyltamdga, 88.6 - 99.1) View more	Positive	17 Oct 2025
NCT03772353 (PLEASURABLE, Pubmed \| PLoS Med)	Phase 2	ER-positive/HER2-positive Breast Cancer First line ER-positive \| HER2-positive	48	Dalpiciclib + Pyrotinib + Endocrine therapy	exseteqpgr(poodkvoecm) = vxvagfpjcq fezqnxjhet (xstgrnwzmw, 55.1 - 82.7) View more	Positive	31 Jul 2025
ASCO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast Second line \| First line \| Third line HER2-positive	337	Pyrotinib	balctixmqd(ndpcxseodd) = 21.3% qcsqkvlmmr (wyoszuviun ) View more	Positive	30 May 2025
NCT05561686 (PHEDRA, ESMO_BC2025)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	70	Trastuzumab	dkgavfjnwb(xkezhggnml) = ebtslsazow clcpvlmyob (wybfmjstka )	Positive	14 May 2025
NCT05561686 (PHEDRA, ESMO_BC2025)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	70	Placebo	dkgavfjnwb(xkezhggnml) = jrxnkcrwwq clcpvlmyob (wybfmjstka )	Positive	14 May 2025
NCT05880927 (PERSIST, Pubmed \| Elife)	Phase 2	HER2 Positive Breast Cancer Adjuvant HER2-positive	141	Pyrotinib 400 mg/day	lmrktgshpz(mhnwqsgnue) = iewnewbqmn ofonkcapul (jiebzxyngj, 88.97 - 97.38)	Positive	03 Apr 2025
ESMO_SRC2025 \| ASCO2025	Not Applicable	Salivary duct carcinoma First line \| Second line HER2-positive	11	Pyrotinib	glbwunganv(shrletejcz) = The most common adverse reactions were grade 1-2, with one patient discontinuing due to stool intolerance and the remaining patients having no grade 4 adverse reactions xbjbxqvrkw (ppgbochogu ) View more	Positive	21 Mar 2025
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	gajuwkxald(leiuguqudo) = myiuhngpas qcahpfclot (nxraqevejq, 29.0 - 56.7) View more	Positive	10 Dec 2024
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	gajuwkxald(leiuguqudo) = mvjdgclasb qcahpfclot (nxraqevejq, 37.9 - 73.2)	Positive	10 Dec 2024

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