FGFRs antagonists(Fibroblast growth factor receptors antagonists), VEGFR1 antagonists(Vascular endothelial growth factor receptor 1 antagonists), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [7]

Active Indication

Alveolar Soft Part SarcomaAdvanced Hepatocellular CarcinomaMetastatic Renal Cell Carcinoma+ [69]

Inactive Indication

adenocarcinoma of biliary tractAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [49]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Advenchen Laboratories LLC

Advenchen Laboratories Nanjing Ltd.

Inactive Organization

Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.Peking University People's Hospital

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (08 May 2018),

Locally Advanced Lung Non-Small Cell Carcinomametastatic non-small cell lung cancer

RegulationOrphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC23H23ClFN3O3

InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N

CAS Registry1360460-82-7

817

Clinical Trials associated with Anlotinib Dihydrochloride

NCT07470840

/ Not yet recruitingPhase 2IIT

A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.

Start Date01 Feb 2027

Sponsor / Collaborator

Fujian Cancer Hospital

NCT07540390

/ Not yet recruitingPhase 3IIT

An Open-label, Multicenter, Randomized Controlled Phase III Clinical Trial of PD-1 Monoclonal Antibody Plus Anlotinib Combined With Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.

The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.

Start Date08 May 2026

Sponsor / Collaborator

Sun Yat-Sen University

NCT07510594

/ Not yet recruitingPhase 2IIT

A Single-Center, Single-Arm, Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as First-Line Treatment for Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma

To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC)

Start Date01 May 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Anlotinib Dihydrochloride

100 Translational Medicine associated with Anlotinib Dihydrochloride

100 Patents (Medical) associated with Anlotinib Dihydrochloride

1,242

Literatures (Medical) associated with Anlotinib Dihydrochloride

01 Jul 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Heterogeneous inorganic nanomedicine delivery system loaded with anlotinib for enhanced treatment of non-small cell lung cancer (NSCLC)

Article

Author: Li, Jun ; Zhu, Mengni ; Peng, Jiangzhou ; Long, Hang ; Xue, Lei ; Guo, Minzhang

Non-small cell lung cancer (NSCLC) poses a formidable therapeutic challenge due to drug resistance and limited treatment efficacy. To address this, we developed a novel nanodrug delivery system, SPIO@SiO₂-ANB, which integrates superparamagnetic iron oxide nanoparticles (SPIOs), a silica (SiO₂) shell, and the surface-loaded multi-target tyrosine kinase inhibitor anlotinib (ANB). This platform enhances drug stability, enables tumor-targeted delivery, and induces ferroptosis. The synthesized nanoparticles demonstrated a monodisperse spherical morphology, pH-responsive ANB release, and efficient cellular internalization. In vitro, SPIO@SiO₂-ANB exhibited superior cytotoxicity against A549 and H460 NSCLC cells compared to free ANB, concurrently elevating intracellular reactive oxygen species (ROS) and modulating key ferroptosis-related proteins (COX-2, xCT, GPX4). In vivo studies using xenograft models revealed improved tumor accumulation and retention of SPIO@SiO₂-ANB, leading to significant tumor growth inhibition, enhanced apoptosis, and suppressed angiogenesis. This work presents a synergistic therapeutic strategy that combines ferroptosis induction with targeted therapy, offering a promising avenue for the safe and effective treatment of NSCLC.

01 Apr 2026·INTERNATIONAL JOURNAL OF CANCER

Tislelizumab plus sitravatinib or anlotinib as maintenance therapy in extensive‐stage small‐cell lung cancer: Results of two prospective phase II studies

Article

Author: Lou, Guangyuan ; Chen, Kaiyan ; Li, Hui ; Lu, Hongyang ; Xie, Fajun ; Yu, Sizhe ; Xu, Yanjun ; Xu, Xiaoling ; Yu, Xinmin ; Gu, Cuiping ; Gong, Lei ; Qin, Jing ; Wang, Wenxian ; Zhao, Jun ; Han, Na ; Fan, Yun ; Huang, Zhiyu ; Shao, Lan

Abstract:

First‐line chemo‐immunotherapy has significantly improved survival in extensive‐stage small‐cell lung cancer (ES‐SCLC). However, rapid disease progression still occurs, with a median progression‐free survival (PFS) of only 4.5–5.8 months from induction therapy. We initiated two single‐arm, phase II studies to assess the first‐line maintenance therapy with tislelizumab plus anti‐angiogenic drugs following induction therapy in ES‐SCLC patients. Previously untreated ES‐SCLC patients were enrolled to receive tislelizumab plus platinum‐based chemotherapy as induction therapy for 4 cycles, followed by tislelizumab plus sitravatinib (Trial 1) or anlotinib (Trial 2) as maintenance therapy in a 21‐day cycle. The primary endpoint was the 1‐year PFS rate in the maintenance analysis set (MAS, including patients receiving ≥1 dose of maintenance therapy). Outcomes in MAS were calculated from the start of maintenance therapy. Twenty‐one patients were enrolled, and 18 patients entered the maintenance phase in each trial. From the start of the maintenance therapy, the median PFS was 6.4 and 7.8 months (1‐year PFS rates of 22.2% and not reached), respectively; the median overall survival (OS) was 18.3 months and not reached. From induction therapy, the corresponding median PFS was 9.1 and 10.8 months, with a median OS of 17.6 months and not reached. In MAS, the most common grade ≥3 treatment‐related adverse events (TRAEs) included hypertension (22.2%) in Trial 1 and fatigue (5.6%) in Trial 2. No patients died from TRAEs in either trial. Maintenance therapy with tislelizumab plus sitravatinib or anlotinib yielded clinically meaningful survival results and was generally well tolerated in ES‐SCLC, warranting further exploration in larger‐scale trials.

02 Mar 2026·Cancer Discovery

Molecular and Immune Correlates of Response to First-Line De-escalated Chemotherapy plus Penpulimab and Anlotinib in Advanced Cervical Cancer

Article

Author: Xie, Xingyun ; Wang, Yuqin ; Liu, Qin ; Fu, Yajuan ; Wang, Zhixin ; Zang, Lele ; Li, Li ; Zhu, Mingxuan ; Huang, Songhua ; Xu, Qin ; Lu, Huaiwu ; Liu, Jing ; Huang, Xiaoxia ; Zhang, Huiqi ; Chang, Lele ; Zhu, Fei ; Sun, Yang ; Chen, Li ; Wang, Yanhong ; Wang, Cong ; Liu, Yunyun ; Zhuo, Yanhong ; Deng, Zhengrong ; Zhang, Peidong ; Chen, Ying ; Ke, Meifang ; Zhou, Shengtao ; Lin, Yingtao ; Hu, Dan ; Li, Peiwei ; Kang, Yaxin

Abstract:

The standard of care for advanced cervical cancer includes chemotherapy, antiangiogenic, and/or immune checkpoint blockade regimens. Although effective, it leads to pleiotropic side effects. Deescalation chemotherapy together with immunotargeted therapies has been proven effective and less toxic in other cancers. In this study, we conducted a multicenter, single-arm, phase II study of first-line deescalated platinum-based chemotherapy plus anlotinib and penpulimab, followed by maintenance therapy solely with anlotinib and penpulimab in patients with PD-L1–positive, persistent, recurrent, or metastatic cervical cancer. Of 32 efficacy-evaluable patients, 30 (93.8%, 95% confidence interval, 79.2%–99.2%) had an investigator-confirmed objective response. Single-nucleus RNA sequencing implied enhanced chemotaxis and proliferative activity of tumor-infiltrating T cells, and activated germinal center B cells portended optimal treatment response. Patients with a high tertiary lymphoid structure-to-tumor area ratio exhibited better survival. Our findings lay the groundwork for the feasibility of first-line de-escalated chemotherapy plus anlotinib and penpulimab in patients with metastatic, persistent, or recurrent cervical cancer.

Significance::

We recruited 34 patients with advanced cervical cancer receiving two cycles of platinum-based chemotherapy plus anlotinib and penpulimab, followed by maintenance therapy solely with anlotinib and penpulimab, and showed safety and efficacy of this deescalation regimen. This work highlights the potential for personalized treatment strategies and feasibility of reduced-toxicity regimens.

News (Medical) associated with Anlotinib Dihydrochloride

22 Apr 2026

·www.prnewswire.com

Innovent to Present New Clinical Data of IBI363（PD-1/IL-2α-biased bispecific fusion protein） at the 2026 ASCO Annual Meeting

SAN FRANCISCO and SUZHOU, China, April 21, 2026 /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, announces that clinical data for its first-in-class IBI363 (PD-1/IL-2α-biased bispecific fusion protein) * as well as TYVYT® (sintilimab injection)** will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 to June 2, 2026, in Chicago, Illinois, U.S. Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "We are excited to announce that at the 2026 ASCO Annual Meeting, we will present new PoC data of IBI363 in NSCLC, across both IO-resistant and first-line settings. With robust PoC data for IO-resistant NSCLC now in hand, we are moving IBI363 into MRCT pivotal development, an important step toward tackling a major global unmet medical need. At the same time, we are encouraged by the promising dose optimization data in first-line NSCLC, and we look forward to continued maturation of PoC full data to inform our next steps. Innovent will continue to push the boundaries of cancer care, as we are dedicated to delivering physicians and patients more innovative, effective, and life-saving treatment options." Abstracts of IBI363(PD-1/IL-2 α -biased bispecific fusion protein) 1. Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC). Abstract Number: 8586 Session Type: Poster Session Title: Lung Cancer/Non-Small Cell Metastatic Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT Presenter: Dr. Haiyan Tu, Guangdong Provincial People's Hospital 2. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC): updated results from a phase I study. Abstract Number: 2618 Session Type: Poster Session Title: Developmental Therapeutics/Immunotherapy Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT Presenter: Dr. Jianya Zhou, First Affiliated Hospital of Zhejiang University School of Medicine 3. Presentation Title: Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO). Abstract Number: TPS8673 Session Type: Poster Session Title: Lung Cancer/Non-Small Cell Metastatic Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT Presenter: Dr. Roy S. Herbst, Yale School of Medicine Abstracts of TYVYT®(sintilimab) 1. Presentation Title: Adjuvant sintilimab plus bevacizumab following curative resection of spontaneously ruptured hepatocellular carcinoma: A prospective exploratory phase II study (CLEAR-2) Abstract Number: TPS4254 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT Presenter: Dr. Yongjun Chen, Ruijin Hospital, Shanghai Jiaotong University School of Medicine 2. Presentation Title: Neoadjuvant chemoradiotherapy with or without PD-1 blockade in pMMR/MSS low rectal cancer patients (CHOICE II): A multi-center, open-label, randomized controlled trial. Abstract Number: 3640 Session Type: Poster Session Title: Gastrointestinal Cancer—Colorectal and Anal Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT Presenter: Dr. Wei Zhang, Changhai Hospital 3. Presentation Title: Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC): A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study Abstract Number: 4148 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT Presenter: Dr. Jia Fan, Zhongshan Hospital, Fudan University 4. Presentation Title: CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer. Abstract Number: TPS3680 Session Type: Poster Session Title: Gastrointestinal Cancer—Colorectal and Anal Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT Presenter: Dr. Yue Liu, The Second Affiliated Hospital of Zhejiang University School of Medicine. 5. Presentation Title: Long-term survival and biomarker analysis of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: A randomized clinical trial. Abstract Number: 3610 Session Type: Poster Session Title: Gastrointestinal Cancer—Colorectal and Anal Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT Presenter: Dr. Xiao Weiwei, Sun Yat-sen University Cancer Center 6. Presentation Title: Larynx preservation via chemotherapy-free neoadjuvant sintilimab-cetuximab-SBRT and response-adapted treatment in locally advanced laryngeal cancer: A phase II, single-arm clinical trial (The NeoVOICE study). Abstract Number: 6095 Session Type: Poster Session Title: Head and Neck Cancer Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT Presenter: Dr. Song Ming, Sun Yat-sen University Cancer Center 7. Presentation Title: Pathological complete response and ctDNA analyses in SCIENCE: Results from a randomized, phase III trial of neoadjuvant chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy in resectable locally advanced esophageal squamous cell carcinoma. Abstract Number: LBA4082 Session Type: Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT Presenter: Dr. Xuefeng Leng, Sichuan Cancer Hospital 8. Presentation Title: Sintilimab (PD-1 antibody) Plus Gemcitabine and Docetaxel (GT) as First-line or Later-line Therapy in Patients with Advanced Epithelioid Sarcoma: A Prospective, Multicenter, Single-arm, Phase II Clinical Study. Abstract Number: 11574 Session Type: Poster Session Title: Sarcoma Session Date & Time: June 1, 2026 1:30 PM-4:30 PM CDT Presenter: Dr. Xiaowei Zhang, Fudan University Shanghai Cancer Center 9. Presentation Title: Sintilimab plus Anlotinib and Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma: A Prospective, Phase II Clinical Trial. Abstract Number: 8050 Session Type: Poster Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT Presenter: Dr. Jianchun Duan, Cancer Hospital, Chinese Academy of Medical Sciences 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 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, 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. Forward-looking statement 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo

ASCOPhase 1Phase 2Clinical ResultPhase 3

07 Apr 2026

·www.prnewswire.com

Akeso Presents Updated Data on Cadonilimab Combination Therapy in PD-(L)1 Inhibitor-Resistant Advanced NSCLC at ELCC 2026

HONG KONG, April 6, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that, at the 2026 European Lung Cancer Congress (ELCC 2026), it reported updated results with a median follow-up of 21.45 months from a prospective, open-label, single-arm, multicenter Phase Ib/II study evaluating cadonilimab in combination with anlotinib and docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after prior PD-(L)1 inhibitor-based therapy. Cadonilimab is the world's first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status, addressing a significant unmet medical need and earning broad recognition from physicians and patients. Cadonilimab-based regimens have previously shown promising therapeutic potential in difficult-to-treat tumors, including immunotherapy-refractory hepatocellular carcinoma (HCC) and gastric cancer. The updated data presented at ELCC 2026 now provide further robust evidence of cadonilimab's important additional value in treating immunotherapy-resistant diseases, beyond its well-established benefit in the all-comer population. Just as importantly, cadonilimab's consistent safety profile makes it a highly preferable backbone with which other treatments can be combined to create efficacious treatment for a multitude of cancers. In this difficult-to-treat population of patients with immunotherapy-resistant advanced NSCLC, the cadonilimab combination regimen demonstrated clinically meaningful anti-tumor activity, durable disease control, and a manageable safety profile, supporting its potential as a new second-line treatment option. Key Findings from the Phase Ib/II Study (Median Follow-Up: 21.45 Months): Progression-Free Survival (PFS): In the overall population, median PFS was 7.0 months, with a 6-month PFS rate of 55.7%. Consistent Benefit Across Subgroups: Median PFS was 7.5 months in the squamous NSCLC (sq-NSCLC) subgroup and 7.4 months in the PD-L1 TPS ≥1% subgroup. Disease Control and Response Durability: The Disease Control Rate (DCR) reached 95.2%; the Objective Response Rate (ORR) was 26.2%, and the median Duration of Response (DoR) was 6.0 months. Patients who achieved circulating tumor DNA (ctDNA) clearance had a median PFS of 9.1 months. After the first treatment cycle (C1), the ctDNA detection rate decreased from 1.5% to 0.5%, demonstrating the regimen's depth of anti-tumor activity at the molecular level. Safety Profile: The triple combination of cadonilimab, anlotinib, and docetaxel was well tolerated, with a grade ≥3 treatment-related adverse event (TRAE) rate of 14.0%. No treatment-related deaths were reported. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. Forward-Looking Statements This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

Clinical ResultImmunotherapyPhase 3Drug Approval

31 Mar 2026

·allsci.com

Lancet: Chia Tai’s benmelstobart and anlotinib combo outperforms pembrolizumab in lung cancer trial

Researchers across 79 centers in China reported that a combination regimen of programmed death-ligand 1 (PD-L1) inhibitor benmelstobart plus the multi-kinase inhibitor anlotinib produced statistically significant improvements in progression-free survival over pembrolizumab monotherapy in PD-L1-positive, driver gene-negative advanced non-small-cell lung cancer (NSCLC), according to the CAMPASS Phase III trial. The results were published in The Lancet Oncology. The trial, funded by Chia Tai Tianqing Pharmaceutical Group, enrolled 531 patients and represents one of the first randomized Phase III datasets to demonstrate head-to-head superiority over pembrolizumab in this setting. Chia Tai is responsible for discovering benmelstobart and development in Greater China, while US-based biotech Apollomics partnered with the China-based firm for rights outside China. Pembrolizumab monotherapy has held a dominant position as first-line treatment for PD-L1-positive advanced NSCLC since its approval based on the KEYNOTE-024 and KEYNOTE-042 trials. However, a substantial proportion of patients progress within a year, and response rates in the broader PD-L1-positive population—defined as tumor proportion score (TPS) of 1% or greater—remain around 30% to 40%. The CAMPASS trial was designed to test whether adding anlotinib, a multi-target anti-angiogenic tyrosine kinase inhibitor, to the PD-L1-targeted benmelstobart could improve outcomes without the addition of chemotherapy. The CAMPASS results The trial randomized patients 2:1, with 354 receiving benmelstobart plus anlotinib and 177 receiving pembrolizumab plus placebo. Patients were aged 18 to 75 years, had an ECOG performance status of 0 or 1, and had no targetable EGFR or ALK mutations. Both squamous and non-squamous histologies were included. Enrollment ran from August 2021 through December 2022 across 79 sites in China. The primary endpoint was progression-free survival assessed by blinded independent central review per RECIST v1.1. Median PFS in the experimental arm was not reached at the time of analysis, compared with 8.9 months in the pembrolizumab arm. The hazard ratio was 0.51 (95% CI: 0.39–0.67; p<0.0001). The 12-month PFS rate was approximately 60% with benmelstobart plus anlotinib versus approximately 40% with pembrolizumab. The PFS benefit was consistent across prespecified subgroups, including patients with TPS 1%–49% and ≥50%, as well as across squamous and non-squamous histologies. Overall survival data, while still maturing with both medians not yet reached, showed a hazard ratio of 0.62 (95% CI: 0.44–0.88; p0.007), indicating an early OS signal in favor of the combination. The objective response rate was approximately 63% in the experimental arm versus 39% in the pembrolizumab arm, a statistically significant difference. The mechanistic rationale for the combination centers on the relationship between tumor angiogenesis and immune suppression. Tumors upregulate VEGF signaling to promote vascular growth, but this process also creates an immunosuppressive microenvironment by reducing T-cell infiltration and promoting regulatory T-cell accumulation. Anlotinib inhibits VEGFR, FGFR, PDGFR, and c-Kit, which normalizes tumor vasculature and is thought to improve T-cell trafficking into the tumor. Benmelstobart then blocks the PD-1/PD-L1 axis, reactivating cytotoxic T-cells within a more accessible microenvironment. The hypothesis is that anti-angiogenic therapy potentiates checkpoint inhibition by making tumors more immunologically permissive, rather than relying on checkpoint blockade alone. The safety profile reflected the dual-agent mechanism. Grade 3 or higher treatment-related adverse events occurred in approximately 60% of patients in the benmelstobart plus anlotinib arm, compared with approximately 35% in the pembrolizumab arm. Anlotinib-related toxicities, particularly hypertension and proteinuria, accounted for a meaningful share of the higher adverse event burden. Treatment discontinuation rates were higher in the experimental arm, however, no new or unexpected safety signals were identified. The investigators characterized the toxicity as manageable with dose modifications. Research context The CAMPASS regimen represents one among several competing approaches to the same problem. Akeso’s ivonescimab, a bispecific antibody targeting both PD-1 and VEGF within a single molecule, reported superiority over pembrolizumab in the HARMONi-2 Phase III trial in 2024 in a Chinese PD-L1-positive NSCLC population. Summit Therapeutics holds ex-China rights to ivonescimab, and the asset has attracted considerable attention as a potential pembrolizumab alternative in the first-line setting. The bispecific format is mechanistically adjacent to the CAMPASS combination but consolidates both activities into one molecule, which may carry pharmacokinetic and dosing advantages. Other China-developed IO combinations—including camrelizumab plus apatinib from Jiangsu Hengrui and sintilimab plus anlotinib from Innovent—are also in late-stage evaluation in overlapping populations. Roche’s atezolizumab plus bevacizumab plus chemotherapy (IMpower150) is approved in non-squamous NSCLC but includes cytotoxic chemotherapy, a distinction that the CAMPASS regimen avoids. The chemotherapy-free design is a feature it shares with the ivonescimab approach, with both positioning against pembrolizumab monotherapy in PD-L1-positive advanced NSCLC. The CAMPASS dataset was generated entirely in China, which carries implications for regulatory and commercial strategy. The trial population reflects a Chinese clinical context, and generalizability to Western populations will require additional data or bridging studies before regulatory submissions outside China. The benmelstobart program is also being evaluated in extensive-stage small-cell lung cancer, where a Phase III trial published in Nature Medicine in 2024 suggests Chia Tai Tianqing is pursuing a broader oncology footprint for the combination platform. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultDrug Approval

100 Deals associated with Anlotinib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alveolar Soft Part Sarcoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	14 Apr 2026
Advanced Hepatocellular Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	30 Dec 2025
Metastatic Renal Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	13 May 2025
Unresectable Renal Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	13 May 2025
Endometrial Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	22 Nov 2024
Extensive stage Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2024
Differentiated Thyroid Gland Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Apr 2022
Thyroid Cancer, Medullary	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	30 Jan 2021
Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2019
Soft Tissue Sarcoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2019
Non-Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	14 May 2018
Locally Advanced Lung Non-Small Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2018
metastatic non-small cell lung cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Non-small cell lung cancer stage III	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Small cell lung cancer limited stage	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2024
Primary peritoneal carcinoma	Phase 3	United States	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	United States	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Italy	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Italy	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	Spain	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04964479 (CAMPASS, Pubmed \| Lancet Oncol)	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1-positive	531	Benmelstobart plus Anlotinib	qvomualqcu(dyuugdtrui) = sycgxorjux ymsvgvwsxi (lcxokdtvkf, 9.2 - 12.6) View more	Positive	01 Apr 2026
				Pembrolizumab plus Placebo	asvvbqoqcz(osteiydawh) = rpsuxppyss nuugxfxpes (rtumrvlpds ) View more
NCT04967625 (ESMO_ELCC2026)	Phase 2	Refractory Small Cell Lung Carcinoma	18	SintilimabAnlotinibb + SintilimabAnlotinib	umhhibaytm(uolfgovyeh) = haernsftqa vhnsvfwpic (msseymexun, 17.3 - 64.3) View more	Positive	25 Mar 2026
				Anlotinib (initially diagnosed with limited-stage SCLC)	umhhibaytm(uolfgovyeh) = uovrihtjan vhnsvfwpic (msseymexun )
NCT05816499 (AK104-IIT-018, ESMO_ELCC2026)	Phase 1/2	Advanced Lung Non-Small Cell Carcinoma Second line EGFR \| ALK \| ROS1	50	Cadonilimab+Anlotinib+Docetaxel	ybfwqmrohq(bbxwdlaxdn) = mavlkdduyv mehcxptmxx (zbohtwhqcb, 39.9 - 70.9) View more	Positive	25 Mar 2026
				Cadonilimab+Anlotinib+Docetaxel (sq-NSCLC)	akupemqbjb(yvnsbcanig) = cglsuozxwt fozyghzzyi (cudfzpeasi, 4.05 - 10.05)
ChiCTR2500110453 (Galaxy-L-01, ESMO_ELCC2026)	Phase 2	KRAS G12C mutant non-squamous non-small cell lung cancer First line KRAS G12C mutation	82	Garsorasib + Anlotinib	brrcwijxze(giiweiozpy) = phlagtmsjp dvznyuewjn (xwbxdbsiyz ) View more	Positive	25 Mar 2026
NCT04964479 (CAMPASS, Pubmed) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 Positive	531	Benmelstobart + Anlotinib	jnxaqyszla(nlauaizbku) = viejlwopgz moewahkxkp (mfvtmqrnwm, 9.2 - 12.6) View more	Positive	10 Mar 2026
				Pembrolizumab + Placebo	jnxaqyszla(nlauaizbku) = vrjipdghfj moewahkxkp (mfvtmqrnwm, 5.8 - 9.5) View more
NCT04846634 (ALTER-L043, Pubmed \| Nat Commun \| NEWS) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	90	Penpulimab + Anlotinib + Chemotherapy	qnpgzoirgb(hvctpwaarw) = qxfpgtrnob oawldepduo (wvqtcqllgx, 54.9 - 90.6) View more	Positive	16 Jan 2026
				Penpulimab + Chemotherapy	qnpgzoirgb(hvctpwaarw) = pirywghqji oawldepduo (wvqtcqllgx, 36.9 - 76.7) View more
NCT06621095 (ALTER-PA-001, NEWS) Manual	Phase 2	Metastatic Pancreatic Cancer First line	38	安罗替尼+贝莫苏拜单抗+白蛋白结合型紫杉醇+吉西他滨	owrbitdmhj(tugoiqmfdj) = vmhccvqkhx sxyichftmj (ibeoteoxgi ) View more	Positive	15 Jan 2026
				白蛋白结合型紫杉醇+吉西他滨	owrbitdmhj(tugoiqmfdj) = oeueskupwq sxyichftmj (ibeoteoxgi ) View more
NCT06051851 (RCT-PAAG, ASCO_GI2026) Manual	Phase 3	Metastatic Pancreatic Cancer First line	155	Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine	pvjwihqcpp(keqpmhztfx) = dkwzljffbg ylgiysomcv (vlpcflitts, 6.7 - 8.7) View more	Positive	10 Jan 2026
				Nab-Paclitaxel+Gemcitabine	pvjwihqcpp(keqpmhztfx) = oucespzebb ylgiysomcv (vlpcflitts, 3.3 - 5.8) View more
ChiCTR2400089133 (ASCO_GI2026) Manual	Early Phase 1	Advanced Esophageal Squamous Cell Carcinoma First line	30	Anlotinib + Penpulimab + Nab-paclitaxel	nyohdlwlin(schwzhuguu) = kwntevnjpl rithwcluur (fhigzfdeig, 7.89 - 15.97) View more	Positive	08 Jan 2026
NCT06573424 (ASCO_GI2026)	Not Applicable	Metastatic Colorectal Carcinoma TP53 pathway \| FLG2 \| nucleotide excision repair (NER)	124	Anlotinib plus Tislelizumab	lirbcpuowg(wgnvzsqiam) = jwjjlkwptm dwuhovpcln (xxylqzxtik ) View more	Positive	08 Jan 2026
				Anlotinib	lirbcpuowg(wgnvzsqiam) = ozczegqmas dwuhovpcln (xxylqzxtik ) View more

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