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Last update 01 Aug 2026

Ramucirumab

Last update 01 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Ramucirumab (Genetical Recombination), Ramucirumab (genetical recombination) (JAN), Ramucirumab (USAN)

+ [11]

Target

VEGFR2

Action

antagonists

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [3]

Active Indication

Unresectable Hepatocellular CarcinomaAdvanced gastric carcinomaMetastatic Gastric Carcinoma+ [32]

Inactive Indication

Advanced Esophageal Squamous Cell CarcinomaAdvanced Gastric AdenocarcinomaAdvanced Gastroesophageal Junction Adenocarcinoma+ [48]

Originator Organization

Dyax Corp.

Active Organization

Eli Lilly & Co.

Pieris Pharmaceuticals, Inc.Eli Lilly Nederland BV

+ [4]

Inactive Organization

Basilea Pharmaceutica AG

Innovent Biologics (Suzhou) Co. Ltd.

Lilly Asia Shanghai Representative Office

+ [1]

License Organization

Eli Lilly & Co.

Basilea Pharmaceutica AGShire Pharmaceuticals LLC

+ [4]

Drug Highest PhaseApproved

First Approval Date

United States (21 Apr 2014),

Gastroesophageal junction adenocarcinomaStomach Cancer

RegulationFast Track (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 9107105H

Source: *****

Sequence Code 9583823L

Source: *****

233

Clinical Trials associated with Ramucirumab

NCT07594548

/ Not yet recruitingPhase 1IIT

A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

Start Date09 Sep 2027

Sponsor / Collaborator

Northwestern University

[+1]

NCT07546812

/ RecruitingPhase 2

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and/or metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.
The primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).

Start Date01 Jul 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT07669740

/ Not yet recruitingPhase 2IIT

A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-Term Recurrence After Adjuvant Therapy

To explore the efficacy and safety of sintilimab combined with ramucirumab and paclitaxel in the treatment of advanced gastric cancer patients with short-term recurrence after postoperative adjuvant therapy, and to identify efficacy-related biomarkers to guide subsequent individualized treatment.

Start Date01 Jul 2026

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

100 Clinical Results associated with Ramucirumab

100 Translational Medicine associated with Ramucirumab

100 Patents (Medical) associated with Ramucirumab

1,333

Literatures (Medical) associated with Ramucirumab

01 Jul 2026·LUNG CANCER

Phase II study of ramucirumab plus erlotinib for treatment-naïve patients with EGFR-mutant non-squamous non-small cell lung cancer and pleural effusion (RELAY-Effusion)

Article

Author: Yamada, Tadaaki ; Tachihara, Motoko ; Kawaguchi, Tomoya ; Kaneda, Hiroyasu ; Shintani, Ayumi ; Kuyama, Shoichi ; Kurata, Takayasu ; Sawa, Kenji ; Tanaka, Hisashi ; Toi, Yukihiro ; Yamamoto, Ken ; Yoshida, Hisako ; Kato, Takahide ; Kawai, Ryota ; Yokoyama, Toshihide ; Azuma, Koichi ; Katakami, Nobuyuki ; Fujisaka, Yasuhito ; Kubo, Akihito ; Ichihara, Eiki

INTRODUCTION:

Malignant pleural effusion (MPE) develops in approximately 30-40% of patients with non-small cell lung cancer (NSCLC), including those harboring epidermal growth factor receptor (EGFR) mutations, and is generally associated with reduced responsiveness to EGFR tyrosine kinase inhibitors. This study aimed to investigate the efficacy of ramucirumab in the context of MPE, which remains unexplored.

METHODS:

In this single-arm, multicenter, phase II study, we enrolled treatment-naïve patients with EGFR-mutant NSCLC complicated by MPE. They received ramucirumab (10 mg/kg) every 2 weeks plus erlotinib (150 mg) daily until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and safety.

RESULTS:

Forty patients were enrolled between December 2021 and December 2023 (median follow-up, 29.5 months). The median PFS and OS were 12.9 (95% confidence interval [CI], 7.3-16.7) and 36.3 (95% CI: 28.5- not available [NA]) months, respectively, with a 12-month OS rate of 87.5% and ORR of 77.5% (95% CI, 61.5-89.2%). The median drainage-free survival was 33.0 months (95% CI: 26.0-NA). Treatment-related adverse events occurred in 85% of patients (grade 5 = 0%; grade 3 or 4 = 22.5%); the most common were acneiform dermatitis (60.0%), decreased appetite (30.0%), increased aspartate aminotransferase concentration (25.0%), paronychia (22.5%), hypertension (22.5%), proteinuria (22.5%), and anemia (22.5%).

CONCLUSIONS:

Although the primary endpoint was not met, the combination provided durable control of MPE and was well tolerated, suggesting potential value in symptom-focused management of this high-risk subgroup.

CLINICAL TRIAL REGISTRATION:

Japan Registry of Clinical Trials (jRCTs051210138).

01 Jul 2026·Applied Health Economics and Health Policy

Structured Expert Elicitation of Long-Term Survival in Non-small Cell Lung Cancer: A Case Study Applying Guidance from NICE Technical Support Document 26

Article

Author: Puri, Tarun ; Jen, Min-Hua ; Summers, Yvonne ; Rajesh, Rahul ; Achra, Monika ; van der Wekken, Anthonie J ; Espinar, Javier Baena ; Sonksen, Michael D ; Forsyth, Jessica E ; Liepa, Astra M ; Lenox-Smith, Alan ; Hochmair, Maximilian ; Ren, Shijie

BACKGROUND:

Extrapolation of overall survival in health technology assessment (HTA) is a key area of uncertainty, as equally well-fitting models can generate divergent lifetime projections. This can lead to significant implications for decision-making. Subject experts are often consulted on the plausibility of survival projections, but input is rarely obtained in a robust manner.

OBJECTIVE:

This case study applies guidance from the National Institute for Health and Care Excellence Decision Support Unit Technical Support Document (TSD) on using structured expert elicitation for long-term survival estimation (TSD 26). This study focuses on its feasibility of implementation from the perspective of a company preparing a HTA submission.

METHODS:

The REVEL trial, evaluating ramucirumab plus docetaxel for stage IV non-small cell lung cancer, was selected as a case study. The elicitation was based on the Sheffield Elicitation Framework (SHELF) and undertaken in accordance with TSD 26.

RESULTS:

Five experts from four countries attended across three virtual workshops. Experts provided quantitative judgements on overall survival at 4 years for the intervention and comparator from the REVEL trial. Qualitative discussion of the change in hazard and scenario testing demonstrated the internal consistency of experts' judgments and provided valuable context for expert judgements. Group discussion in separate workshops posed challenges when the facilitation team had to relay the views of absent experts.

CONCLUSIONS:

This case study demonstrates that it is feasible to follow the recommendations provided in TSD 26 when conducting elicitation for long-term survival outcomes and highlights the critical role of discussing the hazard function in group discussions.

01 Jul 2026·LUNG CANCER

Docetaxel plus ramucirumab immediately after immunotherapy in advanced NSCLC: A phase II study (DRUN)

Article

Author: Kanai, Kuninobu ; Takakura, Toshiaki ; Nakaguchi, Keita ; Murakami, Yusuke ; Furuta, Katsuyuki ; Ozawa, Yuichi ; Shibaki, Ryota ; Akamatsu, Hiroaki ; Shimokawa, Toshio ; Washioka, Atsushi ; Takase, Eri ; Wan, Ke ; Harutani, Yuhei ; Kaki, Takahiro ; Yamamoto, Nobuyuki ; Sugimoto, Takeya ; Sato, Koichi ; Sasaki, Seigo

INTRODUCTION:

Docetaxel plus ramucirumab is a standard second-line treatment for advanced non-small cell lung cancer (NSCLC). Prior immunotherapy has been suggested to potentially affect the efficacy of subsequent docetaxel plus ramucirumab, but prospective evidence is limited.

METHODS:

This multicenter, single-arm, phase II study enrolled patients with advanced NSCLC. Eligible patients had experienced disease progression following a prior immune checkpoint inhibitor (ICI)-containing regimen. Patients received docetaxel 60 mg/m² and ramucirumab 10 mg/kg every 3 weeks. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. This study was registered in the Japan Registry of Clinical Trials (jRCT1051190091).

RESULTS:

Between January 8, 2020, and January 7, 2024,We evaluated 33 patients for efficacy and safety. The median age was 69 years, and 26 patients (79%) had an Eastern Cooperative Oncology Group performance status of 1. The ORR was 33.3% (90% confidence interval [CI], 19.9-49.1), and the DCR was 90.9% (90% CI, 78.1-97.5). The median PFS and OS were 4.9 months (95% CI, 4.4-6.2) and 11.8 months (95% CI, 9.8-18.8), respectively. No new safety signals were observed. Patients who had responded to prior ICI-containing therapy had longer PFS than those who had not responded (hazard ratio, 0.34; 95% CI, 0.14-0.76).

CONCLUSION:

Although the primary endpoint was not met, docetaxel plus ramucirumab demonstrated antitumor activity consistent with previous reports and manageable safety in the post-ICI setting. Efficacy appeared more pronounced in patients with prior response to ICI-containing therapy.

277

News (Medical) associated with Ramucirumab

27 Jul 2026

·www.businesswire.com

Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

Phase 3Clinical ResultPhase 1License out/inDrug Approval

14 Jul 2026

·www.prnewswire.com

Innovent Biologics and Spero Therapeutics Announce Exclusive License for IBI355 (SP001), a Phase 2-Ready Third-Generation Anti-CD40L Antibody

Under the terms of the agreement, Spero will receive exclusive global rights, excluding Greater China, to develop, research, manufacture, and commercialize IBI355 (Spero R&D code: SP001) Innovent will receive an upfront payment, and is eligible to receive development, regulatory and commercial milestone payments, totaling approximately US$1.1 billion, as well as tiered royalties on net sales Spero plans to initiate a Phase 2 trial for IBI355 in Q2 2027 in IgG4-related disease (IgG4-RD), a serious, chronic fibroinflammatory condition with significant treatment burden and limited therapeutic options Innovent plans to initiate a Phase 2 trial in China by early 2027 for Sjögren's disease (SjD), a chronic autoimmune disorder with limited therapeutic options SAN FRANCISCO, CAMBRIDGE, Mass., and SUZHOU, China, July 14, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (01801.HK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced an exclusive license agreement for IBI355 (Spero R&D code: SP001), a third-generation Fc-silent anti-CD40L antibody. Spero will receive exclusive rights to develop, research, manufacture, and commercialize IBI355 worldwide, excluding Greater China, where Innovent retains rights. Spero currently expects to advance IBI355 into a Phase 2 study in IgG4-RD patients in Q2 2027; Innovent expects to initiate a Phase 2 trial in China for SjD by early 2027. IBI355 (SP001) targets CD40L, an immune signal protein that sits upstream of multiple immune pathways and has the potential to redefine treatment paradigms across a range of immune-mediated diseases. Innovent has evaluated this antibody in two healthy volunteer Phase 1 trials: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. Innovent has also evaluated IBI355 in a Phase 1b MAD study in patients with SjD. Data from the Phase 1b SjD study were presented in a poster session at the EULAR 2026 Congress. "CD40L is an important upstream mediator of immune activation and T-cell/B-cell collaboration, both of which are relevant to IgG4-RD progression," said Dr. Arezou Khosroshahi, MD, Professor of Medicine, Emory University School of Medicine. "A non-B cell depleting approach that interrupts CD40L signaling could represent an important area for clinical evaluation in IgG4-RD, where patients need additional options that address chronic inflammation, relapse, and treatment burden." "IgG4-related disease, Sjögren's disease, and other autoimmune conditions impose significant burdens on patients worldwide, with many facing limited treatment options." said Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent Biologics. "We are pleased to partner with Spero Therapeutics on IBI355 to advance the development of this CD40L-targeted approach. By combining Innovent and Spero's immunology expertise and development commitment, we aim to accelerate the delivery of differentiated therapies to patients living with these chronic conditions. Our shared goal is to bring meaningful new options to patients in need, wherever they are." "Having successfully advanced and delivered a therapy for patients with serious infectious diseases, we are now applying the same disciplined development approach to immune-mediated diseases. This in-licensing transaction establishes the foundation of our new pipeline and positions Spero to pursue potentially transformative therapies for patients living with chronic, debilitating conditions," said Esther Rajavelu, President and Chief Executive Officer of Spero Therapeutics. "We view CD40L as a clinically validated pathway with broad applicability across several immune-mediated diseases. In IgG4-RD, we believe this approach has the potential to meaningfully address the burden patients face from a chronic, relapsing condition with limited treatment options. Beyond IgG4-RD, we see opportunities to explore the role of CD40L inhibition across multiple autoimmune and inflammatory conditions. We are delighted to partner with Innovent Biologics, whose scientific leadership, development expertise, and commitment to innovation have been instrumental in advancing this program to its current stage." Under the terms of the license agreement, Spero will receive exclusive rights to develop, research, manufacture, and commercialize IBI355 worldwide, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). Innovent will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments, bringing total value of the deal to approximately $1.1 billion. Innovent is also eligible to receive tiered royalties on net sales generated in Spero's licensed territories. About IBI355 (SP001) IBI355 (SP001) is a third-generation, humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in B-cell, antigen-presenting cell, and platelet biology. By blocking CD40L, IBI355 has the potential to provide a targeted non-B-cell-depleting treatment across multiple immune-mediated diseases where immune-cell interactions drive chronic inflammation, relapse, and tissue damage. IBI355 is designed to address platelet activation concerns associated with earlier anti-CD40L antibodies, while preserving key monoclonal antibody properties, including FcRn interaction that supports IgG-like half-life. About IgG4-Related Disease IgG4-related disease is a serious, chronic fibroinflammatory condition that can affect multiple organs, including the pancreas, salivary glands, lacrimal glands, kidneys, lungs, lymph nodes, and other tissues. The disease can cause immune-mediated inflammation, fibrosis, organ damage, relapse risk, and significant treatment burden. Current approaches can include steroids and B-cell-directed therapies, but additional options are needed to support durable disease control, reduce long-term treatment burden, and preserve immune function. About Sjögren's Disease (SjD) Sjögren's disease is a chronic, systemic autoimmune disorder that primarily affects the salivary and tear glands, but can also involve multiple organs in more severe cases. It is one of the most common autoantibody-driven diseases, yet no approved therapies address its underlying systemic nature, and it predominantly affects women. The disease is marked by autoantibody production, chronic inflammation, and lymphocytic infiltration, leading to symptoms such as dry eyes, dry mouth, joint pain, and fatigue. In some patients, organ involvement can include kidney or lung dysfunction, and there is an increased risk of non-Hodgkin's B-cell lymphoma. More than half of patients develop moderate-to-severe disease, with a burden comparable to other serious autoimmune conditions. About Innovent Biologics 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 19 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 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, Pfizer, 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. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly. About Spero Therapeutics Spero Therapeutics is a clinical-stage biopharmaceutical company focused on advancing next-generation medicines in immunology and inflammation for patients with serious diseases and major treatment gaps. The company's lead program, SP001, is a next-generation, Fc-silent anti-CD40L monoclonal antibody being advanced first in IgG4-related disease, with broader potential for additional immune-related conditions. For more information, visit . Forward-looking statement of Innovent Biologics 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. Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect. Forward-Looking Statements of Spero Therapeutics This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, statements regarding Spero's plans, strategy, and expectations for future development; the potential benefits of SP001; the potential of CD40L blockade in IgG4-related disease and other immune-related conditions; Spero's plans to advance SP001 into clinical development; anticipated development timelines, regulatory activities, and future milestones; and the potential benefits of Spero's agreement with Innovent. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Forward-looking statements are based on Spero's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to the completion and integration of the Innovent transaction; Spero's ability to successfully develop SP001; the timing and outcome of clinical trials and regulatory interactions; the ability to obtain and maintain regulatory approvals; potential safety, efficacy, manufacturing, supply, intellectual property, financing, competitive, and market risks; and other risks described in Spero's filings with the Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Spero undertakes no obligation to update any forward-looking statements, except as required by law. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 1License out/inImmunotherapy

30 Jun 2026

·www.prnewswire.com

Innovent Biologics and Lilly Enter into Commercialization Agreement for Verzenios® (abemaciclib) in Mainland China

SAN FRANCISCO and SUZHOU, China, June 30, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, and Eli Lilly and Company (NYSE: LLY) today jointly announced that they have entered into a distribution and promotion agreement regarding Lilly's CDK4 & 6 inhibitor Verzenios® (abemaciclib) in mainland China: Innovent will be responsible for the importation, marketing, distribution and promotion of Verzenios® (abemaciclib) in mainland China; Lilly will continue to be responsible for manufacturing, supply, and development for the product. Verzenios® (abemaciclib), developed by Lilly, is a CDK4 & 6 inhibitor that has been approved in China for multiple indications, including: (1) Early Breast Cancer: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. (2) Locally Advanced or Metastatic Breast Cancer: a) For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: In combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. In combination with fulvestrant for patients who have experienced disease progression following prior endocrine therapy. b) In combination with imlunestrant: for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer who have previously received endocrine therapy. The product was included in the National Reimbursement Drug List (NRDL) Class B in 2021, becoming the first CDK4 & 6 inhibitor covered by national reimbursement in China. In 2025, it successfully renewed its NRDL listing, achieving full coverage across both early and advanced breast cancer indications. Under the agreement, Innovent will hold sole commercialization rights for Verzenios® (abemaciclib) in mainland China, while Lilly, as the Marketing Authorization Holder (MAH), will continue to be responsible for manufacturing, supply, and ongoing product development. This collaboration combines Innovent's experienced oncology commercialization team and extensive market reach in China with Lilly's expertise in innovative medicine development and lifecycle management, further enhancing access to this important therapy and benefiting more breast cancer patients across the country. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We are delighted to further deepen our strategic partnership with Lilly through this eighth collaboration, bringing the number of our partnered, on-market products in China to seven. This also marks the 19th product in Innovent's portfolio. Enhancing patient access to high-quality, innovative medicines has always been at the core of Innovent's mission. Leveraging our established commercial infrastructure and strong market presence in China, we remain focused on addressing critical unmet needs in major oncology indications. Breast cancer, one of the most prevalent and life–threatening malignancies among women, is a strategic priority within Innovent's oncology portfolio. Through this commercial collaboration with Lilly on Verzenios® (abemaciclib) – backed by its robust clinical efficacy, comprehensive labeled indications and national reimbursement coverage – we are expanding our presence in this area, laying a solid foundation for our pipeline development and market expansion deliver lasting benefits to patients in breast cancer." Huzur Devletsah, Lilly Group Vice President and China General Manager, said: "For 150 years, Lilly has remained committed to putting health above all, advancing human health through scientific innovation and expanding access through collaboration. This agreement for Verzenios® (abemaciclib) is an important step in strengthening patient access in China, combining Lilly's global R&D expertise with Innovent's commercialization capabilities in China. Looking ahead, Lilly will continue to advance its oncology efforts in China. Since the beginning of this year, we have secured approvals for one new medicine (with two indications) and two new additional indications for on market products in China, including Inluriyo®, which has become the first and currently only approved precision therapy in China only targeting ESR1-mutated advanced breast cancer, accelerating the introduction of globally innovative therapies and addressing unmet medical needs." 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 19 products in the market. It has 1 asset in NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Takeda, Pfizer, Roche, 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. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo), Pirtobrutinib (Jaypirca) and abemaciclib (Verzenios) were developed by Eli Lilly and Company. Disclaimer: Innovent does not recommend any off-label usage. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. Forward-Looking Statements of Innovent Biologics 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 21% more press release views with Request a Demo

Drug ApprovalLicense out/inNDA

100 Deals associated with Ramucirumab

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KEGG	Wiki	ATC	Drug Bank
D09371	Ramucirumab	L01XC21	DB05578

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Japan	Eli Lilly & Co.	20 Jun 2016
Advanced gastric carcinoma	Australia	Eli Lilly Australia Pty Ltd.	23 Jul 2015
Metastatic Gastric Carcinoma	Australia	Eli Lilly Australia Pty Ltd.	23 Jul 2015
Colorectal Cancer	European Union	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Colorectal Cancer	Norway	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	European Union	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Hepatocellular Carcinoma	Norway	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	European Union	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Malignant neoplasm of gastro-oesophageal junction	Norway	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	European Union	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Iceland	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Liechtenstein	Eli Lilly Nederland BV	19 Dec 2014
Metastatic Colorectal Carcinoma	Norway	Eli Lilly Nederland BV	19 Dec 2014
Non-Small Cell Lung Cancer	European Union	Eli Lilly Nederland BV	19 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Gastric Adenocarcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	10 Mar 2021
Advanced Hepatocellular Carcinoma	Phase 3	China	Eli Lilly & Co.	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	China	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Hong Kong	Eli Lilly & Co.	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Hong Kong	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Taiwan Province	Lilly Asia Shanghai Representative Office	13 Jun 2017
Advanced Hepatocellular Carcinoma	Phase 3	Taiwan Province	Eli Lilly & Co.	13 Jun 2017
Adenocarcinoma	Phase 3	China	Eli Lilly & Co.	02 Mar 2017
Adenocarcinoma	Phase 3	Malaysia	Eli Lilly & Co.	02 Mar 2017
Adenocarcinoma	Phase 3	Philippines	Eli Lilly & Co.	02 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04632459 (CTgov)	Phase 2	Metastatic gastric adenocarcinoma \| Metastatic Gastric Carcinoma	26	pembrolizumab+ramucirumab	cnguiqebiy = cmrsxjacyt zhzhldflqe (iayhiijqmv, mqemupnuut - pijidgdomq) View more	-	05 Jun 2026
NCT04921904 (ASCO2026)	Phase 1/2	-	20	Abemaciclib + Ramucirumab	atvyjrxlbo(tbkmipwxbs) = Early mPD detection at one month by ctDNA kinetics strongly correlates with shorter PFS, offering a rapid signal of efficacy. xrugamudok (fnzosyjega ) View more	Positive	29 May 2026
NCT02934464 (ARMANI, ASCO2026)	Phase 3	HER2 negative Gastric Cancer Maintenance HER2-negative	276	Paclitaxel + Ramucirumab	ytjdjzwhma(chqyypowbk) = woyumrjbkz esgkxekpre (ncijfsqfrg, 8.5 - 13.5)	Positive	29 May 2026
				Fluoropyrimidine + Oxaliplatin	-
NCT05980000 (ASCO2026)	Phase 2	PD-L1-positive head and neck squamous cell carcinoma First line PD-L1 positive	37	Ramucirumab 10mg/kg and Pembrolizumab 200mg	coqyvfvbtt(cbtkehsouq) = hepcqaefes txrrwqznvp (aimcxaupmy, 12.1 - 49.4)	Negative	29 May 2026
				Pembrolizumab	coqyvfvbtt(cbtkehsouq) = qsnmpxdqjp txrrwqznvp (aimcxaupmy, 9.9 - 65.1)
NCT06616584 (Lung-MAP S1800E, ASCO2026)	Phase 2/3	Non-Small Cell Lung Cancer	378	Docetaxel and Ramucirumab	vziczaodxm(ehhebrzkmp) = nubgdfomio xehkamyqdn (xetxyappuv ) View more	Negative	29 May 2026
				Docetaxel, Ramucirumab, and Cemiplimab	jscrohroap(dlncaoxjzr) = hjngzkbamt zxtumlgyet (zgijcwteuu ) View more
NCT04340882 (ASCO2026)	Phase 2	Non-Small Cell Lung Cancer	30	PembrolizumabDocetaxelRamucirumab + PembrolizumabDocetaxelRamucirumab + PembrolizumabDocetaxelRamucirumabab	ylwpkuaspm(tifycajdpx) = essjpijyds jgqucjcnzu (exzeeplnxt, 5.6 - 9.9) View more	Positive	29 May 2026
JPRN-jRCTs041220120 (RETRIEVE, ASCO_GI2026)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Third line	111	FTD/TPI plus RAM	uixdbzjczg(agbvbkavhx) = tbwtwxrtvq ckrilofomh (roxotqcpae ) View more	Negative	08 Jan 2026
				FTD/TPI	uixdbzjczg(agbvbkavhx) = wqafrvvbcn ckrilofomh (roxotqcpae ) View more
JPRN-jRCTs051190071 (RAMIEL, ASCO_GI2026)	Phase 2	Stomach Cancer Adjuvant	39	Ramucirumab + irinotecan	usddslqvxu(clxjnyzgvk) = yretrtqbow aexycagujh (frqyldtzqo, 8.8 - 42.0) View more	Positive	08 Jan 2026
JPRN-jRCTs041210105 (ASCO_GI2026)	Phase 2	Advanced gastric carcinoma Third line	32	Trifluridine/tipiracil plus Ramucirumab (Advanced Gastric Cancer)	oxffbmjqfx(ckubusbcyb) = jsrxugjcog wnoywtjapn (ozesqsqokf, 2.8 - 5.0) View more	Positive	08 Jan 2026
NCT04660760 (ACCRU-GI-1810, ASCO_GI2026)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Second line	29	FTD-TPI+RAM	ugqozgsudr(vqusgntghi) = mcmdzabvtl ivtixtllwb (izqfkzyrby ) View more	Negative	08 Jan 2026
				PAC+RAM	ugqozgsudr(vqusgntghi) = rzfcnnfwne ivtixtllwb (izqfkzyrby ) View more

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