[Translation] Phase Ib study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combination therapy in subjects with advanced malignancies

1、主要目的：（1）评估IBI363联合治疗在晚期恶性肿瘤受试者中的安全性和耐受性；（2）评估IBI363联合治疗在晚期恶性肿瘤受试者中的抗肿瘤活性。 2、次要目的：（1）评估IBI363联合治疗在晚期恶性肿瘤受试者中的药代动力学（Pharmacokinetics, PK）特征；（2）评估IBI363联合治疗在晚期恶性肿瘤受试者中的免疫原性。

[Translation]

1. Primary objectives: (1) To evaluate the safety and tolerability of IBI363 combination therapy in subjects with advanced malignant tumors; (2) To evaluate the anti-tumor activity of IBI363 combination therapy in subjects with advanced malignant tumors. 2. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of IBI363 combination therapy in subjects with advanced malignant tumors; (2) To evaluate the immunogenicity of IBI363 combination therapy in subjects with advanced malignant tumors.

Start Date31 May 2024

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20232413 / RecruitingPhase 1/2

评价RC148注射液单药及联合方案治疗局部晚期不可切除或转移性恶性实体肿瘤患者的疗效和安全性的多中心Ⅰ/Ⅱ期临床研究

[Translation] A multicenter phase I/II clinical study to evaluate the efficacy and safety of RC148 injection alone and in combination with other drugs in the treatment of patients with locally advanced unresectable or metastatic malignant solid tumors

本研究为多中心、开放性I/II 期临床研究。I期旨在评估单药的安全性、耐受性、最大耐受剂量（MTD）/最大给药剂量（MAD）、II期临床试验的推荐剂量（RP2D）、药代动力学（PK）、药效动力学（PD）、免疫原性、以及初步的抗肿瘤疗效；Ⅱ期探索RC148 联合多西他赛/维迪西妥单抗（RC48）/RC88 在晚期恶性实体瘤的有效性、安全性、耐受性、PK和免疫原性。

[Translation]

This study is a multicenter, open-label Phase I/II clinical study. Phase I aims to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD), recommended dose for Phase II clinical trial (RP2D), pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor efficacy of a single drug; Phase II explores the efficacy, safety, tolerability, PK, and immunogenicity of RC148 combined with docetaxel/vedicizumab (RC48)/RC88 in advanced malignant solid tumors.

Start Date07 Sep 2023

Sponsor / Collaborator

RemeGen Co., Ltd.

ChiCTR2300073213 / SuspendedPhase 4IIT

Hypofractionated radiotherapy combined with sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma: a prospective real-world study

Start Date01 Aug 2023

Sponsor / Collaborator

The Sixth Affiliated Hospital of Sun Yat-Sen University

100 Clinical Results associated with Bevacizumab biosimilar (Innovent Biologics)

100 Translational Medicine associated with Bevacizumab biosimilar (Innovent Biologics)

100 Patents (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

Literatures (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

01 Dec 2024·Critical Reviews in Oncology/Hematology

Sequencing of systemic therapy in unresectable hepatocellular carcinoma: A systematic review and Bayesian network meta-analysis of randomized clinical trials

Review

Author: Yu, Jianan ; Sun, Xuedong ; Cao, Shasha ; Zhang, Yonghong ; Wang, Haochen ; Li, Jianjun ; Wang, Qi ; Han, Yanjing ; Hu, Caixia ; Yang, Zeran ; Jin, Long ; Li, Jian

PURPOSEFor patients with advanced or unresectable hepatocellular carcinoma (HCC), safe and effective therapies are urgently needed to improve their long-term prognosis. Although the guidelines recommend first-line treatments such as sorafenib, lenvatinib, and atezolizumab in combination with bevacizumab (T+A) and second-line treatments such as regorafenib, the efficacy comparison between drugs is lacking, that is, a treatment is not recommended as the optimal or alternative choice for a specific patient population. Therefore, we will conduct a high-quality network meta-analysis based on Phase III randomized controlled trials (RCTs) to systematically evaluate and compare overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and serious adverse events (SAE) of different treatment protocols in the context of first-line and second-line therapies, which are critical for clinical decision making and prognostic improvement in advanced HCC patients.METHODSThe studies of interest were Phase III RCTs evaluating the efficacy or safety of first- or second-line therapies in patients with unresectable or advanced HCC. Literature published in English from the four databases of PubMed, Embase, Cochrane Library, and Web of Science was comprehensively searched from the inception to May 23, 2022. Outcomes of interest included OS, PFS, ORR, and SAE. A league table was developed to show the results of the comparison between different treatments. A histogram of cumulative probability was drawn to discuss the ranking probability of treatments based on different outcomes. The effectiveness and safety of various treatments were comprehensively considered and the two-dimensional diagram was plotted to guide clinical practice. The Gemtc package in R Studio was used for network meta-analysis in a Bayesian framework.RESULTSThe results showed that HAIC-FO was superior to T+A regimen, regardless of OS, PFS or ORR. TACE combined with lenvatinib performed better than T+A in PFS, and ORR. In addition to the T+A regimen, Sintilimab combined with IBI305 and camrelizumab combined with apatinib were also associated with longer OS, PFS, and ORR, and their SAE incidence was not higher than that of T+A, especially for camrelizumab combined with apatinib, its safety was better than that of T+A regimen. There were no new treatments or combinations that were more effective than regorafenib. It was important to note that for PFS, the efficacy of apatinib and cabozantinib was not statistically different from that of regorafenib, so these two treatments could be used as alternative treatment options in cases where regorafenib was not tolerated or treatment failed.CONCLUSIONSWe conducted a network meta-analysis to evaluate the efficacy and safety of multiple treatment modalities by integrating the results of direct and indirect comparisons. This study included high-quality multicenter Phase III RCTs, collated and summarized all treatments involved in advanced or unresectable HCC in first-line and second-line settings, and compared with T+A and regorafenib, respectively, and ranked based on efficacy and safety to support clinical decision making.

01 Oct 2024·Current Treatment Options in Oncology

The Trend of the Treatment of Advanced Hepatocellular Carcinoma: Combination of Immunotherapy and Targeted Therapy

Review

Author: Wang, Yaru ; Luo, Yifeng ; Xu, Xiaoyun ; Zhang, Haiyun ; Ni, Mengjie ; Dong, Heng ; Chen, Jianxiang ; Zhang, Zhengguo

OPINION STATEMENTHepatocellular carcinoma (HCC) is a common type of tumor worldwide. The development of systemic treatment of advanced HCC has remained stagnant for a considerable period. During the last years, a series of new treatment regimens based on the combination of immunotherapeutic drugs and targeted drugs have been gradually developed, increased the objective response rate (ORR), overall survival (OS), and progression free survival (PFS) of HCC patients. Among the different combination therapy groups, atezolizumab plus bevacizumab and sintilimab plus IBI-305 seem to have unique advantages, while head-to-head comparisons are still needed. A comprehensive understanding of the developments, the ongoing clinical trials and the mechanisms of combination of immunotherapy and targeted therapy might lead to the development of new combination strategies and solving current challenges such as the molecular biomarkers, the clinical administration order of drugs and the second-line treatments after combination therapy.

01 Jun 2024·BMJ Open

Efficacy and safety of SBRT combined with sintilimab and IBI305 in patients with advanced HCC and previously failed immunotherapy: study protocol of a phase 2 clinical trial

Article

Author: Tang, Jing ; Xue, Jun ; Wu, Zilong ; Zhang, Jinfeng ; Lin, Zhenyu ; Hu, Jianli ; Zhang, Tao ; Liu, Hongli ; Yang, Yongqiang ; Zhang, Sisi

IntroductionHepatocellular carcinoma (HCC) is a leading cause of cancer-related death in China. The combination of immune checkpoint inhibitors (ICIs) and antiangiogenic drugs, such as bevacizumab and tyrosine kinase inhibitors, has been recommended as first-line treatment for advanced HCC. However, two-thirds of patients did not benefit from this form of immunotherapy. Currently, data on the subsequent regimen for patients previously treated with ICIs are lacking. Studies have shown that the combination of radiotherapy (RT) and ICIs is a potentially effective second-line therapy for HCC. This study aims to assess the efficacy and safety of combined therapy with stereotactic body RT (SBRT), sintilimab and IBI305 (a biosimilar of bevacizumab) in patients with HCC following the progression of first-line ICI therapy.Methods and analysisThis study is an open-label, single-arm, single-centre, phase 2 trial of 21 patients with advanced HCC in whom previous ICI therapy has failed. Participants will receive approximately 30–40 Gy/5–8F SBRT, followed by 200 mg sintilimab and 15 mg/kg IBI305 intravenously every 3 weeks. Treatment will continue until the development of unacceptable toxicity or disease progression. We will use Simon’s two-stage design, with the objective response rate (ORR) as the primary endpoint. Secondary endpoints include ORR of lesions without RT, disease control rate, progression-free survival, overall survival and safety.Ethics and disseminationThe study was authorised by the Medical Ethics Committee. Dissemination of results will occur via a peer-reviewed publication and other relevant media.Trial registration numberChiCTR2200056068.

129

News (Medical) associated with Bevacizumab biosimilar (Innovent Biologics)

08 Oct 2024

·www.pharmaceutical-technology.com

Innovent and ASK Pharm to commercialise limertinib for lung cancer

Limertinib is intended for the treatment of patients with lung cancer. Credit: New Africa/Shutterstock. Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have signed a strategic partnership agreement for the commercialisation of limertinib to treat lung cancer. Limertinib is an orally administrated third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This collaboration will grant Innovent exclusive rights to commercialise the asset within mainland China, and entitles the company to a service fee based on net sales. ASK Pharm will serve as the marketing authorisation holder and will oversee the manufacturing and commercial distribution of the product. ASK Pharm is entitled to upfront payments and milestone payments contingent on meeting regulatory and sales goals. See Also: Activist investor Starboard forges $1bn stake in Pfizer to swing profits Healthcare Payers for the Pharmaceutical Industry Two new drug applications for limertinib are currently under review by China’s National Medical Products Administration. One application is for an indication to treat adults with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), post-EGFR TKI therapy progression. The other is for the first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations in adults. The efficacy and safety of limertinib were evaluated in a randomised, multicentre, double-blind, controlled Phase III clinical trial comparing it to gefitinib for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial successfully met its primary endpoint, indicating a potential new option for patients with this form of lung cancer. Innovent founder, chairman and CEO Dr Michael Yu stated: “We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent’s leadership in oncology. “Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT (sintilimab Injection), BYVASDA (bevacizumab Injection), Retsevmo (selpercatinib), Dupert (fulzerasib) and Taletrectinib (ROS1 Inhibitor). “The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.” In August 2024, the company’s Kristen rat sarcoma G12C inhibitor, Dupert (fulzerasib), received China’s National Medical Products Administration (NMPA) approval to treat advanced non-small cell lung cancer (NSCLC) in adults.

License out/inPhase 3Drug ApprovalCSCO

08 Oct 2024

·www.prnewswire.com

Innovent and Ask Pharm Announce Strategic Collaboration for Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of lung cancer. Under the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China, and will be entitled to receive a commercialization service fee based on the product's net sales in the region. Ask-Pharm as the MAH holder, will be responsible for the production and commercial supply of limertinib and will be eligible for upfront, regulatory and sales milestone payments. Limertinib is an orally administrated, third-generation novel EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by a validated diagnostic test, whose disease has progressed after EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, limertinib's efficacy and safety were compared with gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and detailed data and analysis will be presented at future academic conferences or published in academic journals. Previously, results of limertinib from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent's leadership in oncology. Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT® (sintilimab Injection), BYVASDA® (bevacizumab Injection), Retsevmo® (selpercatinib), Dupert® (fulzerasib) and Taletrectinib (ROS1 Inhibitor, NDA under review). The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients." Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: "We are pleased to form a strategic partnership with Innovent Biologics. Oncology is one of the four core areas of focus for ASK Pharm, and our oncology product line spans chemotherapy drugs, small molecule targeted drugs, and biologics. Limertinib, ASK Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China. Focused on addressing the most common mutations in lung cancer, Ask-Pharm is committed to providing effective drugs for the vast number of patients with EGFR-mutated lung cancer. Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer is the leading cause of cancer-related death and the second more common cancer worldwide. In China, it has both the highest incidence and mortality rates among malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, and approximately 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not eligible to surgical resection. EGFR is the most frequent driver mutation in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR mutations. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, classified as a new molecular entity. Two New Drug Applications (NDAs) of limertinib are currently under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by an approved test, whose disease has progressed following EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, the efficacy and safety of limertinib were compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and the results will be presented at future academic conferences or published in academic journals. Results from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement regarding limertinib in mainland China. 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 11 products in the market. It has 5 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3License out/inClinical ResultNDA

29 Aug 2024

·www.prnewswire.com

Innovent to Present Clinical Data of Multiple Novel Molecules at WCLC and ESMO 2024

SAN FRANCISCO and SUZHOU, China, Aug. 28, 2024 /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 nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) from Sept 7-10, 2024, in San Diego, U.S., and the European Society of Medical Oncology (ESMO) from Sept 13-17, 2024, in Barcelona, Spain. Key data showcase includes: an oral presentation of updated Phase 1 result of its first-in-class PD-1/IL-2 α -bias (IBI363) in NSCLC (up to 3mg/kg dosage) at WCLC, updated Phase 1 results of IBI363 (PD-1/IL-2 α -bias ) combination therapy in colorectal cancer at ESMO, an oral presentation of updated pivotal Phase 2 results of Dupert® (fulzerasib, KRAS G12C inhibitor) in NSCLC at WCLC, an oral presentation of Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors at ESMO, and multiple clinical results of TYVYT® (sintilimab injection). Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules across renowned medical conferences of 2024 including ASCO, ESMO Plenary and ESMO GI in June, and WCLC and ESMO in September. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent remains dedicated to advancing cancer treatment and is committed to offering doctors and patients more innovative, effective, and safe therapeutic options." Details on the abstracts are listed below: WCLC: Oral Sessions Abstract Title: First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 In Patients with Advanced Non-Small Cell Lung Cancer in a Phase 1 Study Abstract No: MA11.04 Session Type and Title: WCLC 2024-MA11. Building on the Foundations of Current Immunotherapies Presentation Time: Tuesday, September 10, 2024, 13:37-13:42 PDT Presenter: Jianya Zhou,The First Affiliated Hospital of Zhejiang University School of Medicine Abstract Title: KRAS G12C Inhibitor IBI351 In Patients (pts) with Advanced Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Pivotal Phase 2 Study Abstract No: OA14.05 Session Type and Title: WCLC 2024-OA14. New Horizons in Targeting KRAS G12C Presentation Time: Monday, September 9, 2024, 15:52-16:02 PDT Presenter: Qing Zhou, Guangdong People's Hospital Abstract Title: Neoadjuvant Sintilimab plus Chemotherapy in EGFR-mutant NSCLC Followed by adjuvant Osimertinib or Observation: A Phase 2 CTONG2104 Trial Abstract No: MA15.11 Session Type and Title: Mini Oral Presentation Time: Tuesday, September 10, 2024 at 3:48-3:53 PM PDT Presenter: Guangdong Lung Cancer Institute, C. Zhang Abstract Title: First-Line Treatment of Locally Advanced or Metastatic Pulmonary Lymphoepithelioma-like carcinoma: A Multicenter, Single-Arm, Phase 2 Trial Abstract No: MA11.03 Session Type and Title: Mini Oral Presentation Time: Tuesday, September 10, 2024 at 1:32-1:37 PM PDT Presenter: The First Affiliated Hospital of Medical University, C. Zhou ESMO: Oral Sessions Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced solid tumors and breast cancer (BC): results from a Phase 1 study Abstract No: 345MO Session Type and Title: ESMO 2024-Mini oral session 1: Breast cancer, metastatic Presentation Time: Sunday, September 15, 2024, 9:15-9:20 AM CEST Presenter: Christina Teng, Scientia Clinical Research, Australia Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced gynecological cancers (Gynecol C): results from a phase 1 study Abstract No: 720MO Session Type and Title: ESMO 2024-Mini oral session 2: Gynecological cancers Presentation Time: Sunday, September 15, 2024, 15:45-15:50 CEST Presenter: Jin Shu, Chongqing University Affiliated Cancer Hospital WCLC: Posters Abstract Title: Neoadjuvant Chemoimmunotherapy for Potentially Resectable IIIA/IIIB NSCLC: Survival Updates and Predictive Effect of MRD Abstract No: EP.08D.01 Session Type and Title: E-Poster Presentation Time: Saturday, September 7, 2024 at 11:58-11:59 AM PDT Presenter: First Hospital of Jilin University, K. Ma Abstract Title: Safety and Efficacy of Sintilimab Combined with Anlotinib in Patients with KRAS-Mutant Advanced Non-Small Cell Lung Cancer Abstract No.: P4.11E.10 Session Type and Title: E-Poster Presentation Time: Monday, September 9, 2024 at 6:30 PM PDT Presenter: Peking University Shenzhen Hospital, F. Wang ESMO: Posters Abstract Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 + bevacizumab (beva) in patients (pts) with advanced colorectal cancer (CRC): A phase I study Abstract No: 574P Session Type and Title: ESMO 2024-Poster Presentation Time: Monday, September 16, 2024 CEST Presenter: Zhen Yu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Abstract Title: Safety and efficacy of IBI354 (anti-HER2 ADC) in patients (pts) with advanced gastrointestinal (GI) cancers: results from a Phase 1 study Abstract No: 576P Session Type and Title: ESMO 2024-Poster Presentation Time: Monday, September 16, 2024 CEST Presenter: Jifang Gong, Peking University Cancer Hospital Abstract Title: Hepatic Artery Infusion Chemotherapy (HAIC) Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Initial Unresectable Hepatocellular Carcinoma (HCC) in Patients with Child-Pugh B Liver Function: A prospective study Abstract No.: 980P Session Type and Title: Hepatocellular carcinoma (HCC) - Poster Presentation Time: Monday, September 16, 2024 Presenter: Tianjin Medical University Cancer Institute & Hospital, Huikai Li Abstract Title: Hepatic arterial infusion chemotherapy combined with Sintilimab and regorafenib as adjuvant therapy for colorectal liver metastasis patients with high risk of recurrent: a single-arm, Phase 2 study Abstract No.: 539P Session Type and Title: Colorectal cancer - Poster Presentation Time: Monday, September 16, 2024 Presenter: Fudan University Shanghai Cancer Center, Lu Wang Abstract Title: Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results Abstract No: 1329P Session Type and Title: NSCLC, metastatic - Poster Presentation Time: Saturday, September 14, 2024 Presenter: Jiangsu Province Hospital, Pei Ma Abstract Title: Sintilimab plus anlotinib in patients with advanced sarcomas (SINANLOSARC): a single-center, single-arm, Phase 2 trial Abstract No.: 1735P Session Type and Title: Sarcoma - Poster Presentation Time: Saturday, September 14, 2024 Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Zengjun Liu Abstract Title: Efficacy and safety of sintilimab in combination with anlotinib plus metronomic chemotherapy in advanced triple negative breast cancer (SPACE): preliminary results of a single-arm, multicenter Phase 2 trial Abstract No.: 389P Session Type and Title: Breast cancer, metastatic - Poster Presentation Time: Monday, September 16, 2024 Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Huihui Li Trial in Progress Abstract Title: Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION) Abstract No.: 1475TiP Session Type and Title: Oesophagogastric cancer, Poster Presentation Time: Monday, September 16, 2024 Presenter: Henan Cancer Hospital, Bei-Bei Chen 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 treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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

Phase 1Phase 2Clinical ResultASCO

100 Deals associated with Bevacizumab biosimilar (Innovent Biologics)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Triple Negative Breast Cancer	ID	PT Etana Biotechnologies Indonesia	14 Jun 2022
Fallopian Tube Carcinoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Ovarian Cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Primary peritoneal carcinoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Uterine Cervical Cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 Mar 2022
Hepatocellular Carcinoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 Jun 2021
Glioblastoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 Dec 2020
Colorectal Cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	17 Jun 2020
Non-Small Cell Lung Cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	17 Jun 2020

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	11 Feb 2019
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ORIENT-32 (ASCO2023) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma First line	43	Sinilimab+bevacizumab	(culzfxauup) = jtckiciutv qoywerakpn (szonrnawtl, NE - NE) View more	Similar	31 May 2023
				Sorafenib	(culzfxauup) = anzzqzfmfs qoywerakpn (szonrnawtl, 11.1 - 21.1) View more
NCT03794440 (ORIENT-32, ASCO_GI2023) Manual	Phase 2/3	Unresectable Hepatocellular Carcinoma First line	536	sintilimab 200 mg+IBI305 15 mg/kg	(fjxapkdkcu) = vdnikekamb ywrcdffied (azxfeyscfw ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	(fjxapkdkcu) = lktzftzmvc ywrcdffied (azxfeyscfw ) View more
NCT03794440 (ASCO_GI2023) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	586	sintilimab+IBI305	(uhgfoacrhw) = ogrzogmgpg sfuuhazkce (fvxpuxeout ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	(uhgfoacrhw) = eyakagwrnm sfuuhazkce (fvxpuxeout ) View more
NCT03802240 (ORIENT-31, ESMO2022) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	476	Sintilimab+IBI305+chemotherapy (Arm A)	(synbgkoapn) = inqyibulht cfhxhnjwfp (cnaikjoffb, 6.6 - 9.3) View more	Positive	11 Sep 2022
				Sintilimab+placebo 2+chemotherapy (Arm B)	(synbgkoapn) = vpozqewmbg cfhxhnjwfp (cnaikjoffb, 4.5 - 6.1) View more
NCT04843943 (ESMO2022) Manual	Phase 2	Hepatocellular Carcinoma	30	bevacizumab biosimilar+Sintilimab	(ordxvhqgzz) = cdtwhwerwe jugjcwwwjb (gdfsqpunti ) View more	Positive	10 Sep 2022
NCT04735861 (INOVA, ESMO2022) Manual	Phase 2	Ovarian clear cell carcinoma	23	sintilimab 200 mg +IBI305 15mg/kg	(fnulhdwgyr) = skmblfdohf jxtmvvyzwn (mbkyjwfvcq, 19.1 - 63.9) View more	Positive	10 Sep 2022
NCT05029973 (ASCO2022) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	30	HAIC+sintilimab+IBI305	mxuuecllfd(yawtiwhuvd) = hbthekefvb bgjorprfew (uvlhsbrchj ) View more	Positive	02 Jun 2022
NCT03794440 (ORIENT-32, Pubmed \| Lancet Oncol) Manual	Phase 2/3	Unresectable Hepatocellular Carcinoma First line	571	Sintilimab+IBI305	(nqmavkigmy) = vnazfqvnai cvijxpwxvv (epkqajivlg ) View more	Positive	01 Jul 2021
				sorafenib	(nqmavkigmy) = wheuuoxqtx cvijxpwxvv (epkqajivlg ) View more
NCT03083990 (CTgov)	Phase 1	-	100	Bevacizumab (IBI305)	(neovjlaoae) = ggiavroqiw epnziwbdqd (ljnxxybyzs, nrndvimvkp - bqndsyrodj) View more	-	04 Nov 2020
				Bevacizumab (Bevacizumab)	(neovjlaoae) = alwpcbqjax epnziwbdqd (ljnxxybyzs, lsgtobzlhu - uiatrihwws) View more
CSCO2020	Not Applicable	Liver Cancer	50	信迪利单抗	yoiljanthp(cjuvhbsysf) = fpmdjwvlki nxmevdoquv (hmwmdbrvkq, 41.3% - 77.9%) View more	-	19 Sep 2020
				IBI305	yoiljanthp(cjuvhbsysf) = aemcghayff nxmevdoquv (hmwmdbrvkq, 52.8% - 91.5%) View more

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