A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.

A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.

Start Date30 Jun 2025

Sponsor / Collaborator

Shanghai Chest Hospital

[+1]

CTR20244543

/ RecruitingPhase 2

优替德隆注射液联合贝伐珠单抗在非小细胞肺癌脑转移患者中的有效性和安全性的Ⅱ期临床试验

[Translation] Phase II clinical trial of the efficacy and safety of eutilide injection combined with bevacizumab in patients with brain metastases from non-small cell lung cancer

第一阶段主要目的：确定第一阶段扩展期及第二阶段联合给药方案；比较两治疗组患者的颅内疗效。次要目的：比较两治疗组患者的其他颅内疗效及全身疗效；比较两治疗组患者的安全性和耐受性。第二阶段主要目的：评价优替德隆注射液联合贝伐珠单抗在患者中的颅内疗效。次要目的：评价优替德隆注射液联合贝伐珠单抗在患者中的其他颅内疗效及全身疗效；评价优替德隆注射液联合贝伐珠单抗在患者中的安全性和耐受性；探索患者生活质量QOL的改善情况

[Translation]

Phase I Main purpose: Determine the combined dosing regimen for the Phase I extension and Phase II; Compare the intracranial efficacy of the two treatment groups. Secondary purpose: Compare other intracranial and systemic efficacy of the two treatment groups; Compare the safety and tolerability of the two treatment groups. Phase II Main purpose: Evaluate the intracranial efficacy of Utidelon injection combined with bevacizumab in patients. Secondary purpose: Evaluate other intracranial and systemic efficacy of Utidelon injection combined with bevacizumab in patients; Evaluate the safety and tolerability of Utidelon injection combined with bevacizumab in patients; Explore the improvement of patients' quality of life QOL

Start Date21 Feb 2025

Sponsor / Collaborator

Chengdu Biostar Pharmaceuticals Ltd.

CTR20242806

/ RecruitingPhase 3

西达本胺联合信迪利单抗和贝伐珠单抗治疗≥2线标准治疗失败的晚期微卫星稳定或错配修复完整（MSS/pMMR）型结直肠癌的随机、开放性、对照、多中心、Ⅲ期临床试验

[Translation] A randomized, open-label, controlled, multicenter, phase III clinical trial of cedabenb combined with sintilimab and bevacizumab in the treatment of advanced microsatellite stable or mismatch repair intact (MSS/pMMR) colorectal cancer after ≥2 lines of standard treatment failure

1.主要目的：确证西达本胺联合信迪利单抗和贝伐珠单抗用于既往≥2线标准治疗失败的晚期微卫星稳定或错配修复完整（MSS/pMMR）型结直肠癌患者的疗效。2.次要目的：观察西达本胺联合信迪利单抗和贝伐珠单抗的安全性；探索联合信迪利单抗和贝伐珠单抗的西达本胺药代动力学（PK）特征。

[Translation]

1. Primary objective: To confirm the efficacy of chidamide combined with sintilimab and bevacizumab in patients with advanced microsatellite stable or mismatch repair intact (MSS/pMMR) colorectal cancer who have failed ≥2 lines of standard treatment. 2. Secondary objectives: To observe the safety of chidamide combined with sintilimab and bevacizumab; to explore the pharmacokinetic (PK) characteristics of chidamide combined with sintilimab and bevacizumab.

Start Date27 Nov 2024

Sponsor / Collaborator

Shenzhen Chipscreen Biosciences Co., Ltd.

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

PURPOSE:

For 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.

METHODS:

The 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.

RESULTS:

The 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.

CONCLUSIONS:

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

OPINION STATEMENT:

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

Introduction:

Hepatocellular 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 analysis:

This 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 dissemination:

The study was authorised by the Medical Ethics Committee. Dissemination of results will occur via a peer-reviewed publication and other relevant media.

Trial registration number:

ChiCTR2200056068.

147

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

02 Jun 2025

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2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Date of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from Phase 1 Clinical Studies in Advanced Colorectal Cancer

SAN FRANCISCO, and SUZHOU, China, June 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) monotherapy and combo-therapy with bevacizumab in advanced colorectal cancer were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI363 demonstrated encouraging response and overall survival benefit in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, supports its unique mechanism of actions (MoA) of turning "cold tumor" into "hot tumor". Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2 α-bias bispecific antibody fusion protein IBI363 monotherapy and combined with bevacizumab in participants with advanced colorectal cancer: results from Phase 1 studies Two Phase 1 studies (NCT05460767, NCT06717880) were conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 monotherapy and combined with bevacizumab in patients with advanced colorectal cancer. IBI363 monotherapy has demonstrated breakthrough antitumor therapeutic potential, showing a significant extension of overall survival compared to data of standard-of-care therapies As of the data cutoff date (Apr 7th, 2025), a total of 68 participants with advanced colorectal cancer received IBI363 monotherapy at the dose levels from 0.1 mg/kg to 3mg/kg. No patients were confirmed as microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). 86.8% of patients were microsatellite stable (MSS) or proficient mismatch repair (pMMR). 61.8% of patients had liver metastases. 63.2% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 23.9% of patients had received prior immunotherapy. Notably, among patients receiving monotherapy with IBI363 (n=68), with a median follow-up time of 20.1 months, the median overall survival (OS) reached 16.1 months, demonstrating a significant improvement compared to the historical data of standard treatments (ranging from 6.4 to 9.3 months1-3). Subgroup analyses revealed that patients with or without liver metastasis both showed excellent overall survival (OS), indicating significant clinical benefit. The median OS were 14.4 months (with liver metastasis) and 17.0 months (without liver metastasis). Among patients treated with monotherapy of IBI363 1 mg/kg every 2 weeks (Q2W) (n=22), the confirmed objective response rate (cORR) was 13.6%. The combination of IBI363 and bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile, with excellent data on objective response rate and progression-free survival As of the data cutoff date (Apr 7th, 2025), a total of 73 patients with advanced colorectal cancer received IBI363 （dose levels from 0.6 mg/kg to 3mg/kg） and bevacizumab combination therapy. No patients were confirmed as MSI-H or dMMR. 91.8% of patients were MSS or pMMR. 56.2% of patients had liver metastases. 54.8% of patients had previously received 3 or more lines of systemic anti-tumor treatments. 16.4% of patients had received prior immunotherapy. In all participants treated with IBI363 in combination with bevacizumab (n=73), the cORR was 15.1% and the disease control rate (DCR) was 61.6%. With a median follow-up time of 9.9 months, the median progression free survival (PFS) reached 4.7 months. W ith a median follow-up time of 9.4 months, OS was not mature, with events in only 13 participants (17.8%). As for the combination therapy in patients without liver metastases (n=32), the confirmed ORR was 31.3%, with a DCR of 81.3%. The median PFS reached to 7.4 months. In those participants who received IBI363 at 3 mg/kg Q3W plus bevacizumab (n=31), confirmed ORR and DCR increased to 19.4% and 71.0%, respectively. The median PFS increased to 5.6 months. In terms of safety, among participants receiving monotherapy and combination therapy, 19 (27.9%) and 26 (35.6%) reported treatment-related adverse events (TRAEs) of Grade 3 or higher, respectively. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. No new safety signals were observed, with a manageable risk-benefit profile in IBI363 alone or in combination with bevacizumab. Tumor immune cell infiltration analysis supports the IBI363 MOA of turning "cold tumor" into "hot tumor", demonstrating enrichment of PD1+CD25+CD8+ cells in baseline tumor tissue association with clinical efficacy In baseline tumor tissues, elevated infiltration of CD8+ cells, CD25+CD8+ cells, and PD1+CD25+CD8+ cells were associated with improved clinical response to IBI363 monotherapy (partial response or stable disease). This supports the potential anti-tumor effects of IBI363 in the treatment of colorectal cancer from the perspective of its mechanism of action. Professor Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: "Colorectal cancer is the third most common cancer type globally and ranks fourth in cancer-related mortality4. About 86% of colorectal cancer are in an immune 'desert' or immune-inflamed suppressed state, rendering traditional immune checkpoint inhibitors (ICIs) ineffective5. For colorectal cancer that has failed standard treatments, there are limited therapeutic options with short survival periods, representing a significant unmet clinical need6. IBI363, as a PD-1/IL-2α-bias bispecific fusion protein, has demonstrated robust antitumor efficacy in preclinical studies through the effective expansion of tumor-specific CD8⁺ T cells (TST cells). Its ability to block PD-1 and stimulate TST cells holds the potential to transform 'cold' tumors into 'hot' tumors. As a monotherapy, IBI363 achieves a median survival of 16.1 months in later-line treatments, which represents a significant improvement compared to the median survival of current standard therapies and also confirms its potential with a strong 'tail effect' as a PD1 plus cytokine bispecific immunotherapy. The combination of IBI363 with bevacizumab is still under continuous follow-up, having shown promising efficacy and tolerable safety, with unique efficacy characteristics particularly in the subgroup without liver metastasis. Overall, clinical data suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and warrants further exploration." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "On top of the preliminary data reported at 2024 ASCO and 2024 ESMO, we are presenting more updated follow-up data and combination therapy results of IBI363 at the ASCO Congress this year. From a comprehensive body of clinical evidence that includes ORR, PFS, OS, IBI363 demonstrated robust antitumor activity of both monotherapy and combination therapy in patients with advanced colorectal cancer who are non-MSI-H/dMMR. We are eyeing on long-term survival data from high dose in longer follow-up period. And the pivotal study of IBI363 targeting advanced CRC is in plan. Observing such results in the context of colorectal cancer, which is typically considered an immunologically 'cold' tumor, further highlights the broad development potential of IBI363. It offers hope for expanding into areas where immunotherapy has been less effective or even unresponsive." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. 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. References 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

Clinical ResultFast TrackPhase 1ASCOImmunotherapy

19 May 2025

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Innovent Released 2024 ESG Report, Underscoring Commitment to Sustainable Development and Global Innovation

SAN FRANCISCO and SUZHOU, China, May 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the release of its "2024 Environmental, Social and Governance (ESG) Report", highlighting the Company's strategies, actions, and achievements in sustainable development across five pillars, which include "Excellent Governance", "Enjoying Good Health", "High Quality as Key", "People First" and "Embracing Ecology". Continue Reading MSCI ESG RATING Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "As China's leading biopharmaceutical company, Innovent consistently navigates the pulse of the times with strategic foresight, forging a closed-loop system for value creation through synergistic integration of global innovation-driven strategies and sustainable development practices. We achieved an MSCI ESG rating of AAA, as the only biotech in China and one of just three globally to receive this rating. Throughout the year of 2024, we remained committed to our mission, 'to empower patients worldwide with affordable, high-quality biopharmaceuticals,' and stayed true to our original aspiration, 'Start with Integrity, Succeed through Action.' We deeply integrated social responsibility into our business practices, actively responded to the United Nations Sustainable Development Goals (SDGs), strengthened our governance structure, improved operational efficiency, advanced high-quality innovation, promoted diversity and empowerment among employees, and strived for low-carbon development. These initiatives firmly honored our commitment to sustainable growth. We have embedded ESG principles into the fabric of our organization, which enables us to continuously create multidimensional value for shareholders, employees, patients, and society." Building Enduring Excellence through Lean Governance Robust governance is the cornerstone of sustainable business development. In 2024, Innovent further refined its ESG governance framework to ensure agility in responding to global changes while maintaining steady, compliant operations. We strengthened compliance management through continuous improvement of risk management systems and the upholding of rigorous business ethics standards. Looking ahead, we are committed to building a stable and sustainable business ecosystem in collaboration with our partners. Board Diversity: added one female Executive Director, with every Board Committee now including at least one female chair or member. Compliance, anti-corruption, and business ethics training: 100% participation among Directors and employees. Supplier business ethics: 100% of suppliers signed the "Commitment to Compliance". Official ESG website: launched in 2024, underscoring the company's firm commitment to sustainable development. ESG recognition: achieved an MSCI ESG rating of AAA, the only biotech in China and one of just three globally to receive this rating. Driving Inclusive Healthcare through Innovation Bridging geographic and economic gaps through innovative therapies remains Innovent's unwavering goal. Guided by our company strategy, "To discover new medicines through innovation and deliver them through our global platforms", Innovent has solidified its oncology leadership in China, achieved multiple groundbreaking advancements in chronic disease therapies, and expanded our global impact. Out dedication to scientific progress is grounded in a strong sense of social responsibility, which extends to improving drug accessibility and affordability for patients worldwide, rural education, volunteer activities, and broader community support initiatives. Improving drug accessibility through an innovative pipeline: 15 commercialized products have benefited 5 million patients cumulatively. 3 New Drug Applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 molecules in early clinical development. Oncology and general biomedicine have become the Company's two growth engines. 6 drugs or assets granted 13 orphan drug designations, with 2 drug candidates for rare diseases in preclinical and clinical stages. SYCUME® (teprotumumab N01 injection) was launched as China's first IGF-1R antibody for the treatment of thyroid eye disease, ending a 70-year absence of treatment options and transforming care for this rare condition. Enhancing drug affordability by supporting medical insurance coverage with 6 medicines (TYVYT®, BYVASDA®, HALPRYZA®, SULINNO®, Olverembatinib, and SINTBILO®) included in China's National Reimbursement Drug List (NRDL) and 8 medicines (Pemazyre®, Cyramza®, Retsevmo®, FUCASO®, TYVYT®, DOVBLERON®, Jaypirca® and DUPERT®) included in the Catalog of Specific Drug Reimbursements under Huimin Insurance Programs. SINTBILO® became China's first domestically developed PCSK9 inhibitor included in the NRDL. Patient assistance programs have benefited over 200,000 patients, with donated medicines valued at more than RMB 3.6 Billion. Health education and public welfare programs benefited over 240,000 patients. Ongoing efforts in supporting rural education have cumulatively benefited nearly 4,000 teachers and students. Innovent volunteer teams contributed a total of 2,754 hours of community service, reflecting our long-term commitment to social responsibility. Delivering Life-Changing Quality High-quality is a foundational principle at Innovent that underpins our mission to deliver safer, more effective therapies to patients. Patient-centricity drives our adherence to internationally recognized quality standards across the entire product lifecycle, from development and manufacturing to distribution. Even in the face of complex external environments, we actively collaborate with industry partners to elevate sector-wide benchmarks and maintain a resilient, sustainable dual-sourcing supply chain. Our responsible marketing practices further prioritize transparency and the protection of patient rights. Innovent Biologics currently operates 140,000 L of total production capacity, comprising 60,000L of antibody production capacity at Suzhou manufacturing site and 80,000L of antibody and ADC production capacity at Hangzhou manufacturing site. With an additional 90,000L of capacity in plan at the Hangzhou site, the total production capacity will reach 230,000L upon full completion. All commercially operational production facilities are 100% GMP-certified. Reached 100% batch success rate in drug substance manufacturing. Maintained 100% pass rate in audits conducted by regulatory authorities and strategic partners. Established dual-source supply chains for raw materials used in self-manufactured commercial products. Conducted 122 quality audits of suppliers; delivered capacity-building training to approximately 170 suppliers; deployed over 400 personnel to provide on-site quality supervision, guidance, and training at 10 key supplier sites. Empowering Talent and Igniting Potential A thriving talent ecosystem fuels our innovation. At Innovent, we view our employees as the foundation of long-term success and are deeply committed to cultivating a fair, inclusive, and empowering workplace. We offer diverse career development pathways and a multi-tiered professional development training system tailored to different career stages. Our comprehensive compensation and benefits framework is designed to strengthen employees' sense of belonging, while enhancing our ability to attract, retain, and develop top talent. Committed to making Innovent a learning institution, we support employees in achieving both personal and professional growth. Women represent 51% of total employees and hold 44.2% of management positions. Key talent retention rate reached 96.8%. Employee satisfaction rate exceeded 98%. The "Innovent Beginning" Campus Recruitment Program offered over 2,100 job opportunities to new graduates from nearly 20 provinces. All operational production facilities are 100% ISO 45001 occupational health and safety (OH&S) certified. Safeguarding the Green Future with a Commitment to Sustainability Green development underpins Innovent's high-quality growth strategy. We are committed to eco-friendly practices that protect natural resources and ecosystems while actively contributing to global climate action. Through comprehensive climate risk assessments, we evaluate the potential operational impacts of climate change and implement measures to reduce our business activities' climate impacts. By integrating green, low-carbon principles across all aspects of our production and operations, we continue to set clear targets that drive continuous improvement in our environmental performance and contribute to a more sustainable future. 100% of operational production facilities are certified under the ISO 14001 Environmental Management System. Successfully completed one internal and one external environmental management audit to ensure ongoing compliance and system integrity. 29% reduction in energy consumption (per unit of production) compared to the previous year. Reduced fresh water use by 22% (per unit of production) compared to the previous year. Recycled a total of 51,100 tons of water, reflecting out commitment to resource conservation. Innovent Shanghai Global R&D Center was awarded LEED Gold certification by the U.S. Green Building Council (USGBC). Innovent remains firmly committed to sustainable development and global innovation. We will continue strategically consolidating our business momentum while pursuing breakthrough innovations in science. By harmonizing business success with long-term social value, Innovent is steadily progressing toward its vision of becoming a premier global biopharmaceutical company. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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. 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, 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. 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25 Nov 2024

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

SAN FRANCISCO and SUZHOU, China, Nov. 24, 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 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore. Details on the abstracts are listed below: Mini Oral Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study Abstract No: 132MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 09:50-09:55 Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study Abstract No: 74MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 10:20-10:25 Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN Posters Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study Abstract No: 75P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhan Wang, Shanghai Changzheng Hospital, The Second Affiliated Hospital of Naval Medical University, CN Abstract Title: A single-arm, multicenter, Phase 2 study of hepatic arterial infusion chemotherapy (HAIC) combined with donafenib and sintilimab as first-line treatment for unresectable intrahepatic cholangiocarcinoma (CHANCE 2203) Abstract No: 137P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Gaojun Teng, Zhongda Hospital, Southeast University, CN Abstract Title: FOLFOX-HAIC combined with sintilimab and bevacizumab for advanced hepatocellular carcinoma: a single-arm, Phase 2 study Abstract No: 207P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Bin Liang/ Zizhuo Wang, Union Hospital Tongji Medical College Huazhong University of Science and Technology, CN Abstract Title: Updated results from Phase 2 study of HAIC plus sintilimab and bevacizumab biosimilar in patients with advanced hepatocellular carcinoma (HCC) Abstract No: 214P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Haibin Zhang, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital of Naval Medical University, CN Abstract Title: Anlotinib Combined with Sintilimab Versus Chemotherapy Combined with Immunotherapy in Perioperative NSCLC: A Phase 2 Study Abstract No: 599P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Tianqing Chu, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, CN Trial in Progress abstracts (TiP) Abstract Title: A randomized, controlled, multicenter Phase 3 study of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) as neoadjuvant treatment for resectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colon cancer: Trial in Progress Abstract No.: 119TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Ruihua Xu, Sun Yat-sen University Cancer Center, CN Abstract Title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy with Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Abstract No.: 722TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhiqiang Gao, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, CN Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present and share a robust set of clinical data at EAMO Asia 2024. Notably, we are highlighting the breakthrough potential for our TOPO1i CLDN18.2 ADC (IBI343) in pancreatic cancer, a global difficult-to-treat cancer. Consistent with the preliminary signal observed in small patient size, the data in dose expansion stage demonstrated encouraging efficacy and good safety, which reinforced our confidence in advancing its development. Given unique design of Fc-silent antibody, combined with stable linker and potent extecan payload, IBI343 pioneered in the exploration of CLDN18.2 ADC agents for PDAC treatment. As one of the few biopharmaceutical companies with both advanced technology platforms and a robust pipeline in "IO+ADC" areas, Innovent remains dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients." 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 under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 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. 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultADCImmunotherapy

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Approved

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Jul 2019
Advanced Hepatocellular Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	11 Feb 2019
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	28 Nov 2016
EGFR positive non-small cell lung cancer	Phase 2	-	Innovent Biologics (Suzhou) Co. Ltd.	30 Jun 2025
Non-squamous non-small cell lung cancer	Phase 2	-	Innovent Biologics (Suzhou) Co. Ltd.	30 Jun 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05617430 (ESMO_ASIA2024) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	38	mFOLFOX6-HAIC + Sintilimab + IBI305	ifvtkwlcza(jvpqofsgfn) = rpbamqfgai ksciaveoyv (dpfimatfge ) View more	Positive	07 Dec 2024
NCT03794440 (ORIENT-32, ASCO2023) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma First line	43	Sinilimab+bevacizumab	lyefjszhyj(pjwszscfnr) = tizgdckdxv syciudutkw (lmfrlermip, NE - NE) View more	Similar	31 May 2023
				Sorafenib	lyefjszhyj(pjwszscfnr) = gaxigsttys syciudutkw (lmfrlermip, 11.1 - 21.1) View more
NCT03794440 (ASCO_GI2023) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	586	sintilimab+IBI305	mnihnxqazk(wqlsmzthos) = qrnqzpqvwa tsibmszgcu (qaweaxccvy ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	mnihnxqazk(wqlsmzthos) = xbpreuymnd tsibmszgcu (qaweaxccvy ) View more
NCT03794440 (ORIENT-32, ASCO_GI2023) Manual	Phase 2/3	Unresectable Hepatocellular Carcinoma First line	536	sintilimab 200 mg+IBI305 15 mg/kg	yokfcrehmc(fcnhzubfnz) = kasivjeses xzrdlzvnpd (jfgmejolfs ) View more	Positive	24 Jan 2023
				sorafenib 400 mg	yokfcrehmc(fcnhzubfnz) = dgsmcnbfwl xzrdlzvnpd (jfgmejolfs ) View more
NCT03802240 (ORIENT-31, ESMO2022) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	476	Sintilimab+IBI305+chemotherapy (Arm A)	vgjhshqaep(hizorfzpmm) = oykeynadhp hsytgbovaq (xeimyksfsm, 6.6 - 9.3) View more	Positive	11 Sep 2022
				Sintilimab+placebo 2+chemotherapy (Arm B)	vgjhshqaep(hizorfzpmm) = zwgjyvjham hsytgbovaq (xeimyksfsm, 4.5 - 6.1) View more
NCT04735861 (INOVA, ESMO2022) Manual	Phase 2	Ovarian clear cell carcinoma	23	sintilimab 200 mg +IBI305 15mg/kg	ajnupygqvh(arqlbvoifi) = mijrrdpspi ghbtemjkbk (pqkqojycaf, 19.1 - 63.9) View more	Positive	10 Sep 2022
NCT05029973 (ASCO2022) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	30	HAIC+sintilimab+IBI305	rrtdmtzhbd(hyseyfkfmp) = vlldqeihxg pjdpuxyzcx (lcasyhdfvj ) View more	Positive	02 Jun 2022
NCT02954172 (CTgov)	Phase 3	Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	450	Bevacizumab+Carboplatin+Paclitaxel (Bevacizumab in Combination With Paclitaxel/Carboplatin)	zfiekxypcl = egvpytbqwl hhfsldsyov (rxvhldaisv, jintyjcelv - odenvvoeme) View more	-	08 Dec 2020
				IBI305+Carboplatin+Paclitaxel (IBI305 in Combination With Paclitaxel/Carboplatin)	zfiekxypcl = hfiytrnume hhfsldsyov (rxvhldaisv, fwebgqripu - induxrhagz) View more
NCT03083990 (CTgov)	Phase 1	-	100	Bevacizumab (IBI305)	yojmfiqsnw(bakkdwomss) = kopetlbois eifdgoayad (zqgulxlrqi, 18.8) View more	-	04 Nov 2020
				Bevacizumab (Bevacizumab)	yojmfiqsnw(bakkdwomss) = exgbfgshyz eifdgoayad (zqgulxlrqi, 19.1) View more
CSCO2020	Not Applicable	Liver Cancer	50	信迪利单抗	pydlecfyqv(vvffocfhjs) = ypngfkhhny rfmwxiesmj (dlfxdzhsvg, 41.3% - 77.9%) View more	-	19 Sep 2020
				IBI305	pydlecfyqv(vvffocfhjs) = egvnsqpmhq rfmwxiesmj (dlfxdzhsvg, 52.8% - 91.5%) View more

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