A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy

This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy

Start Date31 Jul 2026

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT07644208

/ Not yet recruitingPhase 2IIT

A Phase II Study to Evaluate the Efficacy and Safety of PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy in Hepatocellular Carcinoma Patients With Early Recurrence After Curative Hepatectomy and Eligible for Re-resection

This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection.
A total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1/IL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1/IL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery.
The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy.
This study intends to explore the clinical value of PD-1/IL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.

Start Date15 Jun 2026

Sponsor / Collaborator-

NCT07361991

/ Not yet recruitingPhase 1/2IIT

A Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer

This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. This trial will evaluate IBI363 in combination with bevacizumab, with or without nab-paclitaxel, as a second-line treatment.
The study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.

Start Date01 Mar 2026

Sponsor / Collaborator

The First Affiliated Hospital of Zhengzhou University

100 Clinical Results associated with IBI-363

100 Translational Medicine associated with IBI-363

100 Patents (Medical) associated with IBI-363

Literatures (Medical) associated with IBI-363

01 May 2026·BIODRUGS

Programmed Cell Death Protein 1-Interleukin-2 Bispecific Agents for Cancer Therapy

Review

Author: Wu, Can ; Xu, Chang ; Liu, Huicong ; Yan, Tingxu ; Wen, Shuo ; Kong, Eryan ; Chang, Tingmin

Programmed Cell Death Protein 1 (PD-1) / Programmed Cell Death Ligand 1 (PD-L1) inhibitors have revolutionized cancer immunotherapy but are limited by low response rates and drug resistance. Interleukin-2 (IL-2), a potent T-cell activator, is clinically restricted due to regulatory T cell (Treg) activation and severe systemic toxicity. PD1-IL2 bispecific drugs, integrating PD-1 blockade and engineered IL-2 variants (IL-2v) into a single molecule, precisely regulate tumor microenvironment immunity to overcome these limitations. This review summarizes their latest progress, including the synergistic mechanism of PD-1/PD-L1 and IL-2 signaling, molecular designs (e.g., βγ-biased IL-2v and Innovent's α-biased IBI363), and 'cis delivery' for targeted activation. Preclinical and clinical data (e.g., IBI363) show encouraging anti-tumor activity and improved safety in advanced tumors, benefiting PD-1-resistant patients. Challenges remain, such as unclear mechanisms, drug resistance, and long-term safety. Future advancements rely on optimized molecular design, combination therapies, and predictive biomarkers, driving PD1-IL2 bispecific drugs toward more precise and effective tumor immunotherapy for broader patient populations.

Nature cancer

IL-2Rα-biased agonist enhances antitumor immunity by invigorating tumor-infiltrating CD25+CD8+ T cells

Article

Author: Min Wu ; Jia Zou ; Tiongsun Chia ; Yaning Li ; Jian Guan ; Kaijie He ; Ying Zhang ; Bingliang Chen ; Xue Liang ; Jia Lu ; Junjie Deng ; Huisi Liu ; Ye Feng ; Jiya Sun ; Zhihai Wu ; Jinling Xu ; Weiwei Wu ; Xue Li ; Feifei Wang ; Shuaixiang Zhou ; Xiaomin Ling ; Ying Yao ; Fenggen Fu

To avoid regulatory T cell promotion and vascular toxicity, the interleukin-2 receptor-β/interleukin-2 receptor-γ (IL-2Rβγ)-biased approach is used by most IL-2 analogs in immuno-oncology. However, recent clinical disappointments in these IL-2 agonists have questioned this strategy. Here we show that both wild-type (IL-2^wt) and IL-2Rβγ-attenuated (IL-2^α-bias) agonists that preserve IL-2Rα (CD25) activities can effectively expand tumor-specific CD8⁺ T cells (TSTs) and exhibit better antitumor efficacy and safety than the 'non-α' counterpart (IL-2^nα). Mechanistically, TSTs coexpress elevated CD25 and PD-1 and are more susceptible to stimulation by IL-2Rα-proficient agonists. Moreover, the antitumor efficacy of anti-PD-1 depends on activation of PD-1⁺CD25⁺ TSTs through autocrine IL-2-CD25 signaling. In individuals with cancer, a low IL-2 signature correlates with non-responsiveness to anti-PD-1 treatment. In mouse models, IL-2^α-bias, but not IL-2^nα, restores the IL-2 signature and synergizes with anti-PD-1 to eradicate large established tumors. These findings underscore the indispensable function of CD25 in IL-2-based immunotherapy and provide rationales for evaluating IL-2Rα-biased agonists in individuals with cancer.

News (Medical) associated with IBI-363

06 Aug 2026

·www.prnewswire.com

Innovent Announces First Patient Dosed in Pivotal Registrational Study of IBI363/TAK-928 (PD-1/IL-2α-biased Bispecific Fusion Protein) in Combination with Bevacizumab in Late-Line Advanced Colorectal Cancer in China

SAN FRANCISCO and SUZHOU, China, Aug. 5, 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 diseases, announced that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator's choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment. This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation immuno-oncology (IO) therapies in overcoming colorectal cancer—a classic 'immune-cold' tumor. Previously initiated studies of IBI363 include a pivotal Phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, Phase 3 clinical study (NCT06797297) in IO-resistant squamous non-small cell lung cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialize IBI363/TAK-928 in the U.S. Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. This trial (NCT07722494) is a multicenter, randomized, open-label, Phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is overall survival (OS). This study is being conducted in China where Innovent holds development and commercialization rights for IBI363/TAK-928. At the 2025 ASCO Annual Meeting, data from a Phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. [ link ] Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed objective response rate (cORR) was 15.1%, and the disease control rate (DCR) was 61.6%. With a median follow-up of 9.9 months, the progression-free survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, overall survival (OS) data remained immature, with only 13 events (17.8%) observed. The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) in the combination therapy group was 35.6%. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal. Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated: "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks third in incidence and second in mortality among all malignant tumors[1]. Approximately 86% of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional immune checkpoint inhibitors (ICIs)[2]. For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need[3-5]. As a PD-1/IL-2α-biased bispecific molecule, IBI363's dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8⁺ T cells (TST cells)—holds the promise of turning 'cold' tumors 'hot'. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option." Professor Tao Zhang from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "For patients with advanced colorectal cancer (CRC), treatment options become extremely limited after the failure of second-line or later therapies. In particular, patients with MSS CRC—who represent the vast majority of colorectal cancer cases—are largely insensitive to current immune checkpoint inhibitors. Chemotherapy or anti-angiogenic agents offer limited efficacy and fail to deliver durable disease control, leaving patients in urgent need of effective late-line treatment options. IBI363, featuring a unique PD-1/IL-2α-biased dual immuno-activation mechanism, holds the potential to overcome the immunosuppressive state of 'cold tumors.' The early clinical data for IBI363 in combination with bevacizumab are highly encouraging. As a clinician, I look forward to the initiation and progress of the Phase 3 clinical study, hoping it will soon bring meaningful treatment choices and renewed hope of survival to patients with late-line colorectal cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome 'cold' tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy." About MSS/pMMR Colorectal Cancer Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor (mPFS 1.9~5.6 months, mOS 6.4~10.8 months[3-5]). About IBI363/TAK-928 (PD-1/IL-2α-biased bispecific fusion protein) IBI363 is a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein being co-developed by Innovent Biologics and Takeda (Takeda R&D code: TAK-928). 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 is being evaluated in a series of clinical trials globally, including: A pivotal Phase 2 study in China in previously untreated acral and mucosal melanoma A global, multi-center Phase 3 study in immunotherapy-resistant squamous NSCLC A pivotal Phase 3 study in China in advanced CRC refractory or intolerant to standard treatment In parallel, multiple Phase 1b/2 trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far. In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363/TAK-928 globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China. 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. 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. References: GLOBOCAN 2024. Huyghe N, et al. Biomarkers of Response and Resistance to Immunotherapy in Microsatellite Stable Colorectal Cancer: Toward a New Personalized Medicine. Cancers (Basel). 2022 Apr 29;14(9):2241. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Grothey, Axel et al. The Lancet, Volume 381, Issue 9863, 303 – 312. Li J, Qin S, Xu R, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486–2496. doi:10.1001/jama.2018.7855. Prager G et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. SOURCE Innovent Biologics 21% more press release views with Request a Demo

Phase 3Fast TrackPhase 1License out/inImmunotherapy

05 Aug 2026

·www.pharmaindustrial-india.com

Innovent Doses First Patient in Pivotal IBI363/TAK-928 CRC Study

Innovent Biologics announced that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator's choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment. This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation Immuno-Oncology (IO) therapies in overcoming colorectal cancer—a classic 'immune-cold' tumor. Previously initiated studies of IBI363 include a pivotal phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, phase 3 clinical study (NCT06797297) in IO-resistant squamous Non-Small Cell Lung Cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialise IBI363/TAK-928 in the US Takeda will exclusively commercialise IBI363/TAK-928 worldwide outside of the US and greater China. This trial (NCT07722494) is a multicenter, randomised, open-label, phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is Overall Survival (OS). This study is being conducted in China where Innovent holds development and commercialisation rights for IBI363/TAK-928. At the 2025 ASCO Annual Meeting, data from a phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed Objective Response Rate (cORR) was 15.1 percent, and the Disease Control Rate (DCR) was 61.6 percent. With a median follow-up of 9.9 months, the Progression-Free Survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, Overall Survival (OS) data remained immature, with only 13 events (17.8 percent) observed. The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of grade 3 or higher Treatment-Related Adverse Events (TRAEs) in the combination therapy group was 35.6 percent. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism. Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated, "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks 3 rd in incidence and 2 nd in mortality among all malignant tumors. Approximately, 86 percent of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional Immune Checkpoint Inhibitors (ICIs). For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need. As a PD-1/IL-2α-biased bispecific molecule, IBI363's dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8? T cells (TST cells)—holds the promise of turning 'cold' tumors 'hot'. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option." Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal. Dr. Hui Zhou, Chief R&D Officer (Oncology), Innovent, stated, "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome 'cold' tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy."

ImmunotherapyPhase 1Phase 2License out/inPhase 3

05 Jun 2026

·www.fiercepharma.com

Fierce Pharma Asia—China's biotech rise; ASCO highlights; Lilly pipeline deals

China's biotech ascent calls for more regulation in Washington and several prominent ASCO presentations made our news this week. The drumbeat of news regarding Asian pharma—and particularly China—continues to grow louder. At the American Society of Clinical Oncology (ASCO) meeting, Akeso took center stage with an ivonescimab presentation, and Fierce’s Angus Liu took a chance to dive into the bigger picture and symbolism behind the event. Elsewhere, calls in Washington to crack down on China biotech transactions are getting louder. Plus more. 1. As Akeso takes center stage at ASCO, China biotech industry cements its coming of age With its ASCO plenary session this past weekend, Akeso made history for the China biopharma industry. Afterward, in a series of interviews, market watchers explained to Fierce how the country’s biopharma rise is now undeniable—and how it’s not likely to slow any time soon. 2. As China biotech crackdown calls reverberate in Washington, the pushback gets louder, too In Washington, D.C., two lawmakers have called for an expansion of the COINS Act to include biopharma transactions. The act, which recently went into law as part of the U.S. defense spending bill, creates new notification requirements for American companies investing in certain Chinese sectors. While it doesn’t include biotechnology yet, some lawmakers aim to change that. And within the industry, skeptics are speaking up. 3. Takeda touts ‘tremendous potential’ of Innovent’s PD-1/IL-2 bispecific after seeing survival data On the drug development front, ASCO provided an opportunity for partners Takeda and Innovent to share a glimpse of the potential benefits of their bispecific candidate, IBI363, in patients with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC). Speaking with Fierce, Teresa Bitetti, president of Takeda's global oncology business unit, said the drug candidate holds “enormous promise.” Separately, Innovent on Thursday reported a phase 3 win for another Takeda-partnered drug, IBI343, in patients in China and Japan with locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. 4. Legend scientific founder returns to ASCO with new ambition for high-yield, non-gene-editing CAR-T platform Even more intrigue swept ASCO with the revelation that Legend’s scientific founder, Frank Fan, M.D., Ph.D., was returning with a new company, Wondercel Therapeutics. The idea behind Wondercel and its approach is to create an off-the-shelf universal CAR-T platform to outmaneuver two prominent bottlenecks in the cell therapy industry: production scalability and the pitfalls associated with gene editing. Fan made his ASCO return after Legend Biotech stole the show at the conference 9 years ago with data on the drug that eventually became Carvykti. 5. Lilly pens $1.2B deal for Hanmi’s GLP-2 drug being aimed at short bowel syndrome Lately, no week can be complete without an Eli Lilly business development deal, and this week was no exception. On Monday, the Indianapolis drug giant linked up with Korea’s Hanmi Pharm in a $1.2 billion deal centered on a GLP-2 drug prospect. Hours later, the company unveiled a partnership with China’s Haisco centered on a handful of drug prospects. No details on targets were shared with the latter deal announcement. 6. Bristol Myers’ $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice After Bristol Myers Squibb forked over $800 million on a first-in-class bispecific antibody-drug conjugate (ADC), there are indications the bet is paying off. In a China-only study, the drug, an EGFRxHER3 ADC called izalontamab brengitecan (iza-bren), significantly reduced the risk of death by 40% compared with the physician’s choice of chemotherapy in patients with previously treated triple-negative breast cancer. The results could serve to create a budding rivalry between the candidate and existing TROP2 ADCs. Other News of Note: 7. UPDATED: After Takeda’s defeat, Dizal picks up baton to take on J&J in EGFR lung cancer subtype 8. Agios signs $165M deal for blood disorder drug from Korea’s Oscotec that flunked phase 2 study 9. Eisai whips up Alzheimer’s dietary guidance to expand nutrition program beyond cancer 10. Shionogi's COVID antiviral Xocova passes muster with FDA as post-exposure preventative

ASCOImmunotherapyPhase 3

100 Deals associated with IBI-363

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Colorectal Adenocarcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Jul 2026
Squamous non-small cell lung cancer	Phase 3	United States	Innovent Biologics (Suzhou) Co. Ltd.	25 Aug 2025
Resectable Lung Non-Small Cell Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	04 Feb 2026
Non-small cell lung cancer stage III	Phase 2	China	Shanghai Pulmonary Hospital	07 Jan 2026
Pancreatic Cancer	Phase 2	-	Innovent Biologics, Inc.	01 Jan 2026
Locally Advanced Malignant Solid Neoplasm	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Aug 2025
Platinum-Resistant Ovarian Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	31 Aug 2025
Non-squamous non-small cell lung cancer	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	04 Aug 2025
Acral Lentiginous Malignant Melanoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Feb 2025
Mucosal Melanoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	24 Feb 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05460767 (ASCO2025) Manual	Phase 1	Colorectal Cancer KRAS Mutation \| Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	141	IBI363	mlogxwdoam(jxltcjnbze) = dabtldfeye mjezldhxbc (ztxjitprmm ) View more	Positive	30 May 2025
				IBI363 + bevacizumab	mlogxwdoam(jxltcjnbze) = diqweuiaqz mjezldhxbc (ztxjitprmm ) View more
NCT05460767 (ASCO2025) Manual	Phase 1	Advanced Lung Non-Small Cell Carcinoma	136	IBI363	vxenixrmal(ckrfdopeoj) = fweciarrwh yzezlqazdv (slebfehdxt ) View more	Positive	30 May 2025
				IBI363 3 mg/kg Q3WIBI363 3 mg/kg Q3W	ekhaakcjow(dafstkijre) = akvkjfefwb ixnycypyjd (cvqopsxfxl ) View more
NCT05460767 \| NCT06081920 (ASCO2025) Manual	Not Applicable	Mucosal Melanoma \| Melanoma	91	IBI363 (pts with at least one post-baseline tumor assessment)	vznqzlyjgm(uznvrxeqyl) = ovzvlhwdsr fiiciyrqof (vyhbmtjukf, 53.4 - 74.4) View more	Positive	30 May 2025
				IBI363 (pts treated at 1mg/kg and above)	vznqzlyjgm(uznvrxeqyl) = lywfdhjtvf fiiciyrqof (vyhbmtjukf, 57.1 - 79.2) View more
NCT05460767 \| NCT06081920 (SITC2024) Manual	Phase 1/2	Melanoma	40	IBI363	bgvieyucke(hbzcdazqws) = eruymgzdhi zneprfbejh (lnqtsmnjsx, 50.1 - 81.4) View more	Positive	05 Nov 2024
				IBI363 (mucosal melanoma)	bgvieyucke(hbzcdazqws) = hyhddtdjnl zneprfbejh (lnqtsmnjsx, 38.7–78.1) View more
NCT05460767 (ESMO2024) Manual	Phase 1	Colorectal Cancer Last line	35	IBI363 + beva	tfruojxpvq(psvxrerzjx) = quefhgfwih dwlhkhyiqk (mhdpqjpofj ) View more	Positive	16 Sep 2024
NCT05460767 (WCLC2024) Manual	Phase 1	Non-Small Cell Lung Cancer Third line	89	IBI363 0.6 mg/kg Q2W	fzwyihfxxa(xzjbsmcycs) = yrzsjvxutz kshchhayhm (qvqpwqbrws ) View more	Positive	10 Sep 2024
				IBI363 3 mg/kg Q3W	hhnxubstxs(hppciuuspl) = thcrqavgxr goflbedmpb (uexvafrxus, 15.1 - 35.7) View more
NCT05460767 (PRNewswire) Manual	Phase 1	Melanoma	45	IBI363 1mg/kg (既往接受过免疫治疗)	ghyoiqgwly(odqtvxmaeh) = mzgbzluosf cxaoeirkth (utgutezpuz ) View more	Positive	14 Jun 2024
				IBI363 1mg/kg (既往未经过免疫治疗的黏膜型黑色素瘤)	ghyoiqgwly(odqtvxmaeh) = ghaftwaoml cxaoeirkth (utgutezpuz ) View more
NCT05460767 (phase I, ASCO2024)	Phase 1	Colorectal Cancer	68	IBI363 600 ug/kg Q2W	phkjspskxq(zifnzpfzvo) = ltnibretyr kvwpktjneh (trtmihmyav, 46.2 - 95.0) View more	Positive	24 May 2024
				IBI363 1 mg/kg Q2W	phkjspskxq(zifnzpfzvo) = ytxlscfqlf kvwpktjneh (trtmihmyav, 46.2 - 95.0) View more
NCT05460767 (phase I study, ASCO2024)	Phase 1	Melanoma	67	IBI363 100-2000 μg/kg QW/Q2W/Q3W	ytlmwmomxb(qjaofzcibu) = rkqgfwnsjt goykvugqna (msddvnkffu ) View more	Positive	24 May 2024
				IBI363 (In pts had prior IO)	uyifgblokf(sdahjhpumh) = pfelnwfijd peyzauakkd (bljxzlumdc, 11.1 - 34.7) View more
NCT05460767 (phase I study of IBI363, ASCO2024)	Phase 1	Solid tumor	24	IBI363 600 μg/kg QW	btfeezelcj(hakbqjjvfe) = qkptwnwyim vyedcjlhjd (tvissizcqg ) View more	Positive	24 May 2024
				IBI363 600 μg/kg Q2W	btfeezelcj(hakbqjjvfe) = zfshktbflh vyedcjlhjd (tvissizcqg ) View more

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