SAN FRANCISCO, and SUZHOU, China, June 2, 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-2^α-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 7^th, 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 months^1-3).
• 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 7^th, 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. With 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-2^α-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-2^α-bias bispecific antibody fusion protein)

IBI363 is a first-in-class PD-1/IL-2^α-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 www.innoventbio.com, 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

BEIJING, June 1, 2025 /PRNewswire/ — China Liberal Education Holdings Limited (“China Liberal” or the “Company”) (Nasdaq: CLEU), a China-based company that provides technological consulting services for smart campus solutions and other educational services, today announced that on May 30, 2025, the Company received notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company’s securities will be suspended from trading on Nasdaq effective June 3, 2025. The suspension is due to the Company’s failure to submit a request for an extended stay or otherwise address the delinquency in filing its annual report on Form 20-F for the fiscal year ended December 31, 2024, in its written submissions to the Nasdaq Hearings Panel (the “Panel”).

As previously publicly announced and also disclosed in the Company’s Current Reports on Form 6-K filed with the U.S. Securities and Exchange Commission (“SEC”) in May 2025, the Company is awaiting a decision from the Panel regarding its appeal of an earlier determination by Nasdaq’s Listing Qualifications Department (the “Staff”) to delist the Company’s securities. That determination was based on public interest concerns related to the Company’s substantial issuance of ordinary shares in December 2024.

While the Company has submitted written materials in support of its appeal and has requested that the Panel make its decision based solely on the written record, it did not request a stay of suspension or address the additional basis for delisting stemming from the untimely filing of its annual report on the Form 20-F. As a result, the Panel has determined to suspend trading in the Company’s securities.

The Company continues to evaluate all available options and remains committed to compliance with applicable SEC and Nasdaq requirements.

About China Liberal Education Holdings Limited

China Liberal is an educational services provider headquartered in Beijing, China. China Liberal provides a wide range of services, including technological consulting for Chinese universities to improve their campus information and data management systems, designed to enhance the teaching, operating, and management environment of the universities, thus establishing a “smart campus.” Additionally, China Liberal offers tailored job readiness training for graduating students. For more information, please visit the Company’s website at http://ir.chinaliberal.com/.

Forward-Looking Statements

This document contains forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s expectations and projections about future events, which the Company derives from the information currently available to the Company. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those using terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. When evaluating these forward-looking statements, you should consider various factors, including our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as required by law. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can provide no assurance that these expectations will prove to be accurate, and it cautions investors that actual results may differ materially from the anticipated results. Investors are encouraged to review the risk factors that may affect future results in the Company’s filings with the SEC.

Investor Relations Contact

China Liberal Education Holdings Limited
Email: ir@chinaliberal.com 

Ascent Investor Relations LLC
Tina Xiao
President
Phone: +1-646-932-7242
Email: investors@ascent-ir.com