On August 25, 2025 Daiichi Sankyo reported that DATROWAY (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting (Press release, Daiichi Sankyo, AUG 25, 2025, View Source [SID1234655446]).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Breast cancer is the second most common cancer in women in China. 1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).

The approval of DATROWAY by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast01 phase 3 trial. In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. There were two (0.5%) complete responses (CRs) and 131 partial responses (PRs) (36%) seen in the DATROWAY arm compared to zero (0%) CRs and 84 (23%) PRs in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (HR 1.01; 95% CI: 0.83-1.22). In an exploratory sensitivity analysis, OSadjusted for subsequent ADC treatment was 19.1 months in the DATROWAY arm versus 17.5 months in the chemotherapy arm (HR 0.86; 95% CI: 0.70-1.06).

In an exploratory analysis of the 83 patients enrolled in TROPION-Breast01 in China, median PFS was 8.1 months in patients treated with DATROWAY versus 4.2 months with chemotherapy (HR 0.54; 95% CI: 0.30-0.96) and a confirmed ORR of 38.6% was observed in the DATROWAY arm compared to an ORR of 17.9% in the chemotherapy arm.

"Despite the progress we have made in managing HR positive, HER2 negative metastatic breast cancer, many patients still face limited options once their disease progresses after endocrine therapy and chemotherapy," said Professor Binghe Xu, Director of Clinical Trial Center (GCP) of National Cancer Center, Cancer Hospital Chinese Academy of Medical Sciences, and China leading PI of TROPIONBreast01. "The approval of datopotamab deruxtecan, a novel TROP2 directed antibody drug conjugate, represents a meaningful step forward in expanding therapeutic choices for patients with breast cancer."

"The approval of DATROWAY provides a new treatment option for patients with metastatic HR positive, HER2 negative breast cancer, enabling timely access to an innovative TROP2 targeted antibody drug conjugate in China," said Michio Hayashi, China President, Daiichi Sankyo. "DATROWAY is now the second DXd antibody drug conjugate approved in China following ENHERTU and expands our portfolio to meet the evolving treatment needs of patients with a range of breast cancer subtypes."

"Despite considerable advancements in the treatment of HR positive breast cancer, new medicines are still needed to tackle the frequent and complex challenge of disease progression following initial therapies," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "We are proud to bring DATROWAY to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option."

In TROPION-Breast01, the most common (≥20%) adverse reactions, including laboratory abnormalities were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST and increased alkaline phosphatase. Grade 3 or higher adverse reactions in patients (>0.5%) receiving DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), interstitial lung disease (ILD)/pneumonitis (1.1%), acute kidney injury (0.6%), pulmonary embolism (0.6%), vomiting (0.6%), diarrhea (0.6%), hemiparesis (0.6%) and anemia (0.6%). A grade 5 adverse reaction occurred in one patient (0.3%) and was attributed to ILD/pneumonitis.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPIONBreast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.5 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 357,000 cases of breast cancer are diagnosed annually in China, representing the most cases diagnosed anywhere in the world, and of these about 20% are diagnosed in the advanced or metastatic setting.

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer.7 However, after initial treatment, further efficacy from endocrine therapy is often limited.

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized antiTROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from the TROPIONLung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other cancer medicines in various settings.

On August 25, 2025 Daiichi Sankyo reported that DATROWAY (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting (Press release, Daiichi Sankyo, AUG 25, 2025, View Source [SID1234655446]).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Breast cancer is the second most common cancer in women in China. 1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).

The approval of DATROWAY by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast01 phase 3 trial. In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. There were two (0.5%) complete responses (CRs) and 131 partial responses (PRs) (36%) seen in the DATROWAY arm compared to zero (0%) CRs and 84 (23%) PRs in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (HR 1.01; 95% CI: 0.83-1.22). In an exploratory sensitivity analysis, OSadjusted for subsequent ADC treatment was 19.1 months in the DATROWAY arm versus 17.5 months in the chemotherapy arm (HR 0.86; 95% CI: 0.70-1.06).

In an exploratory analysis of the 83 patients enrolled in TROPION-Breast01 in China, median PFS was 8.1 months in patients treated with DATROWAY versus 4.2 months with chemotherapy (HR 0.54; 95% CI: 0.30-0.96) and a confirmed ORR of 38.6% was observed in the DATROWAY arm compared to an ORR of 17.9% in the chemotherapy arm.

"Despite the progress we have made in managing HR positive, HER2 negative metastatic breast cancer, many patients still face limited options once their disease progresses after endocrine therapy and chemotherapy," said Professor Binghe Xu, Director of Clinical Trial Center (GCP) of National Cancer Center, Cancer Hospital Chinese Academy of Medical Sciences, and China leading PI of TROPIONBreast01. "The approval of datopotamab deruxtecan, a novel TROP2 directed antibody drug conjugate, represents a meaningful step forward in expanding therapeutic choices for patients with breast cancer."

"The approval of DATROWAY provides a new treatment option for patients with metastatic HR positive, HER2 negative breast cancer, enabling timely access to an innovative TROP2 targeted antibody drug conjugate in China," said Michio Hayashi, China President, Daiichi Sankyo. "DATROWAY is now the second DXd antibody drug conjugate approved in China following ENHERTU and expands our portfolio to meet the evolving treatment needs of patients with a range of breast cancer subtypes."

"Despite considerable advancements in the treatment of HR positive breast cancer, new medicines are still needed to tackle the frequent and complex challenge of disease progression following initial therapies," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "We are proud to bring DATROWAY to patients in China for the first time, offering those with metastatic HR positive, HER2 negative breast cancer a new and needed option."

In TROPION-Breast01, the most common (≥20%) adverse reactions, including laboratory abnormalities were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST and increased alkaline phosphatase. Grade 3 or higher adverse reactions in patients (>0.5%) receiving DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), interstitial lung disease (ILD)/pneumonitis (1.1%), acute kidney injury (0.6%), pulmonary embolism (0.6%), vomiting (0.6%), diarrhea (0.6%), hemiparesis (0.6%) and anemia (0.6%). A grade 5 adverse reaction occurred in one patient (0.3%) and was attributed to ILD/pneumonitis.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPIONBreast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.5 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 357,000 cases of breast cancer are diagnosed annually in China, representing the most cases diagnosed anywhere in the world, and of these about 20% are diagnosed in the advanced or metastatic setting.

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer.7 However, after initial treatment, further efficacy from endocrine therapy is often limited.

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized antiTROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from the TROPIONLung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in the confirmatory trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other cancer medicines in various settings.

On August 24, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, AUG 24, 2025, View Source [SID1234655447]). IBI363 is Innovent’s self-discovered novel PD-1/IL-2α-bias bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population. Besides, the pivotal trial of IBI363 head-to-head against pembrolizumab (Keytruda) in the treatment of melanoma is underway in China.

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IBI363 as a Next-generation IO therapy Set for First Global Phase 3 Lung Cancer Trial

This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. Major alignments of the Phase 3 program were reached regarding the dose selection, study design, and other critical considerations. Innovent has also received IND approval from China’s National Medical Products Administration (NMPA) for this program. In parallel, Innovent has initiated communications and submissions to other major Health authorities. IBI363 has also received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China for this indication.

The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including China, U.S., Canada, EU, UK, and Japan, etc. The study will evaluate the efficacy and safety of IBI363 3 mg/kg monotherapy compared with docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. The primary endpoint is overall survival.

IBI363’s Breakthrough Data Validates its Dual-immune Activation Mechanism, Stepwise Development in Multiple Tumor Types

At ASCO (Free ASCO Whitepaper) 2025, Phase 1b/2 results demonstrated meaningful and durable clinical activity in areas of high unmet need, including IO-resistant lung cancer, traditionally "cold tumors" such as acral and mucosal melanoma, and microsatellite stable (MSS) colorectal cancer.

These promising data position IBI363 as a potential first-in-class dual-immune activation therapy with broad applicability across difficult-to-treat cancers. Innovent is rapidly progressing IBI363 into registrational studies, with a pivotal program in melanoma already ongoing, a global Phase 3 trial in squamous NSCLC expected to start shortly, and a registration strategy in colorectal cancer in planning.

In parallel, multiple Phase 1b/2 trials are evaluating IBI363 both as monotherapy and in combinations in first-line NSCLC, first-line CRC, and additional tumor types, including platinum-resistant ovarian cancer (PROC), EGFR+ NSCLC, and neoadjuvant therapy for non-squamous NSCLC. This comprehensive development strategy is designed to maximize the value of IBI363 and expand its potential to address multiple large global oncology markets and improve patient outcomes.

Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology and Hematology for Yale Cancer Center and Smilow Cancer Hospital, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology at Yale School of Medicine, shared, "Lung cancer remains the most prevalent malignant tumor worldwide, with particularly high incidence and mortality rates globally. Non-small cell lung cancer constitutes the majority of these cases. Although immunotherapy has significantly improved survival outcomes for some patients, those who do not respond to such treatments and lack driver gene mutations have limited therapeutic options, underscoring the urgent need for enhanced clinical interventions.

Clinical research of the PD-1/IL-2α-biased bispecific molecule IBI363 has revealed encouraging findings. Preliminary trials have demonstrated that IBI363 not only induces tumor remission in a subset of patients but also achieves disease stability in the majority of patients, indicating durable anti-tumor activity. In comparison to traditional chemotherapy, IBI363 appears to offer potential advantages in both objective response rate (ORR) and progression-free survival (PFS), providing new hope for patients diagnosed with lung cancer."

Professor Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated: "As a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein, IBI363 acts by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is engineered to retain 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 dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2α, enabling more precise and effective stimulation of this T-cell subpopulation. IBI363 has demonstrated robust antitumor activity across multiple tumor models and has shown remarkable efficacy in IO-resistant, PD-L1 low expression, and cold tumor settings.

The promising data associated with IBI363 offers a novel treatment avenue for patients with non-small cell lung cancer who have not responded to immunotherapy. As research progresses, this innovative therapy holds the potential to bridge clinical gaps and provide the possibility of long-term survival for a greater number of patients."

Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said, "Today’s IND clearance marks a significant milestone as we initiate the first global Phase 3 trial of our next-generation IO therapy, IBI363 (PD-1/IL-2α-bias). If successful, this trial could bring a potentially transformative treatment to patients with squamous NSCLC worldwide, who currently have limited options after checkpoint inhibitor therapy. Concurrently, we are exploring IBI363 in a broad global clinical program and look forward to more data and continued development in the future.

This achievement also signifies a milestone for Innovent’s global innovation strategy, rooted in our mission to ’empower patients worldwide with affordable, high-quality biopharmaceuticals’ and our vision to ‘build a global premier biopharmaceutical leader.’ Having developed a highly competitive pipeline aligned with our globalization strategy, we have prioritized the global R&D of our assets, alongside expanding our international team and footprint to accelerate the development and access of innovative therapies worldwide.

In addition to IBI363, Innovent is advancing a broader pipeline for global development, including next-generation ADC programs such as bispecific and dual-payload ADCs. We believe our robust pipeline and ongoing R&D efforts will continue to expand our impact in oncology on a global scale."

On August 22, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported a non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of up to $1,200,000 (the "Offering"). Each Unit will consist of (i) one $1,000 principal amount of 8.0% convertible debenture (a "Debenture"), and (ii) 1,666 common share purchase warrants (the "Warrants") (Press release, Defence Therapeutics, AUG 22, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-debenture-units-financing [SID1234655455]).

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The Debentures will bear interest at 8.0% per annum and will mature two years following the issue date. The Debentures are unsecured and will rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the Company (a "Common Share") at the conversion price of $0.60 per Common Share (the "Conversion Price"). The accrued interest of the Debentures will be paid annually in Shares at the Conversion Price or in cash at the Company’s election.

Each Warrant will be exercisable to acquire one Common Share (a "Warrant Share") at an exercise price of $0.75 per Warrant Share for a period of two years from the issue date.

All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the closing date of the Offering in accordance with applicable securities legislation. Completion of the Offering is subject to a number of conditions, including, but not limited to, the receipt of all regulatory approvals. The Company may pay a finder’s fee in connection with the Offering to eligible arm’s length finders in accordance with the policies of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or the solicitation of any offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Debentures and the Shares which may be issued on exercise thereof have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.

On August 22, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported that the Company’s Management will participate in a fireside chat at the Cantor Global Healthcare Conference on Thursday, September 4, 2025 at 2:10 PM EDT and participate in one-on-one investor meetings (Press release, Tvardi Therapeutics, AUG 22, 2025, View Source [SID1234655440]).

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The webcast of the fireside chat will be accessible on the Tvardi Investors’ website. A replay of the webcast will be available for approximately 90 days following the conference.