On March 23, 2026, Haihe Pharmaceuticals reported that its independently developed selective PI3Kα inhibitor. Resorliside mesylate tablets have been approved for marketing in Japan for the treatment of ovarian clear cell carcinoma (OCCC) that has progressed after chemotherapy and carries the PIK3CA gene mutation.

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Resorlisel is the world’s first monotherapy targeted therapy for OCCC that has progressed after chemotherapy, and it is also the world’s first selective PI3Kα inhibitor approved in Japan.Resorlisel possesses a novel chemical structure. This approval is based on a single-arm, open-label, international multicenter pivotal phase II clinical trial (NCT05043922), conducted at 39 centers in China and Japan. The study population included patients with ovarian clear cell carcinoma who had progressed after chemotherapy and carried the PIK3CA gene mutation. The primary endpoint was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). The medication was administered orally at a dose of 40 mg once daily on an empty stomach. Among 84 patients (45.2% in China, 54.8% in Japan) with evaluable efficacy…Resorlisel has demonstrated clinically significant antitumor activity. Its overall safety profile is manageable and well-tolerated. Common adverse reactions include hyperglycemia and rash, which are generally consistent with the safety profile of other approved PI3Kα inhibitors and can be effectively managed and reversed with symptomatic treatment or dose adjustment.

(Press release, Shanghai HaiHe Pharmaceutical, MAR 23, 2026, View Source;utm_source=official [SID1234669250])

On March 23, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its audited financial results for the year ended December 31, 2025, and provided a corporate update.

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"Since our last quarterly update, we have been working diligently to move forward with a Phase 1/2a first-in-human clinical trial of GLIX1 in glioblastoma, and I am pleased to report that we expect to initiate the study by the end of this month, with the commencement of patient enrollment shortly thereafter," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1, the lead asset that we acquired through our collaboration with Hemispherian, is a unique molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models, excellent blood-brain-barrier penetration and a favorable safety profile in toxicology studies. We are eager to establish the safety, recommended dose and proof-of-concept in order to advance this promising candidate through an efficient development pathway.

"In parallel, we continue to conduct pre-clinical activities in support of further development of GLIX1 in additional cancer indications with high unmet needs, and, separately, we are also conducting studies to further investigate and affirm the potential synergistic effect of GLIX1 in combination with PARP inhibitors, as we work to maximize the value of the GLIX1 opportunity.

"In metastatic pancreatic cancer, enrollment has accelerated in the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide, which is being led by Columbia University and supported by both Regeneron and BioLineRx, and we continue to anticipate that a prespecified interim/futility analysis will read out in 2026. We believe PDAC represents another opportunity to introduce a much-needed new treatment option to patients suffering from a very challenging tumor type, while creating sustained value for our company," Mr. Serlin concluded.

Corporate Updates

Announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering GLIX1 for cancers in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold, estimated to be 90% of all cancers.
Patent preserves BioLineRx’s ability to evaluate GLIX1 in other cancers beyond glioblastoma, including both hematological and solid tumor cancer types.
Patent further broadens and strengthens GLIX1’s patent protection until 2040, with a possible patent-term extension of up to five years.
Financial Updates

With $20.9 million on its balance sheet as of December 31, 2025, BioLineRx is maintaining its cash runway guidance into the first half of 2027.
Clinical Updates
GLIX1

On track to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma by the end of the month.
Three renowned academic centers are planned to participate in this clinical trial: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, NYU Langone Health, led by Dr. Alexandra M. Miller and Moffit Cancer Center, led by Dr. Patrick Grogan.
The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.
The Phase 2a expansion part of the trial is planned to include various population cohorts, including GBM (newly diagnosed and/or recurrent), as well as additional cancers with/without standard of care (e.g., PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for rapid and effective advanced clinical development.
Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)

Enrollment has accelerated in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026.
Sickle Cell Disease (SCD) & Gene Therapy

Announced that a poster featuring final results from a Phase 1 clinical trial (NCT05618301) evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD) was presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December.

A second SCD study, sponsored by St. Jude Children’s Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ HSCs for gene therapies for patients with SCD (NCT06442761).
APHEXDA Performance Update

For the full-year 2025, APHEXDA sales were $6.7 million, which provided royalty revenue to the Company of $1.2 million.
Financial Results for the Year ended December 31, 2025

Revenues for the year ended December 31, 2025 were $1.2 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the up-front payment received by the Company under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively amounted to $15.0 million, as well as the up-front payment received under the Ayrmid License Agreement and $6.0 million of net revenues from product sales of APHEXDA in the United States.

Cost of revenues for the year ended December 31, 2025 were $0.2 million, compared to cost of revenues of $9.3 million for the year ended December 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects the amortization of intangible assets, sub-license fees on the up-front payment received for the Ayrmid License Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales.

Research and development expenses for the year ended December 31, 2025 were $8.1 million, a decrease of $1.1 million, or 11.5%, compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX1 project.

There were no sales and marketing expenses for the year ended December 31, 2025, compared to $23.6 million for the year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid license agreement.

General and administrative expenses for the year ended December 31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3%, compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of general and administrative expenses.

Non-operating income (expenses) for the years ended December 31, 2025 and 2024 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, as a result of changes in its share price, offset by warrant offering expenses.

Net financial income for the year ended December 31, 2025 was $0.2 million, compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income for 2025 relates to investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense in connection with the November 2024 amendment to loan agreement with BlackRock, partially offset by investment income earned on bank deposits.

Net loss for the year ended December 31, 2025 was $2.0 million, compared to $9.2 million for the year ended December 31, 2024.

As of December 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $20.9 million, sufficient to fund operations, as currently planned, into the first half of 2027.
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected].

Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 25, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

(Press release, BioLineRx, MAR 23, 2026, View Source [SID1234663821])

On March 23, 2026 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its audited consolidated results for the year ended 31 December 2025 (the "Reporting Period").

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Kelun-Biotech is leveraging its core strengths and proprietary OptiDC technology platform to continue deepening its presence in the ADC and novel DC drug field. The company is actively advancing cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness. At the same time, Kelun-Biotech is steadily advancing product commercialization, achieving transformational growth across its business. To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱), Trastuzumab Botidotin (舒泰莱), Tagitanlimab (科泰莱), and Cetuximab N01 (达泰莱). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List (NRDL), establishing a fully integrated drug development ecosystem that spans R&D through commercialization.

As of now, the company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and are gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders. Looking ahead, the company will leverage its innovative and differentiated pipeline to deliver high-quality therapeutic solutions for major unmet medical needs worldwide.

Core ADC Products’ Commercialization Realized to Solidify Long-term Performance Foundation

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) (佳泰莱)

TNBC:

The Company received marketing authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting).
The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus ICC for 1L advanced TNBC.
HR+/HER2- BC:

In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- BC who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting has been approved for marketing by the NMPA.
A Phase 3 registrational study of sac-TMT versus ICC for treatment of patients with HR+/HER2- BC who received prior ET is in progress.
EGFR-mutant NSCLC:

In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for marketing in LC globally.
In October 2025, the company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy. This is the first ADC globally to show an OS benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy (2L).
The Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of EGFR-mutant NSCLC and a Phase 2 study of sac-TMT monotherapy or in combination with osimertinib as neoadjuvant therapy for EGFR-mutant NSCLC are in progress.
EGFR-wild type NSCLC:

The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA[1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint. This is the first Phase 3 clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.
In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted Breakthrough Therapy Designation by the NMPA.
The Phase 3 registrational study of sac-TMT in combination with pembrolizumab as first-line treatment of PD-L1 negative NSCLC is in progress.
Other indications: The company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC, HNSCC, and TC, etc.

Trastuzumab botidotin (HER2 ADC, also known as A166, 舒泰莱)

In October 2025, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with HER2+ BC who have received one or more prior anti-HER2 therapy. This is the first domestically developed HER2 ADC approved for 2L+ HER2+ BC in China.
An open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ BC that previously received a topoisomerase inhibitor ADC is in progress.
Key Clinical Data Highlighted at International Academic Conferences and in Top Journals

Results from the Phase 3 study of sac-TMT for the treatment of 2L EGFR-mutant NSCLC were selected for LBA and presented as an oral report in the Presidential Symposium session at the 2025 ESMO (Free ESMO Whitepaper) Congress. Sac-TMT achieved statistically significant and clinically meaningful improvements in ORR, PFS, and OS compared to chemotherapy. The study findings were published simultaneously online at the New England Journal of Medicine and in the first issue of 2026.
Results from the study of sac-TMT for the treatment of 3L EGFR-mutant NSCLC were presented as an oral report at the ASCO (Free ASCO Whitepaper) Annual Meeting and published at the British Medical Journal. The final OS analysis of this study will be selected for LBA and presented as a mini oral report at the 2026 ELCC.
Results from the Phase 3 study of sac-TMT for the treatment of 2L+ HR+/HER2-BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Results from the Phase 3 study of trastuzumab botidotin for the treatment of 2L+ HER2+ BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline

Phase 2 clinical stage

SKB315 (CLDN18.2 ADC):

The Phase 1b clinical trial of SKB315 is in progress, for the treatment of GC/GEJC/PDAC, etc.
Results of a Phase 1 study of SKB315 in patients with advanced solid tumors including GC/GEJC were presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
SKB410/MK-3120 (Nectin-4 ADC):

Its partner MSD has launched 4 global Phase 1/2 clinical trial of SKB410/MK-3120 in advanced solid tumor including bladder cancer, etc.
SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing.

SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China.

SKB500 (novel ADC): The Phase 2 study is ongoing in China.

Phase 1 clinical stage

SKB107 (RDC)[2]: The Phase 1 study is ongoing.

SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China.

SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China.

SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.

Strategic Layout of Non-DC Assets with Focus on Combination Therapy & Indication Expansion

Drug candidates for oncology

Tagitanlimab (PD-L1 mAb, also known as A167) (科泰莱): In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of NPC from NMPA. Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
In May 2025, the results of a Phase 3 clinical study of tagitanlimab in combination with cisplatin and gemcitabine for the first-line treatment of NPC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
Cetuximab N01 (EGFR mAb, also known as A140) (达泰莱):

In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.
Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031)(宁泰莱)[3]：

An NDA was accepted for review by the CDE of the NMPA of China for the 1L+ treatment of RET-fusion positive NSCLC.
The company is also conducting a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China.
Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
In May 2025, results from the Phase 1 study of Lunbotinib Fumarate Capsules in patients with advanced RET-mutant MTC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
SKB118/CR-001 (PD-1/VEGF bsAb):

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.
The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026.
Drug candidates for autoimmune diseases

SKB378/WIN378 (TSLP mAb):

In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA.
Its collaboration partner, Windward Bio, has launched the Phase 2 POLARIS global trial in patients with asthma.
SKB575 (TSLP/undisclosed target bsAb): In March 2026, an IND application for SKB575 for the treatment of atopic dermatitis was approved by the NMPA.

Drug candidates for other non-oncology diseases

SKB336 (FXI/FXIa mAb): The company completed Phase 1 clinical trial in China.

Multiple Products First Included in National Reimbursement Drug List with Accelerated Market Coverage

In 2025, the Company witnessed an explosive growth in the commercialization of its innovative achievements. The Company has also filed an NDA for Lunbotinib Fumarate Capsules and expects to commence its commercialization in the second half of 2026 or the first half of 2027, subject to regulatory communications and marketing approval. To date, the company’s initial commercial product portfolio, consisting of five products, has taken shape.

Supported by national innovation policies, the Company has successfully secured the first-time inclusion of three of its commercialized products, namely 佳泰莱, 科泰莱 and 达泰莱, in the National Reimbursement Drug List (國家醫保藥品目錄), which officially took effect on January 1, 2026, and is expected to benefit more patients faster and better.

Steady Advancement of Global Collaboration and Comprehensive Strength Authoritatively Recognized

Collaboration with MSD: As at the date of this announcement, MSD is evaluating initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer, including BC, LC, gynecological cancers, GI cancer and GU cancer. In addition to sac-TMT, the company is also collaborating with MSD on certain ADC assets to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has cleared by the FDA to progress into Phase 2 clinical development. As at December 31, 2025, a total of 39 clinical sites in the United States, Europe and UAE were set up for Lunbotinib Fumarate Capsules.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). Windward Bio has launched the Phase 2 POLARIS global trial in patients with asthma.

Collaboration with Crescent Biopharma. In December 2025, the company and Crescent Biopharma entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD1 x VEGF bsAb, also known as CR-001). Under the collaboration, the company granted Crescent Biopharma exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In return, the compamy obtained exclusive rights from Crescent Biopharma to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China.

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.

Continuous Improvement of ESG Capabilities to Consolidate the Foundation for Sustainable Development

Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability and ensures the Company’s sustainable development. In May 2025, the company was awarded "Best ESG" by Extel. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

Outlook

In 2026, Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; innovating on and optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding business landscape and strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

(Press release, Kelun, MAR 23, 2026, View Source [SID1234663840])

On March 23, 2026 Daiichi Sankyo reported the Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the update of the ENHERTU (trastuzumab deruxtecan) prescribing information following review of data from the DESTINY-Gastric04 phase 3 trial, which now expands the use of ENHERTU in Japan to include the second-line treatment of patients with HER2 positive (immunohistochemistry [IHC] 3+ or IHC 2+/in-situ hybridization [ISH]+) unresectable advanced or recurrent gastric cancer. ENHERTU previously was approved as a third-line treatment based on the results from the DESTINY-Gastric01 phase 2 trial.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed and commercialized by Daiichi Sankyo in Japan.

Gastric cancer is the third most common cancer in Japan.1 More than 125,000 cases of gastric cancer were diagnosed in Japan in 2022, with more than 43,000 deaths.1 Approximately one in five gastric cancers are considered HER2 positive. 2,3 Prior to the results of DESTINY-Gastric04, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.4

In DESTINY-Gastric04, ENHERTU demonstrated a 30% reduction in risk of death compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.550-0.896; p=0.0044). Median overall survival (OS) was 14.7 months with ENHERTU (n=246; 95% CI: 12.1-16.6) compared to 11.4 months with ramucirumab plus paclitaxel (n=248; 95% CI: 9.9-15.5). DESTINY-Gastric04 was presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine.

"Gastric cancer can be particularly challenging to treat and is associated with a poor prognosis, especially in the metastatic setting where outcomes are notably worse for patients with disease progression after first-line treatment," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "The impressive survival results seen in DESTINY-Gastric04 support the expanded use of ENHERTU in Japan, making it available as a new second-line option for patients with HER2 positive metastatic gastric cancer."

In DESTINY-Gastric04, the safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Adverse reactions occurred in 227 patients (93.0%) treated with ENHERTU (6.4 mg/kg), including 26 Japanese patients. The most common adverse reactions were fatigue (48.0%), decreased neutrophil count (48.0%), nausea (44.3%), anemia (31.1%), decreased appetite (29.1%), decreased leukocyte count (26.6%), decreased platelet count (26.6%), diarrhea (25.8%), alopecia (24.2%), increased transaminase (21.7%) and vomiting (20.1%).

ENHERTU is approved in Japan with a Warning in its prescribing information for interstitial lung disease (ILD). ILD occurred in 262 patients (11.6%) treated with ENHERTU across multiple clinical trials. As cases of ILD, including fatal cases, have occurred in ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing regular peripheral artery oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of ENHERTU and take appropriate measures, such as corticosteroid administration. Prior to initiation of ENHERTU therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for ENHERTU therapy.

About DESTINY-Gastric04
DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint is OS. Secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate and safety.

At disclosure of the topline results, an Independent Data Monitoring Committee recommended unblinding DESTINY-Gastric04 based on the superior efficacy of ENHERTU seen at a planned interim analysis.

DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancerrelated death, with a five-year global survival rate of 5% to 10%. 5,6 Approximately one million cases of gastric cancer were diagnosed in 2022. 5 Gastric cancer is the third most common cancer in Japan.1 More than 125,000 cases of gastric cancer were diagnosed in Japan in 2022, with more than 43,000 deaths.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.3,7 Approximately one in five gastric cancers are considered HER2 positive. 2,3

Prior to the results of the DESTINY-Gastric04 trial of ENHERTU, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 15 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

(Press release, Daiichi Sankyo, MAR 23, 2026, View Source [SID1234665016])

On March 23, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of the combination therapy of anti-cancer agent / anti-CD20/CD3 humanized bispecific monoclonal antibody Lunsumio subcutaneous injection 5mg and 45mg [generic name: mosunetuzumab (genetical recombination)] (hereafter, Lunsumio) and anti-cancer agent/antimicrotubule-binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] (hereafter, Polivy) for the treatment of relapsed or refractory large B-cell lymphoma. This marks the first approval in the world for the combination therapy of Lunsumio and Polivy for this indication.

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"For patients with relapsed or refractory large B-cell lymphoma, treatment options remain limited and unmet medical needs persist. The Lunsumio and Polivy combination therapy achieved responses in approximately 70% of patients and showed a 59% reduction in the risk of disease progression or death compared to the chemotherapy control arm. We are committed to delivering this treatment to patients as quickly as possible by providing timely information to healthcare professionals and promoting appropriate use," said Dr. Osamu Okuda, Chugai’s President and CEO.

This approval is based on the results of the global, multi-center, randomized Phase III SUNMO study evaluating the efficacy and safety of the combination therapy compared to the regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx; not approved in Japan) in patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.

In the interim analysis of the study, the objective response rate (ORR), a primary endpoint assessed by an independent review committee, was 69.7% (95% CI: 60.7-77.8) in the Lunsumio and Polivy combination therapy group and 44.1% (95% CI: 31.2-57.6) in the R-GemOx group, with a between-group difference of 25.7% (97.5% CI: 7.4-43.9). At the time of the primary analysis, the progression-free survival (PFS), also a primary endpoint assessed by an independent review committee, was 11.5 months (95% CI: 5.6-18) in the Lunsumio and Polivy combination therapy group and 3.8 months (95% CI: 2.9-4.1) in the R-GemOx group, demonstrating a 59% reduction in the risk of disease progression or death.

The safety profile of the combination therapy of Lunsumio and Polivy was consistent with the known profiles of each agent in their respective individual studies. Adverse events were observed in 131 of 135 patients (97.0%) in the Lunsumio and Polivy combination therapy group and in 61 of 64 patients (95.3%) in the R-GemOx group. The main adverse events in the Lunsumio and Polivy combination therapy group included injection site reactions in 71 patients (52.6%), neutropenia in 62 patients (45.9%), anemia in 41 patients (30.4%), and cytokine release syndrome in 35 patients (25.9%), among others.1

Approval Information (Lunsumio) *Relevant sections only, with modifications underlined

Product name: "LUNSUMIO subcutaneous injection 5mg" and "LUNSUMIO subcutaneous injection 45mg"

Generic name: mosunetuzumab (genetical recombination)

Indications:
The following relapsed or refractory large B-cell lymphomas:

Diffuse large B-cell lymphoma
High-grade B-cell lymphoma

Relapsed or refractory follicular lymphoma

Dosage and administration:
〈Relapsed or refractory large B-cell lymphoma (diffuse large B-cell lymphoma, high-grade B-cell lymphoma) and relapsed or refractory follicular lymphoma (Grade 3B)〉
In combination with polatuzumab vedotin (genetical recombination), mosunetuzumab (genetical recombination) is administered subcutaneously to adults in 21-day cycles.
In the first cycle, 5 mg is administered on Day 1, followed by 45 mg on Days 8 and 15, and from the second cycle onward, 45 mg is administered on Day 1 for up to 8 cycles.

Approval Information (Polivy) *Relevant sections only, with modifications underlined

Product name: "Polivy intravenous infusion 30 mg" and "Polivy intravenous infusion 140 mg"

Generic name: polatuzumab vedotin (genetical recombination)

Indications:
The following large B-cell lymphomas:

Diffuse large B-cell lymphoma
High-grade B-cell lymphoma

Relapsed or refractory follicular lymphoma

Precautions concerning indications:

This drug should be administered to patients diagnosed with Grade 3B by a pathologist with sufficient experience.

Dosage and administration:
In combination with other anti-cancer agents, polatuzumab vedotin (genetical recombination) is usually administered to adults as an intravenous infusion at a dose of 1.8 mg/kg (body weight) once every three weeks for a total of six doses. The initial dose is infused over 90 minutes, and if tolerated well, the infusion time for subsequent doses may be shortened to 30 minutes. The dose may be reduced as appropriate depending on the patient’s condition.

[Reference]

Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma (Press release from Roche issued on June 20, 2025)
View Source

About the SUNMO study

The SUNMO [NCT05171647] study is a multinational, multicenter, randomized Phase III trial that targets patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation, and evaluates the combination therapy of subcutaneously administered Lunsumio (mosunetuzumab) and intravenously administered Polivy (polatuzumab vedotin) in comparison with the R-GemOx regimen [Rituxan (rituximab), gemcitabine, and oxaliplatin]. The primary endpoints are progression-free survival and objective response rate, and the secondary endpoints include overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes (PROs: Patient Reported Outcomes).

About Lunsumio (mosunetuzumab)

Lunsumio is a T-cell-engaging bispecific antibody designed to target CD3 on T cells and CD20 on B cells. Lunsumio is expected to activate immunity mediated by cytotoxic T cells and exert antitumor effects against tumor cells expressing CD20. Lunsumio has been approved in 65 countries worldwide. Clinical studies are currently underway in follicular lymphoma (second line and untreated settings). In December 2025, in addition to the intravenous formulation, Lunsumio obtained manufacturing and marketing approval for a new subcutaneous formulation.

About Polivy (polatuzumab vedotin)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as those expressing CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Roche and is currently being investigated for the treatment of several types of NHL.

About Large B-cell lymphoma (LBCL)

LBCL consists primarily of diffuse large B-cell lymphoma (DLBCL), which is the most common subtype of non-Hodgkin lymphoma (NHL) affecting B-cell lymphocytes, a type of white blood cell. DLBCL is the most common form of aggressive NHL and accounts for approximately 80%2 of LBCL cases. LBCL also includes high-grade B-cell lymphoma (HGBL), which is considered to be even more aggressive and to have a poorer prognosis than DLBCL. Although patients generally respond to frontline therapy, up to 40%3 experience relapse or become refractory, and in such cases, treatment options for salvage therapy are limited.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, MAR 23, 2026, View Source [SID1234663822])