On January 13, 2026 Akeso, Inc. (9926.HK) reported the presentation of a real-world study at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), comparing cadonilimab plus chemotherapy against a PD-1 inhibitor plus chemotherapy for the first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS <5 (a propensity-matched, retrospective cohort study).

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The study results showed that the cadonilimab regimen, compared to the PD-1 monoclonal antibody regimen, significantly prolonged patients’ overall survival (OS) and progression-free survival (PFS). Both OS (HR=0.49, P=0.025) and PFS (HR=0.43, P=0.006) demonstrated statistically significant improvements. The full study has been accepted for publication in the Journal of Gastrointestinal Oncology.

These real-world findings are highly consistent with the "all-comer benefit" profile previously observed for cadonilimab in the Phase III registrational trial COMPASSION-15. This real-world, head-to-head comparison further underscores cadonilimab’s potential to elevate the standard of cancer immunotherapy and address clinical challenges unresolved by single-target PD-1 inhibitors. Based on the data from the pivotal Phase III COMPASSION-15 study, cadonilimab received approval in China in September 2024 for the first-line treatment of advanced gastric cancer across all patient subgroups and this indication was added to cadonilimab’s list of covered indication under National Reimbursement Drug List (NRDL), effective 2026.

Anti-PD-1 antibodies combined with chemotherapy is the international standard of care for advanced gastric cancer. However, its efficacy is significantly limited in patients with PD-L1-low (CPS < 5) or negative (CPS < 1) expression, where these patients constitute nearly half of all advanced gastric cancer cases. As a result, the U.S. Food and Drug Administration (FDA) restricted all approved first-line PD-1 inhibitors for advanced gastric cancer to only PD-L1-positive patients in 2024. This aligns with recommendations from leading guidelines, such as those of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), which prioritize PD-1-based regimens for patients with PD-L1 CPS ≥5. Consequently, PD-L1-low or -negative advanced gastric cancer remains a major unmet clinical need globally due to thelack of effective immunotherapy options. A recent real-world study provides new evidence addressing this challenge.

In this retrospective analysis, patients with PD-L1-low (CPS < 5) advanced G/GEJ cancer received first-line therapy with either cadonilimab plus chemotherapy or a PD-1 inhibitor plus chemotherapy. With a median follow-up of 11.0 months as of February 28, 2025, the results showed that the cadonilimab-based regimen achieved statistically significant and clinically meaningful improvements in both PFS and OS compared to the PD-1 inhibitor-based regimen.

Some Key Findings from the Study published at GI-ASCO:

Significant PFS and OS Improvement: Among PD-L1-low patients, the cadonilimab group achieved a median OS of 14.3 months, significantly longer than the 10.3 months observed in the PD-1 inhibitor group (OS HR=0.49, p=0.025), representing a 51% reduction in the risk of death. The median PFS was also extended to 9.3 months compared to 5.8 months in the control group (PFS HR=0.43, p=0.006), corresponding to a 57% reduction in the risk of disease progression or death.
Higher Objective Response Rate (ORR): The objective response rate was superior in the cadonilimab group compared to the PD-1 inhibitor group (73.3% vs. 57.1%) for PD-L1-low patients.
Manageable Safety and Good Tolerability: The incidence of any-grade adverse events was comparable between the two groups, and no statistically significant difference observed in the rate of grade 3-4 adverse events between the two groups.
Akeso is actively advancing several prospective head-to-head Phase III registration studies with cadonilimab, aiming to elevate current standard immunotherapies. Notably, the international multi-center Phase III registration study COMPASSION-37, evaluating cadonilimab plus chemotherapy versus the PD-1 inhibitor nivolumab plus chemotherapy for first-line treatment of advanced gastric cancer, received approval from the U.S. FDA to initiate at the end of 2025. This milestone marks a new phase in the global development of cadonilimab.

(Press release, Akeso Biopharma, JAN 13, 2026, View Source [SID1234662024])

On January 13, 2026 Rakuten Medical, Inc. and LOTTE Biologics reported that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical’s production capabilities for its innovative oncology therapy, Alluminox platform-based photoimmunotherapy.

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Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical’s global clinical development and future commercialization.

Rakuten Medical’s proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure.

In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon.

Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical’s bioconjugates.

LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical’s programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide.

(Press release, Rakuten Medical, JAN 13, 2026, View Source [SID1234662023])

On January 13, 2026 Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, reported key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The company also highlighted plans to expand its manufacturing and R&D capabilities to support long-term growth, enhance supply resilience and reinforce its long-term commitment to the U.S. market.

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The presentation, composed of two sections— ‘From Biosimilar Excellence to Next-Gen Innovative Therapeutics’ and ‘Scaling Our U.S. Presence with a Next-Gen Manufacturing and R&D Hub’—was delivered on the conference’s Main Track. Celltrion’s Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee outlined the company’s innovative drug pipeline, with plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 ADCs, 4 msAbs, 1 recombinant protein, and 1 peptide. In its biosimilar business, Celltrion aims to commercialize up to 18 products by 2030 and 41 products by 2038.

The company’s ADC candidates are designed to target solid tumor cancers; with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration (FDA) in 2025. CT-P70, a novel ADC candidate being developed for the treatment of non-small cell lung cancer (NSCLC), recently received Fast Track designation from the U.S. FDA, enabling expedited interactions throughout the development process and the potential for accelerated regulatory review.

Celltrion is advancing a portfolio of msAbs that are designed to selectively target cancer cells or are activated only under specific conditions. Celltrion received an IND approval from the U.S. FDA for CT-P72, a tetravalent bispecific antibody being developed to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3).

"We have made significant progress and see compelling opportunities ahead. Building on our company’s global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics," said Jin-Seok Seo, Chief Executive Officer at Celltrion. "Our expanding pipeline of ADCs and msAbs, grounded in deep antibody expertise, underscores our commitment to delivering meaningful value to patients worldwide. We aim to redefine the standard of care in oncology and beyond, while creating long-term sustainable value through scientific excellence and bold innovation."

To reinforce the company’s U.S. manufacturing capabilities, Celltrion recently completed the strategic acquisition of a former Eli Lilly manufacturing facility located in Branchburg, New Jersey, securing 66,000L of drug substance (DS) capacity. The company plans to sequentially increase capacity to a total of 132,000L by 2030, while also extending its capabilities to include drug product (DP) facilities. Through this acquisition, Celltrion plans to ensure long-term supply chain resilience eliminating the tariff and trade risks, ultimately strengthening its competitiveness in the U.S. market.

"The acquisition of the U.S. manufacturing facility represents a pivotal step in strengthening our global supply chain and solidifying our presence in the U.S. market," said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. "By securing large-scale DS capacity in the U.S., we are enhancing supply stability, mitigating trade and tariff risks, and establishing a solid foundation for expanded R&D collaboration and innovation in the region."

(Press release, Celltrion, JAN 13, 2026, View Source [SID1234662022])

On January 13, 2026 Daiichi Sankyo reported the first patient has been dosed in the TROPIONLung17 phase 3 trial evaluating DATROWAY (datopotamab deruxtecan) compared to docetaxel in patients with TROP2 NMR positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations previously treated with immunotherapy and platinum-based chemotherapy.

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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).

The current standard first-line treatment for advanced NSCLC without actionable genomic alterations is immunotherapy with or without platinum-based chemotherapy. 1 However, most patients will eventually experience disease progression and traditional chemotherapy remains the current standard of care in the second-line and beyond settings. 2,3,4,5 While TROP2 is a protein broadly expressed on the surface and inside of NSCLC cells, there is no established predictive biomarker that can identify patients who may benefit from a TROP2 directed antibody drug conjugate. 6,7 TROPION-Lung17 is the first phase 3 clinical trial to prospectively enroll patients with tumors that test positively for TROP2 NMR, a biomarker measured using Quantitative Continuous Scoring (QCS), which is AstraZeneca’s computational pathology platform.

"We initiated TROPION-Lung17 to further evaluate DATROWAY in this patient population, building on results from retrospective analyses of several clinical trials, including TROPION-Lung01, which showed a correlation between TROP2 NMR positivity and outcomes for patients with lung cancer," said Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo.

"TROPION-Lung17 is the first phase 3 trial to prospectively enroll patients using a TROP2 biomarker to determine whether DATROWAY can improve survival compared to current standard of care chemotherapy."

"TROPION-Lung17 aspires to bring a precision medicine approach to patients with advanced lung cancer in the second-line setting, where traditional chemotherapy remains the standard of care," said Leora Horn, MD, MSC, FRCPC, Senior Vice President, Late Development Oncology, AstraZeneca. "Research has shown DATROWAY has the potential to improve outcomes in this setting, and we are confident the TROP2 NMR biomarker and its investigational AI-powered companion diagnostic – previously granted a Breakthrough Device Designation in the U.S. – can help us bring this medicine to the patients most likely to benefit."

TROPION-Lung17 is the ninth phase 3 trial evaluating DATROWAY in NSCLC. Ongoing trials in advanced NSCLC include four phase 3 trials in the first-line metastatic setting evaluating DATROWAY in combination with immunotherapy in tumors without actionable genomic alterations (AVANZAR, TROPION-Lung07, TROPION-Lung08 and TROPION-Lung10) and one phase 3 trial of DATROWAY in combination with osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), (TROPION-Lung14) in EGFR-mutated NSCLC. Additional later-line phase 3 trials include evaluating DATROWAY with or without osimertinib (TROPION-Lung15) and DATROWAY alone (TROPION-Lung17).

About TROPION-Lung17

TROPION-Lung17 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of DATROWAY (6 mg/kg) versus docetaxel in patients with TROP2 NMR positive locally advanced or metastatic nonsquamous NSCLC without actionable genomic alterations previously treated with PD-1/PDL1 inhibitor therapy and platinum-based chemotherapy. All patients will undergo prospective and central tumor testing for TROP2 NMR using the investigational VENTANA TROP2 (EPR20043) RxDx Device (comprised of the companion diagnostic assay and computational pathology algorithm) and those with TROP2 NMR positive tumors will be randomized in a 1:1 ratio to receive either DATROWAY or docetaxel.

The dual primary endpoints of TROPION-Lung17 are progression-free survival as assessed by blinded independent central review and overall survival. Key secondary endpoints include overall response rate, duration of response and safety.

TROPION-Lung17 will enroll approximately 400 patients across multiple sites in Asia, Europe and North America. For more information visit ClinicalTrials.gov.

About TROP2 NMR

TROP2 is a protein broadly expressed in NSCLC tumors.6,7 TROP2 expression on the surface of tumor cells, as measurable with conventional pathology methods, has not been predictive of patient responses to TROP2 directed therapies.8,9 Normalized membrane ratio (NMR) refers to the QCS enabled measure of a tumor cell’s surface TROP2 expression, relative to its surface and cytoplasm TROP2 expression. NSCLC is considered TROP2 NMR positive if at least 75% of tumor cells have a greater proportion of TROP2 in the cytoplasm. TROP2 NMR is being developed to identify patients with NSCLC most likely to benefit from treatment with DATROWAY

Exploratory analyses of the TROPION-Lung01 phase 3, TROPION-Lung02 phase 2 and TROPIONPanTumor02 phase 2 trials have shown a correlation between TROP2 NMR positivity and improved clinical outcomes in patients with NSCLC treated with DATROWAY

Daiichi Sankyo and AstraZeneca are collaborating with Roche Tissue Diagnostics to co-develop and commercialize the VENTANA TROP2 (EPR20043) RxDx Device as a novel AI-powered companion diagnostic for DATROWAY in lung cancer. The device was granted Breakthrough Device Designation by the U.S. Food and Drug Administration. In addition to TROPION-Lung17, it is being used to analyze tissue samples in the TROPION-Lung10 and AVANZAR phase 3 trials.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer globally and is the leading cause of cancer-related death in both men and women.10 More than 2.48 million lung cancer cases were diagnosed in 2022, with 1.8 million deaths globally. NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.

For patients with advanced NSCLC without actionable genomic alterations, immunotherapy with or without platinum-based chemotherapy is the standard first-line treatment.1 While these medicines have improved outcomes in the first-line metastatic setting, most patients experience disease progression and traditional chemotherapy remains the standard of care in the second-line and beyond setting.

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 anti-TROP2 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 40 countries/regions 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 NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy based on the results from the TROPION-Lung05 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.

(Press release, Daiichi Sankyo, JAN 13, 2026, View Source [SID1234662021])

On January 13, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will outline the pillars of its growing global oncology leadership during its presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.

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John V. Oyler, Co-Founder, Chairman, and CEO at BeOne, will highlight the Company’s transformative leadership in treating B-cell malignancies. The presentation will feature BRUKINSA, the global leader among Bruton’s tyrosine kinase (BTK) inhibitors, as well as foundational hematology assets: sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor that received its first global regulatory approvals on December 30, and BGB-16673, a potentially first-in-class and best-in-class BTK chimeric degradation activation compound (CDAC). In addition, Mr. Oyler will share further information on BeOne’s global development superhighway, which encompasses global, wholly internal, and competitively advantaged clinical capabilities that can greatly reduce the cost and time to develop a new medicine, thereby increasing the speed of access to innovation for patients around the world.

"BeOne is emerging as the world’s leading oncology company with established leadership in the treatment of B-cell malignancies, an industry-leading pipeline and a unique set of internal capabilities to address tremendous unmet patient need around the world," Mr. Oyler said. "BRUKINSA has entrenched itself as the best-in-class, foundational BTK inhibitor and global revenue leader with an unparallelled long-term efficacy and safety profile across all approved indications. The investigational combination of BRUKINSA and BCL2 inhibitor sonrotoclax has the potential to change the fixed-duration treatment landscape for CLL with best-in-class rates and kinetics of minimal residual disease. BGB-16673 is the most advanced BTK degrader in the clinic and continues to emerge as a potential first-in-class and best-in-class treatment. Combining one of the industry’s most innovative research teams with our vertically integrated clinical development capabilities puts us in a strong position for our next phase of growth with a solid financial profile and a growing global footprint."

Key themes from BeOne’s presentation (7:30 a.m. PT, Tuesday, Jan. 13, 2026) at the J.P. Morgan Healthcare Conference include:

BeOne is the only company with potentially best-in-class, foundational medicines in three key MOAs in CLL

BeOne is the leading company in the treatment of chronic lymphocytic leukemia (CLL) with three approved or clinical-stage foundational medicines addressing all patient subtypes.

BRUKINSA is now the global revenue leader in the BTKi class and the only BTKi to demonstrate superior progression-free survival (PFS) and cardiac safety profile versus ibrutinib in a Phase 3 head-to-head trial. At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, the Company presented landmark six-year results from the global, Phase 3 SEQUOIA trial of BRUKINSA versus bendustamine plus rituximab (BR) in treatment-naïve CLL or small lymphocytic lymphoma with an estimated 74% PFS compared with 32% PFS for BR. The overall survival (OS) at 72 months was 84% for BRUKINSA and 80% with BR. After adjusting for COVID-19, the OS rates were 88% and 82%, respectively.

BeOne is rapidly advancing the investigational combination of BRUKINSA and sonrotoclax as a potential best-in-class fixed-duration regimen for the treatment of first-line CLL with clinical results showing potential best-in-class rates of undetectable minimal residual disease (uMRD) at the earliest time as exploratory endpoints. The Company anticipates uMRD results from the Phase 3 CELESTIAL trial of zanubrutinib plus sonrotoclax (ZS) versus venetoclax plus obinutuzumab (VO) in 2026.

In addition, the Company continues to advance BGB-16673 as a potentially first-in-class and best-in-class targeted degrader of BTK with Phase 1 trial results in heavily pretreated CLL patients at a median follow-up of 18 months demonstrating an overall response rate of 86% and 12-month progression-free survival of 79%. The Company anticipates potentially pivotal Phase 2 trial results for BGB-16673 in R/R CLL in 2026.

BeOne’s peerless global development superhighway combined with an industry-leading oncology R&D team drives faster development, accelerated regulatory registrations, and broader global patient access

BeOne is leveraging one of the largest oncology research teams in the industry alongside nearly 6,000 clinical development and manufacturing colleagues supporting the Company’s wholly internal, strategically advantaged global development superhighway to rapidly bring our medicines to cancer patients around the world.

The Company’s dedicated team of research scientists holds deep expertise in designing innovative small-molecule inhibitors, biologics, targeted protein degraders, multispecific antibodies and antibody drug conjugates. In the past 18 months, the Company has advanced 15 New Molecular Entities (NME) into the clinic across a broad range of modalities and expects to deliver an additional eight to 10 NMEs per year into the clinic starting in 2026. BeOne plans to share updates for the following programs, each of which has achieved clinical proof of concept and presents a significant market opportunity: CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor, GPC3x41BB bispecific antibody, and CEA ADC.

A strong financial profile enables investment for BeOne’s future growth

BeOne’s strong financial position enables the Company to achieve greater global scale while maintaining profitability in 2026 and beyond.

The Company generated more than $350 million in free cash flow in the third quarter of 2025 with more than $4 billion in cash on hand. BeOne will continue to invest in driving innovation across its hematology and solid tumor pipelines to maximize long-term value for patients and shareholders while pursuing value-creating business development, including opportunities to leverage the Company’s global development superhighway.

Live webcast of BeOne’s presentation can be accessed from the investors section of the Company’s website at View Source Archived replays will be available on the Company’s website.

(Press release, BeOne Medicines, JAN 13, 2026, View Source [SID1234662020])