On November 2, 2025 Samsung Epis Holdings Co., Ltd. reported its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.

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Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. "The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world," said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. "By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers."

(Press release, Samsung Epis Holdings, NOV 2, 2025, View Source [SID1234659229])

On November 2, 2025 OncoHost, a global leader in precision oncology and proteomics-based biomarker development, reported the presentation of two new research posters at the 2025 International Society for Liquid Biopsy (ISLB) Annual Congress. The studies underscore the transformative potential of plasma proteomics in improving clinical decision-making and real-time disease monitoring for patients with non-small cell lung cancer (NSCLC).

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Poster 1: Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA

Presenter: Michal Harel, Ph.D., VP Translational Medicine, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

This study introduces a comparative analysis between plasma proteomic signatures and circulating tumor DNA (ctDNA) to evaluate immunotherapy response in advanced NSCLC.

Leveraging aptamer-based proteomic profiling of approximately 7,000 plasma proteins per sample, researchers identified three key proteomic signatures reflecting:

Soluble PD-1/PD-L1 drug bioavailability,
T-cell activation and immune engagement, and
Intracellular proteins indicating lung tissue damage.
Notably, the tissue-damage signature enabled early detection of non-responders up to 6.6 months before standard imaging. While ctDNA tumor load correlated modestly with this signature, only the proteomic analysis effectively distinguished clinical response groups.

"These results demonstrate the unique systemic insight offered by plasma proteomics – capturing the full tumor-immune interaction beyond what is achievable with ctDNA alone," said Dr. Harel. "This approach has the potential to revolutionize real-time treatment monitoring for immunotherapy patients."

Poster 2: A Plasma Proteomics Test Predicts Immunotherapy Benefit in NSCLC Independent of Genomic Alterations

Presenter: Anna Manasherov, MSN-FNP, MPH, Director, Scientific Affairs, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

The second study evaluated the performance of PROphetNSCLC, OncoHost’s commercially available liquid biopsy proteomics test, in predicting immunotherapy benefit across major genomic subgroups.

Analyzing pre-treatment plasma samples from 308 NSCLC patients treated with immune checkpoint inhibitors, the study revealed that a PROphet-POSITIVE result predicted significantly longer overall survival (HR=0.39, p<0.0001) – a benefit consistently observed across KRAS, STK11, TP53, and KEAP1 mutation subgroups.

Importantly, the predictive power of PROphetNSCLC was maintained independent of mutational status and PD-L1 expression, establishing it as a universal biomarker for immunotherapy benefit prediction.

"The data reinforce the value of PROphetNSCLC as an independent, mutation-agnostic tool supporting oncologists in selecting optimal first-line treatments," said Ofer Sharon, MD, CEO at OncoHost. "Our findings highlight the power of proteomics to transcend genomic boundaries and provide actionable clinical insights."

(Press release, OncoHost, NOV 2, 2025, View Source [SID1234659228])

On November 2, 2025 Akeso (9926.HK) reported that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).

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The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:

Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China’s National Reimbursement Drug List.

First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.

Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab’s substantial clinical benefit across multiple major cancer types and reinforces Akeso’s commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.

(Press release, Akeso Biopharma, NOV 2, 2025, View Source [SID1234659227])