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HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

On December 29, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that the New Drug Application ("NDA") for fanregratinib (HMPL-453) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma ("ICC") with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

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Fanregratinib (HMPL‑453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.[1] Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.

This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study in China. The study has met its primary endpoint of objective response rate (ORR). Results from the secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS) also support the primary endpoint findings. Full results will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

About Fanregratinib
Fanregratinib (HMPL‑453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, DEC 29, 2025, View Source [SID1234661639])

Genmab Portfolio Prioritization Update

On December 29, 2025 Genmab A/S (Nasdaq: GMAB) reported that it will discontinue further clinical development of acasunlimab. This decision was made as part of Genmab’s strategic focus on the most value‑creating opportunities in its late‑stage portfolio and following a thorough assessment of the evolving competitive landscape. While the clinical profile observed to date has been encouraging, Genmab will concentrate resources on programs with the highest potential impact, including EPKINLY (epcoritamab), petosemtamab and rinatabart sesutecan (Rina‑S), which are advancing in late‑stage development. This decision is consistent with Genmab’s disciplined portfolio prioritization and capital allocation framework.

"After careful consideration, we have decided to discontinue the acasunlimab program. Although the data have been encouraging, the compelling opportunities we see in our late‑stage pipeline led us to focus our investments where we believe we can deliver the greatest benefit for patients and shareholders. We are highly energized by the momentum of EPKINLY, petosemtamab and Rina‑S, and we remain committed to executing these programs with speed and rigor," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab.

This decision does not impact Genmab’s full‑year 2025 financial guidance.

(Press release, Genmab, DEC 29, 2025, View Source [SID1234661638])

CARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596

On December 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596. The applications seek to initiate two corresponding Phase Ib/Ⅱ clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (pPCL), respectively.

CT0596 is an allogeneic CAR T-cell therapy targeting BCMA, developed based on CARsgen’s proprietary THANK-u Plus platform. Through the knockout of genes such as NKG2A, TRAC, and B2M, CT0596 is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product’s efficacy and safety profile.

Investigator-initiated trials (IIT) for CT0596 have already been conducted in China to explore its clinical potential in treating R/R MM and pPCL. Data from the first-in-human study, presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated a favorable safety profile and encouraging efficacy signals for CT0596. As of August 31, 2025, all 8 patients with R/R MM who received CT0596 infusion were evaluable for efficacy, with a median follow-up of 4.14 months. Six patients achieved a partial response (PR) or better: 3 achieved complete response/stringent complete response (CR/sCR) (all received full-dose lymphodepletion), 1 achieved very good partial response (VGPR), and 2 achieved PR. Four patients experienced Grade 1 cytokine release syndrome (CRS), with no Grade 2 or higher CRS observed. No immune effector cell-associated neurotoxicity syndrome (ICANS), GvHD, dose-limiting toxicities, treatment discontinuations, or deaths were reported.

Previously, the company also disclosed preliminary clinical data for CT0596 in relapsed/refractory pPCL. Two heavily pretreated pPCL patients with high disease burden and rapid progression both achieved sCR after receiving CT0596 treatment.

The IND applications mark the commencement of the registration clinical development phase for CT0596, which holds the potential to offer a new treatment option for patients with R/R MM and pPCL.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or primary plasma cell leukemia (pPCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by plasma cells.

(Press release, Carsgen Therapeutics, DEC 28, 2025, View Source [SID1234661634])

Harbour BioMed Enters into Long-Term Strategic Collaboration with Lannacheng to Advance Next-Generation Radionuclide Drug Conjugates

On December 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported that it has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd. ("Lannacheng"). The two parties will leverage their respective resources and strengths to jointly advance the development of next-generation radionuclide drug conjugates (RDCs).

Compared with conventional radiotherapy, RDCs utilize tumor antigen–specific ligands to deliver radionuclides directly to tumor lesions for targeted radiotherapy, thereby effectively reducing damage to surrounding healthy tissues. In contrast to antibody–drug conjugates (ADCs), the radionuclides in RDCs can also exert cytotoxic effects on neighboring tumor cells and the tumor microenvironment, even if those cells do not express the target antigen. This mechanism offers a potential advantage in overcoming tumor heterogeneity and drug resistance. In addition, this technology holds the potential to achieve theranostics—integrating both diagnosis and treatment.

With its advanced technology platforms and deep expertise, Harbour BioMed has built a solid foundation in antibody discovery and development. The company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapeutics. In the development of RDCs, fully human antibodies—characterized by low immunogenicity, superior tissue penetration, and high specificity and stability—can significantly enhance the efficiency of targeted delivery, thereby improving therapeutic efficacy while effectively reducing drug-related toxicity and side effects.

Founded in 2021, Lannacheng is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of integrated theranostic radiopharmaceuticals for oncology. The company’s R&D engine, enhanced by its proprietary pharmacokinetic optimization and dual-targeting drug development platforms, combines target validation, radioisotope selection, and linker design to improve pharmacokinetic profiles and advance the development of dual-targeting radiopharmaceutical candidates. Its strengths are further solidified through end-to-end integration of capabilities supported by its controlling shareholder, Dongcheng Biochem, including R&D resources, a stable supply of radioisotopes, and a GMP production facility currently under construction in Yantai. Together, these elements ensure a sustainable, scalable, and rapidly innovating radiopharmaceutical pipeline.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "We are very pleased to establish a long-term strategic collaboration with Lannacheng to jointly advance the development of next-generation RDCs. Harbour BioMed is committed to providing efficient and highly differentiated antibody solutions for innovative therapies through our globally leading Harbour Mice fully human antibody platform. This collaboration will deeply integrate Harbour BioMed’s expertise in antibody discovery with Lannacheng’s strengths in radiopharmaceutical R&D and commercialization, accelerating the development of more precise, effective and safe cancer therapies and bringing new hope to patients worldwide."

Wu Xiaoming, General Manager of Lannacheng, stated: "We are delighted to establish a long-term strategic collaboration with Harbour BioMed to jointly advance the R&D and translation of next-generation radiopharmaceuticals. Lannacheng is committed to leveraging our systematic radiopharmaceutical technology platform, comprehensive industrial capabilities, and global collaboration network to provide efficient, innovative, and differentiated integrated solutions for tumor diagnosis and treatment. This collaboration will fully combine Lannacheng’s strengths in radiopharmaceutical R&D and commercialization and Harbour BioMed’s deep expertise in antibody discovery. Together, we aim to accelerate the development of more precise, effective, and safe cancer treatment therapies, bringing new hope to patients worldwide."

(Press release, Harbour BioMed, DEC 28, 2025, View Source [SID1234661633])

Senhwa Biosciences Aims at Multi-Billion Dollar Global Market with CX-5461 Combined with ADC "Blockbuster" Therapy

On December 28, 2025 Senhwa Biosciences following its recent clinical collaboration with the multinational pharmaceutical company BeOne Medicines to explore combination therapy with its marketed PD-1 inhibitor in the challenging field of cold tumor treatment reported another major milestone. The Company’s first-in-class investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the globally recognized antibody-drug conjugate (ADC), Trastuzumab Deruxtecan (Enhertu), in a Phase 1b clinical trial. The study is designed for HER2-positive solid tumors and breast cancer patients, including those with HER2-low expression and metastatic breast cancer. Supported by the U.S. National Cancer Institute’s (NCI) NExT program, which funds multiple CX-5461 studies including combination strategies, Senhwa is positioning itself at the forefront of one of the most promising areas in oncology therapeutics, and this milestone marks CX-5461’s entry into the fast-growing ADC market.

World’s First G4 Stabilizer Meets Leading ADC

CX-5461 is the world’s first and most advanced G-quadruplex (G4) stabilizer in development. It has shown promising activity in early-phase trials for breast cancer and other solid tumors in study sponsored by SU2C-CCTG in Canada. Its combination with Enhertu is expected to enhance treatment efficacy in HER2-low patients and offer new therapeutic possibilities.

Enhertu, co-developed by AstraZeneca and Daiichi Sankyo, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer. This innovative drug uses a monoclonal antibody to precisely target tumor cells and deliver the chemotherapy payload Deruxtecan directly into the tumor, enabling highly effective cancer cell killing while minimizing harm to healthy cells.

Entering a High-Growth Market

The global ADC market is projected to grow at a CAGR of 28.4%, reaching approximately USD 47 billion by 2029. Analysts believe that Senhwa’s clinical development strategy combining CX-5461 and Enhertu positions the company to directly tap into this high-growth and highly competitive oncology market.

Differentiated Advantage and Strategic Collaboration Potential

Although existing HER2-targeted therapies have transformed the treatment landscape for breast and gastric cancers, their efficacy in HER2-low solid tumors remains limited. Experts suggest that if CX-5461’s novel mechanism of action, when combined with ADC’s precise delivery platform, proves effective, it could break through current treatment barriers, expand indications to additional tumor types, and establish a clear competitive edge.

With global pharmaceutical companies racing into the ADC space, collaborations and licensing agreements have become mainstream. Should Senhwa’s combination therapy demonstrate strong clinical efficacy, it could attract strategic partnerships with major international pharma players, bringing in substantial licensing revenues and long-term collaboration opportunities.

Driving Long-Term Value Creation

Analysts further note that the successful advancement of this trial would significantly enhance Senhwa’s international visibility in oncology, elevate the company’s market valuation, and deliver sustainable long-term returns for investors and shareholders.

HER2 has been validated as a critical oncogenic driver across multiple tumor types. By leveraging the innovative combination of CX-5461 and Enhertu, Senhwa aims to pioneer breakthrough therapies, capture a substantial share of the rapidly growing ADC market, and build a diverse oncology treatment platform. The company reiterated its commitment to strengthening its R&D pipeline, integrating next-generation ADC technologies with its proprietary drug candidates, and advancing toward its vision of becoming a leading Asia-based oncology innovator with a global footprint.

Senhwa Biosciences – CX-5461 NCI-NExT Program Clinical Trial Overview

No.

Study Title

Total Subjects

Primary Endpoints

Global Market Forecast

Pilot Study of Pidnarulex Pharmacodynamics
in Patients with Advanced Solid Tumors

Up to 40 subjects
HRD / Non-HRD (20 each)

Evaluation of RAD51 response and DNA damage response

2024: USD 362.2B
CAGR: 20%
2032: USD 1,557.4B

Phase 1b/2 Trial of Pidnarulex
in MYC Aberrant Lymphoma

Up to 50 subjects
Phase 1b: 36
Phase 2: 8–14

1. Safety and DLT evaluation on CX-5461
2. RP2D for on CX-5461
3. ORR
4. CX-5461 PK
5. Effect on MYC-aberrant lymphoma gene expression

2024: USD 4.9B
CAGR: 5.79%
2035: USD 8.9B

A Phase 1 and Randomized Phase 2 Trial
of Pidnarulex (CX-5461) and Cemiplimab (REGN2810)
in Refractory Microsatellite Stable Colorectal Cancer

Up to 86 subjects
Phase 1: 18
Phase 2: 68

1. CX-5461 RP2D combined with PD-1 inhibitor
2. Safety & tolerability for CX-5461 monotherapy & combination
3. PFS in refractory MSS CRC with liver metastases for CX-5461 monotherapy & combination

2025: USD 58.0B
CAGR: 15%
2035: > USD 250.0B

Phase 1b study
of Pidnarulex and Trastuzumab Deruxtecan
in patients with HER2 expressing Solid Tumors

Up to 36 subjects

1. MTD & RP2D determination for combination of CX-5461 and Trastuzumab Deruxtecan
2. Safety and tolerability in HER2-low and HR+ HER2-ultra-low breast cancer for combination of CX-5461 and Trastuzumab Deruxtecan

2023: USD 10.8B
CAGR: 28.4%
2029: USD 47.0B

(Press release, Senhwa Biosciences, DEC 28, 2025, View Source [SID1234661632])