Henlius Showcases "Globalisation 2.0" Strategy and Mid-to-Long-Term Innovation Blueprint at JPM 2026

On January 16, 2026 Dr. Jason Zhu, Executive Director and Chief Executive Officer of Shanghai Henlius Biotech, Inc. (2696.HK), delivered a keynote presentation outlining Henlius’ "Globalisation 2.0" strategy, diversified innovation pipeline, and its mid-to-long-term development blueprint. The 44th J.P.Morgan Healthcare Conference (JPMHC) was successfully held in San Francisco, the United States, from January 12 to 15. As one of the most influential annual events in the global healthcare sector, JPM serves as a key platform for the capital markets and industry leaders to observe emerging trends in pharmaceutical innovation and industry development. The conference attracted more than 8000 global industry leaders, innovators, entrepreneurs, and investors.

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A Global Biopharmaceutical Vision Toward 2030

Building on its expanding innovation pipeline and accelerating global footprint, Dr. Zhu shared Henlius’ mid-to-long-term vision as a global biopharmaceutical company. To date, Henlius has achieved regulatory approvals for 10 products across 60 markets worldwide, benefiting more than 950,000 patients globally. The Company’s international business continues to grow at a rapid pace. Looking ahead to 2030, Henlius anticipates launching more than 20 products globally, including over 15 products in the U.S. and European markets. The Company will continue to advance innovative modalities such as ADCs, multi-specific antibodies and T-cell engagers (TCEs), covering oncology, autoimmune, metabolic and central nervous system (CNS) diseases. With the continued strengthening of its global commercialisation capabilities, international market revenue is expected to grow further, reinforcing Henlius’ global scale and competitiveness as a global biopharma.

Five Core Capabilities Strengthen the Globalisation Foundation

Dr. Zhu highlighted Henlius’ continuous growth trajectory and phased achievements under its "Globalisation 2.0" strategy:

"With multiple products approved successively in Europe and the United States, and an increasingly mature integrated global operating model, our international business has maintained strong growth momentum. Leveraging our integrated R&D, regulatory and manufacturing capabilities, together with an increasingly mature global clinical and commercialisation network, we have established a systematic capacity to continuously deliver innovative assets worldwide. Over the next five years, stable cash flows from our biosimilar portfolio will further support innovation investment, enabling the advancement of more differentiated molecules, including ADCs, multi-Abs and TCEs, into global markets and building a sustainable, replicable globalisation growth model."

Henlius has established a fully integrated biopharmaceutical platform covering R&D, clinical operations, regulatory affairs, manufacturing and commercialisation. In R&D, the Company has built a diversified pipeline of more than 50 early-stage assets, with approximately 70% classified as best-in-class (BIC) and 15% as first-in-class (FIC). In clinical operations, it operates in-house global clinical teams across China, the United States and other regions, with nearly 600 professionals supporting clinical development in more than 20 countries and over 1000 research centres worldwide, possessing the capability to independently conduct international multicentre clinical trials. In regulatory affairs, the Company has secured a total of 164 IND approvals and 66 New Drug Application (NDA) approvals globally, including 4 Biologics License Application (BLA) approvals from the U.S. FDA, continuously validating its international regulatory and quality management capabilities. In manufacturing and quality, it has completed over 1150 commercial GMP batches, with production facilities certified by regulatory authorities in China, the European Union, the United States and many other countries, providing a strong guarantee for the stable supply of products in the global market. In commercialisation, the company has established a strong oncology-focused commercial team of approximately 1600 professionals in China, while working with more than 20 international commercialisation partners, with its products now marketed in approximately 60 countries and regions.

Core Innovation Assets: Clear 2026 Clinical and Regulatory Milestones

Henlius also outlined clear timelines and development plans for its key innovation assets in 2026:

Serplulimab (trade name: Hetronifly in Europe) – Anti-PD-1 mAb

Approved in over 40 markets globally. By the end of 2026, Henlius expects to achieve:

Accelerated approval for perioperative treatment of gastric cancer in China;
U.S. BLA filings for extensive-stage and limited-stage small cell lung cancer (ES-SCLC and LS-SCLC);
Approval of various indications in the EU;
Completion of enrolment and achievement of primary endpoints in the Japanese bridging study for ES-SCLC.
HLX22 – Novel Epitope Anti-HER2 mAb with a Differentiated Modality

Phase 2 data readout in HER2-low breast cancer in China is expected in the first half of 2026.

HLX43 – PD-L1 ADC ("Pipeline-in-a-Pill") with High-Efficacy, a Favourable Safety Profile and I/O Effects, Potential BIC

By the end of 2026, Henlius anticipates to:

Initiate three global pivotal trials in second-line EGFR wild-type nsqNSCLC, third-line and later sqNSCLC, and second-line sqNSCLC;
Launch two PoC trials in HR-positive and triple-negative breast cancer;
Present clinical data across ESCC, NSCLC, NPC, cervical and ovarian cancers at major congresses (ESCC data were recently presented at ASCO (Free ASCO Whitepaper) GI);
Complete PoC readouts of combination trials with serplulimab ± HLX07 in NSCLC, SCLC and mCRC.
HLX07 – Anti-EGFR mAb with a Dual-Target Synergistic Effect, Expected to Open Up a New First-Line treatment Pathway for EGFR-overexpressing sqNSCLC

Two studies are planned by the end of 2026:

A pivotal Phase 2 trial in cutaneous squamous cell carcinoma;
A global multicentre Phase 2/3 trial in first-line sqNSCLC.
Platform-Driven Innovation Ensures Sustained Output, Building a Next-Generation Pipeline of High-Potential Assets

Henlius’ systematic, platform-based R&D ecosystem continues to generate differentiated innovation candidates. Over the next five years, the Company expects more than 40 new clinical trial applications. At present, the company has established a multi-dimensional innovation platform matrix covering the entire early R&D continuum, from early-stage target screening and validation, to candidate molecule design and optimisation, and through to systematic preclinical development. This integrated platform ecosystem includes a PD-(L)1-centred immune checkpoint inhibitor platform, immune cell engager platforms such as multi-specific T-cell engagers (TCEs), the Hanjugator ADC platform, and the AI-driven one-stop early discovery platform HAI Club. These platforms not only ensure the quality and efficiency of individual R&D programs, but more importantly provide a sustainable, system-level capability to support the development of a globally competitive mid- to long-term innovation pipeline. As a result, the company is able to continuously and efficiently translate cutting-edge scientific discoveries into clinically valuable drug candidates.

Key early-stage assets include:

HLX37: PD-L1 × VEGF bispecific antibody developed based on the immune checkpoint inhibitor platform. It demonstrates high PD-L1 binding affinity and achieves higher tumour microenvironment (TME) enrichment vs. combination therapies, positioning it as a next-generation immunotherapy candidate following serplulimab.
HLX97: Novel oral small-molecule KAT6A/B inhibitor with potential BIC profile, broadly applicable for the treatment of breast cancer, castration-resistant prostate cancer, and NSCLC.
HLX3901: DLL3 × DLL3 × CD3 × CD28 tetravalent TCE developed on the Company’s proprietary TCE platform, featuring longer persistence of activated T cells and greater efficacy in solid tumour treatment.
HLX3902: Potential FIC STEAP1 × CD3 × CD28 trispecific TCE developed on the proprietary TCE platform, demonstrating superior antitumour activity, and increased T-cell infiltration and persistence in TME.
HLX316: Novel potential FIC B7-H3–sialidase fusion protein developed based on Palleon Pharmaceuticals’ EAGLE platform, designed to remove tumour sialic acid to enhance immune response.
HLX48: Safer and more effective cMET x EGFR ADC developed on the Hanjugator ADC platform, designed to maximize antibody function while delivering a stronger bystander effect, for the treatment of NSCLC and colorectal cancer.
HLX49: Potential BIC HER2xHER2 novel bi-paratopic ADC developed on the Hanjugator ADC platform, offering improved efficacy, higher and safer tolerance, and maximized function of antibodies.
At present, the Company’s preclinical asset portfolio spans multiple molecular modalities, including antibodies, multispecific TCEs, ADCs, fusion proteins and small molecules, with a primary focus on solid tumors. Its differentiated development strategy targets both established and emerging targets such as PD-(L)1, DLL3, B7-H3, HER2, EGFR, c-Met and KAT6A/B. The portfolio comprises a balanced mix of potential FIC and BIC candidates, as well as fast-follow programs with higher clinical and commercialisation certainty, laying a solid foundation for the sustained advancement of the mid- to long-term clinical pipeline. By proactively structuring its preclinical portfolio to encompass diverse innovation profiles including FIC, BIC and fast-follow programs, the company has established a tiered R&D architecture that balances frontier innovation with development efficiency and risk management, thereby supporting the continuous progression of its innovation pipeline.

(Press release, Shanghai Henlius Biotech, JAN 16, 2026, View Source;302663316.html [SID1234662075])

Repare Shareholders Approve Acquisition by XenoTherapeutics, Inc.

On January 16, 2026 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported that its Shareholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of the Common Shares, the "Shareholders") by XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly "Xeno") a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement") at the special meeting of Shareholders held today (the "Meeting").

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The special resolution approving the Arrangement was approved by: (i) 99.76% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, and (ii) 99.76% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61- 101 Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.34% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (i) the voluntary liquidation and dissolution of the Company by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (ii) the appointment of KPMG LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.75% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Superior Court of Québec (the "Court") and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on January 23, 2026 and, assuming receipt of the approval of the Court and satisfaction of other customary conditions to closing, the completion of the Arrangement is expected to occur on or about January 28, 2026.

(Press release, Repare Therapeutics, JAN 16, 2026, View Source [SID1234662076])

Antengene Presents at JPM: Strong Clinical Data Update and Strategic Focus on Next-Generation ADCs and TCEs

On January 15, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that it recently presented at the 44th Annual J.P. Morgan Healthcare Conference held in San Francisco. At the conference, Antengene shared the latest data and clinical development plans for its core clinical asset, ATG-022 (a CLDN18.2 antibody-drug conjugate [ADC]), as well as R&D progress on ATG-125 (a B7-H3 x PD-L1 bispecific ADC), its steric hindrance masking AnTenGager T cell engager (TCE) platform, and other key preclinical programs.

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1. Core Clinical Program: ATG-022

Latest data from the Phase I/II CLINCH study: As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21). In addition, one patient in each of the three dose groups achieved a complete response (CR). These results demonstrated the potent anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Promising frontline combination potential: Compared with the data presented at the Company’s R&D Day in November last year, the 1.8 mg/kg dose group demonstrated a further improvement in ORR and a meaningful prolongation in mPFS, while maintaining a favorable safety profile. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was only 19.4%. This differentiated safety profile positions ATG-022 as a potentially best-in-class ADC in terms of safety, with the potential to be combined with checkpoint inhibitors (CPIs) and chemotherapy to transform the current frontline standard-of-care regimen.
First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors: As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers. The efficacy observed to date also supports further exploration of CLDN18.2 as a pan-tumor therapeutic target.
Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase I/II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
2. Next-Generation ADCs and Proprietary TCEs

ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO+ADC " dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of immuno-oncology (IO) therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND for ATG-125 in Q1 2027.

TCE platform with steric hindrance masking technology: AnTenGager is Antengene’s proprietary, second-generation T cell engager (TCE) platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:

ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND for ATG-106 in the first half of 2027.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumor, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The Company has nominated a preclinical candidate (PCC) in January 2026.
Additional TCE programs for solid tumors: Antengene plans to submit an IND for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development.
3. Innovative Treatment for Autoimmune Diseases: Globally First-in-Class ATG-207

ATG-207 is a globally first-in-class dual-function biologic being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present the preclinical data for ATG-207 for the first time at an international scientific conference in 2026.

(Press release, Antengene, JAN 15, 2026, View Source [SID1234662060])

Kelun-Biotech Showcases Innovative Achievements and Future Development Strategy at the 44th Annual JPM Healthcare Conference

On January 15, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK), reported Dr. Ge Michael, President and CEO was invited to attend the conference and delivered a keynote speech on the morning of January 15 (local time) and presented the Company’s latest achievements in drug R&D, commercialization, and globalization, and outlined its innovation strategy and future development plans at the 44th J.P. Morgan Healthcare Conference (JPMHC) was held in San Francisco, California, USA..

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Since initiating its innovation journey in 2012, Kelun-Biotech has rapidly emerged as a leader in China’s innovative drug field, building differentiated technology platforms and robust R&D pipelines. Leveraging its global leading OptiDC platform for antibody-drug conjugates (ADCs) and novel drug conjugates (DCs), the Company continuously advances the differentiated development of ADCs and novel DCs, forming a gradient portfolio for treating multiple tumor types. Currently, Kelun-Biotech has two ADC products on market: sacituzumab tirumotecan (sac-TMT, 佳泰莱) and trastuzumab botidotin (舒泰莱), covering breast cancer and lung cancer indications. Additionally, nine uniquely designed ADC and novel DC drugs—including cutting-edge directions such as bispecific ADC and radiopharmaceutical conjugate (RDC) are in clinical stage. For high-incidence tumor types in China, such as breast cancer, lung cancer, and gastrointestinal tumors, the Company has initiated nine pivotal studies, while multiple Phase II clinical studies targeting gynecological tumors are progressing steadily. Furthermore, Kelun-Biotech has also developed several non-DC candidates and expanded indications into non-oncology areas.

Over the past year, Kelun-Biotech has presented multiple research findings at international academic conferences and published in authoritative journals: three were selected for oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, and three were selected as Late-Breaking Abstracts (LBA) for oral presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Among these, the results of the OptiTROP-Lung04 study of sac-TMT for treating EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) after TKI therapy were presented at the Presidential Symposium session of ESMO (Free ESMO Whitepaper) and simultaneously published in The New England Journal of Medicine, highlighting its global academic and clinical value.

In terms of commercialization, Kelun-Biotech has formed a competitive initial product portfolio. Its core product, the TROP2-directed ADC sac-TMT, has been approved in China for three indications: second-line and above triple-negative breast cancer, second-line and third-line EGFR-mutated NSCLC. The HER2-directed ADC trastuzumab botidotin was approved last year for second-line and above HER2-positive breast cancer, becoming the first domestically developed HER2-directed ADC approved for this indication. Furthermore, the anti-EGFR monoclonal antibody Cetuximab N01 (达泰莱) for RAS wild-type colorectal cancer and the anti-PD-L1 monoclonal antibody tagitanlimab (科泰莱) for nasopharyngeal carcinoma have been launched. Another small-molecule RET inhibitor A400 is expected to be approved within the year, bringing the total number of commercialized products in China to five. Currently, three of the Company’s commercialized products, covering five indications, have been included in the National Reimbursement Drug List (NRDL), further benefiting a broad population of cancer patients.

While strengthening its presence in the domestic market, Kelun-Biotech is actively expanding overseas. It has established collaborations with MSD, Ellipses, Windward Bio and Crescent Biopharma to maximize the value of its pipeline value and corporate worth. Among these, MSD is evaluating 16 global Phase III clinical studies of sac-TMT.

The breakthroughs in both clinical development and commercialization are driven by the Company’s sustained investment in innovative R&D. With over a decade of accumulation in the ADC field, Kelun-Biotech’s proprietary OptiDC platform enables differentiated design of drug candidates, which combines specific targets or targeting mechanisms with the most suitable payload-linker strategy to balance efficacy and safety. Additionally, the company is adopting a "multi-pronged" innovation strategy to continuously enhance platform capabilities. By exploring novel targets, new payloads, and diverse conjugation technologies, it is expanding the application boundaries across both oncology and non-oncology fields.

Looking ahead, Kelun-Biotech will consolidate its foundations in R&D, technologies, platforms, and operations by executing five key development strategies. Concurrently, the Company will elevate its globalization strategy, enhancing its capabilities in product development, registration, and commercialization in ex-China market, advancing on its path to becoming a world-class biopharmaceutical company.

Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation

On January 15, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, reported it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies.

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The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products. Hoth expects to activate clinical trial sites and initiate the study across multiple European countries.

In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19, 2026, positioning the program for rapid, multi-national clinical execution.

"This marks a meaningful regulatory inflection point for Hoth and our oncology-focused pipeline," said Robb Knie at Hoth Therapeutics. "Regulators have confirmed the acceptability of our application for this cancer-related indication."

The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment. These side effects can negatively impact quality of life, disrupt treatment schedules, and increase overall healthcare burden.

Hoth expects to activate sites, initiate patient enrollment, and advance the program into active clinical execution, representing a critical step toward validating a potential new supportive-care therapy for oncology patients.

(Press release, Hoth Therapeutics, JAN 15, 2026, View Source [SID1234662062])