On July 23, 2026 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8013, an antibody drug conjugate (ADC) that targets CD25. The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8013 and to determine the recommended Phase 2 dose.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CD25, also known as interleukin-2 receptor alpha chain (IL-2Rα), is a 55 kDa transmembrane glycoprotein encoded by the IL2RA gene, predominantly expressed on activated T and B cells, regulatory T cells (Tregs), and various hematologic malignancies. BAT8013 was developed using Bio-Thera’s anti-CD25 antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. CD25 is differentially overexpressed on Tregs in the solid tumor microenvironment. Eliminating Tregs using BAT8013 is expected to potentiate the efficacy of other immune-oncology agents like PD-1 and PD-L1 mAbs.

A series of preclinical studies have shown that BAT8013 has good stability and safety and has high anti-tumor activity in combination with Bio-Thera’s PD-1 inhibitor, BAT1308. The small molecule topoisomerase I inhibitor payload carried by BAT8013 has a strong cell membrane penetration ability, so when the target Treg cells are killed, the payload can be released and further kill nearby Treg cells, producing a bystander. BAT8013 has demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacological studies and is a potential "best-in-class" ADC that targets CD25, representing another important milestone in the company’s research and development in the field of innovative oncology drugs.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8013 is designed to assess the safety and tolerability of BAT8013. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. In addition, Bio-Thera Solutions is developing several additional ADCs targeting Folate Receptor alpha, Trop2 and Her2 along with additional innovative oncology assets directed at important IO targets, including novel bispecific targeting PD-L1/4-1BB and PD1/IL15, all in early-stage clinical studies.

(Press release, BioThera Solutions, JUL 23, 2026, View Source [SID1234669401])

On July 23, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported a positive profit alert for the six months ended June 30, 2026 (the "Reporting Period").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on a preliminary review of the Company’s unaudited management accounts for the Reporting Period, the revenue is expected to range between US$120 million (equivalent to approximately HK$941 million) and US$125 million (equivalent to approximately HK$980 million), representing an increase of approximately 19% to 24% compared with approximately US$101 million for the corresponding period in 2025. The profit for the Reporting Period is expected to range between US$62 million (equivalent to approximately HK$486 million) and US$67 million (equivalent to approximately HK$525 million). Total adjusted profit [1] is expected to range between US$70 million (equivalent to approximately HK$549 million) and US$75 million (equivalent to approximately HK$588 million).

The expected revenue growth and scaled profitability are primarily attributable to:

Continued strategic collaborations with global multinational pharmaceutical companies, including the potential 10-year long-term strategic collaboration with AstraZeneca and the global strategic collaboration with Bristol Myers Squibb.
Newly secured out-licensing and collaboration agreements for innovative products, such as the licensing agreement with Solstice Oncology, as well as milestone payments triggered by the advancement of previously out-licensed programs.
Strong business growth of Nona Biosciences, including revenue generated from antibody transactions and antibody discovery, such as the platform collaboration with Lonza in central nervous system.
With seven consecutive profitable half-years, Harbour BioMed has officially entered a phase of "normalized profitability," further validating the sustainability and replicability of the business model underpinning this platform-based biopharmaceutical group.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "Our expected profitability in the first half of 2026 marks an important milestone in Harbour BioMed’s development and strongly validates our differentiated business model. The value of our proprietary technology platforms is gaining recognition through a growing number of deep strategic partnerships with multinational pharmaceutical companies and leading global biotechnology companies. More importantly, these partnerships are not one-off transactions—they are evolving into a sustainable financial foundation that enables us to continuously discover and develop innovative biotherapeutics for patients worldwide. Looking ahead, we will build on this momentum through continued innovation and high-impact collaborations to deliver sustainable long-term growth."

Global Strategic Collaborations Fuel Continued Strong Revenue Growth

The Company’s strong earnings growth was primarily driven by the continued execution and expansion of high-value strategic collaborations with global partners. Harbour BioMed has successfully transformed its proprietary technology platforms and licensing business into a robust and recurring revenue engine.

During the Reporting Period, several major strategic collaborations made significant contributions to revenue. In December 2025, the Company entered into a long-term global strategic collaboration with Bristol Myers Squibb (BMS) to jointly discover and develop next-generation multi-specific antibodies. Under the terms of the agreement, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion. The Company also expanded its strategic collaboration with AstraZeneca to include antibody-drug conjugates (ADCs) and T-cell engager (TCE) therapeutics. In addition, previously announced licensing partnerships with AstraZeneca, Otsuka, Pfizer, Windward Bio and other global pharmaceutical companies continued to generate meaningful revenue. To date, Harbour BioMed’s proprietary technology platforms have been applied across more than 380 drug discovery programs spanning multiple therapeutic areas, with more than 20 molecules having advanced into IND-enabling studies or clinical development, reinforcing the Company’s leadership in next-generation biologics innovation.

Beyond licensing collaboration, Nona Biosciences has entered a period of rapid growth. Revenue generated from its platform-based technology licensing and discovery services, together with milestone payments from existing collaborations, has become another important pillar of the Company’s business. These collaborations not only reflect the strong recognition of the Harbour Mice platform by multinational pharmaceutical companies, innovative biotechnology companies and leading academic institutions worldwide, but also underscore Harbour BioMed’s successful transformation into a sustainable cash-generating business with enhanced financial resilience and a significantly strengthened risk profile.

Technology Platforms and AI Innovation Strengthen the Value Foundation

Harbour BioMed has embraced artificial intelligence (AI) as a core strategic priority, integrating AI technologies throughout the entire drug discovery and development process. In October 2025, the Company launched the first fully human AI-powered heavy-chain-only antibody (HCAb) generation and screening model enabled by its proprietary Hu-mAtrIx AI platform, establishing a closed-loop workflow encompassing AI-driven design, intelligent screening and experimental validation. The model has already demonstrated strong performance, achieving a target hit rate of 78.5%, significantly improving both discovery efficiency and developability.

During the same month, Harbour BioMed initiated the AI + Biopharmaceutical Ecosystem Alliance, bringing together organizations including Insilico Medicine, Molecule Mind and more to systematically transform the drug discovery process through AI-enabled innovation.

In May 2026, the Company reported encouraging preclinical data for LET003, its first next-generation ACVR2A/2B-targeting monoclonal antibody developed using the Hu-mAtrIx AI platform. In June 2026, Harbour BioMed further strengthened its AI strategy by entering into a comprehensive long-term strategic partnership with BioMap, a global leader in foundation AI models for life sciences. Together, the two companies established MegaStream TechBio, a joint venture dedicated to developing innovative AI-enabled drug pipelines for the global market. By integrating proprietary datasets, domain-specific foundation models and a broad portfolio of innovative programs, MegaStream TechBio aims to build a next-generation AI drug discovery engine centered on intelligent wet-lab/dry-lab integration and personalized, multimodal, multi-attribute generative AI models.

Clinical Pipeline Continues to Unlock Long-Term Value

Harbour BioMed continues to make meaningful progress across its differentiated pipeline. The Company now has nearly 30 innovative product candidates spanning immunology, oncology, obesity and metabolic diseases, and central nervous system (CNS) disorders—therapeutic areas with significant unmet medical needs. Multiple programs have advanced into clinical development.

For respiratory and immunological diseases, batoclimab, the Company’s anti-FcRn monoclonal antibody, is the first drug in China to have completed the full clinical development pathway from Phase 1 through pivotal clinical trials. The biologics license application (BLA) has been submitted, and the therapy has the potential to become an important treatment option across multiple autoimmune diseases. Phase 1 data for the Company’s ultra-long-acting anti-TSLP antibody HBM9378 demonstrated a substantially extended half-life, supporting the potential for twice-yearly dosing and reinforcing its best-in-class potential. Initial Phase 2 data in asthma are expected in the second half of 2026, while the Phase 2 SIRIUS study in chronic obstructive pulmonary disease (COPD) has already dosed its first patients. Meanwhile, another ultra-long-acting, TSLP-targeting bispecific antibody, HBM7575, has dosed the first subject in its Phase 1 study for atopic dermatitis and recently received IND clearance for the treatment of asthma.

For immuno-oncology, HBM4003, the Company’s anti-CTLA-4 heavy-chain-only antibody, has demonstrated best-in-class potential. In a Phase 2 study in microsatellite stable (MSS) metastatic colorectal cancer (mCRC), HBM4003 in combination with tislelizumab achieved an objective response rate (ORR) of 34.8% and a median progression-free survival (mPFS) of 4.2 months. Based on these encouraging results, the Company entered into a licensing agreement and equity partnership with Solstice Oncology in February 2026, receiving upfront consideration valued at over $105 million and being eligible for milestone payments of up to approximately US$1.1 billion.

In addition, the Company’s HBM7004, a bispecific antibody for solid tumors, has received IND clearance from the U.S. Food and Drug Administration (FDA), while its IND application has been accepted by China’s National Medical Products Administration (NMPA).

From its foundational proprietary technology platforms and AI-driven innovation to the advancement of a differentiated clinical pipeline and the execution of high-value global partnerships, Harbour BioMed has built a self-reinforcing innovation ecosystem. The Company’s sustained profitability over multiple years demonstrates the successful execution of its unique business model, creating a virtuous cycle that converts technology innovation into long-term commercial value.

Looking ahead, supported by an expanding global partner network, a deeply integrated AI- and automation-enabled R&D platform, and a steadily advancing differentiated pipeline, Harbour BioMed is well positioned to continue delivering sustainable growth. With a strong financial foundation and industry-leading technological capabilities, the Company is evolving from a technology adopter to a technology leader, bringing more innovative antibody therapeutics to patients worldwide.

(Press release, Harbour BioMed, JUL 23, 2026, View Source [SID1234669399])

On July 23, 2026 Laminar Pharma, a leader in the development of innovative therapies based on a novel membrane lipid therapy approach, reported that the last patient has completed their last visit (LPLV) in the company’s Phase 2b/3 clinical trial of its lead asset, LAM561, in patients with newly diagnosed glioblastoma. This milestone marks the conclusion of the active clinical monitoring phase of the trial "LAM561 With RT and TMZ for Adults with Glioblastoma" (NCT04250922) which evaluates LAM561 in combination with standard of care (SoC). The company expects to report topline results from this study during the second quarter of 2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Achieving LPLV represents a key operational step as the trial progresses through the data lock and the highly anticipated overall survival (OS) analysis, triggered once 90 OS events were reached.

This development follows the interim unblinded data announced in March 2025, after the Independent Data Monitoring Committee (IDMC) recommendation in late 2024 for the study to be unblinded and continue without modification. At that time, Laminar Pharma reported a potential clinically relevant improvement in progression-free survival (PFS) for MGMT-methylated patients receiving LAM561 plus SoC compared to the placebo control group. Laminar Pharma’s commitment to international ethical principles for post-trial access and continued patient care is demonstrated by the continuation of LAM561 treatment for patients who were experiencing clinical benefit according to their treating physicians, who prescribed continuing treatment beyond study completion through a compassionate use program that will be available for these patients until marketing authorization is granted. The safety profile observed throughout the trial remained consistent with prior studies, with the combination of LAM561 and SoC proving well-tolerated among the 144 enrolled patients.

"Reaching the ‘last patient, last visit’ is a milestone for Laminar Pharma and brings us one step closer to our goal of delivering a much-needed therapy to patients battling one the most aggressive forms of brain cancer", said Dr. Pablo Escribà, CEO of Laminar Pharma. "We extend our deepest gratitude to the patients, their families, and the clinical investigators and healthcare personnel who have made this trial possible."

Laminar’s LAM561 Phase 2b/3 trial is an international, multicenter, randomized, double-blind (until interim analysis completion), placebo-controlled clinical trial designed to assess the efficacy and safety of LAM561 in combination with radiotherapy and temozolomide in patients with newly diagnosed, IDH-wildtype glioblastoma. The study consisted of two randomized (1:1) arms between LAM561+SoC and placebo+SoC. The primary efficacy endpoint will be overall survival, along with PFS using the Response Assessment in Neuro-Oncology (RANO) criteria.

About Glioblastoma

Glioblastoma (GBM) is the most common primary malignant brain tumor and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumors. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for GBM patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and approximately 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes.

About LAM561

LAM561 (2-hydroxyoleic acid –2-OHOA, idroxioleic acid sodium) is a synthetic derivative of oleic acid and Laminar’s most advanced product under development, which is taken orally. This drug regulates the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promote tumor growth and affecting tumors in the brain. LAM561 is currently being evaluated in a phase 2b/3 trial and has shown promising preliminary clinical activity in the treatment of aggressive brain tumors, including glioblastoma (Lopez et al., 2023).

(Press release, Laminar Pharma, JUL 23, 2026, View Source [SID1234669398])

On July 23, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported that an abstract for the investigator-initiated EFTISARC-NEO Phase II trial evaluating its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), has been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place 23–27 October 2026 in Madrid, Spain.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract reports health-related quality of life (HRQoL) data from EFTISARC-NEO. Details of the accepted abstract and poster are as follows:

Title Health-related quality of life (HRQoL) during neoadjuvant treatment with eftilagimod alfa, pembrolizumab and radiotherapy in patients with soft tissue sarcoma (STS) – results from EFTISARC-NEO trial

Trial EFTISARC-NEO (investigator-initiated Phase II; NCT06128863)

Session category ePoster

First Author Pawel Teterycz, M.D., Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO), Warsaw, Poland

Presentation # 3788eP

Abstract online Monday, 19 October 2026 at 00:05 CEST (ESMO website)

The full abstract will be published on the ESMO (Free ESMO Whitepaper) Congress 2026 website on Monday, 19 October 2026. The presentation will subsequently be made available on Immutep’s website.

(Press release, Immutep, JUL 23, 2026, View Source;v=undefined [SID1234669397])

On July 23, 2026 Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) reported clarification on the primary endpoints from the Phase 3 EPCORE DLBCL-1 study evaluating monotherapy epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, compared with investigator’s choice of chemoimmunotherapy (CIT) of either rituximab plus gemcitabine plus oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation. Genmab and AbbVie previously announced topline results of the study on January 16, 2026, and additional study results were subsequently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress on June 12, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EPCORE DLBCL-1 is a global, Phase 3, open label, multi-center, randomized clinical trial with prespecified primary endpoints that differ by region. In the United States, where overall survival (OS) is the sole primary endpoint, the study did not demonstrate a statistically significant improvement in OS and therefore did not meet its primary endpoint.

Additional results of the EPCORE DLBCL-1 study will be submitted for publication in a peer-reviewed medical journal.

About Epcoritamab
Epcoritamab is approved under the FDA’s accelerated approval pathway for the treatment of adult patients with R/R DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab and AbbVie continue to evaluate the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies. Data from EPCORE DLBCL-2, evaluating fixed duration epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), in patients with newly diagnosed DLBCL are anticipated in 2026. This follows the recent disclosure of topline results from the Phase 3 EPCORE DLBCL-4 study, evaluating fixed-duration epcoritamab in a chemotherapy-free combination with lenalidomide in patients with R/R DLBCL.

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy.

Please see local country prescribing information for all labeled indication and safety information.

About the EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.

More information on this trial can be found at View Source

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.ii,iii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.iv DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.v,vi DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.

(Press release, Genmab, JUL 23, 2026, View Source [SID1234669396])