On August 21, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company’s proprietary PD-L1/4-1BB bispecific antibody, as a monotherapy for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).

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Opamtistomig is the first PD-L1/4-1BB bispecific antibody globally to enter NDA review and was granted Priority Review by the CDE on July 10, 2026. If approved, Opamtistomig would become the world’s first approved antibody drug directly targeting 4-1BB, as well as the first approved agonistic antibody. This milestone would also make 4-1BB the fourth immuno-oncology target worldwide with an approved therapy, following PD-1/PD-L1, CTLA-4 and LAG-3.

The NDA is supported by positive results from a registrational clinical study led by Professor Shen Lin of Peking University Cancer Hospital and conducted across 34 clinical sites. The study completed enrollment of 96 patients with EP-NEC in August 2025. Detailed results are planned for presentation at a leading international medical congress.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The acceptance of Opamtistomig’s NDA marks a major milestone in our mission to develop differentiated immunotherapies for patients with high unmet medical needs. Opamtistomig has received multiple regulatory designations that have accelerated its development, including Breakthrough Therapy Designation and Priority Review from China’s CDE, Orphan Drug Designation and Fast Track designation from the U.S. FDA, and Orphan Drug Designation from the European Medicines Agency.

As the first 4-1BB-targeting bispecific antibody globally to advance into registrational clinical development, Opamtistomig represents a significant breakthrough in the treatment of EP-NEC, a highly aggressive, immunologically ‘cold’ tumor for which there are currently no approved therapies worldwide. Beyond EP-NEC, we are advancing our clinical program across multiple high-burden indications, including non‑small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, and ovarian cancer. Clinical data generated from seven indications have shown promising antitumor activities and support the broad therapeutic potential of Opamtistomig.

We believe Opamtistomig has the potential to become a cornerstone of next-generation immunotherapy and to establish a new paradigm for T-cell agonist development. The NDA acceptance represents an important validation of our differentiated approach and brings us one step closer to delivering a novel treatment option to patients with limited therapeutic alternatives."

Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, added: "The acceptance of Opamtistomig’s NDA marks a critical step forward as Leads Biolabs transitions toward commercialization. Since our founding, we have deliberately moved beyond the highly competitive PD-1/PD-L1 space to pursue differentiated mechanisms and address areas of significant unmet medical needs, with 4-1BB representing one of the most promising frontiers in immuno-oncology.

Today, Opamtistomig stands poised to become the world’s first approved 4-1BB-targeting drug. This achievement reflects our 14-year commitment to differentiated innovation and our determination to tackle some of the most challenging targets in oncology.

We are grateful to the patients, investigators, clinical research teams, regulatory authorities, and all our employees and partners who have contributed to the development of Opamtistomig. We will work closely with regulatory authorities throughout the review process to bring Opamtistomig to patients as quickly as possible."

About EP-NEC

Neuroendocrine carcinoma ("NEC") is a highly malignant immunologically "cold" tumor, accounting for approximately 10% to 20% of neuroendocrine neoplasms. NEC may arise in various organs, including the lung, gastrointestinal tract and bladder. NEC can be classified into pulmonary NEC and extrapulmonary NEC. EP-NEC shares the highly aggressive and metastatic characteristics of small cell lung cancer ("SCLC"), progresses rapidly, and most patients with NEC present with advanced-stage disease or distant metastases at diagnosis. Systemic treatment options for NEC are limited, with suboptimal efficacy and poor prognosis.

There are currently no therapies specifically approved by regulatory authorities worldwide for EP-NEC. First-line treatment for advanced EP-NEC primarily consists of platinum-based chemotherapy, with an objective response rate ("ORR") of approximately 30% to 50% and a median overall survival ("mOS") of only around one year. There is no standard treatment following progression on first-line therapy. Second-line treatment options may include oxaliplatin-based FOLFOX, irinotecan-based FOLFIRI, CAPTEM with or without bevacizumab, or temozolomide monotherapy. However, the efficacy of these treatment options remains limited, with an ORR of approximately 10% to 25% and an mOS of approximately eight months. Accordingly, there remains a substantial unmet medical need for patients with advanced EP-NEC, underscoring the urgent need for new and effective treatment options.

About Opamtistomig

Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across multiple indications, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB-targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors, and has the potential to deliver durable, long-tail survival benefits. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 21, 2026, View Source [SID1234670275])

On August 21, 2026 Henlius (2696.HK) reported its interim results for the 2026 fiscal year. During the reporting period, the company showcased strong organic growth momentum and sustainable earnings generation, with revenue reaching RMB 3.5882 billion, a 27.3% increase YoY, and net profit amounting to RMB 430.4 million, up 10.3% YoY. In the first half of 2026, Henlius reported non-IFRS profit of RMB 572.3 million, a 46.7% YoY increase, and adjusted EBITDA (a non-IFRS measure) of RMB 904.1 million, rising 35.2% YoY. Key financial and operational metrics maintained a steady upward trajectory. Driven by sustained global growth of its core products and end-to-end lean operations across the entire value chain, the company continues to strengthen both revenue scale and earnings quality.

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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "2026 marks a pivotal year of acceleration in Henlius’ journey toward becoming a C-MNC. In the first half of the year, our core products continued to generate tangible value through global commercialization, while multiple differentiated pipeline assets entered critical stages of value validation. The benefits of this dual-engine growth model are increasingly taking shape. Looking ahead, we will remain anchored in addressing unmet patient needs, build on the virtuous cycle of ‘global commercialization fueling innovation and differentiated innovation driving global expansion’, further deepen our Globalization 2.0 strategy, and advance steadily toward high-quality, sustainable growth."

Global Commercialization Advances Across Multiple Fronts, Core Portfolio Reinforces the Foundation for Growth

As of the reporting period, Henlius has 10 products approved in over 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania, and has benefited over 1.1 million patients worldwide. In the first half of 2026, the company maintained its strategic focus on key therapeutic areas, including breast cancer, lung cancer, and gastrointestinal cancers. Global product sales revenue amounted to RMB 2.9386 billion, up 14.9% YoY. Notably, sales revenue from ex-China markets increased significantly by 159.4% year on year to RMB 105.3 million, while product profit from ex-China markets reached RMB 59.5 million, more than four times that of the same period last year, further strengthening the company’s ability to generate value from global commercialization.

In the breast cancer therapeutic area, the company continued to advance its "Full-Course, All-Domain, Global" breast cancer treatment landscape, with global sales revenue from its breast cancer product portfolio reaching RMB 1.6983 billion during the reporting period. The four marketed products collectively delivered strong volume growth, with HANQUYOU (trastuzumab, HERCESSI in the U.S. and Zercepac in Europe), HANBEIYOU (pertuzumab, POHERDY in the U.S. and Europe), HANNAIJIA (neratinib), and fovinaciclib generating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5 million, and RMB 10.7 million, respectively. In the first half of 2026, HANBEIYOU received sequential marketing authorizations from the European Commission and China’s NMPA, marking it as the first and only** Chinese-developed pertuzumab biosimilar approved across all three major markets—China, the U.S., and the EU. In combination with HANQUYOU, it establishes the first Chinese-developed dual HER2-targeted regimen combining trastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning the treatment continuum from neoadjuvant setting to first-line treatment of advanced disease. Furthermore, the company is accelerating the development of a diversified breast cancer pipeline including lasofoxifene (HLX78), a novel endocrine therapy; dulpatatug* (HLX22), a novel-epitope monoclonal antibody (mAb) targeting HER2; HLX87, a HER2-targeted ADC; HLX97, an oral KAT6A/B inhibitor; HLX49, a HER2 biparatopic ADC; and HLX319, the first Chinese-developed fixed-dose subcutaneous co-formulation of pertuzumab and trastuzumab—all aimed at establishing a comprehensive, multidimensional breast cancer treatment portfolio across the disease continuum.

In solid tumor indications, including lung cancer and gastrointestinal malignancies, a multi-product synergistic strategy is cultivating new growth momentum. Serplulimab (Hetronifly in Europe) recorded global sales revenue of RMB 0.5975 billion in the first half of 2026. In June, the product received approval in China for the perioperative treatment of gastric cancer through a priority review pathway, becoming the first and only*** anti-PD-1 mAb globally to be approved for this indication and thereby addressing a significant unmet need in this treatment setting. In terms of international expansion, serplulimab has secured marketing approvals in over 50 countries and regions. During the reporting period, it has obtained approvals for three additional first-line indications—non-squamous non-small cell lung cancer (nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small cell lung cancer (sqNSCLC) in the EU—and has been incorporated into the national healthcare or public reimbursement systems of 12 European countries, including the United Kingdom (UK), Germany, Italy, Spain, and Sweden. HANBEITAI (bevacizumab), another key oncology product in the company’s portfolio, generated sales revenue of RMB 0.2182 billion in the first half of the year, up 87.6% YoY, with a decision on its Biologics License Application expected in the second half of 2026. Furthermore, HLX903, a third-generation oral EGFR-TKI introduced via a licensing-in arrangement, is expected to receive marketing approval in the first half of 2027 and address targeted treatment needs among patients with EGFR-mutant NSCLC upon approval.

In parallel, mature products including HANLIKANG (rituximab) and HANDAYUAN (adalimumab) continued to deliver stable cash flow contributions in the hematology and autoimmune disease therapeutic areas, generating RMB 335.7 million and RMB 30.4 million in sales revenue and licensing income, respectively, in accordance with the relevant collaboration agreements. HLX14 (denosumab), available in two dosage strengths as BILDYOS (60mg/mL) and BILPREVDA (120mg/1.7mL), secured regulatory approvals in the U.S. and European Union, and UK during the second half of 2025, and contributed sales revenue and licensing income of RMB 73.1 million in the reporting period.

In the first half of 2026, with China as its global headquarters, the company moved swiftly to build out its international proprietary commercialization organization, establishing five core functional pillars—commercial alliance, affiliate commercial, market access and pricing, commercial strategy and operations, and medical affairs—thereby creating a dual-engine model combining in-house commercialization with strategic partnerships. Since the start of 2026, the company has announced three major international strategic collaborations in succession, reinforcing its Globalization 2.0 strategy across multiple fronts: in high-value mature markets, the company entered into an agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization rights for serplulimab in Japan; to accelerate its presence in emerging markets, the company formed a strategic collaboration with Abbott to expand serplulimab’s commercial footprint across Asia-Pacific, Africa, Central Asia, and Eastern Europe; and to maximize the global potential of its biosimilar portfolio, the company established a broad-based strategic partnership with Sandoz, covering up to ten biosimilar products, thereby substantially broadening the commercial reach of its pipeline assets across key global markets.

Innovation Pipeline Accelerates, Global Biosimilar Expansion Drives Further Value Creation

Meanwhile, the company continues to ramp up its innovation efforts, with R&D expenditure reaching RMB 1.4507 billion during the reporting period, representing a 45.7% YoY increase. The company’s differentiated innovation pipeline continues to expand, and it has now established multiple technology platforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager (TCE), and AI—with more than 50 early-stage pipeline molecules in reserve, covering therapeutic areas including oncology, immunology and inflammation, neuroscience, and metabolism diseases.

As a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, HLX43 has demonstrated encouraging preliminary efficacy and a favorable safety profile across multiple solid tumors, including NSCLC. Its phase 2 and phase 2/3 international multi-center studies in NSCLC are advancing across regions including China, Europe, the United States, Japan, and Australia. Specifically, the phase 2/3 study in advanced sqNSCLC has received implied approval from Japan’s PMDA and has dosed its first patient in China. In addition, the phase 1b/2 study of HLX43 in combination with serplulimab or pimurutamab (HLX07) for the treatment of advanced/metastatic colorectal cancer (mCRC) has also completed first-patient-in dosing in China. To date, the company has initiated more than ten clinical studies of HLX43 as monotherapy or in combination regimens, with over 1,500 patients enrolled globally, continuing to evaluate its broad therapeutic potential across multiple solid tumors.

Other key pipeline assets are also advancing efficiently. Among them, dulpatatug* is making steady progress in an international multi-center phase 3 clinical study that features a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer. First patient enrollment has been completed across a broad geographic footprint, including China, the U.S., Europe, Japan, Australia, South Korea, and Latin America. Concurrently, a phase 2 study of dulpatatug* for HER2-low breast cancer and a phase 2/3 study of dulpatatug* in combination with the HER2-directed ADC HLX87 for first-line treatment of HER2-positive breast cancer are also advancing steadily. The phase 2/3 clinical trial of pimurutamab in combination with serplulimab and chemotherapy for first-line treatment of advanced sqNSCLC has completed clinical trial notification with Australia’s Therapeutic Goods Administration (TGA) and has reached first patient dosing in China. Meanwhile, next-generation innovative molecules with BIC/FIC potential, including HLX3901 (DLL3 x DLL3 x CD3 x CD28 tetra-specific TCE), HLX3902 (STEAP1 x CD3 x CD28 tri-specific TCE), HLX48( c-MET x EGFR bispecific ADC) , HLX97 (small-molecule KAT6A/B inhibitor) and HLX316 (B7-H3 sialidase fusion protein), are advancing efficiently in parallel with high efficiency, continuously strengthening the company’s long-term growth pipeline. Furthermore, the Company will accelerate the development of early-stage assets, including HLX105 (PD-1×IL-2v fusion protein), HLX109 (IL-1R3 mAb), HLX49 (HER2 biparatopic ADC), and HLX403 (CDH17 ADC), with plans to submit Investigational New Drug (IND) applications for these candidates in the second half of 2026. By leveraging its robust CMC capabilities, the company is further increasing the probability of success in developing complex molecules, thereby enhancing overall drug developability. In addition, the company is proactively applying AI-powered approaches to the R&D of innovative molecules such as HLX203, with the goal of continuously improving the efficiency of drug discovery and development.

In line with its Globalization 2.0 strategy, the company remains committed to unlocking the global potential of its biosimilar portfolio through a parallel China-U.S. development and registration pathway. HLX05-N (proposed cetuximab biosimilar) and HLX18 (proposed nivolumab biosimilar) have each received clinical trial authorizations from regulators in both China and the U.S., and dosed their first patient. In addition, HLX13 (proposed ipilimumab biosimilar), HLX15 (proposed daratumumab biosimilar), and HLX17 (proposed pembrolizumab biosimilar) have all achieved first subject dosing in both China and the U.S. The company is continuously accumulating global clinical data for these assets, laying the foundation for subsequent regulatory development and commercialization.

Globalization 2.0 in Place, Integrated End-to-End Capabilities Reinforce the C-MNC Ambition

Henlius has established a comprehensive and systematic capability for global expansion spanning R&D, clinical development, regulatory affairs, manufacturing, and commercialization, steadily advancing its Globalization 2.0 strategy and marking the initial formation of its "C-MNC" model—a China-headquartered multinational biopharmaceutical company.

On clinical development and regulatory affairs, the company has established dedicated in-house teams in Europe, the U.S., Japan, and Australia, with clinical trials concurrently ongoing in nearly 30 countries and regions, in partnership with over 1,000 clinical research centers. During the reporting period, the company received 32 new clinical trial approvals and 25 marketing authorizations worldwide, covering nearly 50 countries and regions. On manufacturing and supply, its delivery capabilities continued to strengthen. To date, the company has completed more than 1,400 GMP commercial production batches and successfully passed over 100 on-site inspections and audits conducted by regulatory authorities worldwide and international collaborators, with a 100% pass rate. During the period, it also completed 9 first commercial shipments and 18 batch shipments to ex-China markets.

In the first half of 2026, the clinical value of Henlius’ core innovative pipeline continued to emerge, while international regulatory and commercialization milestones were achieved in succession. Synergies across global R&D, manufacturing, and commercialization were further strengthened, collectively demonstrating that the company’s Globalization 2.0 strategy has entered a critical phase of accelerated validation. Looking toward 2030, Henlius will continue to pursue innovation-driven and global growth, accelerating its journey toward becoming a C-MNC. The company aims to bring 10 new products to markets worldwide, with over 5 expected to reach European and U.S. markets, and to grow into a globally influential innovative biopharmaceutical company.

(Press release, Shanghai Henlius Biotech, AUG 21, 2026, View Source [SID1234670274])

On August 21, 2026 AbbVie (NYSE: ABBV) reported new data highlighting research programs across its lung cancer portfolio being presented at the 2026 World Conference on Lung Cancer (WCLC), including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The presentations span clinical, translational and real-world data across next-generation immunotherapies and targeted antibody-drug conjugates (ADCs), designed to generate insights into treatment burden, patient experience and biomarker identification that may help inform future research.

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"Our strategy in lung cancer is focused on building a complementary pipeline that brings together next-generation immunotherapies and targeted antibody-drug conjugates with the potential to address different aspects of tumor biology," said Daejin Abidoye, M.D., vice president and therapeutic area head of oncology, solid tumor and hematology at AbbVie. "Exploring the PD-1/VEGF approach represented by ABBV-1480 and the c-Met targeting by Temab-A are important elements of that strategy and may provide a foundation for potential novel combinations as we work to develop more tailored treatment approaches for people living with lung cancer."

Advancing Novel Therapies Across Various Modalities in NSCLC
Multiple presentations across AbbVie’s NSCLC portfolio will showcase new studies and data analyses spanning multiple treatment modalities, highlighting first-line treatment approaches, patient experience and biomarker-informed research.

ABBV-1480 (RC148): AbbVie, in partnership with RemeGen, will present Phase 1b data evaluating the investigational PD-1/VEGF bispecific antibody, ABBV-1480, in combination with platinum-based chemotherapy as a potential first-line treatment for advanced NSCLC. At the 10 mg/kg dose, identified as the recommended Phase 3 dose for further development in combination regimens in both squamous and non-squamous NSCLC, the primary endpoint of objective response rate (ORR) was 90.0% in squamous NSCLC (n=27/30) and 75.9% (n=22/29) in non-squamous NSCLC. The most common treatment-related adverse events (TRAEs) were a decrease in white blood cells, neutrophil, platelet counts and anemia. No grade ≥3 hemorrhages with the 10 mg combinations were observed. This overall manageable safety profile supports ongoing Phase 3 development for this novel investigational asset.1

Telisotuzumab adizutecan (Temab-A), an investigational c-Met-directed ADC with a topoisomerase 1 inhibitor (Top1i) payload: Building on encouraging preliminary activity2 observed in heavily pretreated patients, AbbVie initiated a Phase 1b/2 M24-536 study (NCT06772623). The study is evaluating a platinum-free combination of Temab-A and a PD-1 inhibitor, as a potential first-line treatment for advanced non-squamous NSCLC. The study includes analyses of c-Met and PD-L1 expression to identify the patients most likely to benefit from treatment.3 Temab-A is also being studied in epidermal growth factor receptor (EGFR)-mutated NSCLC as monotherapy or in combination with osimertinib (NCT07155187).
Clinical Data Showcasing the Potential of ABBV-706 in SCLC
ABBV-706 is an investigational SEZ6-targeted ADC with a Top1i payload, being evaluated in SCLC. Presentations at WCLC include research that further characterizes the program and the potential role of SEZ6 in SCLC.

As previously reported, ABBV-706 demonstrated an ORR of 82% in patients with relapsed/refractory SCLC post platinum-based chemotherapy (n=17).4 New safety analyses from 240 patients who received ABBV-706 monotherapy showed generally manageable hematologic and gastrointestinal toxicities, with the most common gastrointestinal events, including nausea (35.8%), vomiting (17.5%) and diarrhea (10.8%), being largely low grade and most requiring no dose adjustments.5 Grade ≥3 treatment-related pneumonitis or interstitial lung disease was reported in 1.7% of patients receiving ABBV-706 monotherapy.6 Hematologic toxicities, including anemia, neutropenia and thrombocytopenia, were among the most common TRAEs.5 Serious TRAEs occurred in 12.5% of patients. ABBV-706 is being evaluated as monotherapy in a Phase 3 study (NCT07365241) and in combination with atezolizumab in the Phase 2 study (NCT07155174), in SCLC.

Real-world research demonstrated that SEZ6 is broadly expressed in 91% of SCLC patients overall and in more than 96% of patients with brain or liver metastases. These findings further support SEZ6 as a potential therapeutic target in SCLC and other SEZ6-expressing tumors. 7
Additional details on key presentations are available below, and the full WCLC 2026 abstracts are available online.

For information about AbbVie’s clinical trial efforts in lung cancer, please visit clinicaltrials.gov.

Title

Date/Time

Session

Abstract Number

Radiomic Biomarkers on Baseline CT

Scans for Predicting Response to

Teliso-V in NSCLC: A Machine

Learning Approach

Monday,
September 14

10:30AM-12:00PM KST

Poster

Session: P2.077-248.

Pathology and
Biomarkers

P2.137.

Telisotuzumab Adizutecan and PD-1 Inhibitor

in Untreated Advanced Non-Squamous

Non-Small Cell Lung Cancer: A Phase

1b/2 Study

Monday,
September 14

10:30AM-12:00PM KST

Poster

Session: P2.304-390.

Clinical Trials in
Progress

P2.374.

Efficacy and Safety of ABBV-706 Versus

Standard of Care in Relapsed/Refractory

Small Cell Lung Cancer: A Phase 3 Study

Monday,
September 14

10:30AM-12:00PM KST

Poster

Session: P2.304-390.

Clinical Trials in
Progress

P2.377.

A Phase 3, Randomized, Double-Blind Trial

of RC148 (ABBV-1480) Plus Chemotherapy

in First-Line Squamous Non-Small-Cell

Lung Cancer

Monday,

September 14

10:30AM-12:00PM KST

Poster

Session: P2.304-390.

Clinical Trials in
Progress

P2.379.

Peripheral Neuropathy With Teliso-V in

c-Met- Protein Overexpressing NSCLC

in LUMINOSITY: Clinical Characteristics

and PROs

Monday,

September 14

2:17-2:25 PM KST

Poster

Session: PT2.01.

Metastatic
NSCLC –
Antibody-Drug
Conjugate and
Cytotoxic
Therapy

PT2.01.05.

Telisotuzumab vedotin Demonstrates Potent

Antitumor Efficacy in Preclinical Models of

Diffuse Pleural Mesothelioma

Monday,

September 14

2:17-2:25 PM KST

Poster

Session: PT2.05.

Mesothelioma,
Thymoma, and
Other Thoracic
Tumors

PT2.05.05.

Hematologic and Gastrointestinal Toxicity of

ABBV-706 in Advanced Solid Tumors: Safety

Profile from the First-in-Human Study

Tuesday,

September 15

9:30-11:00 AM KST

Poster

Session: P3.282-354.

Small Cell Lung
Cancer and
Neuroendocrine
Tumors

P3.316.

SEZ6 Is Expressed Across Major Clinical and

Demographic Groups of SCLC Patients:

Evidence From a US Clinicogenomic

Database

Tuesday,

September 15

9:30 AM-11:00 AM KST

Poster

Session: P3.282-354.

Small Cell Lung
Cancer and
Neuroendocrine
Tumors

P3.340.

RC148 (ABBV-1480, PD-1/VEGF Bispecific

Antibody) Plus Chemotherapy in First-Line

Locally Advanced or Metastatic Non-Small-

Cell Lung Cancer

Tuesday,

September 15

12:52-1:02 PM KST

Oral Presentation

Session: OA14.

The Breakthrough
Immunotherapy
for Advanced
NSCLC

OA14.01.03.

High Burden and Limited Evidence in Late-

Line ES-SCLC: A Structured Review of

Clinical and Humanistic Outcomes

E-Poster

EP13 Small Cell
Lung Cancer and
Neuroendocrine
Tumors

EP13.05.

Pneumonitis/Interstitial Lung Disease in the

First-in-Human ABBV-706 Study: Incidence,

Management, and Risk Factors

E-Poster

EP13 Small Cell
Lung Cancer and
Neuroendocrine
Tumors

EP13.32.

Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.

AbbVie holds exclusive rights from RemeGen to develop, manufacture, and commercialize ABBV-1480 outside of the Greater China territory.

Emrelis (telisotuzumab vedotin-tllv) is an approved medicine being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses.

(Press release, AbbVie, AUG 21, 2026, View Source [SID1234670272])

On August 21, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported it has completed the acquisition of Kartos Therapeutics, a clinical-stage biopharmaceutical company adding late-stage MDM2 inhibitor navtemadlin in Phase III clinical development in myelofibrosis.

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About navtemadlin
Navtemadlin is an investigational oral MDM2 inhibitor being developed as an add-on therapy to ruxolitinib for patients with myelofibrosis who have a suboptimal response to ruxolitinib. The Phase III POIESIS study is evaluating whether the addition of navtemadlin could improve clinical outcomes compared with ruxolitinib alone in this patient population. Early clinical data demonstrate navtemadlin has the potential to transform suboptimal responses to standard of care ruxolitinib into clinically meaningful responses in patients with intermediate and high risk TP53wt myelofibrosis, to provide both enhanced clinical outcomes and potential disease-modifying benefit.

About myelofibrosis
Myelofibrosis is a myeloproliferative neoplasm, frequently linked to alterations in the JAK/STAT pathway, in which patients develop bone marrow fibrosis due to the abnormal proliferation of hematopoietic stem cells and secretion of fibrogenic cytokines. As marrow function declines, blood production shifts to other organs, most often the spleen, leading to splenomegaly. Myelofibrosis is characterized by bone marrow failure, fibrosis, splenomegaly and a high symptom burden that can significantly affect quality of life, including fatigue, night sweats and other progressive symptoms. It also carries a risk of transformation to acute myeloid leukemia. The median age at diagnosis is approximately 67–69 years and the condition affects around 1.5 per 100,000 people in the U.S. and Europe. Approximately 75–89% of patients are intermediate- or high-risk at diagnosis and more than 95% are TP53wt. Ruxolitinib, a JAK inhibitor, is the first-line standard of care; however, it is estimated that a significant proportion of patients have an initial suboptimal response and approximately 50%-75% discontinue treatment after three years. Median overall survival is typically one to two years after treatment discontinuation, underscoring the need for new strategies that can increase the number of patients that can achieve optimal clinical outcomes.

(Press release, Ipsen, AUG 21, 2026, View Source [SID1234670270])

On August 20, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

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"Advancing RAD202 into Cohort 4 marks a significant step forward in the development of one of our most promising therapeutic candidates," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The DSMC’s recommendation supports the favorable safety profile observed to date and allows us to continue evaluating higher dose levels in patients with HER2-positive advanced solid tumors. As we execute on our clinical development strategy, we remain focused on unlocking the full potential of RAD202 and generating meaningful data that could support a differentiated radiotherapeutic option for HER2-positive patients in need of new treatment alternatives."

The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia. The announcement of the previous dose level in this study of 130mCi was released on 8 April 2026.

About 177Lu-RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, AUG 20, 2026, View Source [SID1234670267])