On March 9, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the full year and fourth quarter 2025, and provided an overview of recent business highlights.

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!

"We are pleased with our progress in 2025, having doubled LOQTORZI sales while completing the transformation from a biosimilars company to an innovative oncology company focused on overcoming immune resistance in cancer. At the same time, we continued to reduce our overall debt since its peak in 2024 by over 90% to $38.8 million," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We are now strategically positioned with growing revenues from our foundational PD-1 inhibitor, potential deal opportunities across the portfolio and geographies, and two promising pipeline candidates with multiple 2026 clinical readouts."

"We are aggressively advancing casdozokitug, our first-in-class IL-27 targeting antibody in 1L hepatocellular carcinoma, which demonstrated a 17% complete response rate in a previous Phase 2 study," said Rosh Dias, MD, Chief Medical Officer. "At the same time, we also have a broad clinical program with tagmokitug, our highly selective CCR8 targeting cytolytic antibody, in multiple tumor cohorts including gastrointestinal cancers and head and neck cancer with strong scientific and clinical rationale in each. We now look forward to initiating the combination study with J&J’s T-cell engager pasritamig, in metastatic castration resistant prostate cancer (mCRPC), in the second half of this year."

"Tumor targeted T regulatory cell depleting agents have broad potential applicability in combination with immune agents like TCE and toripalimab, ADCs, T-cell engagers and radiotherapy," said Theresa LaVallee, PhD, Coherus Chief Scientific and Development Officer. "With a potentially best-in-class molecule we look forward to advancing tagmokitug combinations both with partners and with LOQTORZI."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

LOQTORZI net revenue for Q4 2025 was $12.4 million, an 11% increase over $11.2 million in Q3 2025 and a 64% increase over $7.5 million in Q4 2024. Growth in Q4 2025 was driven largely by higher patient demand from both new account starts as well as repeat use in existing accounts. Average duration of treatment among existing patients also continued to grow.
LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC,) representing an overall $250 million addressable market.
In December 2025, compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) were presented at ESMO (Free ESMO Whitepaper) Asia. In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median OS of 64.8 months, nearly double that of chemotherapy alone (33.7 months), and an observed 38% reduction in risk of death (HR 0.62; 95% CI, 0.45–0.85).
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Preclinical and clinical biomarker research for tagmokitug was published in the December 2025 issue of Molecular Cancer Therapeutics, describing the high selectivity, picomolar binding affinity and significant effector mediated killing of CCR8+ cells. The findings showed that tagmokitug demonstrated no off-target binding and selectively eliminated CCR8+ T regulatory cells and not other T cells, supporting its potential as an anti-cancer treatment.
The Phase 1b tagmokitug/toripalimab combination dose optimization studies in 2L HNSCC and 2L upper GI adenocarcinoma cancers are underway, with initial data readouts expected in mid-2026.
A Phase 1b study evaluating the tagmokitug/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 2H 2026.
A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.
A Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with pasritamig, a T-cell engaging bispecific antibody, is anticipated to begin in 2H 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first line uHCC (unresectable hepatocellular carcinoma) to assess treatment benefit, safety and response biomarkers.

Enrollment is ongoing in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC, with the first data readout expected in mid-2026.
Data presented during ASCO (Free ASCO Whitepaper) GI 2025 demonstrated a 38% overall response rate and a 17% complete response rate with the addition of casdozokitug to the current standard of care.
EQUITY FINANCINGS

In October 2025, the Company sold 4,634,995 shares of common stock and warrants with an exercise price of $0.01 per share to purchase 463,498 shares of common stock for net proceeds of approximately $7.9 million. In February 2026, Coherus sold 28,600,000 shares of its common stock in public offering for proceeds of approximately $47.0 million, net of Underwriters’ discounts and commissions.
FOURTH QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $12.7 million and $7.7 million during the three months ended December 31, 2025 and 2024, respectively, and $42.2 million and $26.4 million during the years ended December 31, 2025 and 2024, respectively. LOQTORZI net product revenue increased $4.8 million and $21.7 million compared to the three months and full year ended December 31, 2024, respectively, driven primarily by volume growth of LOQTORZI, which launched in January 2024. The increase in the full year period was partially offset by a decrease in other revenue primarily driven by a $6.3 million upfront fee recognized in 2024 for the out-license of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) from continuing operations was $4.0 million and $2.8 million during the three months ended December 31, 2025 and 2024, respectively, and $13.8 million and $8.7 million during the years ended December 31, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $31.0 million and $20.8 million for the three months ended December 31, 2025, and 2024, respectively, and $108.9 million and $91.8 million for the years ended December 31, 2025, and 2024, respectively. The increases were primarily due to development costs for casdozokitug and tagmokitug, partially offset by savings from discontinued programs, reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $23.6 million and $29.6 million during the three months ended December 31, 2025, and 2024, respectively, and $100.6 million and $125.5 million during the years ended December 31, 2025, and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures. The year-over-year decrease was further attributable to net charges for write-offs of intangible assets and associated contingent consideration liabilities totaling $4.2 million in 2025 down from $6.8 million in 2024.

Interest expense from continuing operations was $2.3 million and $1.9 million for the three months ended December 2025 and 2024, respectively, and $9.0 million and $10.7 million for the year ended December 31, 2025, and 2024, respectively. Cash paid for interest, which relates to borrowings reflected in both continuing operations and discontinued operations, was $9.9 million and $25.4 million for the years ended December 31, 2025 and 2024, respectively. The year-over-year decrease was primarily due to lower average outstanding debt.

Net (loss) from continuing operations for the fourth quarter of 2025 was $46.9 million, or $(0.39) per share on a diluted basis, compared to a net loss of $46.1 million, or $(0.40) per share on a diluted basis, for the same period in 2024. Net loss for the year ended December 31, 2025, was $183.1 million, or $(1.56) per share on a diluted basis, compared to a net loss of $215.4 million, or $(1.88) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the fourth quarter of 2025 was $40.4 million, or $(0.34) per share on a diluted basis, compared to $39.4 million, or $(0.34) per share for the same period in 2024. Non-GAAP net loss for the year ended December 31, 2025 was $159.2 million, or $(1.36) per share on a diluted basis, compared to a net loss of $166.5 million, or $(1.45) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $172.1 million as of December 31, 2025, compared to $126.0 million as of December 31, 2024. The balance at December 31, 2025 was inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $65.1 million as of December 31, 2025.

Conference Call Information
When: Monday, March 9, 2026, starting at 4:30 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, MAR 9, 2026, View Source [SID1234663361])

On March 9, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 clinical trial evaluating IDE892, an investigational MTA-cooperative PRMT5 inhibitor being developed for patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE892 as a monotherapy agent and in combination with IDE397, IDEAYA’s MAT2A inhibitor, in mid-2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.

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!

"We are excited to have enrolled the first patient in our Phase 1 clinical trial evaluating IDE892 in patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. We designed IDE892 with potential best-in-class properties, including specific biophysical and pharmacokinetic properties that we believe will maximize its therapeutic window and clinical efficacy, both as a monotherapy agent and as a combination partner with our MAT2A inhibitor, IDE397. Next, we look forward to advancing our first-in-class CDKN2A-defiency program to progress our broader corporate strategy of enabling wholly owned rational combinations targeting MTAP-deletion," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE892 was designed to be a potential best-in-class PRMT5 inhibitor, with ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes and observed single-digit nano-molar potency in endogenous MTAP-deleted cell lines, and greater than 50-fold potency differential in MTAP-deleted versus MTAP wild type HCT116 isogenic cell lines. In addition, IDE892 inhibited the arginine dimethylation of a key PRMT5 substrate involved in mRNA splicing, spliceosome protein SmB (SmB-SDMA), with pico-molar potency in MTAP-deleted cell lines with greater than 100-fold potency differential versus an MTAP wild type cell line. IDE892 has demonstrated monotherapy regressions in MTAP-deleted preclinical models, and durable complete responses in combination with IDE397.

Loss of MTAP leads to the accumulation of methylthioadenosine (MTA) and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397. In preclinical studies, dual inhibition of PRMT5 and MAT2A with the combination of IDE892 and IDE397 resulted in potent anti-tumor activity in MTAP-deleted tumor models, including complete and durable responses at well-tolerated doses below those required for monotherapy activity.

IDEAYA has also advanced its CDKN2A-deficiency program and is on track to select a potential first-in-class development candidate in H2 2026 with a target IND in H1 2027. IDEAYA has demonstrated robust monotherapy efficacy with its CDKN2A lead in multiple preclinical models, including in a KRAS mutation pancreatic model. IDEAYA plans to evaluate its CDKN2A-deficiency program preclinically as a monotherapy agent, and in combination with assets in its MTAP-deletion portfolio and potentially other RAS and KRAS targeted assets. CDKN2A-defiency is common in cancer, with a prevalence of over 80% in pancreatic cancer (M. Schutte, et al., Cancer Research, 1997; IDEAYA analysis, TCGA) and is typically co-deleted in MTAP-deletion solid tumors and a common co-alteration with KRAS mutations, particularly in pancreatic cancer, creating rational combination opportunities with MTAP-deletion and KRAS targeted therapies, respectively.

As part of IDEAYA’s strategic prioritization of its proprietary MTAP-deleted pipeline, including IDE397 and IDE892, and the advancement of its CDKN2A-deficiency program, the company has deprioritized its clinical combination activities with Trodelvy and will be concluding enrollment in the ongoing Phase 1/2 trials with Gilead. Based on preliminary data from these trials supporting the mechanistic rationale for the combination in MTAP-deleted cancers, IDEAYA may evaluate additional combinations between IDE397 and other TOP1 payload ADCs in this setting, including IDE034, its B7H3/PTK7 bispecific TOP1 ADC.

MTAP deletion is estimated to occur in 15–20% of non-small cell lung cancer, up to 40% of pancreatic cancer, and approximately 15% of all solid tumors, and is commonly co-deleted with CDKN2A due to the proximity of the two genes on chromosome 9p21. There are no approved therapies for patients with MTAP deletion, highlighting the significant unmet need and important new opportunities for precision therapies.

(Press release, Ideaya Biosciences, MAR 9, 2026, View Source [SID1234663379])

On March 9, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the new drug applications (the "NDAs") for the company’s product, toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the National Medical Products Administration ("NMPA"). JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.

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!

According to data released by GLOBOCAN 2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in China. Immunotherapy (I-O), represented by anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various malignant tumors, including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma. Now, immunotherapy covers nearly all stages of treatment for cancer patients, encompassing adjuvant/neoadjuvant treatment for early-stage tumors, consolidation treatment after radical chemoradiation for locally advanced tumors, and first-line to last-line treatments for advanced tumors. Currently, most immunotherapy drugs in China are administered intravenously, and this not only requires lengthy infusion times, but also imposes significant inconveniences on patients. There is an urgent clinical need for more convenient administration methods for immunotherapy.

Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience for patients. The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland.

The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital. The study aimed to compare the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer ("NSCLC"). The results showed that JS001sc’s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. JS001sc-002-III-NSCLC was the first phase 3 clinical study of domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation. Further details will be presented at an upcoming international academic conference.

Professor Lin WU said, "The JS001sc-002-III-NSCLC study, as China’s first Phase 3 clinical trial of a domestically developed PD-1 monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety. This milestone not only validates the scientific rationale behind the pharmaceutical development of the subcutaneous formulation, but also provides a novel administration pathway for cancer immunotherapy at the clinical level. In the current era of holistic cancer management, treatment convenience and improved quality of life have become critical clinical priorities. The development and application of subcutaneous injection formulations are expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management. We anticipate the early approval of the subcutaneous formulation of toripalimab, which will further enrich China’s cancer immunotherapy landscape and ultimately benefit a broader population of cancer patients."

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI (toripalimab). This signifies JS001sc’s potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer. It also marks another critical milestone in expanding toripalimab’s innovative and clinical value. As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence. Moving forward, we will actively advance the regulatory review process, consistently centering patient needs. Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China’s cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients."

About JS001sc

JS001sc is a subcutaneous injection formulation developed by Junshi Biosciences based on the marketed product toripalimab injection (code: JS001). It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage and is expected to bring convenient administration to patients. The 12 indications in the NDAs of JS001sc covers all currently approved indications of toripalimab injection in the Chinese Mainland.

(Press release, Shanghai Junshi Bioscience, MAR 9, 2026, View Source [SID1234663396])

On March 9, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the closing of a private placement (the "Private Placement") of 17,445,455 units (the "Units") at a price of $0.55 per Unit, for aggregate gross proceeds to Defence of $9,595,000.25. Each Unit is comprised of one common share (each, a "Share") and one common share purchase warrant ("Warrants"). Each Warrant entitles its holder to acquire an additional common share of the Company at a price of $0.65 per share for 24 months following the date of issuance.

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!

As previously announced, the Company executed a binding term sheet (the "Term Sheet") with two arm’s length institutional investors (collectively, the "Investors") in connection with the Private Placement for aggregate gross proceeds of $6,000,000, pursuant to the terms and conditions of a sharing agreement (the "Sharing Agreement") dated and executed as of March 6, 2026 (the "Closing Date"). For more information, please see the Company’s press release dated February 27, 2026.

All 10,909,091 Warrants issued pursuant to the Term Sheet are exercisable at an exercise price of $0.65 per Share for a period of 24 months following the Closing Date. The Warrants include an equity blocker provision that prohibits the holder from exercising any portion of the Warrants if such exercise would result in the holder owning more than 9.99% of the Company’s outstanding Shares. The Investors received a corporate finance fee of 654,546 Units and a non-refundable deposit of 118,182 Units at the Private Placement price in connection with the Sharing Agreement.

Defence intends to use the proceeds from the Private Placement to advance its Antibody Drug Conjugate ("ADC") and Radiopharmaceutical programs, to develop partnerships and for working capital purposes. No finder’s fees were paid in connection with the Private Placement.

Pursuant to applicable Canadian securities laws and in accordance with the Exchange policies, all securities issued under this Private Placement are subject to applicable resale restrictions under applicable securities laws. The Private Placement closed on March 6, 2026.

The Units described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions there from. This press release does not constitute an offer to sell or a solicitation to buy any securities in any jurisdiction.

(Press release, Defence Therapeutics, MAR 9, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-closing-of-private-placement-of-units-for-gross-proceeds-of-9595000 [SID1234663362])

On March 9, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the first patient has been successfully dosed in a Phase Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company’s core investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

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!

ESCC ranks as the seventh most common cancer in China, characterized by insidious onset and poor prognosis. Although immune checkpoint inhibitors combined with chemotherapy have improved objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to chemotherapy alone, median OS remains only 12-17 months. This underscores the limitations of current treatment approaches and the urgent need for improved outcomes, highlighting the necessity to explore more effective innovative strategies to address this significant clinical challenge.

Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

The open-label, multi-center Phase Ⅱ clinical study is led by Professor Shen Lin of Beijing Cancer Hospital and is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig administered in patients with ESCC.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "ESCC is highly prevalent with poor prognosis in China. While immune-chemotherapy combinations have shown progress, the overall survival benefit remains very limited, necessitating breakthrough solutions. The dosing of the first ESCC patient with Opamtistomig marks a critical milestone in our clinical strategy for this core pipeline asset. We anticipate it will overcome current immunotherapy limitations, delivering both higher response rates and prolonged survival benefits for patients."

About ESCC
China is a region with a high incidence of esophageal cancer, accounting for approximately 50% of the newly diagnosed and fatal cases of esophageal cancer worldwide. Esophageal cancer is broadly classified into ESCC and esophageal adenocarcinoma, of which squamous cell carcinoma represents the predominant subtype in China. According to 2022 data published by the International Agency for Research on Cancer (IARC) of the World Health Organization, ESCC ranked seventh among all cancers in China in terms of incidence, with an estimated 224,000 new cases and approximately 187,000 deaths recorded annually. Early-stage esophageal cancer typically presents with no obvious clinical symptoms, and the majority of patients are diagnosed at a locally advanced stage or with distant metastases. As a result, prognosis remains poor, with a five-year survival rate of only 10.0% to 30.0%.

About Opamtistomig (LBL-024)
Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it holds promise to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1–mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.

In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.

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.

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. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig’s potential as a broad-spectrum immuno-oncology therapy.

(Press release, Nanjing Leads Biolabs, MAR 9, 2026, View Source [SID1234663380])