JSKN016 / Alphamab, Pathos AI - LARVOL DELTA

JSKN016-102: Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC (clinicaltrials.gov) - P1 | N=288 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JSKN016-102: Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC (clinicaltrials.gov) - P1 | N=288 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JSKN016-101: To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

First-in-human • New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

JSKN016, a First-in-Class TROP2/HER3 Bispecific Antibody–Drug Conjugate (ADC), in Pretreated Non-Small Cell Lung Cancer (NSCLC) with Rare/Uncommon Driver Genomic Alterations (DGAs) (ESMO Asia 2026) - No abstract available

ADC • Bispecific • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Alphamab Oncology and Pathos Achieved a Licensing Agreement on TROP2/HER3 Bispecific ADC JSKN016 (Alphamab Press Release) - "Pursuant to the licensing agreement, Alphamab granted Pathos an exclusive license to research, develop, manufacture and commercialize JSKN016 in territories outside the Chinese Mainland, Hong Kong, Macau and Taiwan, with Pathos bearing all related development and commercialization costs and expenses under the agreement. Alphamab retains its full and exclusive rights to develop, manufacture and commercialize JSKN016 in the Chinese Mainland, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Alphamab is entitled to receive a non‑refundable upfront payment of US$125 million and milestone payments based on the achievement of certain development and commercialization milestones, totaling up to US$2,093 million, as well as tiered royalties..."

Licensing / partnership • Solid Tumor

VOLUNTARY ANNOUNCEMENT RESEARCH UPDATES OF JSKN016 FOR PRESENTATION AT 2026 ASCO ANNUAL MEETING (HKEXnews) - "As of December 22, 2025, a total of 82 patients with HER2- BC, including 50 patients with TNBC and 32 patients with HR+/HER2- BC were enrolled...As of March 17, 2026, with a median follow-up of 7.8 months, JSKN016 demonstrated a promising safety profile. At RP2D, TRAEs at grade 3 or above were reported in 24.6% of patients, with no grade 4 or 5 TRAEs reported. SAEs were reported in 15.4% of patients, of which 12.3% were treatment-related. At RP2D, dose reduction due to TRAEs occurred in 46.2% of patients...No TRAEs led to death, and no ILD was observed during the study."

P1 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

JSKN016, a first-in-class anti-TROP2/HER3 bispecific antibody-drug conjugate (ADC), in patients (pts) with HER2-negative locally advanced or metastatic breast cancer: Results from a phase I study. (ASCO 2026) - P1 | "JSKN016 demonstrated robust antitumor activity with good safety profile in pts with HER2-negative BC. The results support further development of JSKN016 as monotherapy or in combination. Efficacy of JSKN016 in HER2-BC at 6 mg/kg Q3W."

ADC • Bispecific • Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Conjunctivitis • Dental Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • ERBB3 • HER-2

A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care (clinicaltrials.gov) - P3 | N=364 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P3 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

2026 ASCO Preview | Alphamab Oncology to Present Clinical Data of TROP2/HER3 Bispecific ADC JSKN016 for HER2-Negative Breast Cancer (The Manila Times) - "JSKN016-101 (NCT06592417) is a dose-escalation and dose-expansion clinical study in China, enrolling patients with advanced solid tumors to receive JSKN016 monotherapy. The 2026 ASCO Annual Meeting will feature the presentation of analytical results from the HER2-negative BC cohort of this study. JSKN016 demonstrated very promising efficacy and superior safety profile in late line BC patients. The results guarantee the further development of JSKN016, in combo with chemo, IO and target therapy, in front line and perioperative settings."

P1 data • HER2 Negative Breast Cancer

Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

JSKN016:…Expected Milestones in 2026 (from Q2 2026) (Alphamab Press Release) - "(i) Pre‑IND communication for the combination study of JSKN016 in CDK4/6‑pretreated HR‑positive BC will be completed in the United States; (ii) The phase I clinical study of the subcutaneous formulation of JSKN016 in Australia will complete the first patient dosing; (iii) Results of JSKN016 monotherapy in TNBC and HR‑positive BC will be presented; (iv) Results of JSKN016 monotherapy and combination therapy in NSCLC will be presented; (v) Phase III clinical study of JSKN016 in combination therapy as first‑line treatment for NSCLC will be initiated."

Clinical data • New P3 trial • Preclinical • Trial status • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Alphamab Oncology…is pleased to announce that the first patient has been successfully dosed in a phase III clinical study of JSKN016 (a trophoblast cell surface antigen 2 ('TROP2') and human epidermal growth factor receptor 3 ('HER3') bispecific antibody-drug conjugate ('ADC(s)')) for the treatment of triple-negative breast cancer ('TNBC') (study code: JSKN016-301) (HKEXnews) - "JSKN016-301 is an open-label, randomized, controlled, multicenter phase III clinical study expected to be conducted at approximately 60 clinical sites across the PRC. The study plans to enroll patients with unresectable locally advanced, recurrent or metastatic TNBC who have failed at least two lines of systemic therapy."

Trial status • Triple Negative Breast Cancer

Recent advances in bispecific antibody-drug conjugates for breast cancer therapy. (PubMed, Cancer Chemother Pharmacol) - "BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD63 • EGFR • ERBB3 • HER-2

JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

JSKN016:…Expected Milestones in 2025 (PRNewswire-Asia) - "(i) Initiate patient enrollment in the clinical trial of JSKN016 in combination with IO and chemotherapy as first-line treatment for wild-type NSCLC; (ii) File an application with the CDE for one to two pivotal clinical studies of JSKN016; (iii) File an application with the CDE for BTD for one to two indications of JSKN016; (iv) Release HER2-negative BC related clinical data."

New trial • Non-US regulatory • P1/2 data • Trial status • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer

JSKN016:…Events during the Reporting Period (PRNewswire-Asia) - "Enrollment has been completed in the cohort expansion clinical study of JSKN016 monotherapy in HER2-negative BC....The phase II clinical study of JSKN016 monotherapy in multiple cohorts of...NSCLC to evaluate efficacy, safety, and dose optimization is currently being conducted. Enrollment has been completed for both the cohorts of second-line and third-line treatment for EGFR-mutant patients."

Enrollment status • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer

First-in-human study of JSKN016, a bispecific anti-TROP2/HER3 antibody drug conjugate (ADC): Antitumor activity in patients (pts) with metastatic triple-negative breast cancer (mTNBC) and safety results. (ASCO 2025) - P1 | "JSKN016 demonstrated an excellent antitumor activity in heavily pretreated TNBC, with a manageable and predictable safety profile. Efficacy Findings"

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Dermatitis • Dermatology • Immunology • Interstitial Lung Disease • Mucositis • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • ERBB3

Alphamab Oncology Reports Full Year 2024 Financial Results and Business Highlights (GlobeNewswire) - "In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy /tyrosine kinase inhibitors (TKI) as first-line and later-line treatment of multiple subgroups of non-small cell lung cancer (NSCLC) was approved by CDE; In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy as first-line and later-line treatment of multiple subgroups of non-HER2-positive BC was approved by CDE."

New trial • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer

Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Alphamab-B (09966): Phase I clinical trial of JSKN016 for the treatment of advanced malignant solid tumors completed the administration of the first patient [Google translation] (Sina Corp) - "Alphamab-B...announced that JSKN016...Phase I clinical trial in China successfully completed the administration of the first patient. The clinical trial is an open-label, multi-center, first-in-human, dose-escalation and dose-expansion Phase I clinical trial. The clinical trial aims to evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK) and immune plausibility of JSKN016 in patients with advanced malignant solid tumors, and to determine the maximum efficacy of JSKN016 in patients with advanced malignant solid tumors. tolerated dose (MTD) and/or recommended phase II dose (RP2D). This clinical trial plans to enroll a total of approximately 80 to 140 patients."

Trial status • Oncology • Solid Tumor

Alphamab Oncology Announced Innovative Bispecific Antibody Coupling Drug JSKN016 Clinical Study Accepted by CDE (Alphamab Press Release) - "Alphamab Oncology...announced an application for clinical trial of JSKN016, a new generation of bispecific antibody ADC drug, was officially accepted by CDE and will carry out clinical research on the treatment of advanced malignant solid tumors....This is the first global clinical study of JSKN016 to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of JSKN016 in Chinese subjects with advanced malignant solid tumors."

New trial • Oncology • Solid Tumor