anbenitamab repodatecan (JSKN003) / Alphamab, CSPC Pharma - LARVOL DELTA

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

JSKN003-101: First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Alphamab (Australia) Co Pty Ltd. | Recruiting ➔ Completed | N=45 ➔ 62 | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Solid Tumor • HER-2

Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC) (ESMO 2025) - No abstract available

Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

Efficacy and safety of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with HER2-positive metastatic colorectal cancer (mCRC) (ESMO 2025) - No abstract available

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor

Phase Ⅲ study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician's choice of chemotherapy in platinum-resistant ovarian cancer (PROC) (ESMO 2025) - No abstract available

Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

JSKN003 RECEIVED THE U.S. FDA APPROVAL TO INITIATE A PHASE II CLINICAL STUDY IN THE TREATMENT OF PROC NOT RESTRICTED BY HER2 EXPRESSION (HKEXnews) - "The board (the ‘Board’) of directors (the ‘Directors’) of the Company is pleased to announce that JSKN003 has received approval from the United States (‘U.S.’) Food and Drug Administration (‘FDA’) to initiate a phase II clinical study in the U.S. (study number: JSKN003-202). JSKN003-202 is a randomized, open-label, multi-center phase II clinical study of JSKN003 in the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer (collectively referred to as platinum-resistant ovarian cancer, ‘PROC’) that not restricted by human epidermal growth factor receptor 2 (‘HER2’) expression. This clinical trial aims to evaluate the safety and efficacy and determine the recommended phase III dose."

IND • New P2 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

JSKN003 FOR THE TREATMENT OF GC/GEJ WAS GRANTED ODD BY THE U.S. FDA (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that JSKN003 has been granted Orphan Drug Designation ('ODD') by the U.S. Food and Drug Administration (the 'FDA') for the treatment of gastric cancer and gastroesophageal junction cancer ('GC/GEJ')."

Orphan drug • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A biparatopic HER2-targeting ADC constructed via site-specific glycan conjugation exhibits superior stability, safety, and efficacy. (PubMed, RSC Chem Biol) - "JSKN003 retained its cytotoxic activity against trastuzumab-resistant cells, attributed to efficient payload delivery and blockade of downstream HER2 signaling pathways, demonstrating the potential to overcome clinical trastuzumab resistance. JSKN003 demonstrated excellent antitumor activity and a favorable safety profile in clinical trials, highlighting its potential as a promising therapeutic option for patients with HER2-positive tumors. These findings suggest that JSKN003 could be a valuable therapeutic strategy with excellent efficacy and safety for HER2-expressing tumors in the clinical setting."

Journal • Oncology • HER-2

JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trials. (ASCO 2025) - P1, P1/2, P3 | "Median age was 59.0 years, 65.2% had ≥ 3 prior lines of systemic therapy, 80.4% and 63.0% had previously received bevacizumab and PARP inhibitor, 39.1% were classified as HER2-expressing (IHC: 1+/2+/3+), with 21.7%, 10.9% and 6.5% in 1+, 2+ and 3+, respectively; 45.7% as HER2-no-expressing (IHC: 0), and 15.2% had no tissue samples for assessment. The maturer updated efficacy data reveal that JSKN003 provided substantial improvement in ORR, as well as benefit in PFS and OS in heavily treated PROC, irrespective of HER2 expression. The well tolerated toxicity with long-term observation was consistent with prior experience. A confirmatory trial (NCT06751485) is ongoing in all comers at any HER2 expression level to further support JSKN003 as a treatment option in this population."

Clinical • Platinum resistant • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors. (ASCO 2025) - P1, P1/2 | "Most pts were heavily pretreated (37.5% had ≥3 lines of prior treatment; 45.0% received irinotecan; 67.5% received anti-HER2 therapy; 42.5% received IO therapy). JSKN003 demonstrated promising efficacy in heavily pretreated pts with advanced HER2-overexpressing gastrointestinal tumors, with a manageable and predictable safety profile."

Metastases • Retrospective data • Anemia • Colorectal Cancer • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • BRAF

JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies. (ASCO 2025) - P1, P1/2 | "JSKN003 demonstrated promising efficacy and manageable safety in heavily pretreated HER2-positive breast cancer, including T-DXd-experienced patients. The biparatopic HER2 antibody design likely enhanced its binding efficiency and contributed to the observed clinical benefit. These findings support the planned Phase 3 trial to further evaluate its therapeutic potential."

Retrospective data • Anemia • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Alphamab Oncology Presented Multiple Clinical Data of Anti-HER2 Biparatopic ADC JSKN003 at the 2025 ASCO Annual Meeting (Yahoo Finance) - "Pooled results have demonstrated that JSKN003 monotherapy has promising efficacy signals in patients with PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor....With a median follow-up time of 9.3 months, 46 patients were efficacy evaluable. 42 patients (91.3%) exhibited tumor shrinkage. The objective response rate (ORR) was 63.0%, the median progression-free survival (PFS) was 7.7 months, and the 9-month overall survival (OS) rate was 89.9%. Efficacy was observed across different HER2-expression subgroups."

Platinum resistant • Retrospective data • Ovarian Cancer

JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Gastric Cancer • Oncology • Solid Tumor

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

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

Anti-HER2 Biparatopic ADC JSKN003 Has Been Granted Breakthrough-Therapy Designation for the Treatment of PROC (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels....The grant of Breakthrough Therapy Designation is based on the pooled analysis of two clinical studies, JSKN003-101 and JSKN003-102. JSKN003-101 (NCT05494918) is an open-label, multicenter, dose-escalation Phase I clinical study conducted in Australia, enrolling patients with advanced solid tumors expressing HER2 (IHC≥1+) or with HER2 mutations. JSKN003-102 (NCT05744427) is a Phase I/ II study conducted in China."

Breakthrough therapy • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

First Patient Dosed in a Phase III Clinical Study of Anti-HER2 Biparatopic ADC JSKN003 for the Treatment of HER2-positive Breast Cancer (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-301) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer....JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies."

Trial status • HER2 Positive Breast Cancer

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Alphamab Oncology Announces the First Patient Dosed in a Phase III Clinical Study for Ovarian Cancer of Anti-HER2 Bispecific ADC JSKN003 (PRNewswire-Asia) - "Alphamab Oncology...announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-306) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003....JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels."

Trial status • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Anti-HER2 Bispecific ADC JSKN003 Received Approval to Initiate a Phase III Clinical Study for the Treatment of HER2-positive Breast Cancer (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-301). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer....JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies."

New P3 trial • HER2 Positive Breast Cancer

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=430 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P3 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=725 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=300 ➔ 725 | Trial completion date: Dec 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Alphamab Oncology’s JSKN003 is approved for Phase III clinical trial in ovarian cancer [Google translation] (new.qq.com) - "...on December 27 that JSKN003 has been approved by the CDE of the National Medical Products Administration to conduct a Phase III clinical study (JSKN003-306), which targets the entire population of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have received 1 to 4 lines of treatment."

New P3 trial • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

BOCOM International: Maintain "Neutral" rating on Alphamab-B (09966) and lower target price to HK$5 [Google translation] (iis.aastocks.com) - "Zhitong Finance APP learned that BoCom International released a research report saying that it has lowered the target price of Alphamab-B...to HK$5 and maintained a 'neutral' rating. The company's product sales are under short-term pressure, and the research and development of multiple assets in the HER2 channel are rapidly advancing. The bank predicts that KN026 and JSKN003 are expected to generate a combined peak sales of nearly 5 billion yuan in the country....However, considering the impact of industry compliance regulations on Envida sales and individual drugs under development, The launch pace has been delayed, the 2025 revenue forecast has been lowered to 450 million yuan, and the POS-adjusted peak sales of Envida and KN046 have been lowered to 1.1 billion and 500 million yuan."

Sales projection • Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

JSKN033, an innovative subcutaneous-injected fixed-dose combination (FDC) of biparatopic anti-HER2 antibody drug conjugate (ADC) and PD-L1 inhibitor in advanced solid tumor (SITC 2024) - P1/2 | "Subcutaneous (SC) delivery offers a safer alternative, with comparable efficacy to intravenous delivery, as demonstrated by treatments like amivantamab. JSKN033 is a FDC for SC injection, utilizing innovative technology, comprising JSKN003, a biparatopic HER2-directed ADC, and KN035, a NMPA-approved PD-L1 inhibitor...These results encourage further clinical development of JSKN033. Additionally, the formulation technology may be applicable to other ADC therapies.View this table:View inline View popup Download powerpoint Abstract 1496 Table 1"

IO biomarker • Late-breaking abstract • Metastases • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor

Technical, preclinical, and clinical developments of Fc-glycan-specific antibody-drug conjugates. (PubMed, RSC Med Chem) - "Notably, JSKN003 and IBI343 have demonstrated promising results in phase 1 trials and are advancing into phase 3 studies. This review discusses the advantages of Fc-glycan-conjugation, various glycan-specific conjugation techniques, and the preclinical and clinical development of gsADCs. While challenges such as increased manufacturing cost for large-scale production need continuous innovation to overcome and there are different opinions regarding the pros and cons of reduced/diminished affinities to Fc gamma receptors, ongoing research and clinical progress underscore the potential of gsADCs to renovate ADC cancer therapy."

Journal • Preclinical • Review • Oncology