SHR-4602 / Jiangsu Hengrui Pharma - LARVOL DELTA

SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=11 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=240 ➔ 11 | Not yet recruiting ➔ Terminated; The adjustment of the sponsor's R&D strategy.

Enrollment change • Trial termination • Oncology • Solid Tumor • HER-2

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 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

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

SHR-4602, next generation of HER2-targeting ADC with potent anti-tumor efficacy overcoming the resistance of HER2 ADC with Topo I inhibitor payload in xenograft models (AACR 2024) - P1 | "Herein, we presented a novel HER2 ADC, SHR-4602, which demonstrated good in vitro and in vivo anti-tumor activities and could overcome the resistance caused by HER2 ADC including DS-8201 analogue (synthesized using DS-8201 structure) and SHR-A1811 (composed of trastuzumab, a cleavable linker, and a Topo I inhibitor payload, in phase III clinical trials) in xenograft models. We used a stable enzyme-cleavable linker technology to conjugate the HER2 ADC using the amino acid sequence of pertuzumab and ER300 (eribulin derivative). SHR-4602 represents a new generation HER2-targeting ADC to deliver a potent cytotoxin to HER2 expressing tumor cells and may be more efficacious to the tumors in which current anti-HER2 therapies are ineffective. SHR-4602 is now in the phase I clinical development stage for advanced malignant solid tumors (NCT05819684)."

ADC • Preclinical • Oncology • Solid Tumor • HER-2

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

A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Atridia Pty Ltd. | N=20 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Solid Tumor

Jiangsu Hengrui Medicine Co., Ltd.'s announcement on obtaining approval for drug clinical trials [Google translation] (Sina Corp) - "Recently, Shanghai Shengdi Pharmaceutical Co., Ltd. and Suzhou Shengdia Biopharmaceutical Co., Ltd...received the 'Drug Clinical Trial Approval Notice' for SHR-4602 for injection, SHR-A1811 for injection...approved by the National Medical Products Administration...and will conduct clinical trials in the near future...SHR-4602 is intended to treat solid tumors with HER2 expression or mutation....SHR-A1811 for injection can bind to and internalize HER2-expressing tumor cells..."

New trial • Solid Tumor • HER-2

A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Atridia Pty Ltd. | Initiation date: Nov 2024 ➔ Mar 2025

Metastases • Trial initiation date • Oncology • Solid Tumor

A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Phase II Study of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Combination therapy • Metastases • New P2 trial • Oncology • Solid Tumor

A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Metastases • New P2 trial • Oncology • Solid Tumor

2024 AACR︱Hengrui Medicine’s 9 innovative anti-tumor research results will be announced on the international academic stage soon (Jiangsu Hengrui Press Release) - "The 2024 American Association for Cancer Research (AACR) Annual Meeting will be held in San Diego, USA, from April 5th to 10th local time. As one of the most watched international academic conferences in the field of oncology, the AACR Annual Meeting focuses on early research and innovative progress in oncology, and updates and publishes cutting-edge research results in the field of oncology."

Clinical data • P2 data • Preclinical • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Oncology

A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=133 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • HER-2

A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=133 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor • HER-2