HRS-8080 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

Hengrui Medicine’s 4 new cancer drugs approved for clinical trials, 3 of which are protein degraders [Google translation] (Sina Corp) - "On October 18, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Hengrui Medicine...has 4 new cancer drugs approved for multiple new clinical trial implied licenses. One of them is an anti-CTLA-4 monoclonal antibody new drug, and the other three are Class 1 new drugs for protein degradation therapy. These new drugs have been approved for clinical research on the treatment of malignant tumors with dual or triple drug combination therapy , which means that Hengrui Medicine has an important exploration direction in cancer treatment."

New trial • Oncology • Solid Tumor

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=350 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Oncology • Solid Tumor

Hengrui Medicine’s innovative drug HRS-2189 tablets for combination therapy of advanced solid tumors approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine...received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration, approving the company to conduct an open, multicenter Phase IB/II clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of HRS-2189 combined with fulvestrant with or without HRS-6209, or with HRS-6209 and HRS-8080, or with HRS-6209 and HRS-1358, or with abiraterone acetate tablets (II) and prednisone tablets, or with HRS-5041, or with adebelimumab with or without SHR - 8068 with or without chemotherapy, or with adebelimumab and bevacizumab in subjects with advanced unresectable or metastatic solid tumors."

Trial status • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=300 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=528 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (clinicaltrials.gov) - P1/2 | N=528 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

Hengrui Medicine's three innovative cancer drugs were approved for clinical trials! Two of them are protein degraders [Google translation] (Sina Corp) - "Hengrui Medicine announced on the evening of July 26 that the company and its subsidiary Shandong Shengdi Pharmaceutical's HRS-1358 tablets, HRS-8080 tablets, and HRS-6209 capsules have received drug clinical trial approval notices issued by the China National Medical Products Administration (NMPA) and will conduct clinical trials in the near future. The approved clinical indications are: HRS-6209 combined with HRS-1358 or HRS-8080 or aromatase inhibitors or fulvestrant for the treatment of breast cancer."

New trial • Breast Cancer • Oncology • Solid Tumor

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=350 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=146 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=146 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

Hengrui Medicine (600276.SH): dalpiciclib isethionate tablets and HRS-8080 tablets are approved to carry out clinical trials [Google translation] (Zhitong Finance) - "According to Zhitong Finance APP, Hengrui Pharmaceuticals...announced that the company and its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration to issue the 'Drug Certificate' for dalpiciclib Isomerate Tablets and HRS-8080 Tablets. Clinical Trial Approval Notice, the relevant clinical trials are specifically: safety, tolerability, pharmacokinetics and efficacy of HRS-8080 combined with dalpiciclib in patients with ER-positive, HER2-negative unresectable or metastatic breast cancer. Multi-center, open-label phase Ib/II clinical study."

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

A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults (clinicaltrials.gov) - P1 | N=156 | Enrolling by invitation | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Monotherapy • Breast Cancer • Oncology • Solid Tumor