JS105 / Shanghai Junshi Biosci, Risen (Suzhou) Biosci - LARVOL DELTA

Efficacy and safety of JS105, a selective inhibitor of mutant PI3Kα, in patients with advanced cancer (ESMO 2025) - P1, P1/2 | "The combination therapy study enrolled patients with HR-positive, HER2-negative advanced breast cancer to receive JS105 150 to 250 mg in combination with dalpiciclib and fulvestrant for a 28-day cycle. Among the 23 patients with PIK3CA mutations, the ORR and DCR were 39.1% and 87.0% (Table). Table: 466P The best overall response of two studies (Based on investigator assessment per RECIST 1.1) Monotherapy Study Combination Therapy Study Evaluable patients with PIK3CA mutation and measurable lesions, n 32 23 Best Overall Response, n (%) Complete Response (CR) 0 0 Partial Response (PR) 9 (28.1) 9 (39.1) Stable Disease (SD) 19 (59.4) 11 (47.8) Progressive Disease (PD) 4 (12.5) 3 (13.0) Objective Response Rate (ORR), %, (95% CI) 28.1 (13.7, 46.7) 39.1 (19.7, 61.5) Disease Control Rate (DCR), %, (95% CI) 87.5 (71.0, 96.5) 87.0 (66.4, 97.2) Conclusions JS105 monotherapy or combination therapy demonstrated a favorable safety profile and promising efficacy in patients..."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.

New P3 trial • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903 (clinicaltrials.gov) - P1 | N=174 | Recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.

New P1 trial • Breast Cancer • Cervical Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • PIK3CA

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor • PIK3CA

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Not yet recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor • PIK3CA

Junshi Biosciences Announces 2022 Interim Financial Results and Provides Corporate Updates (GlobeNewswire) - "In May 2022, the IND application for JS105 (PI3K-α inhibitor) jointly developed by the Company and Risen (Suzhou) Biosciences Co., Ltd. was approved by the NMPA....In July 2022, the FDA approved the IND application of JS105 (PI3K-α inhibitor) in combination with fulvestrant for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor-2 (HER-2) negative patients as well as both female (postmenopausal) and male patients with PIK3CA-mutated advanced or metastatic breast cancer."

IND • New trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PI3K