SPH4336 / Shanghai Pharma - LARVOL DELTA

Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. (PubMed, Oncologist) - P1/2 | "SPH4336 demonstrated an acceptable safety profile and dose-dependent plasma exposure in patients with various advanced solid tumors. (ClinicalTrials.gov Identifier: NCT05905614; IRB Approved.)."

Journal • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov) - P2 | N=14 | Terminated | Sponsor: Shanghai Pharma Biotherapeutics USA Inc. | N=33 ➔ 14 | Trial completion date: Mar 2025 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Oct 2024; Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Shanghai Pharmaceuticals’ SPH4336 tablets were approved for clinical trials, and they will work together with osimertinib to fight against advanced KRAS mutant tumors. [Google translation] (pharnexcloud.com) - "On September 18, according to the latest announcement on the CDE official website, SPH4336 tablets submitted by Shanghai Pharmaceuticals obtained implicit approval for a new clinical trial, with the proposed indication being the combination with osimertinib for the treatment of advanced solid tumors with KRAS mutations."

New trial • Oncology • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Aug 2024 ➔ Nov 2024

Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Oct 2023 | Trial primary completion date: Jun 2024 ➔ Oct 2023

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

First-in-human phase 1 study of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "This study demonstrated that SPH4336 was well tolerated at doses ranging from 50 to 600 mg dose levels. A dose of 400 mg could be considered for further clinical trials. Clinical trial information: NCT05905614."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Hematological Disorders • Oncology • Sarcoma • Solid Tumor • CDK4

Shanghai Pharmaceuticals (601607.SH): Terminate clinical trials and subsequent development of four R&D projects: B001, B001-A, I022 (combination therapy, first-line treatment for breast cancer) and I022-K [Google translation] (iis.aastocks.com) - "Shanghai Pharmaceuticals...announced that based on a comprehensive assessment of the future market value of the R&D projects, business synergy, and subsequent development investment, it decided to terminate the clinical trials and subsequent development of the four R&D projects B001, B001-A, I022...and I022-K."

Discontinued • Trial termination • Breast Cancer • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Active, not recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

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

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023 ➔ Sep 2023

Combination therapy • Enrollment open • Trial initiation date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

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

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Initiation date: Jul 2023 ➔ Oct 2023

Combination therapy • Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Initiation date: Jun 2023 ➔ Oct 2023

Combination therapy • Trial initiation date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Shanghai Pharma Biotherapeutics USA Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Mar 2025 | Initiation date: Dec 2022 ➔ Jul 2023 | Trial primary completion date: Dec 2025 ➔ Mar 2025

Enrollment open • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Active, not recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

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

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Combination therapy • New P2 trial • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Combination therapy • Metastases • New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

SPH4336 independently developed by Shanghai Pharmaceuticals (02607) for the indication of liposarcoma obtained the US FDA Orphan Drug Qualification [Google translation] (Sina Corp) - "Shanghai Pharmaceuticals...announced that recently, the company's self-developed SPH4336 for the indication of liposarcoma has been granted orphan drug qualification by the US Food and Drug Administration (hereinafter referred to as 'US FDA') ( Orphan-drug Designation)."

Orphan drug • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Shanghai Pharmaceuticals: Signed a new drug combination development cooperation agreement with Kangfang Pharmaceuticals [Google translation] (Daily Economic News - NBD) - "...Shanghai Pharmaceuticals announced that the company recently signed the 'New Drug Combination Development Cooperation Agreement' with Akeso Pharmaceuticals, agreeing that the two parties will cooperate in combination drugs in China (including mainland China, Hong Kong, and Macau) In this way, we will jointly develop the combination therapy of SPH4336 tablets and Kaitanil^® in well-differentiated liposarcoma (WDLS)/dedifferentiated liposarcoma (DDLS) and other tumor indications, and promote the research and development and production of combination products; and based on the agreement Cooperate on IND or CTA applications including combination products, clinical phase Ib/IIa clinical trials, and subsequent phase III clinical trials that may be conducted by both parties."

Licensing / partnership • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Metastases • New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Shanghai Pharma Biotherapeutics USA Inc.

New P2 trial • Liposarcoma • Oncology • Sarcoma • Solid Tumor