clifutinib (HEC73543) / HEC Pharm - LARVOL DELTA

Efficacy and Safety of Clifutinib, a Novel, Highly Selective, Oral FLT3 Inhibitor, in Patients with FLT3-Mutated Relapsed or Refractory Acute Myeloid Leukemia:Updated Results from a Phase I Study (ASH 2023) - P1, P3 | "This phase 1 study has demonstrated an acceptable safety profile and a significant anti-leukaemic activity of clifutinib in FLT3 mutant R/R AML, with the best response at the dose of 40 mg/day in FLT3-ITD(+)/TKD(-) AML. A confirmatory phase 3 study is currently ongoing to further evaluate the efficacy and safety of clifutinib dosed at 40 mg/day in R/R AML pts after first-line therapy with FLT3-ITD(+)/TKD(-) (NCT05586074)."

Clinical • P1 data • Acute Myelogenous Leukemia • Anemia • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • FLT3

A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers. (PubMed, Front Pharmacol) - P1 | "High-fat food intake enhanced bioavailability and increases the systemic exposure levels of HEC73543 and its metabolite M3. NCT05454098 (http://www.clinicaltrials.gov/)."

Journal • P1 data • PK/PD data • Acute Myelogenous Leukemia

A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers (Front Pharmacol) - "Median Tmax of HEC73543 were comparable between the two groups. The most frequently Treatment-Related Adverse Events (TRAEs) were elevated blood triglycerides, oral ulceration, hyperuricemia, diarrhea, thoracalgia. Most TRAEs were Grade 1 or 2."

P1 data • Acute Myelogenous Leukemia

Clinical Study on the Mass Balance of Clifutinib (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML (clinicaltrials.gov) - P1/2 | N=133 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2025 ➔ May 2026

Enrollment open • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Discovery of FLT3-ITD Inhibitor Clifutinib: A Novel Biphenylacetylene Urea Derivative in Clinical Trials for the Treatment of Relapsed/Refractory FLT3-ITD+ Acute Myeloid Leukemia. (PubMed, J Med Chem) - P3 | "Moreover, compound 9e displayed favorable drug-like properties and significantly suppressed tumor growth in MV-4-11 (1.5 mg/kg, qd, tumor growth inhibition (TGI) = 193.5%) and MOLM-13 (4.5 mg/kg, qd, TGI = 94%) xenograft tumor models in mice without significant weight loss. Compound 9e (named Clifutinib) is currently being evaluated in a phase III clinical trial (NCT05586074) for the treatment of relapsed/refractory FLT3-ITD-positive AML."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: May 2026 ➔ Jun 2027

Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

VOLUNTARY ANNOUNCEMENT COOPERATION BETWEEN SHENYANG SUNSHINE AND SUNSHINE LAKE PHARMA IN RESPECT OF CLIFUTINIB BESYLATE (HKEXnews) - "Shenyang Sunshine Pharmaceutical Co., Ltd...entered into the cooperation agreement (the 'Agreement') with Sunshine Lake Pharma Co., Ltd...and its subsidiary YiChang HEC ChangJiang Pharmaceutical Co., Ltd...in respect of clifutinib besylate (the 'Clifutinib'). Pursuant to the Agreement, Shenyang Sunshine will obtain the exclusive commercialization rights of the Clifutinib, a product of Sunshine Lake Pharma, for specific indications in Mainland China. Shenyang Sunshine will pay Sunshine Lake Pharma an initial payment as well as the corresponding research and development and sales milestone payments in accordance with the Agreement. Sunshine Lake Pharma will continue to be responsible for the research and development, registration, production and other works of the Clifutinib....There is no assurance that the product will eventually be commercialized successfully."

Licensing / partnership • Hematological Malignancies • Oncology

A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov) - P1 | N=75 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Phase III of HEC73543 tablets for the treatment of relapsed and refractory acute myeloid leukemia with FLT3-ITD mutation [Google translation] (163.com) - "Approved by the National Medical Products Administration and the Hospital Ethics Committee, a randomized, open, salvage chemotherapy-controlled, multi-center phase III clinical trial of HEC73543 tablets for the treatment of relapsed and refractory acute myeloid leukemia with FLT3-ITD mutations is underway. We are currently recruiting subjects from the public."

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2022 ➔ Mar 2023

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

Clifutinib Food Effect Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Dec 2022 | Trial primary completion date: Aug 2023 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

PRELIMINARY RESULTS OF A PHASE I STUDY OF CLIFUTINIB, A HIGHLY SELECTIVE, POTENT ORAL FLT-3 INHIBITOR, IN PATINETS WITH FLT3-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (EHA 2022) - P1 | "Conclusion Preliminary results of this phase 1 study demonstrated that Clifutinib has an acceptable safety profile and promising antitumor activity, especially at the dose of 40 mg daily. A confirmatory phase 3 study is planned to further evaluate the efficacy and safety of Clifutinib at 40 mg daily in FLT3-mutated R/R AML."

P1 data • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3

Clifutinib Food Effect Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Initiation date: Aug 2022 ➔ Nov 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov) - P3 | N=324 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Jun 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Clifutinib Food Effect Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: Apr 2022 ➔ Dec 2022 | Trial primary completion date: Oct 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML (clinicaltrials.gov) - P1/2 | N=133 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: Oct 2024 ➔ Oct 2026 | Initiation date: Jan 2022 ➔ Oct 2022 | Trial primary completion date: Jul 2023 ➔ Feb 2025

Trial completion date • Trial initiation date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

A Phase Ⅰb/Ⅱ Clinical Study of Crifortinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML (clinicaltrials.gov) - P1/2; N=133; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3