Shenzhen Hepalink Pharmaceutical Group Co., Ltd.

Global Heparin Industrial Chain

Hepalink is a leader in the heparin industrial chain segment and one of a few biopharmaceutical companies with vertically integrated capabilities covering the entire heparin industrial chain

All of Hepalink’s enoxaparin sodium preparations are made of the company’s own heparin APIs, and are completely traceable

Approved Indications of Enoxaparin in China

Prophylaxis of VTE diseases：: · Prophylaxis of VTE in total hip arthroplasty (THA); · Prophylaxis of VTE in total knee arthroplasty (TKA); · Prophylaxis of VTE in orthopedic trauma; · Prophylaxis of VTE in pelvic surgery; · Prophylaxis of VTE in general surgery; · Prophylaxis of VTE in medical treatment

Treatment of existing DVT：: · Anticoagulant treatment of DVT with or without pulmonary embolism

Prophylaxis of VTE

Anticoagulant in ACS treatment

Treatment of VTE

Anticoagulant in hemodialysis

Enoxaparin sodium injection

1 drug adopted for treatment in

4 therapeutic areas

NSTE-ACS：: · Anticoagulant in the treatment of unstable angina / non-Q wave myocardial infarction; · Anticoagulant in PCI treatment

STEMI：: · Anticoagulant in the medical treatment of STEMI; · Anticoagulant in PCI treatment

Hemodialysis：: · Prevention of thrombosis in the extra-corporeal circulation of hemodialysis

VTE：venous thromboembolism DVT：deep venous thrombosis NSTE-ACS：Non-ST elevation-acute coronary syndrome STEMI：ST-segment elevation myocardial infarction PCI：percutaneous coronary intervention

Clinical Application of Enoxaparin

Cancer

Therapeutic Advantage and Guideline Recommendation

·ACC9 Guideline

·Recommended by the China Guideline issued in 2015

·6-14 days of prophylaxis (LMWH/LDUH/mechanical prophylaxis) in hospitalized high VTE risk patients with a Padua score≥4

·Cancer patients with venous thromboembolism (VTE)

·Cancer patients with thrombocytopenia

Gynecology & Obstetrics

Therapeutic Advantage and Guideline Recommendation

·WHO recommendations for the prevention of VTE associated with COVID-19 infections

·Pregnant women with heart diseases

·Potential Applications* :
- Recurrent spontaneous abortion
- Antiphospholipid syndrome
- Prethrombotic state

Cardiology

Therapeutic Advantage and Guideline Recommendation

·2014 AHA and ACS Guidelines

·2018 ECS Guideline

·2020 Guideline for the primary care of patients with STEMI

·Chinese expert’s consensus on the use of enoxaparin for anticoagulation in patients with ACS

·The TIMI 11B study

·Unstable angina

·Non-ST-elevated myocardial infarction

·Acute ST-elevated myocardial infarction

·Acute heart failure patients on medical treatment

·Hospitalized patients with atrial fibrillation

·ICU-treated COVID-19 infected patients with underlying heart diseases or prior cardiovascular events

·Pregnant women with heart diseases

Surgery

Therapeutic Advantage and Guideline Recommendation

·The 2015 guideline issued in China recommends 6-14 days of prophylaxis (LMWH/LDUH/mechanical VTE prophylaxis) in hospitalized high VTE-risk patients with a Padua score≥4

·Patients with mid/high VTE risks receiving:
- Orthopedic surgery
- General surgical treatment
- Surgical cancer treatment

Respiratory Diseases

Therapeutic Advantage and Guideline Recommendation

·2015 consensus on the comprehensive prevention of thrombosis: patients with TIA should be considered for LMWH treatment as early as possible. The consensus also recommends to combine LMWH with mechanical VTE prophylaxis

·Patients with severe COVID-19 infections and those hospitalized for the infection

·Patients with acute diseases including impaired respiratory functions or severe infections

·Patients with deep venous thrombosis or pulmonary embolism (PE), excluding those PE patients who may need thrombolytic therapy or surgical treatment

Medical Nephrology & Dialysis

Therapeutic Advantage and Guideline Recommendation

·ACOG Guidelines: LMWH is the preferred anticoagulant for the prevention of thrombosis during pregnancy

·Enoxaparin does not cross the placenta, is therefore safer to the pregnant woman and the fetus

·Meta-analysis showed that LMWH can improve the rate of live birth and reduce abortion

·Chinese Experts’ Consensus on the Use of LMWH in the Prevention of Spontaneous Abortions has commended LMWH in the prevention and treatment of RSA patients with PTS, APS, or AID etc**.

** RSA, recurrent spontaneous abortion. PTS, postthrombotic syndrome. APS, antiphospholipid antibody syndrome. AID, autoimmune disorder

·Chronic kidney disease patients with VTE

·Extracorporeal circulation during dialysis

·Rheumatic disease patients with VTE

Hematology

Therapeutic Advantage and Guideline Recommendation

·Based on Caprini risk modeling, Guideline recommends LMWH as anticoagulant in surgical patients with mid/high VTE risk (Caprini score >3)

·Acute lymphocytic leukemia

·Cancer patients with thrombocytopenia

·Rare hereditary hemorrhagic diseases

Neurology

Therapeutic Advantage and Guideline Recommendation

·Patients undergoing major orthopedic surgeries require routine prophylaxis of VTE that should be determined by the VTE risk score

·Medicinal prophylaxis is required in patients with Caprini score ≥2

·Enoxaparin can significantly reduce the incidence of DVT and PTE without increasing the risk of excessive bleeding in patients who received major orthopedic surgeries

·Patients with brain tumors

·Transient ischemic attacks

Transplants

Therapeutic Advantage and Guideline Recommendation

·ASCO, ESMO, NCCN, and BJH Guidelines

·Patients awaiting or received liver transplants

Gastroenterology

Therapeutic Advantage and Guideline Recommendation

·The 2016 ACCP guideline for the prevention of VTE in non-orthopedic surgical patients recommends LMWH for anticoagulation in surgical patients with mid/high VTE risks (Caprini score>3)

·High thrombotic risk patients receiving high-risk endoscopic surgeries