Pipeline

Product
Indication
Processes
Delivery Systems
Country
Preclinical
IND
Phase I
Phase II
Phase III
NDA
D23
Budesonide delayed-release tablet
IgAN*
Melt Extrusion Deposition (MED®)
3DμS®-IT
CN
U.S.

Key Enhancement: Precise ileum-targeted delivery

Delivery System: 3D Microstructure for Intestine Targeting (3DμS® -IT)

Indication: Adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression

T20G
Apixaban Gastroretentive Extended-Release Capsule
VTE* NVAF* DVT* PE*
Melt Extrusion Deposition plus Micro-Injection Molding (MED&MIM)
3DμS®-GR
U.S.

Key Enhancement: The unique petal-like structure enables gastric retention.

Delivery System: 3D Microstructure for Gastric Retention (3DμS® -GR)

Indication:

  • To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF).
  • For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
  • For the treatment of DVT and PE,and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy.
  • Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.
T24
Ramelteon dual-release tablet
Insomnia
Melt Extrusion Deposition (MED®)
3DμS®-MR
CN

Key Enhancement: Single dosing with dual precise timed-release, addressing both sleep initiation and sleep maintenance difficulties in patients with insomnia.

Delivery System: 3D Microstructure for Modified Release (3DμS® -MR)

Indication: Insomnia characterized by difficulty falling asleep and/or early morning awakening

T25
Octreotide acetate tablet
Acromegaly
Melt Extrusion Deposition plus Semi-Solid Extrusion (MED&SSE)
3DμS®-OM
CN
U.S.

Key Enhancement: Improved oral bioavailability of peptide therapeutics

Delivery System: 3D Microstructure for Oral Macromolecules(3DμS® -OM)

Indication: The drug is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues

T26
Itraconazole Tablet
Mycoses
Melt Extrusion Deposition (MED®)
3DμS®-SE
U.S.

Key Enhancement: To enhance the oral bioavailability of poorly soluble drugs

Delivery System: 3D Microstructure for Solubility Enhancement  (3DμS® -SE)

Indication:

  • Fungal infections caused by susceptible organisms involving the skin, hair, nails, and mucous membranes.
  • Fungal infections caused by susceptible organisms involving the skin and subcutaneous tissues.
  • Systemic mycoses.
    Product
    D23
    Budesonide delayed-release tablet
    Indication
    IgAN*
    Processes
    Melt Extrusion Deposition (MED®)
    Delivery Systems
    3DμS®-IT
    Phase
    CN: Phase II
    U.S.: IND

Key Enhancement: Precise ileum-targeted delivery

Delivery System: 3D Microstructure for Intestine Targeting (3DμS® -IT)

Indication: Adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression

    Product
    T20G
    Apixaban Gastroretentive Extended-Release Capsule
    Indication
    VTE* NVAF* DVT* PE*
    Processes
    Melt Extrusion Deposition plus Micro-Injection Molding (MED&MIM)
    Delivery Systems
    3DμS®-GR
    Phase
    U.S.: Phase I

Key Enhancement: The unique petal-like structure enables gastric retention.

Delivery System: 3D Microstructure for Gastric Retention (3DμS® -GR)

Indication:

  • To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF).
  • For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
  • For the treatment of DVT and PE,and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy.
  • Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.
    Product
    T24
    Ramelteon dual-release tablet
    Indication
    Insomnia
    Processes
    Melt Extrusion Deposition (MED®)
    Delivery Systems
    3DμS®-MR
    Phase
    CN: Phase I

Key Enhancement: Single dosing with dual precise timed-release, addressing both sleep initiation and sleep maintenance difficulties in patients with insomnia.

Delivery System: 3D Microstructure for Modified Release (3DμS® -MR)

Indication: Insomnia characterized by difficulty falling asleep and/or early morning awakening

    Product
    T25
    Octreotide acetate tablet
    Indication
    Acromegaly
    Processes
    Melt Extrusion Deposition plus Semi-Solid Extrusion (MED&SSE)
    Delivery Systems
    3DμS®-OM
    Phase
    CN: IND
    U.S.: IND

Key Enhancement: Improved oral bioavailability of peptide therapeutics

Delivery System: 3D Microstructure for Oral Macromolecules(3DμS® -OM)

Indication: The drug is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues

    Product
    T26
    Itraconazole Tablet
    Indication
    Mycoses
    Processes
    Melt Extrusion Deposition (MED®)
    Delivery Systems
    3DμS®-SE
    Phase
    U.S.: IND

Key Enhancement: To enhance the oral bioavailability of poorly soluble drugs

Delivery System: 3D Microstructure for Solubility Enhancement  (3DμS® -SE)

Indication:

  • Fungal infections caused by susceptible organisms involving the skin, hair, nails, and mucous membranes.
  • Fungal infections caused by susceptible organisms involving the skin and subcutaneous tissues.
  • Systemic mycoses.

IgAN: Immunoglobulin A Nephropathy
VTE: Venous Thromboembolism
NVAF: Nonvalvular Atrial Fibrillation
DVT : Deep Vein Thrombosis
PE: Pulmonary Embolism

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