New drug approvals - July 2025

Active Ingredient (Strength)

Dupilumab(200mg/1.14mL),
Dupilumab(300mg/2mL)

Application type

NDA-2

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

15/07/2025

Registration No.

SIN17291P,
SIN17292P

Indications:
DUPIXENT is indicated for the treatment of adults and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.DUPIXENT can be used with or without topical corticosteroids.

DUPIXENT is indicated in patients 6 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by elevated blood eosinophils and/or elevated FeNO.

DUPIXENT is indicated as maintenance therapy for oral corticosteroid-dependent asthma.

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled severe chronic rhinosinusitis with nasal polyposis (CRSwNP).

DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe prurigonodularis (PN) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

DUPIXENT is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

Active Ingredient (Strength)

Influenza virus (NH) A/Thailand/8/2022 (H3N2) - like virus (A/Thailand/8/2022)(7.0 ± 0.5 log10 FFU/dose),Influenza virus (NH) A/Victoria/4897/2022 (H1N1) pdm09 - like virus (A/Norway/31694/2022)(7.0 ± 0.5 log10 FFU/dose),Influenza virus (NH) B/Austria/1359417/2021 (B/Victoria lineage) - like virus (B/Austria/1359417/2021)(7.0 ± 0.5 log10 FFU/dose)

Application type

NDA-1

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

31/07/2025

Registration No.

SIN17298P

Indications:
FluMist Trivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist Trivalent is approved for use in persons 2 through 49 years of age.

Active Ingredient (Strength)

Tenecteplase(5,000 units (25 mg)/vial)

Application type

NDA-2

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Date of Approval

22/07/2025

Registration No.

SIN17293P

Indications:
METALYSE is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Active Ingredient (Strength)

Trastuzumab(60mg/vial)

Application type

NDA-2: Biosimilar

Product Registrant

INNOGENE KALBIOTECH PTE. LTD.

Date of Approval

02/07/2025

Registration No.

SIN17274P

Indications:
Metastatic Breast Cancer (MBC)
Trazher is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2:
a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease
b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with Trazher. This indication is based on data from one Phase III trial which studied the use of Trazher in combination with anastrozole (see Clinical/ Efficacy Studies).
Experience with other aromatase inhibitors is limited.

Early Breast Cancer (EBC)
Trazher is indicated for the treatment of patients with HER2 positive early breast cancer.
- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see Clinical/ Efficacy Studies).
- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
- in combination with neoadjuvant chemotherapy followed by adjuvant Trazher therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in
diameter (see Special Warnings and Precautions for Use, and Clinical/ Efficacy Studies).
Trazher should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic Gastric Cancer (MGC)
Trazher in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the
stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Trazher should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.

Active Ingredient (Strength)

Guselkumab(200 mg/20mL),
Guselkumab(200 mg/2mL),
Guselkumab(200 mg/2mL)

Application type

NDA-2,
NDA-2,
NDA-3

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

10/07/2025

Registration No.

SIN17285P,
SIN17286P,
SIN17287P

Indications:
Plaque psoriasis
Adults
TREMFYA® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis
TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Ulcerative colitis
TREMFYA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Crohn’s disease
TREMFYA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Palmoplantar pustulosis
TREMFYA® by subcutaneous (SC) administration is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy.

*Evaluated via Access

Active Ingredient (Strength)

A/Darwin/9/2021 (H3N2)-like strain(15mcg/0.5ml),A/Victoria/4897/2022 (H1N1) pdm09-like strain(15mcg/0.5ml),B/Austria/1359417/2021-like strain(15mcg/0.5ml)

Application type

NDA-2

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

04/07/2025

Registration No.

SIN17277P

Indications:
Vaxigrip is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the influenza B virus type contained in the vaccine for active immunisation of adults, including pregnant women, and children from 6 months of age and older