New drug approvals - October 2025

Active Ingredient (Strength)

Influenza virus surface antigens (haemagglutinin and neuraminidase)(7.5 micrograms HA per 0.5 mL dose)

Application type

NDA-2

Product Registrant

SEQIRUS PTE. LTD.

Date of Approval

29/10/2025

Registration No.

SIN17377P

Indications:

AUDENZ® is indicated for active immunisation against influenza A in persons from 6

months of age and older in an officially declared pandemic.

AUDENZ® should be used in accordance with official recommendations.

The available evidence was based on immunogenicity studies conducted in healthy subjects following administration of two doses of monovalent vaccine of different influenza subtypes. See also Section 5.1 Pharmacodynamic properties - Clinical trials

Active Ingredient (Strength)

Influenza virus surface antigens (haemagglutinin and neuraminidase) A/turkey/Turkey/1/2005(H5N1)-like strain used (NIBRG-23)(7.5 micrograms HA per 0.5 mL dose)

Application type

NDA-2

Product Registrant

SEQIRUS PTE. LTD.

Date of Approval

16/10/2025

Registration No.

SIN17363P

Indications:
CELLDEMIC® is indicated for active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older. CELLDEMIC® should be used in accordance with official recommendations.

Active Ingredient (Strength)

Lazertinib Mesylate Monohydrate eqv Lazertinib(80 mg),
Lazertinib Mesylate Monohydrate eqv Lazertinib(240 mg)

Application type

NDA-1,
NDA-3

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

02/10/2025

Registration No.

SIN17349P,
SIN17348P

Indications:
LAZCLUZE® in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

* Evaluated via Project ORBIS

Active Ingredient (Strength)

Tirzepatide(2.5mg/0.5mL),
Tirzepatide(5mg/0.5mL),
Tirzepatide(7.5mg/0.5mL),
Tirzepatide(10mg/0.5mL),
Tirzepatide(12.5mg/0.5mL),
Tirzepatide(15mg/0.5mL)

Application type

NDA-2, NDA-3

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

10/10/2025

Registration No.

SIN17351P,
SIN17352P,
SIN17353P,
SIN17354P,
SIN17355P,
SIN17356P

Indications:
Type 2 diabetes mellitus
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.

Weight management
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m2 (obesity) or
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus

Active Ingredient (Strength)

Asciminib hydrochloride eqv asciminib(100 mg)

Application type

NDA-3

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

06/10/2025

Registration No.

SIN17350P

Indications:
Scemblix® is indicated for the treatment of adult patients with:
•Newly diagnosed or previously treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
•Ph+ CML in CP harboring the T315I mutation.

Active Ingredient (Strength)

Denosumab(120mg/mL)

Application type

NDA-2

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

17/10/2025

Registration No.

SIN17364P

Indications:
Prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with multiple myeloma and in patients with bone metastases from solid tumours.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Active Ingredient (Strength)

Enzalutamide(80mg),
Enzalutamide(40mg)

Application type

NDA-2,
NDA-3

Product Registrant

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Date of Approval

21/10/2025

Registration No.

SIN17369P,
SIN17368P

Indications:
Xtandi is indicated:
• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 4.4, 4.8 and 5.1).
• for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).
• for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.