New Drug Approvals

New drug approvals - May 2025

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Therapeutic Products

10 July 2025

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For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

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Product Name	COMIRNATY, DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE, 30 MICROGRAMS/DOSE
Active Ingredient (Strength)	Bretovameran(30 μg/dose)
Application type	NDA-2
Product Registrant	BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Date of Approval	13/05/2025
Registration No.	SIN17235P
Indications: COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

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Product Name	DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Active Ingredient (Strength)	Datopotamab deruxtecan(100 mg/vial)
Application type	NDA-1
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	10/05/2025
Registration No.	SIN17234P
Indications: DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. *Evaluated via ACCESS

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Product Name	EBGLYSS SOLUTION FOR INJECTION IN PRE-FILLED PEN 250MG/2ML
Active Ingredient (Strength)	Lebrikizumab(250 mg/2 mL)
Application type	NDA-1
Product Registrant	DKSH SINGAPORE PTE. LTD.
Date of Approval	02/05/2025
Registration No.	SIN17229P
Indications: Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

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Product Name	LEQEMBI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML
Active Ingredient (Strength)	Lecanemab(100 mg/ml)
Application type	NDA-1
Product Registrant	EISAI (SINGAPORE) PTE. LTD.
Date of Approval	02/05/2025
Registration No.	SIN17228P
Indications: LEQEMBI is indicated for slowing the progression of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. The safety and efficacy of lecanemab have not been established in patients with moderate or severe Alzheimer's disease.

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Product Name	OPSYNVI FILM-COATED TABLETS 10MG/20MG, OPSYNVI FILM-COATED TABLETS 10MG/40MG
Product Name	OSYNVI FILM-COATED TABLETS 10MG/20MG, OPSYNVI FILM-COATED TABLETS 10MG/40MG
Active Ingredient (Strength)	Macitentan(10mg),Tadalafil(20mg), Macitentan(10mg),Tadalafil(40mg)
Application type	NDA-2, NDA-3
Product Registrant	JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval	22/05/2025
Registration No.	SIN17241P, SIN17242P
Indications: OPSYNVI® is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 inhibitor (PDE5i) indicated for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II-III.

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Product Name	TALZENNA CAPSULE 0.1MG, TALZENNA CAPSULE 0.35MG, TALZENNA CAPSULE 0.5MG
Active Ingredient (Strength)	Talazoparib tosylate eqv Talazoparib(0.1 mg), Talazoparib tosylate eqv Talazoparib(0.35 mg), Talazoparib tosylate eqv Talazoparib(0.5 mg)
Application type	NDA-3
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	21/05/2025
Registration No.	SIN17238P, SIN17239P, SIN17240P
Indications: Breast cancer TALZENNA is indicated for the treatment of adult patients with germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have previously been treated with chemotherapy. These patients could have received chemotherapy in the neoadjuvant, adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Prostate cancer TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Drug caption

Product Name	TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML
Active Ingredient (Strength)	Tislelizumab (100mg/10mL)
Product Registrant	Beigene Singapore Pte. Ltd.
Date of Approval	7 May 2025
Registration No.	SIN17230P
Indications: Nasopharyngeal cancer (NPC) TEVIMBRA, in combination with gemcitabine and cisplatin is indicated for the first-line treatment of patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.

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Product Name	VABYSMO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.05ML
Active Ingredient (Strength)	Faricimab(6.0 mg/0.05 mL)
Application type	NDA-2
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	29/05/2025
Registration No.	SIN17245P
Indications: Vabysmo is indicated for the treatment of adult patients with: • neovascular (wet) age-related macular degeneration (nAMD) (see section 3.1.2 Clinical Efficacy Studies). • visual impairment due to diabetic macular edema (DME) (see section 3.1.2 Clinical Efficacy Studies). • macular edema secondary to retinal vein occlusion (RVO) (see section 3.1.2 Clinical Efficacy Studies).

Drug caption

Product Name	WELIREG® FILM-COATED TABLET 40MG
Active Ingredient (Strength)	Belzutifan(40.00mg)
Application type	NDA-1
Product Registrant	MSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval	09/05/2025
Registration No.	SIN17233P
Indications: WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor (VEGF) targeted therapy.

Drug caption

Product Name	ZERPIDIO (SERPLULIMAB) CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML
Active Ingredient (Strength)	Serplulimab(100mg/10ml)
Application type	NDA-1
Product Registrant	INNOGENE KALBIOTECH PTE. LTD.
Date of Approval	29/05/2025
Registration No.	SIN17246P
Indications: Zerpidio in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

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