New drug approvals - May 2025
- Please click here for a list of summary reports of benefit-risk assessments.
- Please click here for description of application types.
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals