Enhertu has been approved in the country one after another.

On December 25, Daiichi Sankyo announced that its blockbuster HER2 ADC drug, trastuzumab (Enhertu®), co-developed with AstraZeneca, has been approved for marketing in China for a new indication: adult patients with HR-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (IHC 0, with membrane staining) breast cancer.

New developments in FDA approvals.

On December 24, the FDA approved Narsoplimab from Omeros, the first MASP-2 antibody, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA).

What other hot topics in the domestic and international pharmaceutical markets were worth noting in the past day? Let Amino Jun take you to find out.

/ 01 /
Market Express

1) Enhua Pharmaceutical and Luye Pharma reach an agreement for the domestic commercialization of three psychiatric drugs.

On December 24, Enhua Pharmaceutical announced a strategic cooperation agreement with Luye Pharma Group, acquiring exclusive commercialization rights in mainland China for three of the latter's long-acting injectable antipsychotic drugs. This cooperation covers Recombinant Human (risperidone microspheres for injection (II)), Rebasil (paliperidone palmitate injection (II)), and Mebiride (paliperidone palmitate injection), all three drugs used to treat schizophrenia.

/ 02 /
Medical News

1) Enhertu receives approval for another indication in the country

On December 25, Daiichi Sankyo announced that its blockbuster HER2 ADC drug, trastuzumab (Enhertu®), co-developed with AstraZeneca, has been approved for marketing in China for a new indication: adult patients with HR-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (IHC 0, with membrane staining). This is the fifth indication approved for Enhertu in China.

2) Novo Nordisk's Pasis growth hormone approved for marketing.

On December 25, according to the NMPA website, Novo Nordisk's Parcy growth hormone was approved for marketing, for the purpose of supplementing endogenous growth hormone in children with growth hormone deficiency (GHD).

3) Johnson & Johnson's Evantuza subcutaneous injection formulation approved for marketing.

On December 25, according to the NMPA website, Johnson & Johnson's Evantuumab injection (subcutaneous injection) was approved for marketing, for use in combination with lanzatinib for the treatment of EGFR-mutant non-small cell lung cancer (NSCLC).

/ 03 /
Overseas Pharmaceutical News

1) FDA approves the world's first MASP-2 antibody

On December 24, the FDA approved Narsoplimab from Omeros, the first MASP-2 antibody, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA).

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