Enhertu Gains Fifth Indication in China; FDA Approves World’s First MASP-2 Antibody
Daiichi - Sankyo
Pharmaceutical Development, Production, Sales, and Consulting Service Provider
AstraZeneca
Pharmaceutical Technology Research and Development Provider
Johnson & Johnson
Medical Device R&D and Manufacturer
Omeros
Biopharmaceutical Research, Production, and Sales Company
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© Amino Observation - Innovative Drug Team Original Production
Author | Huang Kai
Enhertu has been successively approved in China.
On December 25, Daiichi-Sankyo announced that another new indication for its重磅 HER2 ADC drug Trastuzumab Deruxtecan (Enhertu®) co-developed with AstraZeneca has been approved for marketing in China. It is indicated for adult patients with HR-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (IHC 0, with membranous staining) breast cancer.
FDA Approval New Developments.
On December 24, the FDA approved the first MASP-2 antibody, Omeros' Narsoplimab, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA).
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Market Express
1) Nhwa Pharmaceutical and Luye Pharma Reach Commercialization Agreement in China for Three Psychiatric Drugs
On December 24, Jiangsu Nhwa Pharmaceutical Co., Ltd. announced that it had reached a strategic cooperation agreement with Luye Pharma Group to obtain the exclusive commercial rights for three long-acting injectable antipsychotic products in mainland China. The collaboration covers Riketuo (Risperidone Microspheres for Injection (II)), Ruibailai (Paliperidone Palmitate Injection (II)), and Meibirui (Paliperidone Palmitate Injection), all of which are used for the treatment of schizophrenia.
/ 02 /
Pharmaceutical News
1) Another Indication of Enhertu Approved in China
On December 25, Daiichi Sankyo announced that Enhertu (Trastuzumab Deruxtecan), its key HER2 ADC drug co-developed with AstraZeneca, has been approved for another new indication in China. It is indicated for adult patients with HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0, with membranous staining) breast cancer. This marks the fifth indication approved for Enhertu in China.
2) Novo Nordisk's Pasireotide Approved for Marketing
On December 25, according to the NMPA website, Novo Nordisk's Pasitropin was approved for marketing in China, intended for use in children with growth hormone deficiency (GHD) to supplement endogenous growth hormone.
3) Johnson & Johnson's Amivantamab Subcutaneous Injection Approved for Marketing
On December 25, according to the NMPA website, Johnson & Johnson's Amivantamab Injection (Subcutaneous Injection) was approved for marketing in China. It is used in combination with Lazertinib for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
/ 03 /
Overseas Pharmaceutical News
1) FDA Approves World's First MASP-2 Antibody
On December 24, the FDA approved the first MASP-2 antibody, Omeros' Narsoplimab, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA).
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