71 New Drug Approvals from NMPA: Lee's Pharma's PD-L1 Inhibitor and Takeda's Antiviral Maribavir Granted Marketing Authorization

Dec 21, 2023 16:14 CST Updated 16:14

Lepu Pharmaceutical

New drug research and development, API production, formulation production, and marketing

Nhwa

Developer and Manufacturer of Central Nervous System (CNS) Drugs

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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Just now, NMPA released the information on the delivery of drug approval certificates on December 21, 2023.This batch includes 71 approved application numbers, of which 15 are for consistency evaluation., including the following approved varieties:

Lepu Pharmaceutical Co., Ltd., Compound Glycyrrhizin Tablets

Shandong Huasu Pharmaceutical Co., Ltd., Benidipine Hydrochloride Tablets

Jiangsu Nhwa Pharmaceutical Co., Ltd., Fentanyl Citrate Injection

MYSUN PHARMA, Acyclovir Tablets

etc.

This time, 28 additional marketing application acceptance numbers have been approved, including the following approved products:

Qilu PharmaceuticalEtanercept for Injection; China Resources Double-Crane PharmaceuticalSugammadex Sodium Injection; HAINAN SIMCERE PHARMACEUTICAL CO., LTDApremilast Tablets; Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.Micafungin Sodium for Injection; Chia Tai Tianqing PharmaceuticalPosaconazole Injection; Zhejiang Huahai Pharmaceutical Co., Ltd.Lacosamide Tablets; Haisco Pharmaceutical(Meishan) Co., Ltd.Gliclazide Modified-Release Tabletsetc.

In addition,Socazolimab Injection, a Class 1 biological new drug developed by Zhaoke (Guangzhou) Oncology Pharmaceutical Limited (a wholly-owned subsidiary of Lee's Pharmaceutical)(Its registered name in CDE is: Sockchu Injection)Approved for Marketing， For the treatment of recurrent or metastatic cervical cancer.

It is reported that Socazolimab Injection is the fifth PD-L1 to be submitted for marketing in China, and also the first PD-(L)1 in China to be submitted for second-line cervical cancer.

Takeda's Maribavir Tablets Approved for Marketing in China，For the treatment of cytomegalovirus (CMV) infection and/or disease in adult patients after hematopoietic stem cell transplantation or solid organ transplantation, who are refractory to one or more prior treatments (ganciclovir, valganciclovir, cidofovir, or foscarnet) with or without genotypic resistance.

According to publicly available data, Maribavir tablets are the world's first and currently only antiviral agent that targets and inhibits the UL97 protein kinase and its natural substrates. Its approval will provide a new oral treatment option for transplant recipients in China suffering from refractory CMV infections or diseases.