China Approved Seven New Drugs in December 2023 Targeting Cervical Cancer, Diabetes, and Rare Diseases

　　【Pharmaceutical Network Product InformationIn December 2023, China approved the listing of seven new drugs, including Sockazolimab, Tepotinib, Faricimab, Maribavir, Nirsevimab, Recombinant Human Thrombin, and Trientine.
 

On December 21, according to NMPA, Lee's Pharmaceutical's SocaZoli monoclonal antibody was approved for marketing in China for the treatment of recurrent or metastatic cervical cancer (Application No.: CXSS2101042). SocaZoli monoclonal antibody (ZKAB001) was developed by Sorrento Therapeutics. In October 2014, Lee's Pharmaceutical acquired the rights for the development and commercialization of this product in Greater China.
 

It is reported that currently, SocaZolimab is undergoing various cancer trials, including recurrent or metastatic cervical cancer, first-line treatment in combination with carboplatin and etoposide for extensive-stage small cell lung cancer, treatment in combination with nab-paclitaxel for advanced urothelial carcinoma, maintenance therapy after adjuvant chemotherapy for high-grade osteosarcoma, neoadjuvant treatment for esophageal squamous cell carcinoma in combination with nab-paclitaxel and cisplatin, and adjuvant treatment for postoperative patients with biliary tract malignancies in combination with capecitabine.
 

On December 8, according to Merck, Tepotinib (Tepmetko®) received approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations. Tepotinib (Tepmetko®) is the first approved oral, highly selective MET inhibitor for the treatment of advanced NSCLC with METex14 skipping mutations.
 

On December 18, the National Medical Products Administration officially approved Roche's ophthalmic injection bispecific antibody Faricimab (trade name: Vabysmo) for the treatment of diabetic macular edema (DME). As an innovative bispecific antibody specifically designed for intravitreal injection, Faricimab can simultaneously target and inhibit key pathogenic factors causing various retinal diseases—angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A). Building on the foundation of existing anti-VEGF treatments, it makes a bold breakthrough by binding to and inhibiting both Ang-2 and VEGF-A pathways. This enhances vascular stability while also reducing retinal leakage.
 

On December 21, Takeda China announced that its innovative antiviral drug Maribavir Tablets (brand name "Yitai") has been officially approved by the National Medical Products Administration (NMPA) for the treatment of cytomegalovirus (CMV) infection and/or disease in adult patients who have undergone hematopoietic stem cell transplantation or solid organ transplantation. These patients must be refractory to one or more prior treatments (ganciclovir, valganciclovir, cidofovir, or foscarnet), with or without genotypic resistance. It is reported that Maribavir Tablets have obtained orphan drug designations in the United States, Europe, South Korea, and Australia. The drug was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2021 and received approval from the European Commission in November 2022.
 

Nirsevimab, developed by AstraZeneca, is a long-acting monoclonal antibody targeting respiratory syncytial virus (RSV) designed for all infants. In the Phase III clinical trial named MELODY, results showed that a single dose of nirsevimab reduced RSV-related acute lower respiratory tract infections (such as bronchiolitis or pneumonia) requiring medical attention by 74.5% in healthy infants entering their first RSV season compared to placebo. Nirsevimab was first approved for marketing in the European Union in October 2022.
 

Recombinant Human Thrombin is a highly specific human serine protease independently developed by Zelgen. It is used for adults when standard surgical hemostasis techniques (such as suturing, ligation, or electrocoagulation) are ineffective or not feasible, promoting hemostasis of oozing blood from surgical wounds or capillaries and small veins. Reportedly, Recombinant Human Thrombin is a highly specific human serine protease developed based on Zelgen's complex recombinant protein new drug and antibody new drug R&D and industrialization platform. It is the first recombinant human thrombin produced in China using recombinant gene technology and has been scientifically and rigorously tested in Phase III clinical trials before being approved for marketing as a biological hemostatic product. Globally, the only similar product that has been marketed and sold overseas for many years is Recothrom from the United States.
 

Orphalan's New Class 5.1 Drug, Tetrathydrozoline Hydrochloride Film-Coated Tablets, Approved for Marketing in December 2023 for the Treatment of Rare Disease Hepatolenticular Degeneration (Wilson's Disease). Hepatolenticular degeneration is a rare autosomal recessive genetic disorder caused by abnormal copper deposition in various tissues of the body. Clinical manifestations include acute or chronic liver disease symptoms, progressively worsening extrapyramidal symptoms, psychiatric symptoms, and corneal pigmentation rings. Other common symptoms include hemolytic anemia, osteoarticular symptoms, and hematuria. Tetrathydrozoline hydrochloride is a copper chelating agent that acts similarly to penicillamine and promotes copper excretion through the kidneys. The drug was originally developed by Merck KGaA.
 

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