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1. Data Analysis of Clinical Trial Applications/Approvals and Marketing Applications/Approvals for Innovative Drugs/Improved New Drugs in China This Week

1.1 General Overview

According to the statistics from the Mosentropy Medicine database, during the period of 2026.01.19-2026.01.25, a total of 102 innovative drugs / improved new drugs clinical applications / marketing applications were accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (counted by acceptance number, excluding supplementary applications). Among them, there were 68 acceptance numbers for domestically produced drugs and 34 acceptance numbers for imported drugs.

This week, a total of 54 innovative drugs/modified new drugs received "tacit approval" for clinical trial applications, including 29 chemical drugs, 21 biological drugs, and 4 traditional Chinese medicines. Among them, the noteworthy ones are:

(1) EPX-100 Oral Solution

On January 20, the CDE official website announced: EPX-100 oral solution submitted by Epygenix Therapeutics has obtained clinical trial implied permission for the treatment of Dravet syndrome. Public information shows that EPX-100 modulates serotonin signaling by targeting the central 5-hydroxytryptamine 2 (5HT-2) serotonin receptor.

(2) BAY-3547926 Injection, BAY-3547922 for Injection

On January 20, the CDE website announced: Bayer's BAY-3547926 Injection and BAY-3547922 for Injection obtained clinical trial tacit approval for the treatment of hepatocellular carcinoma (HCC). Public data shows that BAY-3547926 is a radiopharmaceutical u-particle targeted therapy (TAT) targeting GPC3, a radioactive conjugate constructed based on actinium-225 (225Ac), demonstrating significant anti-tumor activity in GPC3-dependent tumor models. BAY-3547922 for Injection is a monoclonal antibody-chelator. When combined with the radioactive isotope zirconium Zr89 (Zr89), the monoclonal antibody fragment of BAY-3547922 specifically targets and binds to relevant antigens expressed on tumor cells, which may allow tracking of TAA-expressing tumor cells on positron emission tomography/computed tomography (PET/CT).

(3)GenSci-145 Tablets

On January 22, the CDE website announced: GenSci-145 tablets submitted by Jin Sai Pharmaceuticals have obtained clinical trial implied permission, intended for use in locally advanced or metastatic solid tumors carrying PIK3CA mutations. Public information indicates that GenSci-145 is a novel mutation-selective PI3Ka inhibitor, which demonstrated selective inhibitory activity against various PIK3CA hotspot mutations in preclinical studies and exhibited good blood-brain barrier penetration ability. No traditional side effects such as hyperglycemia were observed, offering hope to provide an effective treatment option for patients with PI3K-mutated tumors accompanied by brain metastases.

This Week 2 New Drugs Approved for Marketing:

On January 22, the National Medical Products Administration (NMPA) released the delivery information of drug approval certificates: the approval of Yiling Pharmaceutical's Phenylaminophenol Injection for market entry in Shijiazhuang, China. It is indicated for mild to moderate pain in adults after surgery and can be combined with opioid analgesics to treat moderate to severe postoperative pain. Public data shows that Phenylaminophenol Injection belongs to non-steroidal analgesic and anti-inflammatory drugs. Its mechanism of action involves decomposing into biphenylacetic acid in the body and exerting precise analgesic effects by inhibiting prostaglandin synthesis.

On January 23, the National Medical Products Administration (NMPA) granted conditional approval for the marketing of Libivirumab Injection (brand name: Huayouan) developed by Huahui Anjian (Beijing) Biotechnology Co., Ltd. through a priority review and approval process. The drug is indicated for the treatment of adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. Public data shows that Libivirumab, developed by Huahui Anjian, is the world's first neutralizing antibody targeting the preS1 region of the large envelope protein on the surface of hepatitis B/hepatitis D viruses (HBV/HDV). By specifically binding to the PreS1 region on the HBV/HDV surface, it blocks the interaction between HBV, HDV, and their receptor NTCP, thereby preventing viral entry into hepatocytes and neutralizing viral infection.