Ten Innovative Drugs Approved in China in February 2025

In February 2025, at least 8 new drugs were approved for marketing in China. These new drugs cover types such as monoclonal antibodies, bispecific antibodies, and small molecules, bringing new treatment options for lung cancer, head and neck cancer, multiple myeloma, hepatitis C, and kidney disease.

Sinocelltech: Finolimab Injection

Mechanism of Action: Anti-PD-1 Monoclonal Antibody

Indications: Squamous Cell Carcinoma of the Head and Neck, Hepatocellular Carcinoma

On February 8, the NMPA announced the approval of Sinocelltech Group Limited's Class 1 new drug, Finolimab Injection, for marketing. It is to be used in combination with platinum-based chemotherapy for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (HNSCC). On February 28, Finolimab received another approval from the NMPA for a new indication, to be used in combination with Bevacizumab Injection (SCT510) for patients with unresectable or metastatic hepatocellular carcinoma who have not previously received systemic therapy.

Fenolimab is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody that enhances immune responses in the tumor microenvironment by blocking the binding of PD-1 to its ligands, thereby inhibiting tumor growth. The approval of this combination therapy further expands the application scope of the drug, providing a new treatment option for patients with hepatocellular carcinoma.

Dongyang Light Pharma: Naphthylphosphate Neptasvir Combined with Icotinib Phosphate

Mechanism of Action: NS5A Inhibitor Combined with NS5B Inhibitor

Indications: Chronic hepatitis C virus infection

On February 8, the NMPA announced the approval of Dongyangguang Pharmaceutical's Class 1 innovative drug, Naphthalenetrisulfonic Acid Phosphate Capsules, for marketing. This medication is suitable for use in combination with Elbasvir Tablets to treat treatment-naive or interferon-experienced adults with genotype 1, 2, 3, or 6 chronic hepatitis C virus (HCV) infection, with or without compensated cirrhosis.

In a Phase 2 clinical study published in the September 2024 issue of the Chinese Journal of Hepatology, the overall SVR12 (sustained virologic response rate at 12 weeks post-treatment) for the combination of nacitantasvir phosphate and echapavir was 96.7%. This combination therapy can cover patients with genotypes 1, 2, 3, and 6 of hepatitis C. As the goal of eliminating hepatitis C by 2030 progresses, this combination therapy is expected to become a blockbuster product with sales exceeding 2 billion yuan.

Johnson & Johnson: Amivantamab

Mechanism of Action: EGFR/MET Bispecific Antibody

Indications: Non-small cell lung cancer with EGFR exon 20 insertion mutations

On February 11, Johnson & Johnson announced that the EGFR/MET bispecific antibody therapy, amivantamab injection, had been approved by the NMPA for marketing. It will be administered in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations as confirmed by testing.

Amivantamab is a humanized bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET). The approval of amivantamab is based on the Phase III clinical study PAPILLON, which showed that compared with chemotherapy alone, the combination of amivantamab and chemotherapy reduced the risk of disease progression or death by 61%.

Johnson & Johnson: Tarquetumab

Mechanism of Action: GPRC5D×CD3 Bispecific Antibody

Indications: Multiple Myeloma

On February 11, Johnson & Johnson announced that talquetamab injection had been approved by the NMPA for marketing in China. It is indicated as monotherapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

This is the world's first bispecific antibody drug targeting GPRC5D and CD3. Talquetamab redirects T cells to attack tumor cells by targeting the CD3 receptor on the surface of T cells and the GPRC5D receptor on the surface of multiple myeloma cells, thereby inhibiting tumor formation and growth. Clinical trials have shown that talquetamab achieves an overall response rate (ORR) exceeding 70% with durable responses, including 65% of patients who had previously received T-cell redirection therapy reaching remission.

The drug is also undergoing multiple Phase III clinical trials to explore its application across different treatment lines for multiple myeloma.

Merck: Cefalosporin Sodium and Tazobactam Sodium for Injection

Mechanism of Action: Enzyme Inhibitor Combination Product

Indications: Complicated intra-abdominal infections, complicated urinary tract infections, etc.

On February 11, MSD's new enzyme inhibitor combination drug - Ceftolozane Sodium and Tazobactam Sodium for Injection was approved for marketing in China. It is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adult and pediatric patients (from birth to under 18 years of age) caused by susceptible Gram-negative and Gram-positive microorganisms, in combination with metronidazole; treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adult and pediatric patients (from birth to under 18 years of age) caused by susceptible Gram-negative microorganisms; and treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in adult patients (18 years of age and above) caused by susceptible Gram-negative microorganisms.

Ceftolozane and Tazobactam Sodium for Injection contains the cephalosporin antibiotic ceftolozane and the β-lactamase inhibitor tazobactam. According to a press release from Merck, this new enzyme inhibitor combination drug can help doctors address increasingly complex drug-resistant infections in clinical treatment, offering patients a new treatment option.

Fosun Pharma, Ardelyx: Tenapanor Hydrochloride Tablets

Mechanism of Action: NHE3 Inhibitor

Indications: CKD adult dialysis patients

On February 26, Desen Pharmaceutical's Tenapanor Hydrochloride Tablets, a novel phosphorus-lowering drug licensed from Ardelyx, received NMPA approval for marketing in China. It is indicated for controlling serum phosphorus levels in adult dialysis patients with chronic kidney disease (CKD) who show insufficient response or intolerance to phosphate binders. Tenapanor Hydrochloride Tablets are an oral inhibitor of intestinal sodium/hydrogen exchanger 3 (NHE3). By inhibiting NHE3, it tightens intercellular junctions and reduces paracellular phosphate permeability, the primary pathway for intestinal phosphate absorption, thereby decreasing phosphate absorption and lowering blood phosphorus levels.

According to the introduction in Fosun Pharma's press release, Tenapanor can be used in combination with existing phosphate binders to further significantly reduce blood phosphorus levels and improve the rate of achieving target blood phosphorus levels. A randomized, double-blind, placebo-controlled study included 164 hyperphosphatemia patients undergoing hemodialysis; after 8 weeks of treatment with Tenapanor combined with phosphate binders, blood phosphorus levels decreased by an additional 0.57 mmol/L compared to treatment with phosphate binders alone. A multicenter, randomized, open-label study included 303 dialysis patients whose phosphate binder therapy did not meet targets; switching to a Tenapanor-based phosphorus-lowering regimen (Tenapanor 30 mg BID, with phosphate binders added if blood phosphorus levels were not met) for 10 weeks increased the rate of achieving target blood phosphorus levels by 34.4%-38.2%.

Connem Biotech: Sipulimab

Mechanism of Action: IL-4Rα Biologics

Indications: Seasonal Allergic Rhinitis (SAR)

On February 7, 2025, Sipulimab was approved by the National Medical Products Administration (NMPA) for the treatment of Seasonal Allergic Rhinitis (SAR). This drug is the first IL-4Rα biologic approved for the treatment of seasonal allergic rhinitis and the second IL-4Rα monoclonal antibody globally (the first being Dupilumab from Sanofi).

Suptibayt monoclonal antibody is a highly effective humanized monoclonal antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). By binding to IL-4Rα, suptibayt monoclonal antibody can dually block the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), both of which are key factors in triggering type 2 inflammation. This mechanism enables it to effectively inhibit Th2-type inflammatory responses, thereby alleviating symptoms of related diseases.

The drug was approved in September 2024 for adult patients with moderate to severe atopic dermatitis, and in December for chronic rhinosinusitis with nasal polyps.

Johnson & Johnson: Guselkumab

Mechanism of Action: Interleukin-23 (IL-23) Inhibitor

Indications: Crohn's Disease

On February 25, 2025, Guselkumab was approved in China for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologics. This marks the drug's first global approval for Crohn's disease.

Guselkumab is a fully human interleukin-23 (IL-23) inhibitor with a unique dual mechanism of action: Guselkumab can bind with high affinity to the p19 subunit of IL-23, blocking the interaction between IL-23 and its receptor; it can also target CD64+ inflammatory cells, which are the primary producers of IL-23, neutralizing IL-23 at its source and effectively blocking inflammatory signaling pathways. This dual mechanism allows it to exhibit significant anti-inflammatory effects in the treatment of autoimmune diseases.

Guselkumab has been approved in China for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. In the United States, guselkumab is also approved for the treatment of moderately to severely active ulcerative colitis.

Tainuomabo: Stedutamab Injection

Mechanism of Action: Anti-Tetanus Toxin Monoclonal Antibody

Indications: Emergency prevention of tetanus in adults

On February 11, Tetanus Single Antigen Monoclonal Antibody Injection, a recombinant anti-tetanus toxin monoclonal antibody new drug independently developed by Tianmai Biotech, was approved for marketing by the NMPA. This product, as an upgraded version of the new "tetanus shot," is used for emergency prevention of tetanus in adults. According to the company's press release, the product takes effect quickly through intramuscular injection to provide urgent protection. Moreover, it does not require a skin test, observation (for outpatients), differentiation of body weight or wound size, and provides full protection with a single dose. Studies have shown that 95.4% of patients reached protective levels within 12 hours after receiving the Tetanus Single Antigen Monoclonal Antibody, which acts faster and is significantly higher than the HTIG group (53.2%).

SciClone Pharmaceuticals: Telavancin Hydrochloride for Injection

Mechanism of Action: Glycopeptide Antibiotics

Indications: HABP/VABP

On February 13, Sai Life Sciences' telavancin hydrochloride for injection was approved by the NMPA for marketing in China. It is indicated for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. Telavancin hydrochloride for injection is a glycopeptide antibiotic that exhibits rapid bactericidal activity against Gram-positive pathogens, including MRSA. The product features a unique dual antibacterial mechanism of action: it inhibits bacterial cell wall synthesis while also binding to the bacterial cell membrane, disrupting its barrier function—a mechanism not possessed by vancomycin—thereby exerting its bactericidal effects quickly. Compared with vancomycin, telavancin has a longer half-life, requiring only once-daily dosing.

Editor of this article: Zhang Jie