Multiple Imported Drugs Gain Approval in China for Oncology and Anti-infective Indications

　　【Pharmaceutical Network Product InformationWith the acceleration of new drug approval and review in China, not only domestically produced drugs but also imported new drugs have continued to receive approval. On February 11, multinational pharmaceutical companies such as Johnson & Johnson and Merck announced that their products had been approved in China, with indications covering treatment areas such as oncology and anti-infectives.
 

　　Johnson & Johnson: Two FIC Bispecific Antibodies Approved for Marketing in China
 

On February 11, Johnson & Johnson announced that the marketing applications for Ryque (Amivantamab) and Talique (Talquetamab) have been approved by the National Medical Products Administration.
 

Among them, Amivantamab is the world's first approved EGFR/c-MET bispecific antibody. This approval is for use 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.
 

Talquetamab is the first approved bispecific antibody drug targeting GPRC5D. This product, as a single agent, is suitable for adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Clinical validation shows that the overall response rate (ORR) of talquetamab exceeds 70% with durable responses, including 65% of patients who had previously received T-cell redirection therapy achieving remission.
 

　　Merck: Antibiotic Combination Approved for Marketing in China
 

On February 11, the NMPA website showed that Merck's antibiotic compound "Ceflogozole-Tazobactam Sodium for Injection" was approved for marketing.
 

According to reports, the product is manufactured byCephalosporinsThe combination drug consisting of the antibiotic ceftolozane and the β-lactamase inhibitor tazobactam was originally owned by Cubist and later acquired by Merck. It was first approved for marketing in the United States in December 2014 under the brand name Zerbaxa, indicated for use in combination with metronidazole to treat complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis) caused by designated susceptible microorganisms. In 2019, a new indication was added for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults aged 18 years and older.
 

Previously, the industry had predicted that the annual sales peak of Zerbaxa would exceed 1 billion US dollars.
 

　GSK: Mepolizumab New Indication Submitted for Marketing Approval in China
 

In addition, some imported drugs are on the way to冲刺上市.
 

On February 11, the website of China's National Medical Products Administration (CDE) showed that the marketing application of Mepolizumab Injection, an anti-IL-5 monoclonal antibody submitted by GlaxoSmithKline (GSK) as a Category 2.2 biologic product, has been accepted.
 

It is speculated in the industry that the indication for which Mepolizumab is being submitted for marketing approval in China this time may be Chronic Obstructive Pulmonary Disease (COPD). For this indication, Mepolizumab has not yet been approved worldwide.
 

Public information shows that Mepolizumab is the world's first approved anti-IL-5 monoclonal antibody. It works by binding to IL-5, blocking the interaction between IL-5 and the surface receptor on eosinophils, inhibiting the biological activity of eosinophils and continuously reducing their numbers to normal levels. This decreases the growth of eosinophils, as well as the inflammation and tissue damage mediated by them, helping maintain a healthy state.
 

On November 19, 2021, mepolizumab was approved for the treatment of adult eosinophilic granulomatosis with polyangiitis (hereinafter referred to as "EGPA") in China. EGPA is a rare autoimmune disease. Unlike other vasculitides, EGPA affects the respiratory tract and lungs earlier and more frequently, and as the disease progresses, multiple systems in the patient's body can be affected, causing irreversible organ damage and posing a serious threat to the patient’s life. The approval of this drug indication provides Chinese EGPA patients with a more effective and safer treatment option.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.