Pfizer and Sanofi Secure NMPA Approvals for New Oncology and Cardiovascular Drugs in China

　　【Pharmaceutical Network Product Information】Since entering the 21st century, life science technology has experienced rapid development, with new technologies such as small molecule targeting, immunotherapy, cell therapy, and gene therapy flourishing. It is reported that recently, several new drugs from foreign pharmaceutical companies have been approved for marketing. For example, an innovative therapy from Novartis received FDA approval, while new drugs from Pfizer, Sanofi, and other pharmaceutical companies were approved by the NMPA.
 

　　Pfizer's Ogedituzumab Approved for Marketing by NMPA
 

Recently, Pfizer's Inotuzumab Ozogamicin for Injection (formerly known as Ozogamicin Inotuzumab) has received NMPA approval for marketing. This drug is mainly used to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL). This is the first antibody-drug conjugate (ADC) targeting CD22 approved for marketing in China.
 

Inotuzumab ozogamicin is an antibody-drug conjugate developed by Pfizer and Celltech. It consists of a monoclonal antibody (mAb) targeting CD22 linked to the cytotoxic agent calicheamicin. The CD22 antigen is expressed on the cancer cells of more than 90% of patients with B-ALL.
 

As early as August 2017, the drug had received FDA approval for marketing, and it is used to treat relapsed or refractory precursor B-cell acute lymphoblastic leukemia.
 

　Sanofi's Dronedarone Hydrochloride Tablets Approved for Marketing by NMPA
 

Recently, Sanofi's Dronedarone Hydrochloride Tablets (trade name: Multaq) received NMPA marketing approval and officially launched in China. The drug is mainly used to treat patients with sinus rhythm who have a history of paroxysmal or persistent atrial fibrillation (AF), reducing the risk of hospitalization due to atrial fibrillation.
 

Dronedarone Hydrochloride Tablets, a new type of antiarrhythmic drug, have shown significant efficacy in maintaining sinus rhythm and reducing the recurrence of atrial fibrillation. Evidence suggests that it can maintain sinus rhythm for up to 158 days, providing long-term, stable support for patients with paroxysmal or persistent atrial fibrillation after cardioversion. Additionally, results from the ATHENA study indicate that Multaq can reduce the risk of cardiovascular hospitalization or all-cause mortality by 24% in patients with atrial fibrillation.
 

Dronedarone is a Class III antiarrhythmic drug, originally developed by Sanofi-Aventis. It was launched in the United States and Europe in 2009. Before Sanofi obtained NMPA approval for marketing in China, dronedarone was produced and sold in China by CSPC Ouyi. According to relevant data forecasts, the drug's global market peak sales are expected to exceed 400 million US dollars.
 

　　Novartis' Long-Acting siRNA Therapy for Lowering Lipids Approved by FDA for Marketing
 

Recently, Novartis announced that the U.S. FDA has approved Leqvio (inclisiran) for marketing. This drug is a small interfering RNA (siRNA) therapy used to reduce low-density lipoprotein cholesterol (commonly known as "bad cholesterol" or LDL-C). After the initial injection and the injection at the third month of treatment, patients only need to receive treatment twice a year to effectively reduce the level of low-density lipoprotein LDL-C in blood circulation, achieving the effect of lowering blood lipids.
 

Leqvio, a long-acting lipid-lowering drug, has the active ingredient Inclisiran. As a "first-in-class" siRNA therapy, Leqvio can bind to the mRNA encoding PCSK9 protein and reduce its level through RNA interference, preventing the liver from producing PCSK9 protein. It is reported that Novartis has obtained global rights for the development, manufacturing, and commercialization of the drug.