Multinational Pharma Companies Secure Approvals for Multiple New Drugs in China Amid Strategic Market Expansion

　　【Pharmaceutical Network Industry Dynamics】China's huge pharmaceuticals market is attracting more and more attention from multinational drug companies. Since the beginning of this year, many companies have been actively adjusting their management structures in China and promoting the launch of new drugs… It is reported that recently a large number of new drugs from multinational pharmaceutical companies have been approved for clinical trials and market launch.
 

AstraZeneca
 

On September 16, the CDE website showed that AstraZeneca's PARP1 inhibitor AZD5305 and amyloid monoclonal antibody CAEL-101 injection were approved for clinical trials. AZD5305 is a selective PARP1 inhibitor independently developed by AstraZeneca, which aims to kill cancer cells by disrupting the DNA damage repair mechanism of tumor cells through selectively targeting PARP1.
 

CAEL-101 is a potential first-in-class amyloid monoclonal antibody. Results from a Phase Ia/Ib study showed that CAEL-101 significantly improved organ function (including cardiac and renal function) in patients with relapsed and refractory AL amyloidosis who did not respond to standard-of-care treatment. For this indication, CAEL-101 has been granted orphan drug designation by the U.S. FDA and the European Medicines Agency (EMA).
 

　Eli Lilly
 

On September 15, the CDE website showed that the clinical trial application of Eli Lilly's LY3819469 injection for the treatment of cardiometabolic diseases was accepted. This is the first RNAi therapy drug applied by Eli Lilly in China. RNA interference (RNAi) is a highly conserved post-transcriptional gene silencing phenomenon in the process of evolution. It is triggered by double-stranded RNA (dsRNA), leading to highly specific degradation of homologous mRNA, blocking the process of mRNA translating into pathogenic proteins, thereby exerting a therapeutic effect.
 

In 2018, Eli Lilly partnered with Dicerna to leverage the latter's proprietary RNAi technology platform for drug development, focusing on cardiometabolic diseases, neurodegenerative disorders, and pain, with over 10 targets as part of the collaboration.
 

On the same day, the CDE website also showed that Eli Lilly's Tirzepatide injection has been approved for clinical use to treat adult patients who are overweight or obese, reducing their risk of major cardiovascular events, decreasing the risk of developing type 2 diabetes, and improving renal outcomes. Tirzepatide is a once-weekly GLP-1R/GIPR dual agonist injection that was approved by the FDA in May 2022 for the treatment of type 2 diabetes. In September 2022, the marketing application for this indication was accepted by the CDE.
 

Takeda
 

On September 13, the CDE website announced that two Class 1 new drugs submitted by Takeda had received clinical trial implied permission. They are: 1) Modakafusp alfa injection (TAK-573), a potential "first-in-class" immunotargeted attenuated cytokine targeting CD38, intended for development in multiple myeloma (MM); 2) SUMO inhibitor TAK-981 injection, intended for development in CD20-positive relapsed/refractory non-Hodgkin lymphoma.
 

In addition, on August 10, the listing application for another new indication of Takeda's innovative digestive product Vonoprazan Fumarate Tablets was accepted by the Center for Drug Evaluation of the National Medical Products Administration. Vonoprazan Fumarate Tablets were approved in December 2019 for the initial treatment of reflux esophagitis and in October 2021 for maintenance treatment in patients with recurrent reflux esophagitis. The proposed additional indication this time is: combination with appropriate antibiotic therapy to eradicate Helicobacter pylori (Hp). If approved, it will add a new treatment option for the eradication of Helicobacter pylori in China, optimize existing treatment regimens, benefit patients more effectively, and become another milestone for Takeda China in the field of gastroenterology.
 

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