Recently, a number of multinational pharmaceutical companies have been approved in China for a number of new drugs

【Pharmaceutical Network Industry News】China's huge pharmaceutical market is attracting the attention
of more and more multinational pharmaceutical companies.

Since the beginning of this year, many enterprises are actively adjusting their management structures in China and promoting the listing of new drugs.
.
.
It is understood that in the near future, a large number of multinational pharmaceutical companies have been approved for clinical and listed new
drugs.

AstraZeneca's September 16, CDE website showed that AstraZeneca's PARP1 inhibitor AZD5305 and amyloid monoclonal antibody CAEL-101 injection were approved clinically
.

AZD5305 is a selective PARP1 inhibitor independently developed by AstraZeneca that aims to destroy the DNA damage repair mechanism of tumor cells by selectively targeting PARP1 to kill cancer cells
.

CAEL-101 is a potential first-in-class amyloid monoclonal antibody, and the results of a Phase I/Ib study showed that CAEL-101 significantly improved organ function (including heart and kidney function)
in patients with relapsed and refractory amyloidosis who do not respond to standard care therapy.

For this indication, CAEL-101 has been granted orphan drug status
by the US FDA and the European Medicines Agency (EMA).

Lilly On September 15, the CDE website showed that the application for clinical trial of Lilly LY3819469 injection was accepted for the treatment of cardiometabolic diseases
.

This is the first RNAi therapy drug
declared by Eli Lilly in China.

RNA interference (RNAi) is a highly conserved post-transcriptional gene silencing phenomenon
during evolution.

It is induced by double-stranded RNA (dsRNA), which leads to highly specific degradation of homologous mRNAs, blocking the process of mRNA translating into disease-causing proteins, thus exerting therapeutic effects
.

In 2018, Lilly reached an agreement with Diacerna to develop drugs using the latter's proprietary RNAi technology platform, focusing on cardiometabolic diseases, neurodegenerative diseases and pain, with more than 10 targets in the
collaboration.

On the same day, the CDE website also showed that Lilly Tirzepatide (tisipatide) injection has also been approved clinically for drug intervention in adults who are overweight and obese, reducing their risk of major cardiovascular events, reducing the risk of developing type 2 diabetes and improving renal outcomes
.

Tirzepatide is a once-weekly GLP-1R/GIPR double agonist approved by the FDA in May 2022 for the treatment of type 2 diabetes
.

In September 2022, Tirzepatide's application for marketing for this indication was accepted
by CDE.

Takeda On September 13, the CDE website announced that two Class 1 new drugs submitted by Takeda were implied for clinical trials, namely: 1) potential "first-in-class" immune-targeted attenuated cytokine modakafusp alfa injection (TAK-573) targeting CD38, which is intended to be developed for multiple myeloma (MM); 2) SUMO inhibitor TAK-981 injection, proposed for CD20-positive relapse / refractory non-Hodgkin lymphoma
.

In addition, on August 10, the listing application for another new indication of Takeda's innovative product vonola fumarate raw tablets in the field of digestion has also been accepted
by the Drug Evaluation Center of the State Drug Administration.

Vonola fumarate tablets have been approved in December 2019 for the initial treatment of reflux esophagitis, and in October 2021 approved for maintenance therapy
in patients with recurrent reflux esophagitis.

The target indication to be added this time is to eradicate Helicobacter pylori (Hp)
in combination with appropriate antibiotic therapy.

If approved, new treatment options will be added to the domestic Helicobacter pylori eradication treatment, enabling the optimization of existing treatment options to better benefit patients, and will also be another milestone
in the digestive field of Takeda China.

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