[FDA] The first C5aR inhibitor comes out!

According to statistics from the U.

The number of new drugs approved by the FDA in the past ten years

Source: FDA website, public information

The first C5aR inhibitor is released, and ANCA-related vasculitis has a new drug after many years

On October 7, 2021, the U.

Details of new drugs approved by the FDA

Source: FDA website, Meinenet Global Drug Research and Development Library

Tavneos was approved in Japan at the end of September for the treatment of granulomatous polyangiitis (GPA) and microscopic polyangiitis (MPA)

avacopan specific information

Source: Meinenet Global Drug Research and Development Library

ANCA-associated vasculitis is a rare autoimmune disease.

This approval is mainly based on the results of a key Phase III clinical trial called ADVOCATE

The latest research and development pattern of C5/C5aR of the complement system, domestic Shutaishen takes the lead

According to data from the global drug research and development database of Minai.

Of the three C5 drugs already on the market, two are innovative drugs, and the remaining one is a biosimilar drug

The biosimilar of eculizumab under the trade name Elizaria was launched in Russia in 2019 and is currently only approved in Russia for the treatment of paroxysmal nocturnal hemoglobinuria and hemolytic urine syndrome.

C5/C5aR target drug development status distribution

Source: Meinenet Global Drug Research and Development Library

Looking back at China, research and development companies such as Shutaishen, Beihai Kangcheng, Corning Jerry, and Shanghai Pioneer Biomedicine have deployed C5/C5aR targeted drugs, becoming one of the few players on the complement system track

Shutaishen is currently one of the few domestic biopharmaceutical companies focusing on complement targeting drugs, and is a veritable leader on the C5/C5aR track

Shutaishen R&D pipeline

Source: Shutai Shen's official website

BDB-001 is the fastest-growing C5/C5aR targeted drug in China.

The C5/C5aR targeted drugs of Corning Jereh and Shanghai Pioneer Biomedicine are still in the preclinical stage, and there is not much specific disclosure information

New treatment for chronic myeloid leukemia, Novartis Scemblix approved for marketing

On October 29, 2021, the U.

Details of new drugs approved by the FDA

Source: FDA website, Meinenet Global Drug Research and Development Library

Chronic myelogenous leukemia (CML), also known as chronic myeloid leukemia, is a malignant tumor formed by abnormal proliferation of bone marrow hematopoietic stem cells

asciminib specific information

Source: Meinenet Global Drug Research and Development Library

The safety and effectiveness of Scemblix have been fully verified in the Phase III ASCEMBL trial and Phase I CABL001X2101 trial

Note: The information comes from the FDA official website, corporate website, and Minet.