This domestic Class 1 antirheumatic drug will be imitated

On October 12, the latest announcement on the CDE official website showed that Jiangsu CP Qingjiang Pharmaceutical was accepted by
CDE for the marketing application of ellamod tablets submitted by generic class 4.
At present, in China, Ellamod tablets (trade name: Edexin) is an exclusive product of Simcere Pharmaceutical, and it is also a domestic Class 1 drug
.

Ellamod is a "slow-acting antirheumatic drugs" (DMARDs), suitable for the symptomatic treatment of active rheumatoid arthritis, which can inhibit osteoclast activity, reduce bone loss, and promote osteoblastic differentiation and bone reconstruction, can improve bone marrow edema, bone erosion in early patients, and significantly improve joint symptoms
.
Compared with other traditional slow-acting antirheumatic drugs, such as methotrexate and leflunomide, there are certain advantages: lower incidence/severity of liver damage; low risk of infection; It works on both T/B cells, can lower globulins, and is effective
against Sjogren's syndrome.
Due to its high safety, long-lasting and remarkable effects, ellamod has gradually become the "handle"
in DMARDs.

The ellamod tablets developed by Simcere Pharmaceutical are the world's first approved elamaud drug and the only domestic approved olamod drug, and are the only small molecule DMARDs
independently developed in China in the past ten years.
Addsin has been included in the national medical insurance drug list
since 2017.
Many clinical practice guidelines and pathway recommendations issued by the National Health Commission of China, the Chinese Medical Association, the Association of the Asia-Pacific Rheumatology Alliance and the Ministry of Health, Labour and Welfare of Japan have recommended ellamod as the main treatment for
active rheumatoid arthritis.

In addition, Simcere is currently promoting the expansion
of new indications for Eramod for Sjogren's syndrome (pSS).
After accumulating some research proofs, in April 2020, Edexin entered the "Standards for the Diagnosis and Treatment of Primary Sjogren's Syndrome"
formulated by the Rheumatology and Immunology Branch of the Chinese Medical Doctor Association.
At present, the new indication of ellamod is in the clinical stage (acceptance number CXHL2000340/1/2), and it is expected to become the first drug
to write primary Sjogren's syndrome into the instructions in the future.

But it should be noted that despite being the first to be marketed in the world, Simcere's ellamod tablets are a Me-too drug
.
The Ellamod compound was first discovered by Toyama Chemical in Japan, and in 1988 the compound patent JPH0249778A was filed, and then Toyama Chemical and Eisai Pharmaceutical collaborated on research and development
for rheumatoid arthritis.
Later, in 1994, he applied for patent WO1994023714A1 involving the treatment of rheumatoid arthritis in Japan, Europe, the United States, etc.
, and applied for a patent for preparation and preparation method involving
ellamod tablets from 2001 to 2003.
Eisai first submitted a marketing application in Japan in 2003 and was approved for listing
in August 2012.
However, due to various factors, Eisai did not have a patent layout in China, and Simcere Pharmaceutical was the first to be listed in China, thus losing the Chinese market
.