Sunshine Guojian SSGJ-613 Phase Ia study enrollment completed, the new indication for acute gouty arthritis has been approved by NMPA and Phase Ib/II clinical trials will be launched in the near future

Sunshine Guojian (stock code: 688336), a pioneer of Chinese antibody drugs, recently announced that an evaluation of its recombinant anti-IL-1β humanized monoclonal antibody injection (R&D code: SSGJ-613) has recently received the State Drug Administration (hereinafter referred to as the "NMPA") approved and issued the "Drug Clinical Trial Approval Letter" for acute gouty arthritis clinical trials, SSGJ-613 has completed the enrollment of all subjects in the Phase Ia clinical trial, and will be carried out in the near future Phase Ib/II clinical trial in acute gouty arthritis indication
.
Gout is a crystal-related arthropathy caused by the deposition of monosodium urate in the joints.
It is directly related to hyperuricemia caused by disturbance of purine metabolism and/or decreased uric acid excretion.
It belongs to metabolic rheumatism
.
According to the "2017 White Paper on the Status Quo of Gout in China", the number of hyperuricemia patients in China has reached 170 million, of which more than 80 million are gout patients, and they are rapidly increasing at an annual growth rate of 9.
7%
.
In the 2018 edition of the European League Against Rheumatism (EULAR) updated evidence-based expert recommendations for the diagnosis of gout, the course of gout is divided into preclinical and gout stages, and acute gouty arthritis is one of the main symptoms of gout.
one
.
At present, in the treatment of acute gouty arthritis in China, colchicine and non-steroidal anti-inflammatory drugs are the first-line drugs
.
For patients with frequent gout attacks and treatment with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids (oral and injectable) ineffective, poorly tolerated, or contraindicated, European League Against Rheumatism (EULAR), USA The Association of Rheumatology (ACR) guidelines for gout management and the Chinese guidelines for the diagnosis and treatment of hyperuricemia and gout both suggest that IL-1 or TNF-α antagonists should be considered.
In 2013, the European Medicines Agency (EMA) approved IL-1β antagonists.
Canakinumab is an indication for the treatment of acute gouty arthritis, but there is no self-developed monoclonal antibody against IL-1β on the market in China, and there is still a huge unmet clinical need in this therapeutic area
.
SSGJ-613 is a novel anti-IL-1β antibody with novel variable region sequences
.
The experimental results show that SSGJ-613 has a completely different binding epitope from the currently marketed product with the same target, Canakinumab
.
Canakinumab (trade name Ilaris) is a fully humanized monoclonal antibody developed by Novartis that targets and inhibits IL-1β.
The sales volume in 2021 will reach 1.
059 billion US dollars
.
In addition to gout indications, IL-1β is also related to some tumors and cardiovascular diseases.
Considering the huge base of China's population, such drugs will have broad demand
.
Dr.
Lou Jing, Chairman of Sunshine Guojian, said, "Gout is a disease that the Chinese are very familiar with, and the patient population in China is huge.
We are very pleased that SSGJ-613 has been approved for clinical use.
We will advance the process of clinical trials as soon as possible.
Gout patients bring much-needed drugs to fill the gaps in related fields in China
.
"