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Sunshine Guojian Pharmaceutical Shanghai said its anti-IL-1β monoclonal antibody (SSGJ-613) for acute gouty arthritis secured new drug application acceptance from China's drug regulator.
Phase three trial results showed the therapy demonstrated pain relief on par with steroids and superior recurrence prevention, with a favorable safety profile, according to a Friday filing with the Shanghai bourse.
Sunshine Guojian Pharmaceutical Shanghai said its anti-IL-1β monoclonal antibody (SSGJ-613) for acute gouty arthritis secured new drug application acceptance from China's drug regulator.
Phase three trial results showed the therapy demonstrated pain relief on par with steroids and superior recurrence prevention, with a favorable safety profile, according to a Friday filing with the Shanghai bourse.
Sunshine Guojian Pharmaceutical Shanghai received the approval of China's drug administrator to begin clinical trials for SSGJ-627 injection.
The drug is a monoclonal antibody injection targeting ulcerative colitis, according to a Thursday filing with the Shanghai bourse.
Shares of the pharmaceutical company were down 6% in recent trade.
Sunshine Guojian Pharmaceutical Shanghai appointed Niu Hongmei as chief financial officer to succeed Sun Yongzhi, who resigned due to a job transfer.
Niu joined the drugmaker as financial manager in June 2017, according to a Wednesday filing with the Shanghai bourse.
Sun continues to serve as a director of Sunshine Guojian Pharmaceutical Shanghai.
Shares of the company closed 1% lower Wednesday.
China's medical products administrator approved Sunshine Guojian Pharmaceutical's clinical trial application for its SSGJ-627 antibody injection, according to a Friday filing with the Shanghai Stock Exchange.
The injection is a recombinant anti-TL1A humanized monoclonal antibody, helping treat autoimmune and inflammatory conditions, the filing said.
China's medical products administrator approved Sunshine Guojian Pharmaceutical's clinical trial application for its SSGJ-627 antibody injection, according to a Friday filing with the Shanghai Stock Exchange.
The injection is a recombinant anti-TL1A humanized monoclonal antibody, helping treat autoimmune and inflammatory conditions, the filing said.
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