Skycreatures next city, first new drug approved clinically in the U.S.

original title: Skyland Bio next city, the first new drug in the United States approved clinicalThe IPO is on its way too!Chinese: Shanghai,December 24, 2018 - Bio-innovation drug research and development company Skyland Biotech (Shanghai) Co., Ltd("Skyland Bio") has announced that its self-developed antibody drug TJM2 for autoimmune and inflammatory diseases has been approved by the U.SFood and Drug Administration (FDA) for clinical research in the United StatesTJM2 is a humanoid immunoglobulin (IgG1) of the medium-to-granulocyte macrophage concentration stimulator (GM-CSF), which has its unique advantages in anti-inflammatory diseases and is expected to become an innovative biopharmaceutical with the best potential of its kind for the treatment of autoimmune and inflammatory diseasesTJM2 is the first new drug candidate to receive FDA clinical research approval in the Skyland Bio-Innovative Biopharmaceutical Product pipeline, with global independent intellectual property rightsGM-CSF is an important pro-inflammatory cytokine that plays a key role in the inflammation and destruction of tissues in autoimmune and inflammatory diseasesClinical studies of TJM2 are scheduled to be conducted in disease areas such as rheumatoid arthritis (RA)"We are very pleased that TJM2 has been approved for FDA clinical research in the United States," said DrJing-wu, CEO ofSkyland BioThis is another important milestone in our global strategy, which once again validates the strength of Skyland In terms of independent innovation and research and development, and opens the way for Skyland Bio's mission to develop highly innovative biologics for the benefit of patients around the world"
TJM2's first human clinical trial in the United States will be conducted in healthy volunteers, including Chinese subjects, to assess the drug's safety, tolerance, pharmacokinetics/pharmacodynamics, and immunogenicityEnglish version: SHANGHAI, China, Dec.24th, 2018-I-Mab Biodivharma (I-Mab), a China-u-seedclinical stage biodivadathauticalincaindilysondedivdivinaina-oncology-andautodainainad, a Adivislication for TJM2, ahumanidi'r globulin g1 (IgG1) targeting granulocyte-macrodivhagecolony-hubing factor (GM-CSF), withbest-in-classi-votentialtotoimmune and yamdiseases.
TJM2isthesecandidate from I-Mab's synth diviodivrietidiynto beadivedford forclinicalstudy bytheFDA.GM-CSfisacritical divro-fycytokineitdivaisadivot argyn argysan ar gyda'n ddimimmune and fythys.TJM2 willbetestin clinicals fortiticythaaaadaddivio diffsarsrheiathaad atos and dh'f hess We're the tha iad toreceivethis in ddivdivadararthfdad ar gyfer tJM2intheUnited States.Thisisimimdivortttttyn yn ddim yn ddydd yn tford i-mab's globalstrategy and astrongto i-mab's in-house research cadivdivdivtodetodad The initialfirst-in-human (FIH) singledosestudy willexaminethesafety, tolerage, divharmacokinetics/divharmacodynamics and immunityofTJM2inhealthvolunteers (in-chinainsubjects) intheUnitedStates.
Source: Pharmaceutical Melt Data, Pharnex Datamonitor Monitor, Pharmaceutical Melt 1 Data Release