VOLUNTARY ANNOUNCEMENT - NBL-012 OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.
2021-01-08 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
— 1 — Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. CSPC PharmaCeutiCal GrouP limited ʮ ̡ (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) VoluNtarY aNNouNCeme Nt NBl-012 oBtaiNS CliNiCal trial aPProVal iN the u.S. The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ,” together with its subsidiaries, the “ Group”) is pleased to announce that NBL-012, a fully human antibody drug independently discovered and developed by NovaRock Biotherapeutics Limited, a subsidiary of the Company, has obtained approval of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA). NBL-012 is for treating chronic inflammatory diseases such as psoriasis, hidradenitis suppurativa (HS), inflammatory bowel disease (IBD) and other autoimmune diseases. The Phase I clinical trials will evaluate the safety and tolerability and pharmacokinetic profile of NBL-012. about NB l-012 IL-23p19 is an emerging clinically validated target for various autoimmune diseases including psoriasis, hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD). The prevalence of these autoimmune diseases is between 0.1% and 0.3% worldwide and as life-long and tend-to- relapse diseases, they significantly negatively impact patients’ quality of life. Antibodies targeting IL-23p19 have demonstrated superior clinical efficacy, safety and durability than TNF-α inhibitors, IL-17A antibodies and IL-23p40 antibodies. NBL-012 is a new specific and potent IL-23p19 antibody. It acts upstream of the IL-23/IL-17 inflammatory axis, leading to sustained inhibition of Th17 cell differentiation and IL-17 production. As a fully human IgG4 antibody, NBL-012 should carry fewer risks of immunogenicity liability and undesirable Fc-mediated tissue damage. The development of NBL-012 will bring new and effective treatment options to patients with autoimmune diseases around the world. — 2 — about Nova rock Biotherapeutics limited NovaRock Biotherapeutics is an innovative and dynamic biotech company dedicated to the research and development of antibody therapies for cancer and autoimmune diseases in the U.S. NBL-012 is the first molecule entering clinical studies from the emerging pipeline of NovaRock Biotherapeutics, marking the 3-year-old company advancing into the clinical development stage. Several other monoclonal and multi-specific antibody molecules in its pipeline are also following to enter clinical studies soon. By Order of the Board CSPC Pharmaceutical Group limited Cai dongchen Chairman Hong Kong, 8 January 2021 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Prof. LO Yuk Lam, Dr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.
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