海思科医药集团股份有限公司关于获得创新药HSK45019片IND申请《受理通知书》的公告

Core Viewpoint - Haikang Pharmaceutical Group Co., Ltd. has received acceptance notices for three innovative drug IND applications, indicating progress in its drug development pipeline and potential new treatment options for various diseases [1][5][10]. Group 1: HSK45019 - HSK45019 is a small molecule inhibitor developed by the company, aimed at treating inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease [2]. - Current treatments for IBD often have limited efficacy or significant side effects, highlighting the unmet clinical need for effective alternatives [2]. - The drug is classified as a Class 1 chemical drug according to the National Medical Products Administration [2]. Group 2: HSK50042 - HSK50042 is an oral, potent, and highly selective small molecule inhibitor intended for the treatment of respiratory diseases [7]. - Preclinical studies indicate that HSK50042 can effectively improve lung disease symptoms in model mice at low doses, demonstrating good efficacy and safety [7]. - This drug is also classified as a Class 1 chemical drug [7]. Group 3: HSK55718 - HSK55718 is a small molecule non-opioid innovative analgesic developed for acute pain management, aiming to provide effective pain relief while minimizing adverse effects and addiction risks [11][12]. - The drug addresses the need for non-opioid alternatives in postoperative pain management, as traditional opioids have significant side effects [11][12]. - HSK55718 is classified as a Class 1 chemical drug [12]. Group 4: HSK39297 - HSK39297 has been included in the list of breakthrough therapy drugs by the National Medical Products Administration, which may expedite its development and approval process [13][14]. - This drug is a small molecule inhibitor targeting complement factor B, intended for treating complement-mediated hemolytic diseases and primary or secondary glomerular diseases [16]. - Clinical results from a 12-week study in patients with primary IgA nephropathy showed significant reductions in proteinuria, supporting its potential for breakthrough therapy designation [16][17].