Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. announced that its subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has successfully completed a key clinical trial for HB0017 injection, aimed at treating moderate to severe plaque psoriasis, achieving all primary and key secondary efficacy endpoints [1][2]. Drug Information - Drug Name: HB0017 Injection - Formulation: Injection - Indication: Psoriasis - Registration Category: Class 1 therapeutic biological product [1]. Clinical Trial Details - The Phase III clinical trial included 408 patients with moderate to severe plaque psoriasis in China, demonstrating significant efficacy with a PASI 75 response rate and sPGA 0/1 response rate at week 12 [1]. - The treatment regimen is expected to offer the longest dosing interval among similar products, with efficacy indicators continuing to improve and stabilize during the maintenance phase [1]. - HB0017 shows strong competitive advantages over existing products targeting the same pathway, both in the core treatment phase (first 12 weeks) and the maintenance phase (12-52 weeks) [1]. - Safety profile of HB0017 is favorable, with no new safety signals identified compared to previous studies and similar drugs [1]. Investment and Development Costs - The company has invested approximately RMB 37.205 million in the development of the HB0017 injection project to date [3]. Future Development - In addition to the completed Phase III trial for plaque psoriasis, HB0017 is also undergoing a Phase III trial for ankylosing spondylitis, with positive results from previous Phase II trials [2].

Core Points - Huahai Pharmaceutical announced that its subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., and its wholly-owned subsidiary, Huabo Biopharmaceutical Technology (Shanghai) Co., Ltd., have successfully completed a key clinical trial for HB0017 injection for the treatment of psoriasis, achieving all primary and key secondary efficacy endpoints [2] Group 1 - The clinical trial was a multicenter, double-blind, randomized, placebo-controlled study [2] - The trial results indicate significant efficacy of HB0017 in treating psoriasis [2] - This development may enhance Huahai Pharmaceutical's position in the biopharmaceutical market [2]

Core Viewpoint - Huahai Pharmaceutical's HB0017 injection has successfully met primary and key secondary efficacy endpoints in a pivotal clinical trial for the treatment of psoriasis [1][2] Group 1: Clinical Trial Results - The Phase III clinical study for HB0017 injection included 408 patients with moderate to severe plaque psoriasis and achieved all predefined primary efficacy endpoints, including PASI75 and sPGA0/1 at week 12 [2] - The treatment regimen during the maintenance phase is expected to offer the longest dosing interval among similar products, with efficacy indicators continuing to rise and remain stable during this period [2] - HB0017 demonstrated strong competitive advantages in both the core treatment phase (first 12 weeks) and the maintenance phase (weeks 12-52) compared to already marketed products targeting the same pathway [2] Group 2: Safety and Tolerability - HB0017 exhibited good overall safety and tolerability, with adverse event types and severity aligning with expectations based on prior clinical studies and similar drugs, with no new safety risk signals identified [2] Group 3: Product Development and Future Prospects - HB0017 is a monoclonal antibody targeting interleukin-17A (IL-17A) and is intended for treating moderate to severe plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases [3] - In addition to the completed Phase III trial for plaque psoriasis, the company is concurrently conducting a Phase III trial for ankylosing spondylitis, with promising efficacy and safety results from previous Phase II studies [3] - The company has invested approximately RMB 372 million in the development of the HB0017 injection project to date [3]

Core Viewpoint - Huahai Pharmaceutical's HB0017 injection has successfully met primary and key secondary efficacy endpoints in a pivotal clinical trial for the treatment of psoriasis [1][2] Group 1: Clinical Trial Results - The Phase III clinical study for HB0017 injection included 408 patients with moderate to severe plaque psoriasis and achieved all predefined primary efficacy endpoints, including PASI75 and sPGA0/1 at week 12 [2] - The treatment regimen during the maintenance phase is expected to offer the longest dosing interval among similar products, with efficacy indicators continuing to rise and remain stable during this period [2] - HB0017 demonstrated strong competitive advantages in both the core treatment phase (first 12 weeks) and the maintenance phase (weeks 12-52) compared to already marketed products targeting the same pathway [2] Group 2: Safety and Tolerability - The overall safety and tolerability of HB0017 are good, with adverse event types and severity aligning with expectations based on previous clinical studies and similar drugs, with no new safety risk signals identified [2] Group 3: Product Development and Future Plans - HB0017 is a monoclonal antibody targeting interleukin-17A (IL-17A) and is intended for treating moderate to severe plaque psoriasis, ankylosing spondylitis, and other autoimmune diseases [3] - In addition to the completed Phase III trial for plaque psoriasis, the company is concurrently conducting a Phase III trial for ankylosing spondylitis, with promising efficacy and safety data from a Phase II trial [3] - The company has invested approximately RMB 372 million in the development of the HB0017 injection project to date [3]