Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]

Investment Rating - The report assigns a "Buy" rating for the company, Health元 (600380.SH) [5][18] Core Insights - Health元 is a large integrated pharmaceutical group that has transitioned from a health supplement business to a comprehensive pharmaceutical enterprise, focusing on innovation and internationalization to drive growth [5][28] - The pressure from price reductions on key products has eased, and the launch of new products is expected to drive a turnaround in the company's main business [5][33] - The company is accelerating its innovation pipeline, particularly in the respiratory disease sector, with several new drugs entering clinical trials and expected to contribute to revenue growth [5][28][49] Summary by Sections Company Overview - Health元 was founded in 1992 and has grown into a large integrated pharmaceutical group through acquisitions and expansion into various therapeutic areas, including respiratory, digestive, and infectious diseases [28][29] - The company has established a strong presence in the inhalation drug market and is focusing on high-end complex formulations [28][45] Financial Performance - Revenue is projected to reach CNY 158.11 billion in 2025, with a growth rate of 1.2%, and net profit is expected to be CNY 14.66 billion, growing by 5.7% [18][3] - The company has experienced a decline in revenue due to price reductions from centralized procurement but is expected to stabilize and grow with new product launches [33][37] Product Pipeline and Innovation - The company has a robust pipeline focusing on respiratory diseases, with key products like the tobramycin inhalation solution and the flu drug marapavir expected to drive future growth [49][50] - Health元 is actively pursuing international expansion, establishing production bases overseas and enhancing its research and development capabilities through partnerships [28][50] Market Position and Strategy - The company is positioned as a leader in the respiratory field, with a focus on chronic obstructive pulmonary disease (COPD) and asthma, leveraging its established market presence to capitalize on new product launches [16][49] - Health元's marketing strategy has shifted towards digital channels, significantly improving brand visibility and sales in the health supplement segment [38][41]

Core Viewpoint - The report highlights the trends and statistics in the Chinese chemical pharmaceutical industry, indicating a slight decline in production while maintaining overall growth in the sector [1]. Industry Summary - As of October 2025, the production of chemical pharmaceutical raw materials in China reached 313,000 tons, showing a year-on-year decrease of 1.6% [1]. - From January to October 2025, the cumulative production of chemical pharmaceutical raw materials was 3,049,000 tons, reflecting a cumulative growth of 1.3% [1]. - The report is based on data from the National Bureau of Statistics and is compiled by Zhiyan Consulting, a leading industry consulting firm in China [1]. Company Summary - Listed companies in the sector include Heng Rui Medicine, East China Pharmaceutical, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1].

Core Viewpoint - Lijun Group's subsidiary, Lijun Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression [2] Group 1 - The approval includes a new indication for NS-041 tablets specifically targeting the treatment of depression [2] - The clinical trial approval notification numbers are 2025LP03436 and 2025LP03437 [2]

Core Viewpoint - Lijun Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, expanding its indications beyond epilepsy [1] Group 1: Company Developments - Lijun Pharmaceutical's wholly-owned subsidiary, Lijun Group Lijun Pharmaceutical Factory, has been granted a clinical trial approval notice for NS-041 tablets, specifically for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, making it the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] - The clinical trial for the epilepsy indication of NS-041 was approved on December 27, 2023, and is currently undergoing Phase II clinical research [1] Group 2: Drug Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms related to depression [1] - In preclinical studies for the depression indication, NS-041 demonstrated significant antidepressant effects in classical acute and chronic depression models in mice [1] - The selectivity of NS-041 is higher than that of other drugs targeting the same pathway currently under investigation, and no potential ocular toxicity risks have been identified [1]

Core Viewpoint - Lijun Pharmaceutical's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy [1][2] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to treat depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist, currently the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] Group 2: Clinical Research and Efficacy - The clinical trial for the depression indication follows the approval for epilepsy, with the latter currently in Phase II clinical research [1] - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, improving symptoms of depression [1] - NS-041 has shown good antidepressant effects in classical acute and chronic depression models in mice, with higher target selectivity than other drugs in development and no potential ocular toxicity risks identified [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 has reached approximately RMB 58.54 million [2]

Core Viewpoint - Lijun Pharmaceutical's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, marking a significant advancement in its drug development pipeline [1] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group Lijun Pharmaceutical Factory, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to treat depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, currently the only KCNQ2/3 agonist in China approved for both epilepsy and depression clinical studies [1] - The clinical trial for the epilepsy indication was approved on December 27, 2023, and is currently in Phase II [1] Group 2: Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [1] - Preclinical studies of NS-041 in classic acute and chronic depression models in mice have shown promising antidepressant effects, with higher target selectivity compared to other investigational drugs targeting the same pathway [1] - No potential ocular toxicity risks have been identified in the studies conducted [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 tablets amounts to approximately RMB 58.54 million [2] - The drug was introduced through a licensing agreement signed in 2024 with Neuron Pharma (Shanghai) Co., Ltd., granting Lijun Pharmaceutical exclusive rights in the Greater China region [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任 何損失承擔任何責任。 自願公告 NS-041 片新增治療抑鬱症適應症 獲得藥物臨床試驗批准通知書 近日，麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*（「本公司」）全资控 股子公司麗珠集團麗珠制藥廠（「麗珠制藥廠」）收到國家藥品監督管理局核准簽發的關於 NS-041 片新增針對治療抑鬱症適應症的《藥物臨床試驗批准通知書》（通知書編號： 2025LP03436、2025LP03437），同意 NS-041 片新增適應症開展臨床試驗。現將有關詳情公 告如下： 藥品基本情況 藥物名稱：NS-041 片 劑型：片劑 註冊分類：化學藥品 1 類 本次 NS-041 片新增獲批的臨床試驗適應症為治療抑鬱症，研究表明，KCNQ2/3 通道激活劑 能夠調節中腦腹側被蓋區多巴胺神經元的興奮性，從而改善相關抑鬱症狀。在該適應症的臨 床前研究中，NS-041 片在小鼠經典急性和慢性抑鬱模型中，均表現出 ...

Core Viewpoint - LIZHU Group's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, marking a significant development in the company's product pipeline [1] Group 1: Company Developments - LIZHU Group's wholly-owned subsidiary, LIZHU Pharmaceutical Factory, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to include a new indication for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1] - NS-041 is currently the only KCNQ2/3 agonist in China approved to conduct clinical research for both epilepsy and depression [1] Group 2: Clinical Trial Status - As of December 27, 2023, NS-041 has also been approved to initiate clinical trials for the epilepsy indication, which is currently undergoing Phase II clinical research [1]