Core Viewpoint - The announcement highlights that Health元's subsidiary, Lijun Pharmaceutical Group, 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 - Health元's subsidiary, Lijun Pharmaceutical Group, has received a clinical trial approval notice from the National Medical Products Administration for NS-041 tablets to include a new indication for the treatment of depression [1] - NS-041 tablets are 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 targeted drug 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 tablets have also been approved to conduct clinical trials for the indication of epilepsy, which is currently undergoing Phase II clinical research [1]

证券代码：600380 证券简称：健康元 公告编号：临 2025-082 健康元药业集团股份有限公司 关于获得药物临床试验批准通知书的公告 健康元药业集团 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，健康元药业集团股份有限公司（以下简称：本公司）控股子公司丽珠医 药集团股份有限公司的控股子公司丽珠集团丽珠制药厂（以下简称：丽珠制药厂） 收到国家药品监督管理局核准签发的关于 NS-041 片新增针对"治疗抑郁症"适应症 的《药物临床试验批准通知书》（通知书编号：2025LP03436、2025LP03437）， 同意 NS-041 片新增适应症开展临床试验。现将有关详情公告如下： 一、药品基本情况 药物名称：NS-041 片 剂型：片剂 注册分类：化学药品 1 类 申请适应症：抑郁症 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月 13 日受理的 NS-041 片符合药品注册的有关要求，同意开展抑郁症的临床 试验。 二、药品研发及相关情况 NS ...

Core Viewpoint - The announcement highlights that the company’s subsidiary, Lijun Pharmaceutical Group Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, in addition to its existing indication for epilepsy [1] Group 1 - NS-041 is a novel highly selective KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders such as epilepsy and depression [1] - It is currently the only KCNQ2/3 targeted drug in China approved to conduct clinical research for both epilepsy and depression [1] - The clinical trial for the epilepsy indication was approved on December 27, 2023, and is currently in Phase II [1]

Core Viewpoint - The announcement indicates that the company's subsidiary, Lizhu Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets, which are aimed at treating depression and epilepsy, marking a significant development in the field of neuropsychiatric disorders [1] Group 1 - The NS-041 tablet is a novel high-selectivity KCNQ2/3 agonist, targeting both epilepsy and depression, making it the only KCNQ2/3 targeted drug in China approved for clinical research in both conditions [1] - As of the announcement date, there are no new generation targeted KCNQ2/3 drugs available in the domestic market [1] - Following the approval for clinical trials, the drug must still undergo clinical testing and receive further review and approval from the National Medical Products Administration before it can be manufactured and marketed, indicating several uncertainties ahead [1]

Core Viewpoint - The company announced that its subsidiary, Lijun Pharmaceutical Group Co., Ltd., received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression [1] Group 1 - The approval includes a new indication for NS-041 tablets specifically targeting the treatment of depression [1] - The notification numbers for the clinical trial approval are 2025LP03436 and 2025LP03437 [1]

Core Viewpoint - The company has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy, making it the only KCNQ2/3 targeted drug in China approved for both conditions [1][2]. Group 1: Clinical Trial Approval - The National Medical Products Administration has granted approval for NS-041 tablets to conduct clinical trials for the new indication of "treatment of depression" [1]. - NS-041 tablets are a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1]. Group 2: Clinical Research Findings - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [2]. - In preclinical research, NS-041 tablets demonstrated significant antidepressant effects in both acute and chronic depression models in mice, with higher target selectivity compared to other investigational drugs [2]. Group 3: Licensing and Rights - NS-041 tablets were introduced through a licensing agreement signed in 2024 between the company and Neurona Therapeutics (Shanghai) Co., Ltd., granting the company exclusive rights to the drug in Greater China [2].

Core Viewpoint - The company has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy, making it the only KCNQ2/3 targeted drug in China approved for both conditions [1][2]. Group 1: Clinical Trial Approval - The National Medical Products Administration has granted approval for NS-041 tablets to conduct clinical trials for the new indication of "treatment of depression" [1]. - NS-041 tablets are a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1]. Group 2: Clinical Research Findings - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [2]. - In preclinical research, NS-041 tablets demonstrated significant antidepressant effects in both acute and chronic depression models in mice, with higher target selectivity compared to other drugs in development [2]. Group 3: Licensing and Rights - NS-041 tablets were introduced through a licensing agreement signed in 2024 between the company and Neurona Therapeutics (Shanghai) Co., Ltd., granting the company exclusive rights to the drug in Greater China [2].

Core Viewpoint - The National Medical Products Administration (NMPA) has rejected 118 drug listing applications over three days, including 13 first-generic products, indicating a trend towards stricter drug approval processes [1][27]. Group 1: Drug Approval Rejections - The NMPA denied applications for several first-generic drugs, including indomethacin gel patches from Jiutian Pharmaceutical and meloxicam nano-crystal injections from Health元药业 [1][27]. - The rejection of these applications poses a risk to pharmaceutical companies that have made significant investments in these products [1][27]. Group 2: Market Impact and Competition - Jiutian Pharmaceutical, known for its core product, the Loxoprofen sodium gel patch, faced a setback with its indomethacin gel patch application, which had a market share of only 0.16% compared to Nipro Pharma's indomethacin patch, which has over 45% market share and annual sales exceeding 110 million yuan [4][10]. - Four companies have submitted applications for the indomethacin gel patch, with three already receiving clinical approval, indicating a competitive landscape [5][10]. Group 3: Other Drug Applications - Other first-generic applications, such as for bilastine oral solution and brivaracetam orally disintegrating tablets, were also rejected, reflecting the stringent review process [1][27]. - The market for amlodipine besylate, a cornerstone drug for hypertension, remains strong, with sales exceeding 3.6 billion yuan in 2024, despite the influx of generic competitors [11][14]. Group 4: Future Opportunities - The failure of Jiutian Pharmaceutical and Dongyangguang Pharmaceutical in their respective applications highlights the need for companies to focus on quality and clinical needs rather than merely following trends in drug formulation [27]. - The approval of alternative formulations, such as the dry suspension and orally disintegrating tablets, suggests that there are still opportunities for innovation in the market [20][21].

Market Overview - The Chinese medical equipment market is projected to reach 1.35 trillion yuan in 2024, with an average growth rate exceeding 12% over the past decade, making it the second-largest market globally [2][6] - Shenzhen's pharmaceutical and medical device industry is expected to achieve a production value of 157.6 billion yuan in 2024, with medical devices alone surpassing 102.8 billion yuan, maintaining its position as the leading region in China for ten consecutive years [3] Industry Innovation - China is increasingly focusing on quality improvements in its medical equipment sector, with one-third of global medical equipment patents originating from the country, indicating a strengthening of domestic innovation capabilities [2][6] - Shenzhen has nurtured 35 listed companies in the pharmaceutical and medical device sectors, along with over 1,000 enterprises above designated size, showcasing a robust industrial ecosystem [3] Recent Developments - Notable recent collaborations include a 47 billion HKD (approximately 5.99 billion USD) partnership between Crystal Technology and DoveTree for AI drug development, marking a significant milestone in the commercialization of AI in pharmaceuticals [4] - Health元's innovative drug, Marpacisavir capsules, has received approval for market launch, representing a breakthrough in flu treatment with a unique mechanism requiring only one oral dose [5] Future Directions - Shenzhen aims to focus on four emerging sectors: cell and gene therapy, biomanufacturing, AI in pharmaceuticals, and health consumer products, to enhance its competitive edge in the medical equipment industry [6][7] - The establishment of an "AI + Biomanufacturing Public Service Platform" is set to accelerate the R&D cycle for biomanufacturing companies, significantly reducing development time from years to months [7]

Core Insights - The article discusses the recent developments in the pharmaceutical industry, particularly focusing on the approval of innovative drugs and their market implications [12][15]. Market Performance - The pharmaceutical and biotechnology indices experienced a slight decline, with the medical biotechnology index down by 0.29%, outperforming the Shanghai Composite Index by 0.05 percentage points [5]. - The Hang Seng Healthcare Index fell by 2.26%, while the Hong Kong innovative drug ETF decreased by 2.18% [5]. Innovative Drug Approvals - Eight innovative drugs received approval last week, including: - **Fitusiran** for hemophilia A or B [11]. - **库莫西利** (Kumosili), a CDK2/4/6 inhibitor for HR+/HER2- breast cancer, which is expected to address resistance issues seen with existing treatments [12][14]. - **玛帕西沙韦** (Marpasiwe), an antiviral for influenza, showing significant efficacy in clinical trials [15]. Clinical Trials and Research - The article highlights ongoing clinical trials, including a significant Phase III trial for **库莫西利**, which demonstrated a median progression-free survival (PFS) of 16.62 months, extending PFS by 9.16 months compared to the control group [14]. - A total of 96 new clinical trial registrations were disclosed, with 30 trials in Phase II or higher [7]. Industry Trends - The innovative drug sector remains a key investment focus, with ongoing business development activities and cross-border transactions indicating strong confidence in domestic innovation capabilities [6]. - The global market for CDK4/6 inhibitors is projected to reach approximately $24 billion, driven by increasing indications for early-stage breast cancer [12]. Challenges - The article notes that resistance to CDK4/6 inhibitors remains a significant challenge, with about 20% of HR+ breast cancer patients showing primary resistance to endocrine therapy [12].