丨 2025年11月26日 星期三 丨 11月24日，诺和诺德宣布，其针对司美格鲁肽治疗阿尔茨海默病的两项大型Ⅲ期试验均未达到主要目 标。数据显示，与安慰剂相比，用药患者病情进展未获显著延缓。受此消息影响，公司股价大跌。 港交所官网显示，11月24日，科望医药、明宇制药递表港交所。公开资料显示，两家生物科技公司分别 成立于2017年和2018年，目前均处于临床阶段，未有产品获批上市。 点评：今年以来，港股市场再度成为生物医药企业的"融资港湾"，科望医药、明宇制药递表，也反映出 港股市场在该领域的吸引力正在不断提升。然而，投资者也需保持理性，关注企业研发进展及潜在风 险，避免盲目跟风。 NO.4信达生物玛仕度肽高剂量9mg上市申请获受理 NO.1司美格鲁肽治疗阿尔茨海默病的临床试验失败 点评：阿尔茨海默病的致病机理至今未明确，相关药物研发的失败率一直高居不下，诺和诺德此次宣布 的消息，是对该领域在研药物的又一次打击。不过，中国药企在该领域的研发热情逐年升温，或将给患 者带来新的希望。 NO.2基石药业舒格利单抗的新适应证在欧盟获批 11月25日，基石药业宣布，欧盟委员会（EC）已批准舒格利单抗的新适应证：单药用 ...

丨2025年11月26日星期三丨 NO.1 司美格鲁肽治疗阿尔茨海默病的临床试验失败 11月24日，诺和诺德宣布，其针对司美格鲁肽治疗阿尔茨海默病的两项大型Ⅲ期试验均未达到主要目 标。数据显示，与安慰剂相比，用药患者病情进展未获显著延缓。受此消息影响，公司股价大跌。 点评：阿尔茨海默病的致病机理至今未明确，相关药物研发的失败率一直高居不下，诺和诺德此次宣布 的消息，是对该领域在研药物的又一次打击。不过，中国药企在该领域的研发热情逐年升温，或将给患 者带来新的希望。 点评：今年以来，港股市场再度成为生物医药企业的"融资港湾"，科望医药、明宇制药递表，也反映出 港股市场在该领域的吸引力正在不断提升。然而，投资者也需保持理性，关注企业研发进展及潜在风 险，避免盲目跟风。 NO.4 信达生物玛仕度肽高剂量9mg上市申请获受理 11月25日，信达生物发布公告，宣布玛仕度肽注射液高剂量9mg用于成人中重度肥胖患者长期体重控制 的上市申请，已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理。 点评：对于国内中重度肥胖人群，玛仕度肽有望在减重手术之外，提供一个新治疗选择。但随着减肥药 市场竞争日益激烈，该产品的 ...

Novo Nordisk A/S (NYSE:NVO) stock fell on Monday after the company released topline results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer’s disease.The trials did not confirm the superiority of semaglutide versus placebo in the reduction of progression of Alzheimer’s disease, as measured by the change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) score compared to baseline.The decision to pursue an Alzheimer’s disease indication with semagluti ...

Policy Developments - The National Medical Products Administration (NMPA) has released new guidelines to streamline the registration process for new functional cosmetics, implementing an immediate review system [1] - The guidelines encourage the launch of international cosmetic products in China without the need for overseas sales proof and support the development of products targeting the elderly population [1] Drug and Device Approvals - Heng Rui Medicine has received clinical trial approval for Fumaric Acid Teglutik Injection, which is set to be the first domestically developed Class 1 opioid analgesic in China, expected to be approved for market in January 2024 [2] - Heng Rui Medicine also announced the approval for clinical trials of HRS-6209 capsules, a selective CDK4 inhibitor for advanced solid tumors, and HRS-2189 tablets, a KAT6 inhibitor for advanced malignancies, both of which have no similar products approved domestically or internationally [3] - Fuhong Hanlin's HLX11 (Pertuzumab) has been approved by the FDA for HER2-positive breast cancer treatment, marking it as the first interchangeable biosimilar for cancer treatment approved in the U.S. [4] Capital Markets - SenseTime Medical has initiated a Series A financing round, with post-investment valuation exceeding 3 billion yuan, following a recent strategic financing round [5] - Yabao Pharmaceutical plans to sell 62% of its stake in Taiyuan Pharmaceutical for approximately 87.19 million yuan, resulting in a significant change in ownership structure [6] Industry Developments - Kangfang Biotech has received approval for clinical trials of its dual-specific antibody new drug AK152 for Alzheimer's disease, marking a significant advancement in the treatment of this condition [7][8]

Core Insights - Novo Nordisk (NVO.US) plans to announce late-stage trial results for oral semaglutide targeting mild Alzheimer's disease patients by the end of this year, which could significantly impact the company's stock [1] - Morgan Stanley analysts predict a potential stock price increase of 15% or a decrease of up to 10%, depending on the trial results, but estimate only a 25% chance of success [1] - Goldman Sachs analysts acknowledge a high risk of trial failure but believe the risk/reward is skewed positively [1] - Evidence supporting the expansion of semaglutide's application beyond diabetes and obesity treatment would be viewed as a major positive by the market [1] - Danske Bank analysts see potential for positive trial outcomes based on retrospective study data, suggesting GLP-1 may have cognitive protective effects [1] Industry Context - Despite two new Alzheimer's drugs approved by U.S. regulators in the past three years, these treatments only slow disease progression by about one-third and carry risks of rare but potentially fatal brain hemorrhages [2] - A positive trial outcome for Novo Nordisk could lead to a significant stock price increase, representing a major surprise in the market [2]

Summary of Innovus Bio Conference Call Company Overview - **Company**: Innovus Bio - **Drug**: Buntanetab - **Indication**: Alzheimer's Disease - **Current Phase**: Phase three pivotal study Key Points and Arguments Alzheimer's Drug Development Landscape - Historical context: Several drugs developed around 2000 improved cognition short-term, followed by a 20-year period with no approvals [2][3] - Recent approvals focus on slowing cognitive decline rather than improving cognition [3] - Over 180 ongoing Alzheimer's studies indicate a surge in drug development [3] Buntanetab's Unique Mechanism - Buntanetab is positioned as a disease-modifying drug that improves cognition short-term while protecting nerve cells long-term [4][7] - It is orally available, easy to administer, and has no side effects [8] - Targets four toxic proteins associated with Alzheimer's: plaque, tau, alpha-synuclein, and TDP-43 [11][12] - Acts on mRNA to inhibit the synthesis of these proteins, differentiating it from existing drugs [12] Efficacy in Animal Studies - Demonstrated both symptomatic and disease-modifying efficacy in eight different animal models [23] - Protects nerve cells from dying in traumatic brain injury and glaucoma models [21][22] Human Clinical Trials - Conducted 12 studies in humans, including small studies in healthy volunteers and early Alzheimer patients [23] - Small studies showed significant improvement in cognition compared to placebo, with a 3.5 to 4.5 ADS cog points improvement [25] - A larger study with 350 patients did not meet primary endpoints but showed a significant dose-response curve in early moderate patients [26][27] - Ongoing large study with 760 early Alzheimer patients lasting 18 months, with dual endpoints for symptomatic and disease modification [36] Comparison with Existing Treatments - Buntanetab shows a 3 to 4 point improvement in ADS cog at three months, compared to existing drugs like Aricept and Kisumbla, which show limited efficacy over time [31][34] - The drug works effectively across various demographics, including APOE4 positive and negative patients [27][28] Future Outlook - Anticipated NDA filings: Six-month data by the end of next year and 18-month data by 2027 [36] - The study design includes both symptomatic and disease-modifying endpoints, with a focus on volumetric MRI and biomarkers [37] Intellectual Property - Innovus Bio has 13 patent families extending patent life until 2044, including a novel crystal form developed last year [38] Additional Important Information - The drug's mechanism improves axonal transport, which is crucial for cognitive function [15][20] - Inflammation reduction is achieved indirectly by keeping nerve cells healthy, thus preventing immune system attacks [19][20] - The drug's efficacy is supported by biomarker improvements in neurofilament light and inflammatory factors [30]

Core Viewpoint - The approval process for the first domestically developed Alzheimer's drug, "Jiuyiqi" (Glycyrrhizin Sodium Capsules), has encountered significant setbacks, indicating challenges in the drug's re-registration and the broader difficulties in Alzheimer's drug development in China [1][7]. Approval Challenges - "Jiuyiqi" was conditionally approved in November 2019 for treating mild to moderate Alzheimer's disease, but its re-registration application has not been approved, as indicated by the absence of an approval number in the recent notification from the National Medical Products Administration (NMPA) [1][3]. - The NMPA requires companies to submit a new application for re-registration, and "Jiuyiqi" has faced scrutiny regarding its clinical trial data and the adequacy of its ongoing studies [2][3]. Industry Context - The drug's approval difficulties reflect a global challenge in Alzheimer's drug development, primarily due to the unclear pathogenic mechanisms of the disease and the complexities involved in clinical trials [7][8]. - The pricing of "Jiuyiqi" has made it a more accessible option for patients compared to imported alternatives, which can cost significantly more [7]. Controversies and Legal Issues - "Jiuyiqi" has been surrounded by controversy regarding its efficacy and the reliability of its clinical trials, leading to public debates and legal disputes among key figures in the scientific community [4][5]. - Despite the controversies, the drug was included in the national medical insurance directory, highlighting its perceived value in the market [6]. Future Prospects - The future of "Jiuyiqi" and its potential re-registration remains uncertain, as the company must provide additional data to support its application [7][8]. - The case of "Jiuyiqi" serves as a significant example in the history of original drug development in China, illustrating the complexities and challenges faced by pharmaceutical companies in the Alzheimer's treatment landscape [7][8].

Core Viewpoint - The article discusses the ongoing challenges faced by Green Valley Pharmaceutical regarding its Alzheimer's drug GV-971 (甘露特钠胶囊), which has not received re-registration approval, leading to potential production halts and supply shortages [4][21]. Group 1: Drug Approval and Market Status - GV-971, developed for mild to moderate Alzheimer's disease, was conditionally approved in November 2019, marking the first new Alzheimer's drug approval in 17 years [8]. - The drug has faced significant scrutiny regarding its efficacy and clinical trial data, with notable public disputes among experts [8][9]. - As of May 2023, reports indicated nationwide shortages of GV-971, with prices on e-commerce platforms soaring to 5000 yuan per box, compared to its original price of 296 yuan when included in medical insurance [20]. Group 2: Production and Regulatory Challenges - Green Valley announced in May 2023 that it would halt production of GV-971 due to the expiration of its drug registration certificate, which is typically renewed six months prior to expiration [20][21]. - The failure to secure re-registration approval is believed to be linked to poor clinical trial data or unclear efficacy [21]. - The company has faced criticism for its handling of the drug's international clinical trials, which were suspended in May 2022 [8][9]. Group 3: Patient Impact and Alternatives - Patients have expressed concerns over the potential impact of drug shortages, but experts suggest that the drug's mechanism does not lead to immediate adverse effects upon discontinuation [21]. - Alternatives for patients include symptom-targeting medications and non-pharmacological interventions, although no similar mechanism drugs have been approved [21].

Core Viewpoint - The re-registration application for GV-971 (甘露特钠胶囊) by Green Valley Pharmaceutical has been denied, marking a significant challenge for this Alzheimer's disease drug that has been controversial since its conditional approval in 2019 [1][4]. Company Summary - GV-971, developed by Green Valley, is aimed at improving cognitive function in patients with mild to moderate Alzheimer's disease. It was conditionally approved in November 2019, filling a 17-year gap in new Alzheimer's drug approvals [1][2]. - The drug's approval was based on its unique mechanism targeting the gut-brain axis, using low molecular weight acidic oligosaccharides derived from marine brown algae, differing from the mainstream β-amyloid hypothesis [2]. - Following the denial of the re-registration application, Green Valley's production has been halted, and the drug has faced supply shortages and price increases across various platforms [1][4]. Industry Summary - The denial of GV-971's re-registration reflects the complexities involved in the development and approval of Alzheimer's drugs, highlighting potential issues with clinical trial data and efficacy [4][5]. - The drug's conditional approval required the completion of clinical trials and submission of formal reports, which have not been satisfactorily met, leading to the current situation [2][3]. - There are currently no other drugs with a similar mechanism approved, although alternative symptomatic treatments are available, such as donepezil, which some patients have switched to following GV-971's supply issues [5].

Core Viewpoint - Wanbangde Pharmaceutical Holdings Group Co., Ltd. has launched a national conference for the Phase II/III clinical trial of its new drug Huperzine A controlled-release tablets for Alzheimer's disease, emphasizing the importance of local research and collaboration among experts [1][2]. Group 1: Clinical Trial Launch - The national launch conference for the Phase II/III clinical trial of Huperzine A controlled-release tablets was held in Beijing [1]. - Experts gathered to discuss the significance of the trial and to collaborate on high-quality development of the drug [1]. Group 2: Research and Development Insights - Professor Jia Jianping highlighted the trial's importance and encouraged local researchers to take pride in their work [1]. - Zhao Guanjia, the director of Wanbangde's research institute, discussed the company's focus on Huperzine A and its extensive groundwork in related research [1]. Group 3: Safety and Efficacy - Researcher Gan Yong shared the development history of Huperzine A controlled-release tablets, noting the urgent need for effective and well-tolerated drugs for Alzheimer's patients [2]. - Director Yan Feng provided insights into the safety profile of the drug, indicating that preliminary data supports its good safety and pharmacological characteristics [2]. Group 4: Training and Standardization - The conference included comprehensive training on the research protocol, operational processes, and key execution points to ensure a unified understanding among all researchers [2].