Core Insights - Novo Nordisk has submitted applications to the FDA for the approval of icodec insulin for the treatment of type 2 diabetes and Mim8 for the treatment of hemophilia A [1] Group 1: Icodec Insulin - Icodec insulin is a long-acting insulin formulation designed based on oral insulin OI338, with a half-life of 196 hours [2] - The design modifications include replacing an 18C fatty acid with a 20C fatty acid to enhance binding affinity to human serum albumin, and substituting Tyr with His at position 16 of the B chain to reduce affinity to human insulin receptors [2] - The initial BLA submission in April 2023 included indications for both type 1 and type 2 diabetes, but the FDA advisory committee found insufficient data for type 1 diabetes, leading to a narrowed indication for type 2 diabetes in the resubmission [2] Group 2: Mim8 - Mim8 is a bispecific antibody developed using Genmab's DuoBody technology, designed to mimic the action of coagulation factor VIIIa (FVIIIa) and bridge factors IXa (FIXa) and X (FX) [3] - It exhibits approximately 15 times the coagulation activity compared to emicizumab [3] - Hemophilia A, affecting around 80%-85% of the estimated 1.125 million hemophilia patients globally, is caused by a deficiency or defect in FVIII [3] Group 3: Hemophilia Treatment Landscape - There are currently 46 approved hemophilia drugs globally, with only 8 being non-factor therapies [4] - Among these, several drugs have been approved specifically for hemophilia A patients, including concizumab, valoctocogene roxaparvovec, emicizumab, marstacimab, and fitusiran [4]

Core Insights - The National Medical Products Administration (NMPA) approved 43 new class 1 innovative drugs in the first half of 2025, a 59% increase year-on-year, nearing the total of 48 approvals for the entire year of 2024 [1] - The approval of innovative drugs is accelerating, with expectations for a record high in 2025 [1] Drug Type Distribution - Chemical drugs lead with 24 varieties, accounting for 56% of approvals; biological products follow with 14 varieties (32%); and traditional Chinese medicine and natural products account for 5 varieties (12%) [2] - The industry is transitioning from a "single-pole dominance" to a "multi-polar balance" [2] Therapeutic Area Insights - Oncology drugs dominate with 20 varieties, making up 47% of approvals; anti-infective drugs, traditional Chinese medicine, and endocrine/metabolic drugs each have 5 varieties (12%) [2] - The approval landscape shows a diverse range of therapeutic areas, with notable mentions for rare diseases and pediatric drugs [3] Review and Approval Process - 17 new drugs, approximately 40% of the total, received breakthrough therapy designation, including 8 biological products and 8 chemical drugs [2] - The NMPA is prioritizing the development of drugs for rare diseases and pediatric use, with specific plans in place for expedited review [3] Policy Support for Innovation - China's pharmaceutical innovation is rapidly advancing, with the country holding about 25% of the global innovative drug pipeline [4] - Recent policy measures, such as the implementation of the "Full Chain Support for Innovative Drug Development" plan, have significantly improved the speed of new drug inclusion in medical insurance [4] Future Initiatives - The NMPA plans to implement further measures to support innovative drug development, focusing on clinically valuable products and global synchronization of research [5] - Efforts will include optimizing review processes, enhancing intellectual property protections, and aligning with international standards to facilitate global competitiveness [5]

公司具备证券投资咨询业务资格 证券研究报告 医药生物 [Table_Title] 全国各地出台创新药械支持政策 [Table_ReportDate] 2025 年 04 月 14 日 [Table_ReportType] 医药生物行业周报（4 月第 2 周） [Table_S 行业ummary 观点：] 请务必阅读文后重要声明及免责条款 [Table_Industry] [Table_BaseData] 1) 周度市场回顾。上周（4 月 7 日-4 月 11 日）医药生物 收跌-5.61%，跑输 Wind 全 A（-4.31%）和沪深 300（- 2.87%）。从板块来看，血液制品（4.06%）和线下药店 （1.81%）为避险板块，领涨其他子板块，医疗研发外 包（-16.04%）、体外诊断（-8.28%）和医药流通（-6.4%） 跌幅居前。从个股来看，涨幅前三的个股为奕瑞科技 （20.5%）、一品红（17.0%）和永安药业（13.9%），跌 幅前三的个股为润都股份（-27.8%）、多瑞医药（- 27.2%）和博腾股份（-22.2%）。 2) 全国各地出台创新药械支持政策。本周北京和深圳都 出台了关于创新药械的 ...

Investment Rating - The industry investment rating is "Outperform the Market" [52] Core Views - The report emphasizes the ongoing disruptions caused by the US-China tariff policies and suggests focusing on opportunities in non-US markets and import substitution [4][9] - The report highlights that the adjustment of tariffs is expected to impact the trade of pharmaceutical products between China and the US, while companies primarily exporting to markets outside the US will be less affected [4][9] Summary by Sections Tariff Policy Overview - Since April 2, 2025, the US government has imposed a 34% "reciprocal tariff" on Chinese goods, with frequent adjustments to tariff rates and exemptions for certain pharmaceutical products [4][5] - As of April 11, 2025, the tariff rates for bilateral trade between China and the US have been adjusted to 125%, with China indicating it will not respond to further tariff increases from the US [5] Opportunities in the Biopharmaceutical Sector - The report identifies potential for domestic products to increase market share in the blood products sector due to tariff impacts, particularly for albumin, where US imports are significant [9] - It suggests monitoring companies such as Palin Bio, Tiantan Bio, and Huashan Bio for potential growth in market share as import costs rise [9] Medical Devices - The report notes that the tariff policies and anti-dumping investigations are likely to accelerate the domestic substitution process in medical devices, particularly in electrophysiology and imaging fields [10] - Companies like Yirui Technology and United Imaging are highlighted as making progress in domestic production capabilities [10] Investment Strategies - The report recommends focusing on "innovation," "overseas expansion," "equipment upgrades," and "consumption recovery" as key investment themes [12] - Specific companies to watch include BeiGene, Mindray, and Xiamen Innovax for their innovative products and overseas market potential [12] Key Companies to Watch - Notable companies include: - **Nocera Biopharma**: Expected to achieve significant revenue growth with its core product, demonstrating strong cash flow and reduced losses [13][14] - **Sino Biopharmaceutical**: Rapid revenue growth with a focus on innovative products and a strong pipeline [18] - **Kexing Biopharma**: Stable domestic business with promising overseas expansion [18] - **Wuxi Biologics**: Recognized for its strong technical capabilities and expanding overseas operations [22] Market Performance - The report notes a decline in the pharmaceutical sector, with a 5.61% drop in the past week, while the overall market saw a smaller decline [31][42] - The biopharmaceutical sector is highlighted as having the smallest decline among sub-sectors, indicating relative resilience [44]

Investment Rating - The industry investment rating is "Outperform the Market" [52] Core Viewpoints - The ongoing US-China tariff policies are causing disruptions, suggesting a focus on non-US market expansion and import substitution opportunities in the biopharmaceutical sector [4][9] - The report highlights that the adjustment of tariffs is expected to impact the trade of pharmaceutical products between China and the US, with companies primarily exporting to markets outside the US being less affected [4][9] - The report emphasizes the potential for domestic products to gain market share in the biopharmaceutical sector due to increased tariffs on US imports [9][10] Summary by Sections Tariff Policy Overview - As of April 11, 2025, the tariff rates for bilateral trade between China and the US have been adjusted to 125%, with China indicating it will not respond to further tariff increases from the US [4][5] Biopharmaceutical Sector Insights - The blood products sector is expected to stabilize prices and increase the market share of domestic products due to tariff impacts on imports, particularly for albumin [9] - The medical device sector is anticipated to accelerate domestic substitution due to reliance on North American production, with specific focus on electrophysiology and imaging products [10] - The report suggests monitoring companies such as Palin Bio, Tian Tan Bio, and Huashan Bio for potential growth opportunities in the blood products market [9][10] Investment Strategies - The report recommends focusing on "innovation," "overseas expansion," "equipment upgrades," and "consumer recovery" as key investment themes [12] - Specific companies highlighted for innovation include BeiGene, Dongcheng Pharmaceutical, and others with strong global competitiveness [12] - Companies like Mindray Medical and United Imaging are noted for their potential in overseas markets [12] Key Companies to Watch - Notable companies include: - **Nocera Biopharma**: Expected to achieve significant revenue growth with its core product, showing a 49% year-on-year increase in sales [13] - **Sino Biopharmaceutical**: Rapid revenue growth with a focus on innovative products [18] - **Kexing Biopharma**: Stable domestic business with promising overseas expansion [18] - The report also highlights the potential of companies like East China Pharmaceutical and others in the nuclear medicine sector [17] Market Performance - The biopharmaceutical sector has seen a decline of 5.61% recently, with specific sub-sectors experiencing varying levels of impact [31][44]