Market Performance - The pharmaceutical sector experienced a decline of -1.18% on January 15, 2025, underperforming the CSI 300 index by 1.38 percentage points, ranking 25th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, other biological products (-0.04%), hospitals (-0.75%), and medical consumables (-0.77%) performed relatively well, while pharmaceutical distribution (-2.57%), medical devices (-2.51%), and offline pharmacies (-2.11%) lagged behind [1] - Top three gainers included Shanhe Pharmaceutical (+20.01%), Duori Pharmaceutical (+11.48%), and Yahong Pharmaceutical (+7.69%); top three losers were Sunflower (-20.00%), Hongbo Pharmaceutical (-20.00%), and Huaren Health (-19.99%) [1] Industry News - Ipsen announced that the FDA has granted breakthrough therapy designation for its investigational monoclonal antibody IPN60340, which is used in combination with Ven-Aza for the treatment of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable for intensive therapy [2] - The designation is based on data from the Phase 1/2 EVICTION trial, showing that patients receiving the combination treatment had a nearly doubled complete remission rate compared to historical standard treatment data, particularly in subtypes that typically respond poorly to standard treatment [2] - IPN60340 targets BTN3A, a key immune regulatory molecule widely expressed in various cancers, promoting the recognition and elimination of tumor cells by γ9δ2 T cells [2] Company News - Saint Noble Bio (688117) announced an expected net profit attributable to shareholders of 152-190 million yuan for 2025, representing a year-on-year growth of 204.42%-280.53%, with a non-recurring net profit expected to be 149-186 million yuan, reflecting a growth of 226.07%-307.58% [3] - Yipinhong (300723) reported similar profit expectations for 2025, with a net profit forecast of 152-190 million yuan and a non-recurring net profit of 149-186 million yuan, both showing significant year-on-year growth [3] - Chutian Technology (300358) expects to achieve a net profit of 235-300 million yuan for 2025, marking a turnaround from losses in the previous year, with a non-recurring net profit forecast of 135-200 million yuan [3] - Ganli Pharmaceutical (603087) received approval from the Ethiopian National Food and Drug Administration for the registration of its insulin glargine injection and pre-filled pen, allowing for import and sale in Ethiopia [3]

Core Viewpoint - The Shandong Provincial Government has introduced a new implementation plan aimed at enhancing the regulatory framework for pharmaceuticals and medical devices, focusing on innovation, efficiency, and collaborative support for the industry [1]. Group 1: Focus on Innovation and Support - The new implementation plan positions regulatory authorities as "innovation partners," providing proactive support during the early stages of product development for innovative drugs and devices. This includes assigning dedicated personnel for face-to-face guidance, aiming to reduce common issues and compliance risks in the R&D and registration processes [3]. - A notable example of this initiative is the expedited approval and production of Gan Li Pharmaceutical's insulin injection, which exceeded expectations [3]. Group 2: Focus on Review Efficiency and Process Optimization - The reform emphasizes a systematic restructuring of the review and approval processes, incorporating digital transformation. It aims to achieve full online processing for drug and medical device registrations, ensuring that all steps from application to certification are managed digitally, thereby minimizing the need for physical presence [4]. - The regulatory body will publicly commit to specific processing timelines for high-frequency matters, enhancing predictability for enterprises regarding the review process [4]. Group 3: Focus on Systematic Collaboration and Ecosystem Support - The plan aims to create a supportive ecosystem for the rapid development of innovative drugs and devices by ensuring smooth connections across various stages, including R&D, clinical trials, and market access. This includes optimizing the registration of clinical trial institutions and enhancing regulatory support for these entities [5]. - The regulatory authority will also strengthen collaboration with other departments, such as health and insurance, to address common challenges faced by innovative products in funding, clinical promotion, and insurance access [5].

Group 1: WuXi AppTec - WuXi AppTec expects a net profit of approximately RMB 19.15 billion for the year 2025, representing a year-on-year growth of about 102.6% [1] - The company anticipates total revenue of around RMB 45.46 billion for 2025, reflecting a year-on-year increase of approximately 15.8%, with a 21.4% growth in revenue from continuing operations [1] - Basic earnings per share are projected to be around RMB 6.70, which is an increase of approximately 104.3% compared to the previous year [1] Group 2: Rongchang Biologics - Rongchang Biologics has signed an exclusive licensing agreement with AbbVie for RC148, granting AbbVie exclusive rights for development, production, and commercialization outside Greater China [2] - The agreement includes an upfront payment of USD 650 million and potential milestone payments up to USD 4.95 billion, along with double-digit royalties on net sales outside Greater China [2] - This licensing deal is expected to accelerate the global development and commercialization of RC148, enhancing the company's brand value and international influence [2] Group 3: National Medical Insurance Administration - The sixth batch of centralized procurement for high-value medical consumables has been conducted, with 202 out of 496 products winning bids, ensuring a diverse supply of mainstream products [3][4] - The procurement process emphasizes principles such as maintaining clinical stability, ensuring quality, and preventing price undercutting, with a focus on grouping products based on clinical demand [4] - The procurement includes drug-coated balloons and urological intervention consumables, with all 42 products from 32 companies in the drug-coated balloon category winning bids [3][4] Group 4: New Drug Listings and Market Expansion - As of January 11, over 11,000 designated medical institutions have equipped new drugs added to the medical insurance directory for 2025, including 105 negotiated drugs and 19 commercial insurance innovative drugs [5][6] - Among the 105 new negotiated drugs, 88 have available institution information, with significant coverage across provinces, indicating a strong distribution network [6] - The approval of insulin glargine injection by the European Commission marks a significant entry for Gan Li Pharmaceutical into the European market [7] Group 5: WuXi Biologics - WuXi Biologics' subsidiary, WuXi HeLian, has made a conditional cash offer to acquire all issued shares of Dongyao Pharmaceutical at HKD 4 per share, representing a premium of approximately 99% over the last undisturbed closing price [8] - The total consideration for the acquisition could reach approximately HKD 3.1047 billion, with the offer contingent on obtaining at least 60% of the voting rights [8] - This acquisition aims to expand production capacity and enhance the project and client portfolio in the ADC CDMO sector [8] Group 6: Sanofi Biologics - Sanofi Biologics expects a net profit for 2025 to be between RMB 152 million and RMB 190 million, indicating a year-on-year growth of 204.42% to 280.53% [9] - The projected net profit excluding non-recurring gains is expected to be between RMB 149 million and RMB 186 million, reflecting a significant increase compared to the previous year [9] - The growth is attributed to the company's strategic focus on expanding production capacity and increasing market demand for peptide raw materials [9]

Core Viewpoint - Recently, Ganli Pharmaceutical (603087) announced the approval of its insulin glargine injection and pre-filled pen by the Ethiopian National Food and Drug Administration, marking a significant opportunity for the company in the Ethiopian market [1] Company Summary - The insulin glargine product is designed for diabetes patients, characterized by long-acting and stable blood sugar control, requiring subcutaneous injection once daily with a duration of action lasting up to 24 hours [1] - As of September 30, 2025, the company has invested a total of 936 million RMB in research and development for the insulin glargine project [1] Industry Summary - According to the International Diabetes Federation, the estimated number of diabetes patients aged 20-79 in Ethiopia is approximately 2.3 million, with a diabetes prevalence rate of 3.6% in 2024 [1] - While the approval of the drug registration provides a sales opportunity in the Ethiopian market, the company faces uncertainties related to market demand fluctuations, policy environment changes, and exchange rate volatility [1]

Group 1 - The company, Ganli Pharmaceutical Co., Ltd., has received approval from the Ethiopian Food and Drug Authority for the registration of its insulin glargine injection and pre-filled pen, indicating a significant step in its market expansion in Ethiopia [1][2] - The approved drug, BasalinTM, is indicated for diabetes treatment and is available in two forms: injection and pre-filled pen, both with a concentration of 100 units/ml in a 3ml vial [1] - The insulin glargine is a long-acting insulin that requires daily subcutaneous injection, providing a stable blood glucose level for up to 24 hours [1] Group 2 - Ethiopia has a population of approximately 130 million, with a projected diabetes patient population of around 2.3 million among individuals aged 20-79, representing a prevalence rate of 3.6% [2] - The average annual expenditure on diabetes-related healthcare per patient in Ethiopia is estimated at $96.2 [2] - Sanofi is currently the main supplier of insulin glargine in Ethiopia, with global sales of its insulin products projected to reach €2.855 billion (approximately $2.989 billion) in 2024 [2] Group 3 - As of September 30, 2025, the company has invested a total of 936 million RMB in research and development for the insulin glargine project [3]

Core Viewpoint - Ganli Pharmaceutical has received approval from the Ethiopian Food and Drug Authority for its insulin products, indicating a significant step in expanding its market presence in Ethiopia [1]. Group 1 - The company announced the receipt of registration certificates for Glargine Insulin Injection and Glargine Insulin Injection Pre-filled Pen [1]. - The registration numbers for the products are 11865/13208/NMR/2025 and 11864/13210/NMR/2025, respectively [1].

Core Viewpoint - Ganli Pharmaceutical has received regulatory approval for its insulin products in Ethiopia, marking a significant milestone for the company in expanding its market presence in the region [1]. Company Summary - Ganli Pharmaceutical (603087) announced on January 15 that it has obtained the registration approval for Glargine Insulin Injection and Glargine Insulin Injection Pre-filled Pen from the Ethiopian National Food and Drug Administration [1]. - The approved Glargine Insulin is a long-acting insulin that requires subcutaneous injection once daily, providing a sustained hypoglycemic effect for 24 hours [1]. - The characteristics of Glargine Insulin include a long duration of action, stable blood concentration without peaks, and smooth glucose control [1].

Group 1 - Siyuan Electric reported a total operating revenue of 21.205 billion yuan for 2025, a year-on-year increase of 37.18%, with a net profit attributable to shareholders of 3.163 billion yuan, up 54.35% year-on-year [1] - VisiOn expects a negative net profit for 2025, indicating a loss in operating performance [2] - Chongqing Steel anticipates a net loss of 2.5 billion to 2.8 billion yuan for 2025, which is an improvement from a net loss of 3.196 billion yuan in the previous year [3] - Lianfa Co. forecasts a net profit of 280 million to 320 million yuan for 2025, representing a year-on-year growth of 38.92% to 58.77% [4] Group 2 - CICC announced that the audit work related to the absorption merger with Dongxing Securities and Xinda Securities has not yet been completed [5] - Dalong Real Estate's subsidiary won a project bid worth 763 million yuan [6] - Zhongchuang Zhiling plans to issue convertible bonds to raise no more than 4.35 billion yuan for various projects [7] - Jintong Co. intends to acquire a 24% stake in Jinsha Molybdenum for 1.731 billion yuan [8] Group 3 - Nami Technology expects a net profit of 128 million to 145 million yuan for 2025, an increase of 54.51% to 75.03% year-on-year [9] - China State Construction reported a new contract total of 4.5458 trillion yuan for 2025, a 1% increase year-on-year [12] - China Metallurgical Group's new contract amount for 2025 is expected to decrease by 10.8% to 1.1136 trillion yuan [13] Group 4 - Beiding Co. reported a net profit of 111 million yuan for 2025, a year-on-year increase of 59.05% [14] - Southwest Securities expects a net profit of 1.028 billion to 1.098 billion yuan for 2025, an increase of 47% to 57% [15] - China Eastern Airlines reported a 4.93% year-on-year increase in passenger capacity for December 2025 [20] Group 5 - *ST Aowei's stock may be delisted due to a closing price below par value [21] - Yilian Network expects a net profit of 2.542 billion to 2.648 billion yuan for 2025, a decrease of 0% to 4% year-on-year [22] - Huochen Co. anticipates a net profit of 420 million to 540 million yuan for 2025, recovering from a loss of 2 million yuan in the previous year [17] Group 6 - Guoli Electronics expects a net profit of 68 million to 80 million yuan for 2025, an increase of 124.89% to 164.57% [28] - Jinchuan Group forecasts a net profit of 11 billion to 12 billion yuan for 2025, a year-on-year increase of 73.57% to 89.34% [41] - Triangle Tire plans to invest 3.219 billion yuan in a new tire project in Cambodia [42]

Group 1 - The core point of the article is that Ganli Pharmaceutical has received regulatory approval for its insulin products in Ethiopia, which is a significant milestone for the company [1] Group 2 - Ganli Pharmaceutical announced on January 15 that it received the registration approval for Glargine Insulin Injection and Glargine Insulin Injection Pre-filled Pen from the Ethiopian National Food and Drug Administration [1] - Glargine insulin is a long-acting insulin that is injected subcutaneously once daily, providing a blood sugar-lowering effect that lasts for 24 hours [1] - The characteristics of Glargine insulin include a long duration of action, stable blood concentration without peaks, and smooth blood sugar control [1]

一、药物基本情况 1、药品名称：Basalin TM 甘李药业股份有限公司 关于甘精胰岛素注射液及其预填充注射笔获得埃塞 俄比亚药品注册批件的公告 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，甘李药业股份有限公司（以下简称"公司"、"甘李药业"）收到埃 塞俄比亚国家食品药品监督管理局（Ethiopian Food and Drug Authority）核准签 发的甘精胰岛素注射液及甘精胰岛素注射液预填充注射笔注册批件（批件号： 11865/13208/NMR/2025、11864/13210/NMR/2025）。现将相关情况公告如下： 证券代码：603087 证券简称：甘李药业 公告编号：2026-005 2、药品通用名：甘精胰岛素注射液、甘精胰岛素注射液预填充注射笔 3、适应症：糖尿病 4、剂型：注射剂 5、规格：3ml：100 units/ml（卡式瓶）、3ml：100 units/ml（预填充注射笔） 6、批件号：11865/13208/NMR/2025、11864/13210/NMR/2025 7、申请人：甘 ...