（记者 张明双） 奇正藏药（002287.SZ）8月7日在投资者互动平台表示，公司2025年暂未推出新药。公司的新药小儿热 立清颗粒于2025年5月收到国家药品监督管理局签发的《药物临床试验批准通知书》，同意本品在儿童 人群开展用于急性上呼吸道感染风热夹湿证的临床试验。公司将依据通知书以及新药开发与药品注册法 规要求，开展Ⅱ期和Ⅲ期临床试验并完成相关工作，整合申报资料以申报产品上市。其他在研产品研发 进展情况请关注公司将于2025年8月23日发布的《2025年半年度报告》。 每经AI快讯，有投资者在投资者互动平台提问：请问贵公司，2025年推出了哪些新药，向国家药品监 督管理局申请了哪些新药？ ...

Group 1 - The core viewpoint of the report is that Pacific Securities has given a "buy" rating for Enhua Pharmaceutical (002262.SZ) based on its strong product performance and growth potential [2] - Enhua Pharmaceutical's core products are experiencing steady growth, with rapid expansion in anesthetics and neurology-related new products [2] - The company is continuously enhancing its R&D capabilities and expanding its pipeline of new drugs [2] Group 2 - The report highlights potential risks, including price reductions for some core products and the risk of regulatory tightening [2] - There are concerns regarding the market performance of new analgesic products not meeting expectations [2] - The progress of innovative drug development may not align with anticipated timelines [2]

Core Viewpoint - The company reported a strong performance in the first half of 2025, with significant revenue and profit growth, driven by robust sales of core products and rapid growth in new products [1][2]. Financial Performance - In the first half of 2025, the company achieved operating revenue of 3.01 billion yuan, a year-on-year increase of 8.93% [1] - The net profit attributable to shareholders was 700 million yuan, reflecting a year-on-year growth of 11.38% [1] - Basic earnings per share (EPS) reached 0.69 yuan, up 11.29% year-on-year [1] Product Performance - Anesthesia products generated revenue of 1.63 billion yuan, accounting for 54.29% of total revenue, with a year-on-year growth of 7.32% [1] - Mental health products achieved revenue of 621 million yuan, representing 20.63% of total revenue, with a year-on-year increase of 4.29% [1] - Neurology products saw revenue of 166 million yuan, making up 5.51% of total revenue, with a remarkable year-on-year growth of 107.33% [1] R&D Investment - The company invested 395 million yuan in R&D in the first half of 2025, a year-on-year increase of 23.97%, representing 13.12% of total revenue [2] - There are currently 17 innovative drug projects in the pipeline, indicating a rich new drug pipeline [2] - The company has completed one Phase III clinical study and two Phase II studies, with additional studies ongoing [2] Profit Forecast - Projected operating revenues for 2025-2027 are 6.40 billion, 7.26 billion, and 8.24 billion yuan, with year-on-year growth rates of 12.39%, 13.34%, and 13.51% respectively [2] - Expected net profits for the same period are 1.29 billion, 1.48 billion, and 1.69 billion yuan, with growth rates of 13.19%, 14.03%, and 14.56% respectively [2] - EPS forecasts for 2025-2027 are 1.27, 1.45, and 1.66 yuan, with corresponding PE ratios of 17, 15, and 13 times [2]

Market Performance - The pharmaceutical sector increased by 1.92% on July 24, 2025, outperforming the CSI 300 index by 1.21 percentage points, ranking 7th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, vaccines (+8.53%), hospitals (+3.95%), and medical research outsourcing (+3.37%) showed the best performance, while pharmaceutical distribution (+1.24%), medical consumables (+1.34%), and other biological products (+1.37%) lagged behind [1] - Top three gainers in individual stocks were Zhendong Pharmaceutical (+19.96%), Opcon Vision (+14.13%), and Maipu Medical (+10.58%); the largest decliners were Chengda Pharmaceutical (-13.12%), Renmin Tongtai (-8.95%), and Kangentai (-7.77%) [1] Industry News - The China National Medical Products Administration (NMPA) has accepted Bayer's application for the new drug BAY 2927088, an oral, reversible tyrosine kinase inhibitor (TKI) Sevabertinib, which has received breakthrough therapy designation from both the FDA and NMPA for treating adults with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 activating mutations who have received prior systemic therapy [2] Company News - Heng Rui Medicine (600276) announced that its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received approval from the NMPA for the clinical trial of HRS-1893 tablets, aimed at treating heart failure with preserved ejection fraction [3] - Heng Rui Medicine (600276) also reported that its subsidiary Beijing Shengdi Pharmaceutical Co., Ltd. received approval for the clinical trial of HRS-8179 injection, intended for the prevention of severe cerebral edema after large-area cerebral infarction [3] - Sino Medical (688108) projected a revenue of 240 million yuan for the first half of 2025, a year-on-year increase of 12.53%, with a net profit attributable to shareholders of 13.84 million yuan, up 296.54%, and a non-recurring net profit of 7.98 million yuan, up 163.35% [3] - Three Life National Health (688336) announced a collaboration with Pfizer, granting exclusive development and commercialization rights for 707 projects in mainland China, with total option and exercise fees not exceeding 150 million USD [3]

Core Viewpoint - Roche reported a strong performance in the first half of 2025, achieving a 7% growth in total sales to CHF 30.944 billion (approximately USD 39.0512 billion) driven by robust demand for its pharmaceuticals [1] Group 1: Pharmaceutical Division Performance - The pharmaceutical division saw a notable sales increase of 10%, reaching CHF 23.985 billion, supported by five key growth drivers: Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus, which collectively generated CHF 10.6 billion, a CHF 1.7 billion increase from the first half of 2024 [2] - Ocrevus sales reached CHF 3.506 billion, an 8% increase, with the U.S. market contributing CHF 2.462 billion, accounting for over 70% of total sales [2] - Hemlibra sales were CHF 2.421 billion, up 17%, with international markets (excluding the U.S., Europe, and Japan) showing a 66% growth [2] - Vabysmo sales increased by 18% to CHF 2.067 billion, with Europe and Japan growing by 33% and 31%, respectively [2] - Xolair experienced a remarkable 34% growth, with sales of CHF 1.445 billion, all from the U.S. market [2] - Phesgo emerged as a strong performer in breast cancer treatment, with sales of CHF 1.197 billion, a 55% increase, and international sales growing by 182% [2] Group 2: Regional Sales Performance - The U.S. market remains the primary revenue source for the pharmaceutical division, with sales of CHF 12.67 billion, a 10% increase [3] - European market sales reached CHF 4.566 billion, growing by 5%, while the Japanese market also grew by 5% to CHF 1.425 billion [3] - The international market, including Asia-Pacific and Latin America, showed the fastest growth at 14%, with sales of CHF 5.324 billion, driven by the successful promotion of products like Phesgo and Hemlibra [3] Group 3: Diagnostics Division Performance - The diagnostics division reported sales of CHF 6.959 billion, remaining flat at constant exchange rates but declining by 3% in Swiss francs [4] - Despite an 18% decline in sales in the Asia-Pacific region due to medical pricing reforms in China, strong demand for pathology solutions and blood screening tests mitigated this pressure, with pathology laboratory sales growing by 12% to CHF 0.852 billion [4] - Regional performance included a 5% growth in Europe, the Middle East, and Africa, with sales of CHF 2.485 billion, and a 6% increase in North America to CHF 2.235 billion [4] Group 4: Research and Development Progress - Roche's growth is supported by ongoing advancements in its R&D pipeline, with several key molecules entering Phase 3 development, including prasinezumab for early Parkinson's treatment and zosurabalpin for severe bacterial infections [5] - The company received regulatory approvals for Susvimo for diabetic retinopathy, Itovebi for advanced breast cancer, and Evrysdi for spinal muscular atrophy, with Phesgo's label update expected to reduce treatment costs significantly in Western Europe [5] - For the full year 2025, Roche maintains its guidance for mid-single-digit sales growth at constant exchange rates and high-single-digit growth in core earnings per share [5] Group 5: Overall Performance Summary - Overall, Roche delivered a strong performance in the first half of 2025, driven by robust growth in its pharmaceutical business and stable adjustments in its diagnostics division, with promising prospects for future development [6]

Group 1 - The company completed a share repurchase plan, buying back 914,200 shares for approximately 25 million yuan, which will be used for employee stock ownership or equity incentives [1][2] - The company has been actively investing in new drug development, recently obtaining approval for the new drug Marcilosavir, which enhances its product line [1][2] - The company has maintained high R&D investment, totaling nearly 2 billion yuan from 2021 to 2024, which supports product innovation and maintains a gross margin above 77% [1][4] Group 2 - The share repurchase accounted for 0.10% of the total share capital, with a repurchase average price of 27.35 yuan per share [2] - The company has a remaining 1.311 million shares in the repurchase account, which will not have voting rights or profit distribution until used [2] - The newly approved drug for chronic constipation and fecal impaction has a significant market potential, with projected sales of 838 million yuan in urban public hospitals in 2024 [3] Group 3 - In the first quarter of 2025, the company's R&D expenditure reached 100 million yuan, with a cumulative investment of nearly 1.5 billion yuan over the past three years [4] - The company’s gross margin for the first quarter of 2025 was 77.25%, consistently above 77% since 2014, indicating strong competitive positioning [4] - The company employs a balanced strategy across traditional Chinese medicine, chemical drugs, and innovative drugs, contributing to stable cash flow and market competitiveness [4]

Group 1: Marketing Reform and Sales Performance - The company initiated a direct sales reform pilot in 9 provinces starting in 2022, achieving significant results with steady profit growth in these regions [1] - The direct sales reform has been completed in 15 provinces, covering major OTC markets, which is expected to enhance sales efficiency and profitability [1] - The marketing reform introduced new performance metrics such as per capita efficiency and store efficiency, moving away from solely focusing on growth rates [1] Group 2: Financial Indicators and Profitability - The company is experiencing positive feedback from its marketing reform, with good completion rates for sales and payment indicators [2] - The company aims to exceed previous net profit levels, supported by steady growth of existing products and new drug development projects [2] - The company plans to enhance its profit margin to meet or exceed the industry average, ensuring long-term stable development [2] Group 3: New Drug Development - The Huanglian Jiedu Wan is the first "general" syndrome-type traditional Chinese medicine new drug in China, with clinical trials involving 840 cases [3] - The project employs a unique evaluation method combining "syndrome types + biomarkers," which could set a precedent for the evaluation standards of syndrome-type traditional Chinese medicine [3] - If approved, Huanglian Jiedu Wan will provide new treatment options for numerous diseases related to heat toxin syndrome [3] Group 4: Investment in Subsidiaries - Chengdu Zeling Biopharmaceutical Technology Co., Ltd. is a subsidiary in which the company holds a 17.6926% stake, making it the second-largest shareholder [3] - The subsidiary focuses on innovative drug research and has completed multiple rounds of financing [3]

Core Insights - The 2024 "Annual Report on Progress of New Drug Registration Clinical Trials in China" indicates a significant increase in drug clinical trial registrations, reaching 4,900, a year-on-year growth of 13.9% [2] - The report highlights that domestic pharmaceutical companies are actively engaged in clinical research, with 92.8% of the new trials initiated by domestic sponsors [2] Summary by Categories Overall Clinical Trial Registration - In 2024, the total number of drug clinical trial registrations in China reached 4,900, with new drug trials accounting for 2,539, representing 51.8% of the total [2] - The efficiency of clinical trial registration and implementation has improved compared to 2023, with average registration times for new drug trials reduced to 67.4 days [6] Drug Types and Categories - Chemical drugs dominate the clinical trials, making up over 70% of the total, while biological products account for 21.1% [4] - Among new drug trials, Class I registered drugs constitute 68.3%, with Phase I trials representing 46.92% of the total [4] Focus Areas in Clinical Trials - Antitumor drugs have the highest representation in clinical trials, with chemical drugs accounting for 24.7% and biological products for 43.1% [7] - The report indicates a notable increase in clinical trials for cell and gene therapies, with a growth rate exceeding 40% for newly registered trials [9][11] Pediatric and Rare Disease Drug Development - The number of clinical trials for pediatric and rare disease drugs has increased, with pediatric trials totaling 249, representing 9.8% of the new drug trials [14] - Rare disease drug trials reached 121, with a focus on blood system diseases, neurological diseases, and antitumor drugs, which together accounted for 63.6% of the total [16]

Core Viewpoint - Shanghai Yizhong is facing significant performance pressure as its second-largest shareholder, Shanghai Kaibao, plans to reduce its stake amid high stock prices and declining earnings [2][9]. Shareholder Actions - On July 16, Shanghai Kaibao announced plans to sell up to 6.2011 million shares of Shanghai Yizhong, currently holding 24.7035 million shares, representing 11.95% of the company [2][4]. - This marks the second time Shanghai Kaibao has reduced its stake, having previously sold 1.0476 million shares in 2022 for approximately 97.2716 million yuan [2][8]. - As of July 17, Shanghai Yizhong's stock price was 67.9 yuan per share, reflecting a 70% increase year-to-date, with the current market value of Shanghai Kaibao's holdings around 1.677 billion yuan [4][9]. Company Performance - Shanghai Yizhong reported a revenue of 71.0322 million yuan in Q1 2025, a year-on-year increase of 3.39%, but net profit fell by 51.38% to 14.186 million yuan [3][10]. - The company experienced a significant decline in performance in 2024, with revenues dropping to 174 million yuan, a decrease of 51.83%, and net profit down 95.68% [10]. - The core product, paclitaxel micelles, was not included in the medical insurance directory until November 2024, impacting market access and sales performance [9][10]. Financial Metrics - In 2024, Shanghai Yizhong's sales and R&D expenses were 115 million yuan and 37.2037 million yuan, respectively, reflecting increases of 8.28% and 65.71% [10]. - For Q1 2025, sales and R&D expenses were 28.2088 million yuan and 9.2766 million yuan, accounting for 39.7% and 13.06% of total revenue [10].

Core Viewpoint - Recently, Buchang Pharma (603858.SH) announced that its subsidiary, Zhejiang Tianyuan Biopharmaceutical Co., Ltd., has received the drug registration certificate for the quadrivalent influenza virus split vaccine from the National Medical Products Administration, making it the 9th certified company for this vaccine in China [1] Group 1: Vaccine Approval and Market Potential - The quadrivalent influenza vaccine is a key step in Buchang Pharma's strategy to expand from traditional Chinese medicine into biopharmaceuticals and vaccines [1] - Research indicates that approximately 84 million to 144 million people in China contract influenza annually, highlighting the significant market potential for vaccination [1] - The current vaccination rate for influenza in China is low, indicating substantial room for growth [1] Group 2: Timing and Production Advantages - The approval of the vaccine is timely, as the peak influenza season occurs from November to March, and vaccination requires 2-4 weeks to develop protective antibodies [1] - The vaccine was approved in July, allowing ample time for production and market distribution to meet the upcoming vaccination peak [1] Group 3: Product Details - The quadrivalent influenza virus split vaccine contains 15μg of each type of influenza virus hemagglutinin per 0.5ml dose, and is classified as a prescription biological product [3][4] - The vaccine is manufactured by Zhejiang Tianyuan Biopharmaceutical Co., Ltd., located in Hangzhou, Zhejiang Province [3][4] Group 4: R&D Investment and Commitment - As of June 30, 2025, Buchang Pharma has invested approximately 126 million yuan in the vaccine project, reflecting its commitment to new drug development [7] - The company emphasizes strict quality control throughout the drug development, manufacturing, and sales processes, showcasing its technical capabilities [7] Group 5: Shareholder Returns and Corporate Responsibility - Buchang Pharma has consistently returned value to shareholders through cash dividends and share buybacks, having paid out a total of 9.183 billion yuan since its listing [8] - The company plans to reduce its registered capital by repurchasing 44.8536 million shares, which is expected to enhance per-share value and stabilize stock prices [8] - Buchang Pharma has contributed over 32 billion yuan in taxes since its establishment, demonstrating its commitment to social responsibility and local economic development [8]