Investment Rating - The investment rating for the industry is "Positive" and the rating has been maintained [2] Core Views - The pharmaceutical and biotechnology industry index experienced a decline of 4.40%, ranking 23rd among 31 primary industries, underperforming the CSI 300 index which fell by 2.19% [6][18] - The valuation of the pharmaceutical and biotechnology industry as of November 28, 2025, is a PE (TTM overall method, excluding negative values) of 29.46x, down from 30.89x in the previous period, indicating a downward trend and below the average [22] - The report highlights potential beneficiaries from the upcoming ASH data, particularly in blood diseases and companies with solid grassroots channels, as well as those with differentiated advantages in oncology, autoimmune, and rare disease products [10] Summary by Sections Industry Review - The pharmaceutical and biotechnology industry index fell by 4.40%, with chemical preparations and medical devices showing declines of 2.86% and 2.95% respectively, while offline pharmacies and vaccines saw larger declines of 8.22% and 6.42% [6][18] - The PE ratio for the pharmaceutical and biotechnology industry is 29.46x, with the highest valuations in the vaccine (47.56x), hospital (41.17x), and medical device (36.77x) sectors, while pharmaceutical circulation has the lowest at 14.58x [22] Important Industry News - The National Administration of Traditional Chinese Medicine and the National Healthcare Security Administration released a directory for traditional Chinese medicine diseases suitable for disease-based payment [26][27] - AstraZeneca's drug "Durvalumab" received FDA approval for a new indication in perioperative treatment of gastric cancer [32] - Otsuka Pharmaceutical's new drug for IgA nephropathy, "Sibeprenlimab," has been approved by the FDA [38] - Bayer's first-in-class lung cancer drug "Sevabertinib" has been approved by the FDA for specific patient populations [40] Investment Recommendations - Focus on innovative pharmaceutical companies that may benefit from the medical insurance or commercial insurance directories, blood cancer targets with imminent ASH data releases, and biotech and CXO leaders with solid technology platforms and international collaboration expectations [10]

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for future performance [6][7]. Core Insights - The company is positioned as an innovative leader in the CDMO (Contract Development and Manufacturing Organization) sector, focusing on providing customized R&D and manufacturing services for pharmaceutical and biotech companies globally. The company's revenue has shown a compound annual growth rate (CAGR) of 20.67% from 2019 to 2024, with a projected revenue of 51.61 billion yuan in 2024 [1][3]. - The company's contract manufacturing revenue has significantly increased, accounting for 75% of total revenue in 2024, with international revenue making up 79.12% of total sales [2][3]. - The global CDMO market is experiencing robust growth, with an expected market size of $168.4 billion by 2028 and $338.5 billion by 2030, which the company is well-positioned to benefit from [3][4]. Summary by Sections Financial Performance - The company's revenue increased from 20.17 billion yuan in 2019 to 51.61 billion yuan in 2024, with a net profit growth from 2.38 billion yuan in 2019 to 10.33 billion yuan in 2023. However, net profit in 2024 was impacted by non-recurring losses, dropping to 6.06 billion yuan, a decrease of 41.34% year-on-year. In Q1-Q3 2025, net profit rebounded to 7.48 billion yuan, up 18.51% year-on-year [1][7]. Business Strategy - The company has a clear strategic focus on innovative drug CDMO services, with a growing pipeline of projects in peptide and conjugated nucleic acid technologies. The company is expanding its production capacity for peptides to 800 kg/year and is establishing commercialization capabilities for small nucleic acids [4][7]. Market Outlook - The report highlights the high market demand for innovative drugs, which is driving the growth of the CDMO sector. The company is expected to benefit from this trend, with projected revenues of 56.70 billion yuan, 62.78 billion yuan, and 69.57 billion yuan for 2025, 2026, and 2027, respectively [7][9].

证券代码：603456 证券简称：九洲药业 公告编号：2025-069 浙江九洲药业股份有限公司 关于控股子公司获得美国 ANDA 批准文号的公告 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，浙江九洲药业股份有限公司（以下简称"公司"）控股子公司浙江九 洲生物医药有限公司（以下简称"九洲生物"）向美国食品药品监督管理局（以 下简称"FDA"）提交的西格列汀二甲双胍缓释片简略新药申请的（以下简称 "ANDA"）已获得美国 FDA 的暂时批准（暂时批准：指 FDA 已经完成仿制药 的所有审评要求，但由于专利权或专卖权未到期而给予的一种批准形式），具体 情况如下： 一、药品的基本情况 药品名称：西格列汀二甲双胍缓释片 剂型：片剂 规格：100mg/1000mg 和 50mg/1000mg 申请事项：ANDA 申请人：浙江九洲生物医药有限公司 ANDA 号：217017 二、药品其他相关情况 西格列汀二甲双胍缓释片主要用于经二甲双胍单药治疗血糖仍控制不佳或 正在接受二者联合治疗的 2 型糖尿病患者。西格列汀二甲双胍缓释片的原 ...

智通财经APP讯，九洲药业(603456.SH)发布公告，近日，公司控股子公司浙江九洲生物医药有限公司 (简称"九洲生物")向美国食品药品监督管理局(简称"FDA")提交的西格列汀二甲双胍缓释片简略新药申 请的(简称"ANDA")已获得美国FDA的暂时批准(暂时批准：指FDA已经完成仿制药的所有审评要求，但 由于专利权或专卖权未到期而给予的一种批准形式)。 西格列汀二甲双胍缓释片主要用于经二甲双胍单药治疗血糖仍控制不佳或正在接受二者联合治疗的2型 糖尿病患者。西格列汀二甲双胍缓释片的原研药为JanumetXR，由默沙东公司研发，于2012年2月在美 国上市。目前该药品在美国尚处于专利保护期内，美国市场上仅有原研产品上市销售。根据公开数据显 示，2024年该药品美国市场销售额约11亿美元。 ...

Core Viewpoint - The company has received temporary approval from the FDA for its abbreviated new drug application (ANDA) for Sitagliptin Metformin Extended-Release Tablets, indicating progress in its product development and potential market entry in the U.S. [1] Company Summary - The company's subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., submitted the ANDA for Sitagliptin Metformin Extended-Release Tablets to the FDA [1] - The drug is primarily used for treating type 2 diabetes patients who have inadequate blood sugar control with Metformin alone or are receiving combination therapy [1] - The original drug, Janumet XR, was developed by Merck and launched in the U.S. in February 2012, and it is currently under patent protection [1] Market Potential - The U.S. market sales for Sitagliptin Metformin Extended-Release Tablets are projected to be approximately $1.1 billion in 2024 [1] - The company has invested around RMB 14.73 million in the research and development of this product to date [1] Competitive Position - The FDA's approval signifies that the company's product has met safety and efficacy standards comparable to the original drug, enhancing its market competitiveness [1] - The product will only be eligible for sale in the U.S. market after the patent expires and the FDA grants final approval [1]

西格列汀二甲双胍缓释片主要用于经二甲双胍单药治疗血糖仍控制不佳或正在接受二者联合治疗的2型 糖尿病患者。西格列汀二甲双胍缓释片的原研药为JanumetXR，由默沙东公司研发，于2012年2月在美 国上市。目前该药品在美国尚处于专利保护期内，美国市场上仅有原研产品上市销售。根据公开数据显 示，2024年该药品美国市场销售额约11亿美元。 九洲药业（603456）(603456.SH)发布公告，近日，公司控股子公司浙江九洲生物医药有限公司(简称"九 洲生物")向美国食品药品监督管理局(简称"FDA")提交的西格列汀二甲双胍缓释片简略新药申请的(简 称"ANDA")已获得美国FDA的暂时批准(暂时批准：指FDA已经完成仿制药的所有审评要求，但由于专 利权或专卖权未到期而给予的一种批准形式)。 ...

九洲药业公告，控股子公司九洲生物向美国食品药品监督管理局提交的西格列汀二甲双胍缓释片ANDA 已获得暂时批准。该药品主要用于2型糖尿病患者的血糖控制，原研药为Janumet XR，由默沙东公司研 发。九洲药业在该药品上的累计研发投入约为1473万元。西格列汀二甲双胍缓释片的ANDA通过美国 FDA上市许可批准，将进一步提升公司产品的市场竞争力。但该产品需要在专利权到期并得到FDA最终 批准后才能获得在美国市场销售的资格。 ...

Core Viewpoint - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Tofisopam, an oral anticoagulant drug, which will enhance the company's product portfolio and market competitiveness [1][1][1] Summary by Relevant Sections Product Approval - The company has obtained the "Chemical Raw Material Drug Marketing Application Approval Notice" for Tofisopam, indicating compliance with national drug registration requirements [1][1] - The drug is primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as for treating or preventing deep vein thrombosis and pulmonary embolism [1][1] Market Potential - In 2023, the sales revenue of Tofisopam in domestic sample hospitals and retail pharmacies was approximately 361 million yuan [1][1] - The company submitted the marketing application to the Center for Drug Evaluation in July 2024 and has invested about 6.69 million yuan in the research and development of Tofisopam to date [1][1] Strategic Impact - The approval of Tofisopam is expected to enrich the company's product structure and enhance its market competitiveness [1][1]

Market Overview - The medical services sector increased by 0.56% on November 25, with ST Zhongzhu leading the gains [1] - The Shanghai Composite Index closed at 3870.02, up 0.87%, while the Shenzhen Component Index closed at 12777.31, up 1.53% [1] Top Gainers in Medical Services - ST Zhongzhu (600568) closed at 2.57, up 4.90% with a trading volume of 53,900 shares and a turnover of 13.85 million yuan [1] - Chengda Pharmaceutical (301201) closed at 47.78, up 2.97% with a trading volume of 112,700 shares and a turnover of 540 million yuan [1] - Boji Pharmaceutical (300404) closed at 10.10, up 2.75% with a trading volume of 108,600 shares and a turnover of 10.9 million yuan [1] Top Losers in Medical Services - Jiuzhou Pharmaceutical (603456) closed at 18.75, down 0.85% with a trading volume of 181,100 shares and a turnover of 343 million yuan [2] - Tongce Medical (600763) closed at 41.95, down 0.66% with a trading volume of 49,600 shares and a turnover of 210 million yuan [2] - Yingkang Life (300143) closed at 10.12, down 0.49% with a trading volume of 44,700 shares and a turnover of 4.56 million yuan [2] Capital Flow Analysis - The medical services sector experienced a net outflow of 113 million yuan from institutional investors, while retail investors saw a net inflow of 30.37 million yuan [2][3] - Major stocks like WuXi AppTec (603259) had a net inflow of 67.13 million yuan from institutional investors, while Sunshine Nuohua (688621) saw a net outflow of 2.29 million yuan from retail investors [3] Summary of Individual Stock Performance - Sunshine Nuohua (688621) had a net inflow of 38.24 million yuan from institutional investors, but a net outflow of 3.59 million yuan from retail investors [3] - Chengda Pharmaceutical (301201) also saw a significant net inflow of 36.45 million yuan from institutional investors, with a net outflow of 13.58 million yuan from retail investors [3] - New Mileage (002219) had a net inflow of 14.15 million yuan from institutional investors, while retail investors experienced a net outflow of 6.70 million yuan [3]

Core Viewpoint - Jiuzhou Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Tofacitinib, indicating a significant milestone for the company in expanding its product portfolio [2] Group 1 - The company announced the receipt of the approval notice for Tofacitinib, with the notification number 2025YS01026 [2]