Core Insights - On December 2, 2023, brokerage firms provided target prices for listed companies, with notable increases for Xianhui Technology, Kweichow Moutai, and Delong股份, showing target price increases of 42.61%, 42.06%, and 36.94% respectively, across the battery, liquor, and automotive parts industries [1][2]. Target Price Increases - The companies with the highest target price increases are: - Xianhui Technology (688155) with a target price of 84.00 and an increase of 42.61% [2] - Kweichow Moutai (600519) with a target price of 2040.00 and an increase of 42.06% [2] - Delong股份 (300473) with a target price of 38.59 and an increase of 36.94% [2] - A total of 15 listed companies received brokerage recommendations on December 2, with Mengbaihe, Aladdin, and Jiuzhou Pharmaceutical each receiving one recommendation [2]. Rating Adjustments - On December 2, one company had its rating upgraded, specifically China Resources Sanjiu (0009999), which was upgraded from "Hold" to "Buy" by Western Securities [3][4]. First-Time Coverage - Nine companies received first-time coverage from brokerages on December 2, including: - Mengbaihe (603313) rated "Hold" by Industrial Securities [5] - Jiuzhou Pharmaceutical (603456) rated "Buy" by Xiangcai Securities [5] - Delong股份 (300473) rated "Buy" by Northeast Securities [5] - Others include Minshida, Tongfu Microelectronics, Xianhui Technology, Rongqi Technology, Tianyue Advanced, and Beifang Huachuang, all receiving various ratings [5].

Core Insights - The company is an industry-leading CDMO driven by innovation, providing comprehensive pharmaceutical R&D and manufacturing services, with a focus on small molecules, peptides, conjugates, and small nucleic acids [1][4] - The company's revenue has grown from 2.017 billion in 2019 to an expected 5.161 billion in 2024, with a CAGR of 20.67%, and a revenue of 4.160 billion in Q1-Q3 2025, representing a year-on-year growth of 4.92% [1] - The company's net profit attributable to shareholders increased from 238 million in 2019 to 1.033 billion in 2023, with a projected net profit of 606 million in 2024, a decline of 41.34% due to non-recurring losses, and a net profit of 748 million in Q1-Q3 2025, a year-on-year increase of 18.51% [1] Business Segmentation - The revenue share from contract customization services has increased significantly, from 37.55% in 2019 to 75.00% in 2024, indicating a clear strategic focus on innovative drug CDMO services [2] - The gross margin for contract customization services in 2024 was 38.38%, with varying margins for different drug categories, such as 35.58% for central nervous system drugs and -5.74% for anti-infective products [2] - The company's foreign revenue reached 4.025 billion in 2024, accounting for 79.12% of total revenue, highlighting a growing international presence [2] Industry Outlook - The global pharmaceutical CDMO market has shown robust growth, with revenues increasing from 7.57 billion in 2019 to an expected 38.71 billion in 2024, driven by rising demand for innovative drugs and outsourcing by pharmaceutical companies [3] - The global CDMO market size grew from 44.6 billion USD in 2018 to 79.7 billion USD in 2023, with a CAGR of 12.3%, and is projected to reach 168.4 billion USD by 2028 and 338.5 billion USD by 2030 [3] - The company is well-positioned to benefit from the growth of the global CDMO industry due to its focus on innovative drug development [3] Technological Advancements - The company has developed a rich pipeline of CDMO projects, with advancements in technologies such as continuous flow, chiral catalysis, fluorochemistry, biocatalysis, and solid-state research [4] - The peptide department is expanding its commercial capacity to 800 kg/year, enhancing the delivery capability for peptide products [4] - The company is also establishing a commercial capacity for small nucleic acids, with R&D platforms set up domestically and internationally [4] Investment Outlook - The company is expected to achieve revenues of 5.670 billion, 6.278 billion, and 6.957 billion from 2025 to 2027, with net profits of 930 million, 1.031 billion, and 1.147 billion respectively, indicating a positive long-term growth outlook [5] - The projected EPS for the same period is 1.05, 1.16, and 1.29, reflecting confidence in the company's future performance [5]

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]

Core Viewpoint - Jiuzhou Pharmaceutical (603456.SH) announced that its subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., has received temporary approval from the FDA for its Abbreviated New Drug Application (ANDA) for Sitagliptin Metformin Extended-Release Tablets, which are used for treating type 2 diabetes patients whose blood sugar is not adequately controlled with metformin alone or who are receiving combination therapy [1] Group 1 - The Sitagliptin Metformin Extended-Release Tablets are primarily indicated for type 2 diabetes patients [1] - The original drug, JanumetXR, was developed by Merck and launched in the U.S. in February 2012 [1] - Currently, the original product is the only one available in the U.S. market, as it is still under patent protection [1] Group 2 - The projected sales for the drug in the U.S. market in 2024 are approximately $1.1 billion [1]

Core Viewpoint - Jiuzhou Pharmaceutical's subsidiary, Jiuzhou Biotech, has received temporary approval from the FDA for the ANDA of Sitagliptin Metformin Extended-Release Tablets, which is primarily used for blood sugar control in type 2 diabetes patients [1] Group 1 - The drug is a generic version of Janumet XR, originally developed by Merck [1] - The total R&D investment by Jiuzhou Pharmaceutical in this drug amounts to approximately 14.73 million yuan [1] - The approval of the ANDA will enhance the company's market competitiveness, although the product must wait for patent expiration and final FDA approval to be eligible for sale in the U.S. market [1]

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]