Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration for its heavy tartrate norepinephrine injection (specification: 1ml:2mg), successfully passing the consistency evaluation for generic drugs [1] Group 1: Product Approval and Market Impact - The heavy tartrate norepinephrine injection is primarily used for blood pressure control in certain acute hypotensive states, as well as for assisting treatment in cardiac arrest and severe hypotension [1] - The company submitted the consistency evaluation supplementary application for the 1ml:2mg specification to the National Medical Products Administration in June 2024, which has been accepted [1] - As of the announcement date, the company has invested approximately RMB 1.6 million in R&D expenses for the consistency evaluation of this product [1] Group 2: Market Potential - The total procurement amount for heavy tartrate norepinephrine injection (1ml:2mg) in hospitals across mainland China in 2024 is RMB 1.584 billion [1] - Drugs that pass the consistency evaluation will receive greater support in areas such as medical insurance payments and procurement by medical institutions, which is beneficial for expanding the market share of this product and enhancing its market competitiveness [1]

业内人士分析本轮险资举牌呈现三大特征。首先，举牌更频繁，今年不到半年举牌16次，去年同期仅4次。业内人士认为， 这与监管政策驱动紧密相关。今年以来，多项政策鼓励险资入市，如中央金融办明确国有保险公司长周期考核，监管引导 大型国有保险公司增加A股投资，金融监管总局上调险资权益资产配置比例上限等。 【环球网财经综合报道】近日险资掀起新一轮举牌潮，本周内便有三起举牌事件，且对象均为H股。5月19日，平安人寿公 告称，平安资产受托其资金投资农业银行H股，5月12日持股达股本10%触发举牌；5月16日，平安人寿又公告，平安资产 受托资金于5月9日投资邮储银行H股达股本10%触发举牌。5月14日，新华保险增持上海医药H股24.8万股，持股比例升至 5%触及举牌线。 据统计，今年以来险资已举牌16次，接近去年全年20次水平。 其次，举牌标的以港股为主，尤其是银行股H股。今年16次举牌中13次为港股，去年20次举牌中7次为港股。险资偏好港 股，一是港股估值低、性价比高；二是新会计准则下H股更适配险资，红利标的采用FVOCI类计量方式，可发挥业绩"减震 器"作用；三是税收优惠，国内机构投资者通过沪港通、深港通投资H股可享企业所 ...

Policy Trends - Recent COVID-19 infections show a slight increase in some regions, but the clinical severity has not changed significantly according to a Chinese CDC expert [2] Drug and Device Approvals - Changshan Pharmaceutical's nadroparin calcium injection has received a drug registration certificate from Belarus, used for treating venous thromboembolism and other related conditions [3] - Shanghai Pharmaceuticals announced that its rivaroxaban tablets have received approval from the US FDA, aimed at reducing the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients, among other uses [4] Capital Markets - Shanghai Kejun Pharmaceutical Technology Co., Ltd. completed a B+ round financing exceeding 100 million yuan, with funds primarily allocated for the phase III clinical development of its core product CG-0255 in the cardiovascular field [5] Industry Developments - Jingyin Pharmaceutical and CRISPR Therapeutics have formed a strategic partnership to jointly develop and commercialize a long-acting siRNA therapy for thrombotic diseases [6] - Buchang Pharmaceutical's subsidiary signed a commissioned research agreement with Fubicheng Pharmaceutical for the development of MF59 adjuvant [7] - Sanofi and Pfizer entered into a licensing agreement for a bispecific antibody product targeting PD-1 and VEGF, with Pfizer gaining exclusive rights outside mainland China [9] Public Sentiment Alerts - Jinhua Co., Ltd. reported that shareholder Xinyu Jinyu has reduced its holdings by 133,500 shares, representing 0.035765% of the company's total share capital [10] - Fosun Pharma announced the resignation of its Senior Vice President Rong Yang for personal reasons, effective May 16, 2025 [11]

Group 1 - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for Rivaroxaban tablets [1] - Rivaroxaban is indicated for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1][2] - The company has invested approximately RMB 8.2 million in the research and development of Rivaroxaban [1] Group 2 - The market for Rivaroxaban in the U.S. generated approximately $8.13 billion in sales in 2023, with projected sales of about $6.33 billion for the first three quarters of 2024 [2] - Competitors in the U.S. market for Rivaroxaban include Janssen Pharmaceuticals and several generic manufacturers [2] Group 3 - The FDA has also approved the ANDA for Mometasone Furoate nasal spray by Zhejiang Xinyi Ruijue Pharmaceutical [4] - Mometasone Furoate is used for the prevention and treatment of seasonal allergic rhinitis in adolescents and adults, as well as for chronic sinusitis with nasal polyps in adults [5] - The nasal spray generated approximately $43.7 million in sales in the U.S. in 2023, with projected sales of about $33.45 million for the first three quarters of 2024 [5]

Group 1 - Hongjing Technology signed a service contract for an intelligent computing project with a total amount of 597 million yuan, valid for 5 years [1] - Weifu High-Tech's subsidiary invested 220 million yuan to establish a joint venture with Shanghai Baolong Automotive Technology [2] - Zhongshan Public received approval for the registration of short-term financing bonds amounting to 2 billion yuan and medium-term notes of 3 billion yuan [3] Group 2 - Lianhua Technology established a venture capital fund with a total commitment of 200 million yuan, contributing 100 million yuan as a limited partner [4] - Changan Technology's shareholder signed an agreement to transfer 6.27% of the company's shares to Hefei State Capital Venture Investment [6] - Hangzhou Garden announced a cash dividend of 0.5 yuan per 10 shares, totaling 6.62 million yuan [8] Group 3 - Huamao Technology plans to acquire 100% equity of Fuchuang Youyue, leading to a temporary suspension of its stock [9] - Zhuojin Co. won a bid for a soil remediation project in Hefei with a contract value of 67.68 million yuan [10] - Shanghai Pharmaceuticals received FDA approval for two drugs, enhancing its product portfolio [10] Group 4 - Fuxing Pharmaceutical's senior vice president resigned for personal reasons [12] - Baolong Technology's subsidiary plans to invest 180 million yuan in a joint venture [13] - ST Zhongdi intends to utilize surplus funds from a project company, with a maximum of 106 million yuan [14] Group 5 - Nanchao Food reported a significant decline in net profit for April, down 82.14% year-on-year [16] - Changshan Pharmaceutical received a drug registration certificate in Belarus for a new product [18] - Nanshan Aluminum established a wholly-owned subsidiary for photovoltaic energy projects with an investment of 5 million yuan [20] Group 6 - Bozhong Precision announced the resignation of a director and deputy general manager [22] - Xinjiang Jiaojian won a bid for a highway construction project valued at 451 million yuan [23] - Guangzhou Restaurant declared a cash dividend of 0.48 yuan per share, totaling 273 million yuan [25] Group 7 - Weili Medical's subsidiary obtained a medical device operating license, allowing it to engage in wholesale activities [27] - New Australia Co. announced a cash dividend of 0.3 yuan per share, totaling 219 million yuan [28] - Lianhua Technology's subsidiary entered the new third board innovation layer [29] Group 8 - Huaxi Energy's chairman resigned due to personal reasons [31] - Yipin Hong plans to use up to 500 million yuan of idle funds for cash management [33] - Shouhua Gas intends to purchase bauxite resources through market means [34] Group 9 - Jincheng signed a service agreement for underground mining operations at the Komakau Copper Mine, valued at approximately 805 million USD [34] - Wanrun New Energy signed a supply contract with CATL for lithium iron phosphate products, with a total supply of about 1.32 million tons [35] - Weili plans to transfer 100% equity of a subsidiary to Chengfa Environment for 100 million yuan [36] Group 10 - Zhenlei Technology's subsidiary received government subsidies of 2.21 million yuan, positively impacting profits [38] - Weir shares plan to change their name to "Haowei Group" to reflect strategic direction [39] - YTO Express reported a revenue increase of 16.32% in April, totaling 5.755 billion yuan [39]

Group 1 - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for rivaroxaban tablets [1] - The drug is indicated for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treating and preventing deep vein thrombosis (DVT), treating pulmonary embolism (PE), and preventing venous thromboembolism (VTE) in acutely ill patients [1][2] - The company has invested approximately RMB 8.2 million in research and development for this drug [1] Group 2 - The market competition for rivaroxaban tablets in the U.S. includes the original developer Janssen Pharmaceuticals and generic manufacturers such as Apotex, Aurobindo Pharma, Lupin, Dr. Reddy's Laboratories, and Macleods Pharmaceuticals [2] - Rivaroxaban tablets generated approximately $8.13 billion in sales in the U.S. in 2023, with projected sales of about $6.33 billion for the first three quarters of 2024 [2] - The approval of the ANDA is expected to positively impact the company's expansion into overseas markets [2]

药物名称：利伐沙班片 剂型：片剂 规格：10 mg, 15 mg, 20 mg（按 C19H18ClN3O5S 计） 申请事项：ANDA 申请人：常州制药厂有限公司 ANDA 号：ANDA 216995 二、该药品相关信息 利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险；用于 治疗和预防深静脉血栓形成（DVT）；用于治疗肺栓塞（PE）；用于预防急性病 患者静脉血栓栓塞（VTE）等。利伐沙班片最早由 BAYER 和 JANSSEN 联合研 发并于 2011 年在美国上市。2021 年 12 月，常州制药厂就该药品向美国 FDA 提 出 ANDA 申请，并于近日获得批准文号。截至本公告日，公司针对该药品已投 入研发费用约人民币 820 万元。 1 证券代码：601607 证券简称：上海医药 公告编号：临2025-056 上海医药集团股份有限公司 关于利伐沙班片获得美国 FDA 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个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下 属常 ...

证券代码：601607 证券简称：上海医药 公告编号：临2025-057 上海医药集团股份有限公司 关于糠酸莫米松鼻喷雾剂获得美国 FDA 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个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下 属浙江信谊瑞爵制药有限公司（以下简称"信谊瑞爵"） 收到美国食品药品监 督管理局（以下简称"美国 FDA"）的通知，其关于糠酸莫米松鼻喷雾剂（基 本情况详阅正文，以下简称"该药品"）的简略新药申请（"ANDA"，即美国 仿制药申请）已获得批准（"Approval"），现将相关情况公告如下： 一、该药品基本情况 药物名称：糠酸莫米松鼻喷雾剂 剂型：鼻喷雾剂 规格：50 微克/揿（0.05%）（按 C27H30Cl2O6计） 申请事项：ANDA 申请人：浙江信谊瑞爵制药有限公司 ANDA 号：ANDA 211706 二、该药品相关信息 糠酸莫米松鼻喷雾剂主要用于预防/治疗青少年和成人的季节性鼻炎，以及 治疗成人伴有鼻息肉的慢性鼻窦炎。糠酸莫米松鼻喷雾剂最早 ...

香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * （於中華人民共和國註冊成立的股份有限公司） （股份代碼：02607） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於利伐沙班片獲得美國 FDA 批准文號的公告》、《上 海醫藥集團股份有限公司關於糠酸莫米松鼻噴霧劑獲得美國 FDA 批准文號的公告》僅供參 閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海，2025 年 5 月 21 日 於本公告日期，本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生；非執行董事為張文學先生；以及獨立非執行董事為顧朝陽 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Changzhou Pharmaceutical Factory, has received notification from the U.S. Food and Drug Administration (FDA) that its abbreviated new drug application (ANDA) for rivaroxaban tablets has been approved, which is significant for expanding the company's overseas market presence [1] Summary by Relevant Sections - **Drug Approval** - The FDA has approved the ANDA for rivaroxaban tablets, which are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] - **Application Timeline** - The ANDA application was submitted in December 2021, and the approval was recently granted [1] - **Research and Development Investment** - As of the announcement date, the company has invested approximately 8.2 million yuan in research and development for this drug [1] - **Market Potential** - In 2023, the sales revenue of rivaroxaban tablets in the U.S. was approximately 8.13 billion dollars, with projected sales of about 6.33 billion dollars for the first three quarters of 2024 [1] - **Strategic Importance** - The approval is expected to have a positive impact on the company's efforts to further penetrate the overseas market [1]