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中疾控专家回应新冠感染临床严重性变化情况;三生国健与辉瑞一款双特异性抗体达成协议
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]
上海医药集团股份有限公司
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]
5月20日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-20 10:19
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]
上海医药: 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
Zheng Quan Zhi Xing· 2025-05-20 09:12
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]
上海医药(601607) - 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
2025-05-20 08:46
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 ...
上海医药(601607) - 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
2025-05-20 08:46
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 ...
上海医药(02607) - 海外监管公告
2025-05-20 08:45
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 ...
上海医药:常州制药厂利伐沙班片获美国FDA批准
news flash· 2025-05-20 08:25
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]
格隆汇公告精选︱比亚迪8月新能源汽车销量17.5万辆;丽珠集团新冠疫苗被纳入序贯加强免疫紧急使用
Ge Long Hui· 2025-05-19 01:20
Group 1 - BYD reported August sales of 174,915 new energy vehicles, a year-on-year increase of 184.84% [1] - Cumulative sales from January to August reached 978,795 units, representing a year-on-year growth of 267.31% [1] - The company sold 5,092 new energy passenger vehicles overseas in August [1] Group 2 - Zhongke Electric's subsidiary plans to establish a joint venture with Chongqing Fudi for the production of anode materials, with a registered capital of 1 billion RMB [2] - Zhongke Electric's subsidiary will contribute 650 million RMB, while Chongqing Fudi will contribute 350 million RMB [2] Group 3 - Yuyuan Group intends to transfer 13% of its shares in Jinhuijiu for approximately 1.937 billion RMB, reducing its stake to 25% [3] - The company plans to further reduce its holdings by more than 5% within the next six months [3] Group 4 - Lizhu Group's recombinant COVID-19 fusion protein vaccine has been included in the emergency use for sequential booster immunization [4] Group 5 - Guanghui Energy plans to repurchase shares worth between 800 million and 1 billion RMB to support employee stock ownership plans [5] Group 6 - Cambrian has launched four cloud-based intelligent chips, although mass sales will require a longer time frame and initial technical service investments [7] Group 7 - LePu Medical has received approval from the China Securities Regulatory Commission for the issuance of Global Depositary Receipts (GDRs) and listing on the Swiss Stock Exchange [9] - The GDR issuance will correspond to no more than 180,458,875 new A-shares [9] Group 8 - Fushi Holdings' subsidiary has entered into an exclusive advertising agency cooperation with the Central Radio and Television Station's automotive channel for three years [10] Group 9 - Guangzhou Port's container throughput in August was 1.981 million TEUs, a year-on-year increase of 2.4% [11] - The total cargo throughput for August was 44.788 million tons, a decrease of 0.6% [11] Group 10 - Ningbo Port expects to complete a container throughput of 3.58 million TEUs in August, a year-on-year increase of 10.2% [12] - The total cargo throughput is projected to decline by 3.0% [12] Group 11 - Ming Tai Aluminum reported a 7% year-on-year decrease in aluminum plate and strip sales in August, while aluminum profile sales increased by 47% [13] Group 12 - Electric Power Investment plans to invest in multiple wind and solar projects, with total static investments of 1.585 billion RMB for wind and 538 million RMB for solar [14] Group 13 - Northeast Pharmaceutical has signed a cooperation agreement with MedAbome for the development of the MAb11-22.1 antibody project [19] Group 14 - New Five Feng plans to acquire equity in Tianxin Seed Industry and several other companies for a total price of approximately 2.208 billion RMB [26] Group 15 - Sumeida's subsidiary plans to transfer 100% equity of eight photovoltaic power station project companies, with an estimated transaction value of 657 million RMB [27] Group 16 - *ST Tongzhou intends to acquire 51% equity in Tongtaiwei, fulfilling the capital contribution obligation of 10.2 million RMB [29] Group 17 - Tianyin Holdings' subsidiary plans to invest 120 million RMB in Xundong Xintong to acquire 40% equity [30] Group 18 - Hainan Haiyao plans to publicly transfer 43% equity in Shanghai Lishengte to attract new investors [31] Group 19 - New Asia Process plans to transfer 7.76% of its shares to Xiangcai New Materials at a price of 5.274 RMB per share [32] Group 20 - Lanwei Medical plans to raise no more than 664 million RMB through a private placement for provincial laboratory construction projects [34] Group 21 - Lida New Materials plans to issue convertible bonds to raise no more than 300 million RMB for a new aluminum material project [35] Group 22 - Gekewei has successfully launched its 12-inch CIS integrated circuit project, achieving over 95% yield [51] Group 23 - Baijin Medical's tricuspid valve ring product has received registration approval [52] Group 24 - Shanghai Pharmaceuticals has received approval to initiate Phase I clinical trials for a recombinant anti-CD20 humanized monoclonal antibody [53] Group 25 - Junda Co. has increased the production capacity of its solar cell production base project from 8GW to 10GW [54]
5月14日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-14 10:14
Group 1 - Vanke A's largest shareholder, Shenzhen Metro Group, plans to provide a loan of up to 1.55 billion yuan to repay the company's bonds [1] - Yidelong reported a net profit of 41.77 million yuan for Q1 2025, a year-on-year increase of 34.19% [1] - Overseas Chinese Town A achieved a contract sales amount of 1.78 billion yuan in April, a year-on-year increase of 10% [1][2] Group 2 - Dajin Heavy Industry's subsidiary signed a contract worth approximately 1 billion yuan for an offshore wind power project with a European energy company [4] - Liao Port Co. announced the resignation of Chairman Wang Zhixian due to reaching retirement age [4] - China Energy Construction's application for a specific stock issuance has been approved by the Shanghai Stock Exchange [6] Group 3 - Xinhua Insurance reported a 27% year-on-year increase in premium income from January to April, totaling 85.38 billion yuan [11] - 吉祥航空's passenger turnover increased by 6.34% in April, with a seat occupancy rate of 86.16% [13] - New City Holdings reported a contract sales amount of approximately 1.76 billion yuan in April, a year-on-year decrease of 52.46% [28] Group 4 - Three Yuan Bio announced a preliminary ruling of a 3.49% countervailing duty on its products in the U.S. [23] - Shanghai Pharmaceutical's product, Wengjing Decoction Granules, has been approved for production [20] - A strategic cooperation agreement was signed between *ST Dali and Zhuhai Yunzhou Intelligent Technology Co., Ltd. to promote the development of intelligent unmanned equipment [22] Group 5 - The construction of the automotive lightweight forging precision processing project by Sanlian Forging has been completed [25] - The company Tianma Technology reported an output of approximately 1,480.16 tons of eel in April [18][19] - The company Victory Technology plans to invest up to 3 billion yuan for share repurchase [42]