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复星医药(600196) - 复星医药关于控股子公司药品获欧盟孤儿药资格认定的公告

2025-05-26 09:00
证券代码:600196 股票简称:复星医药 编号:临 2025-093 上海复星医药(集团)股份有限公司 关于控股子公司药品获欧盟孤儿药资格认定的公告 HLX22 为本集团(即本公司及控股子公司/单位,下同)自 AbClon, Inc.许可引 进、并后续自主研发的新型靶向 HER2 的单克隆抗体,拟用于胃癌和乳腺癌等实体瘤 的治疗。2025 年 3 月,HLX22 用于治疗胃癌(GC)已获美国食品药品监督管理局(FDA) 授予孤儿药资格认定(Orphan-drug Designation)。 截至本公告日期(即 2025 年 5 月 26 日),HLX22 单药用于治疗 HER2 过表达晚 期实体瘤于中国境内(不包括港澳台地区,下同)已完成 I 期临床研究;HLX22 联 合标准治疗(即曲妥珠单抗联合化疗,下同)一线治疗局部晚期或转移性胃食管交 接部癌和胃癌的国际多中心 III 期临床试验正在中国境内、日本及澳大利亚开展, 且该国际多中心 III 期临床试验申请已于美国等国家/地区获许可;HLX22 联合标准 治疗一线治疗 HER2 阳性的局部晚期/转移性胃癌、HLX22 联合标准治疗或联合德曲 妥珠单抗治疗 ...
复星医药:HLX22获欧盟孤儿药资格认定
news flash· 2025-05-26 08:33
Core Viewpoint - Fosun Pharma's subsidiary Henlius Europe GmbH has received orphan drug designation from the European Commission for HLX22, a humanized anti-HER2 monoclonal antibody injection for gastric cancer treatment [1] Group 1: Product Development - HLX22 is developed by the company under a license from AbClon, Inc. and is intended for the treatment of solid tumors such as gastric and breast cancer [1] - As of April 2025, the company has invested approximately 310 million yuan in the research and development of HLX22 [1] Group 2: Market Potential - According to IQVIA MIDAS data, the global sales of targeted HER2 monoclonal antibody products are projected to be approximately 9.029 billion USD in 2024 [1] - The orphan drug designation will facilitate HLX22's subsequent research, registration, and commercialization in the European Union by providing policy support [1]
中国制药2025年美国临床肿瘤学会(ASCO)摘要初读
Morgan Stanley· 2025-05-23 10:50
Investment Rating - The industry view is rated as Attractive [7] Core Insights - The report highlights over 70 oral presentations from Chinese scholars at the 2025 ASCO, including 11 late-breaking abstracts, showcasing advancements in various pharmaceutical developments [1] - Sino Biopharma's combination of Benmelstobart (PD-L1) with anlotinib showed superior efficacy in first-line squamous non-small cell lung cancer (sq-NSCLC) with a median progression-free survival (mPFS) of 10.12 months compared to 7.79 months for tislelizumab [2] - CSPC's SYS6010 (EGFR ADC) demonstrated preliminary efficacy in advanced gastrointestinal cancers with mPFS of 5.8 months in gastric cancer patients [3] - Kelun Pharma's sac-TMT (TROP2 ADC) achieved a confirmed overall response rate (ORR) of 59.3% in first-line non-squamous NSCLC [4] - Fosun Pharma's HLX43 (PD-L1 ADC) showed an ORR of 31.3% in late-line solid tumors, with competitive results in NSCLC patients [5] Company Summaries Sino Biopharma - The combination therapy of Benmelstobart and anlotinib is expected to release Phase 3 data for first-line NSCLC and maintenance treatment after radiochemotherapy soon [2] - TQB2102 (HER2 bsAbADC) achieved an ORR of 53.4% in late-line HER2 low-expressing breast cancer [2] CSPC - SYS6010 in combination with SYH2051 showed preliminary efficacy for second-line advanced gastrointestinal cancers, with a G3+ treatment-related adverse event (TRAE) rate of 48% [3] - ALMB-0168 (Cx43 agonist) for relapsed/refractory osteosarcoma showed an ORR of 20% and a disease control rate (DCR) of 90% [10] Kelun Pharma - Sac-TMT demonstrated a 70.7% ORR and a mPFS of 13.4 months in first-line triple-negative breast cancer (TNBC) [11] - In the third-line EGFR-mutant NSCLC setting, sac-TMT achieved a PFS of 6.9 months compared to 2.8 months for docetaxel [11] Fosun Pharma - HLX43's competitive ORR of 38.1% in NSCLC patients during the dose-expansion phase indicates potential for further development [5]
复星医药: 复星医药关于股东部分股份质押的公告
Zheng Quan Zhi Xing· 2025-05-22 10:21
Core Viewpoint - The announcement details the pledge of shares by the controlling shareholder, Fosun High Technology, which has pledged a total of 711,300,000 shares, accounting for approximately 26.63% of the company's total shares as of May 21, 2025 [1][4]. Summary by Sections Share Pledge Overview - As of May 21, 2025, Fosun High Technology holds 35.99% of the company's total shares, with the pledged shares representing 26.63% of the total shares [1][4]. - The total number of shares held by Fosun High Technology and its concerted actions is 967,812,180 shares, of which 890,278,680 are A shares [1][4]. Details of the Pledge - The pledged shares amount to 30,000,000 A shares, which is 1.12% of the total shares, and the funds from this pledge are intended for debt repayment [1][4]. - The pledge does not involve any major asset restructuring or performance compensation guarantees [1][4]. Cumulative Pledge Situation - As of May 21, 2025, the cumulative pledged shares by Fosun High Technology and its concerted actions total 711,300,000 shares, which is 73.50% of their total holdings [1][4]. - Approximately 47,234,250 shares are expected to mature within the next year, representing 48.81% of the pledged shares and about 17.68% of the company's total shares [1][4]. Financial Health and Management - The controlling shareholder's operations are reported to be normal, with sufficient funds for repayment sourced from various means, including bond issuance and investment returns [1][4]. - The company will closely monitor the progress of the share pledges and fulfill its disclosure obligations as required by law and regulations [1][4].
复星医药(02196) - 海外监管公告 - 关於股东部分股份质押的公告

2025-05-22 10:10
上 海 復 星 醫 藥( 集 團 )股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司) (股份代號:02196) 香港交易及結算所有限公司及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份內容而產生或因倚賴該等內容而引致的任何損 失承擔任何責任。 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。 茲載列上海復星醫藥(集團)股份有限公司(「本公司」)在上海證券交易所網站刊登的《關於 股東部分股份質押的公告》,僅供參閱。 承董事會命 上海復星醫藥(集團)股份有限公司 董事長 陳玉卿 中國,上海 2025 年5 月2 2 日 於本公告日期,本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生及王可心先生;本公司之非執行 董事為陳啟宇先生、徐曉亮先生、潘東輝先生及吳以芳先生;以及本公司之獨立非執行董事為李玲女士、湯 谷良先生、王全弟先生及余梓山先生。 * 僅供識別 ● 截 至 2025 年 5 ...
复星医药(600196) - 复星医药关于股东部分股份质押的公告

2025-05-22 10:01
证券代码:600196 股票简称:复星医药 编号:临 2025-092 上海复星医药(集团)股份有限公司 关于股东部分股份质押的公告 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。 重要内容提示(简称同正文) ● 截 至 2025 年 5 月 21 日 收 市 , 控 股 股 东 复 星 高 科 技 持 有 本 公 司 961,424,455 股股份(其中:A 股 889,890,955 股、H 股 71,533,500 股),约占 截至当日收市本公司股份总数的 35.99%。本次股份质押后,复星高科技累计质 押本公司股份数量为 711,300,000 股(均为 A 股),约占截至当日收市本公司股 份总数的 26.63%。 ● 截至 2025 年 5 月 21 日收市,本公司控股股东复星高科技及其一致行动 人(即复星高科技董监高、复星国际有限公司及其董高<包括本公司实际控制人>, 下同)合计持有本公司 967,812,180 股股份(其中:A 股 890,278,680 股、H 股 77,533,500 股),约占截至当日收市 ...
中证上海科技领先指数报1547.52点,前十大权重包含岩山科技等
Jin Rong Jie· 2025-05-21 15:41
Group 1 - The Shanghai Composite Index increased by 0.21%, while the CSI Shanghai Technology Leading Index reported a value of 1547.52 points [1] - The CSI Shanghai Technology Leading Index has risen by 3.22% in the past month, decreased by 6.91% over the last three months, and increased by 5.45% year-to-date [2] - The index consists of 50 listed companies in Shanghai with strong profitability, growth potential, and high R&D investment, reflecting the overall performance of the technology sector in the region [2] Group 2 - The top ten weighted companies in the CSI Shanghai Technology Leading Index include WuXi AppTec (10.44%), SMIC (9.61%), and Will Semiconductor (7.75%) [2] - The index's holdings are primarily from the Shanghai Stock Exchange (77.27%) and the Shenzhen Stock Exchange (22.73%) [2] - The industry composition of the index shows that Information Technology accounts for 48.25%, Healthcare for 26.04%, Communication Services for 14.06%, Industry for 10.46%, and Materials for 1.19% [2] Group 3 - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December [3] - If a sample company ranks in the top two by total market capitalization within its industry, it is prioritized for retention during adjustments [3] - The weight factors are adjusted in line with the sample adjustments, and special circumstances may lead to temporary adjustments [3]
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
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-20 23:43
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]
三生国健双抗新药授权辉瑞;华神科技收到四川证监局行政监管措施决定书|医药早参
Mei Ri Jing Ji Xin Wen· 2025-05-20 23:21
Group 1 - Sanofi's innovative drug company, Sangfor, has granted Pfizer exclusive global rights (excluding mainland China) for the development, production, and commercialization of the PD-1/VEGF bispecific antibody SSGJ-707, marking a significant milestone for domestic pharmaceutical companies in entering the global market [1] - Pfizer will pay a non-refundable and non-offsettable upfront payment of $1.25 billion, with potential milestone payments reaching up to $4.8 billion based on development, regulatory approval, and sales, along with a double-digit percentage sales revenue share based on product sales in authorized regions [1] Group 2 - Yipinhong announced the acquisition of a 15.25% stake in its subsidiary Guangzhou Rui'an Bo from minority shareholder Arthrosi for $6.8 million (approximately 49 million RMB) to enhance its market rights for the innovative drug AR882 in China and to promote efficient research and rapid market entry [2] - The transaction's pricing and the ongoing technical support from Arthrosi will be closely monitored for future clinical progress and market access efficiency [2] Group 3 - Huasheng Technology received an administrative regulatory measure from the Sichuan Securities Regulatory Bureau, which ordered the company to rectify issues related to accounting irregularities, non-operating fund occupation, and inadequate internal controls [3] - The regulatory action highlights weaknesses in the company's governance structure and compliance awareness, potentially affecting the rights of minority investors [3] Group 4 - Fosun Pharma announced the resignation of Rong Yang, CEO of its U.S. subsidiary, due to personal reasons, raising concerns about the continuity of leadership and strategic direction in the critical U.S. market for innovative drug commercialization [4] - The company is currently expanding its capabilities in the U.S. for both generic and innovative drug registration and commercialization [4]
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]