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泽璟制药(688266) - 君合律师事务所上海分所关于苏州泽璟生物制药股份有限公司2024年年度股东大会的法律意见书
2025-05-16 11:30
中国上海石门一路 288 号兴业太古汇香港兴业中心一座 26 层 邮编:200041 电话:(86-21)5298 5488 传真:(86-21)5298 5492 junhesh@junhe.com 君合律师事务所上海分所 关于苏州泽璟生物制药股份有限公司 2024 年年度股东大会的 本所律师根据有关法律法规的要求,按照律师行业公认的业务标准、道德规 范和勤勉尽责精神,出席了本次股东大会,并对本次股东大会召集和召开的有关 事实以及公司提供的文件进行了核查验证,现出具法律意见如下: 一、关于本次股东大会的召集和召开程序 法律意见书 苏州泽璟生物制药股份有限公司: 君合律师事务所上海分所(以下简称"本所")接受苏州泽璟生物制药股份 有限公司(以下简称"公司"或"泽璟制药")的委托,指派本所经办律师出席 了公司于 2025 年 5 月 16 日召开的公司 2024 年年度股东大会(以下简称"本次 股东大会")的现场会议。现本所根据《中华人民共和国公司法》《中华人民共 和国证券法》《上市公司股东会规则》等中国(仅为本法律意见书之目的,"中 国"不包括香港特别行政区、澳门特别行政区及台湾地区)现行法律、法规和规 范性 ...
攻坚脱发难题,泽璟制药重度斑秃新药上市申请获受理
Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for its new drug application (NDA) for JAK inhibitor Jika Xitini tablets to treat severe alopecia areata, marking the second indication for this drug [1][2] Group 1: Company Developments - Zai Jian Pharmaceutical is the first domestic company in China to apply for a JAK inhibitor for treating severe alopecia areata, filling a significant gap in the market [2] - The company reported a revenue of 533 million yuan in 2024, representing a year-on-year growth of 37.91%, with its core product, Donafenib tablets, now available in over 1,000 hospitals nationwide [3] - Zai Jian Pharmaceutical is actively pursuing clinical research for Jika Xitini tablets across multiple immune-inflammatory diseases, with successful Phase III trials for severe alopecia areata and Phase II trials for idiopathic pulmonary fibrosis [2][3] Group 2: Market Potential and Future Plans - The company aims to explore the commercial potential of both existing and upcoming products over the next 3-5 years, with expectations of 1-2 major products entering late-stage clinical research [3] - Zai Jian Pharmaceutical has several products in the pipeline, including ZG005 and ZG006, which are positioned at the international forefront and have shown promising efficacy and safety in early clinical trials [3] - The company plans to collaborate with external organizations to bring these products to the global market, benefiting more patients [3]
5月13日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-13 10:21
Group 1 - Shengyi Electronics plans to repurchase shares with a total amount between 50 million and 100 million yuan, at a price not exceeding 43.02 yuan per share, for employee stock ownership plans [1] - Guoyao Modern's subsidiary has passed the consistency evaluation for the quality and efficacy of a generic drug, which is used for treating severe infections [1] - Tianhe Magnetic Materials' subsidiaries have obtained project filing notices for high-performance rare earth permanent magnet projects, with total investments of 100 million yuan and 50 million yuan respectively [1][2] Group 2 - Dream Lily intends to repurchase shares with an amount between 85 million and 170 million yuan, at a price not exceeding 10.90 yuan per share, supported by a loan commitment of up to 150 million yuan [3] - Weifu High-Tech has received a loan commitment of up to 135 million yuan from a financial institution for share repurchase [3] Group 3 - Lu'an Environmental Energy reported a coal sales volume of 4.51 million tons in April, a year-on-year increase of 17.75% [5] - *ST Tianshan reported a significant decline in livestock sales and revenue, with a revenue of 70,500 yuan in April, down 95.68% year-on-year [7] Group 4 - Feirongda announced a cash dividend of 0.38 yuan per 10 shares, with a total distribution of 21.9 million yuan [8] - Zhejiang Rongtai's shareholders and executives plan to reduce their holdings by up to 1.93% of the company's shares [9] Group 5 - Changhua Group's subsidiary won the land use rights for an industrial site in Ningbo for 27.05 million yuan, intended for manufacturing and related business [11] - Zejing Pharmaceutical's new drug application for a treatment for severe alopecia has been accepted by the regulatory authority [13][14] Group 6 - Hainan Mining plans to distribute a cash dividend of 0.8 yuan per 10 shares, totaling 1.59 billion yuan [15] - China Jushi plans to distribute a cash dividend of 0.24 yuan per share, totaling 9.61 billion yuan [16] Group 7 - Zhengzhong Design's subsidiary has obtained a utility model patent for an acrylic signage guide [18] - Rundu Co., Ltd. received approval for a veterinary drug product, which is intended for treating bacterial diseases in livestock [20] Group 8 - Emei Mountain A announced the resignation of its general manager due to work reasons [22] - Tonghua Dongbao's insulin injection has received a registration certificate in Nicaragua, allowing for sales in that market [23] Group 9 - Dizu Fashion's subsidiary has completed the registration of a private equity investment fund [24] - Ningbo Gaofa plans to increase capital by 60 million yuan in its subsidiary for operational needs [26] Group 10 - Haichuan Intelligent has obtained two utility model patents for material handling devices [27] - Newland's subsidiary signed a deep cooperation agreement with Alibaba Cloud for AI model applications [29] Group 11 - Rui Neng Technology's controlling shareholder plans to reduce its stake by up to 2.89% [30] - Guomai Culture intends to repurchase shares between 50 million and 100 million yuan for capital reduction [31] Group 12 - Shaanxi Construction won major construction projects totaling 7.88 billion yuan in April [32] - Hanyu Pharmaceutical signed a joint development agreement for a new peptide drug with a partner [34] Group 13 - Yunnan Copper is planning to acquire a 40% stake in Liangshan Mining, leading to a stock suspension [35] - Haizheng Pharmaceutical plans to repurchase shares between 50 million and 100 million yuan for employee stock ownership [36] Group 14 - Tianqiao Hoisting's controlling shareholder plans to increase its stake by 75 million to 150 million yuan [37] - Tiandi Online's controlling shareholder is transferring shares to introduce a strategic investor [38] Group 15 - Hongchang Technology plans to invest 15 million yuan in a joint venture with a partner [39] - Rabbit Baby's subsidiary is preparing for an IPO in Hong Kong [41] Group 16 - Wol Nuclear Materials is planning to issue H-shares for listing in Hong Kong [42] - Tangyuan Electric plans to raise up to 864 million yuan through a private placement for various projects [43] Group 17 - Tongrun Equipment's major shareholders plan to reduce their holdings by up to 2% [44] - Linzhou Heavy Machinery plans to raise up to 600 million yuan through a private placement [46] Group 18 - China Merchants Securities announced the resignation of its vice president [47] - Shangsheng Electronics plans to issue convertible bonds to raise up to 330 million yuan for various projects [48] Group 19 - Longda Co., Ltd.'s major shareholder plans to reduce its stake by up to 1% [49] - China Medical plans to acquire 100% of Jinsui Technology for 302 million yuan [50] Group 20 - Silek has signed a strategic cooperation agreement with a battery manufacturer [51] - Boyun New Materials' major shareholder plans to reduce its stake by up to 3% [53]
泽璟制药(688266) - 泽璟制药关于自愿披露盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理的公告
2025-05-13 08:46
证券代码:688266 证券简称:泽璟制药 公告编号:2025-019 苏州泽璟生物制药股份有限公司 关于自愿披露盐酸吉卡昔替尼片治疗重度斑秃的 新药上市申请获得受理的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: 二、药品相关情况 盐酸吉卡昔替尼(曾用名:盐酸杰克替尼)是一种新型的 JAK 抑制剂,对 JAK 激酶的四个亚型 JAK1、JAK2、JAK3 和 TYK2 都有显著的抑制作用。吉卡 昔替尼能够有效抑制炎症和抑制 T 细胞过度激活,亦能显著增加真皮层的厚度 和促进毛囊再生,增加毛囊密度。 本次获得 NDA 受理的适应症是用于治疗重度斑秃,是盐酸吉卡昔替尼片第 二个申请新药上市的适应症。在我国,目前尚无国产 JAK 抑制剂类药物获批用 于治疗重度斑秃。 盐酸吉卡昔替尼片治疗中、高危骨髓纤维化适应症的 NDA 申请目前正在国 家药监局审批过程中。另外,盐酸吉卡昔替尼片目前正在开展多个免疫炎症性疾 病的临床研究。吉卡昔替尼片治疗重度斑秃的 III 期临床试验、治疗特发性肺纤 维化的 II 期临床 ...
泽璟制药:盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理
news flash· 2025-05-13 08:25
智通财经5月13日电,泽璟制药(688266.SH)公告称,公司收到国家药品监督管理局核准签发的《受理通 知书》,公司递交的盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请(NDA)获得受理。这是盐酸吉 卡昔替尼片第二个申请新药上市的适应症。盐酸吉卡昔替尼是一种新型的JAK抑制剂,对JAK激酶的四 个亚型JAK1、JAK2、JAK3和TYK2都有显著的抑制作用。本次获得NDA受理的适应症是用于治疗重度 斑秃,是盐酸吉卡昔替尼片第二个申请新药上市的适应症。在我国,目前尚无国产JAK抑制剂类药物获 批用于治疗重度斑秃。 泽璟制药:盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理 ...
小细胞肺癌:中国管线全球领先,研发聚焦三大新领域
KAIYUAN SECURITIES· 2025-05-12 06:44
Investment Rating - The investment rating for the biopharmaceutical industry is "Positive" (maintained) [2] Core Insights - The report highlights the aggressive nature of small cell lung cancer (SCLC), with extensive stage SCLC accounting for approximately 75% of cases, which often rely on systemic treatment and have a poor prognosis [6][21] - The first-line treatment for extensive stage SCLC primarily involves PD-1/PD-L1 immunotherapy combined with doublet chemotherapy, while there are limited approved drugs for later-line treatments, indicating a significant unmet clinical need [24][30] - The report identifies three key areas of focus for research and development in the SCLC field: Antibody-Drug Conjugates (ADC), DLL3 T-cell engagers (TCE), and next-generation immune-oncology (IO) therapies [30][34] Summary by Sections 1. SCLC Overview - SCLC accounts for about 15%-20% of all lung cancer cases, with a high incidence of early metastasis [18][19] - The majority of SCLC cases are extensive stage, which has a poor prognosis and relies heavily on systemic therapies [21][22] 2. Treatment Landscape - The standard treatment for extensive stage SCLC has been established as a combination of chemotherapy and PD-1/PD-L1 immunotherapy, but the overall prognosis remains poor [24][25] - The NCCN and CSCO guidelines recommend various treatment options, including the recent inclusion of Tarlatamab as a preferred second-line treatment [28][29] 3. Research and Development Focus - ADCs are rapidly advancing in the SCLC field, targeting multiple hot spots such as B7-H3, DLL3, and TROP-2, with no ADC products currently approved for SCLC [37][38] - DLL3 TCEs, particularly Tarlatamab, have shown promising early data and are expected to reshape the treatment landscape for SCLC [30][31] - Next-generation IO therapies are being developed to challenge the current PD-L1 standard in first-line SCLC treatment [8][36] 4. Investment Recommendations - The report suggests that companies with strong pipelines in the SCLC space, such as Zai Lab, Zai Lab-U, Innovent Biologics, and others, are likely to benefit from the anticipated growth in the market as new data emerges [9]
泽璟制药(688266) - 中国国际金融股份有限公司关于苏州泽璟生物制药股份有限公司2024年度持续督导现场检查报告
2025-05-08 09:16
中国国际金融股份有限公司 关于苏州泽璟生物制药股份有限公司 2024 年度持续督导工作现场检查报告 上海证券交易所: 根据中国证券监督管理委员会2019年12月31日作出的《关于同意苏州泽璟生物制药 股份有限公司首次公开发行股票注册的批复》(证监许可[2019]2998号),苏州泽璟生 物制药股份有限公司(以下简称"泽璟制药"、"公司")获准向社会公开发行人民币 普通股(A股)60,000,000股,每股面值人民币1元,发行价格为每股人民币33.76元,募 集资金总额为人民币2,025,600,000.00元,扣除承销及保荐费用、发行登记费以及累计发 生的其他相关发行费用(共计人民币117,379,245.32元,不含税)后,募集资金净额为 人民币1,908,220,754.68元。2020年1月23日,公司在上海证券交易所科创板挂牌上市。 根据中国证券监督管理委员会2022年11月3日作出的《关于同意苏州泽璟生物制药 股份有限公司向特定对象发行股票注册的批复》(证监许可[2022]2649号),公司于2023 年4月向特定对象发行人民币普通股(A股)24,489,795股,每股面值人民币1元,发行 价格为每 ...
泽璟制药(688266) - 中国国际金融股份有限公司关于苏州泽璟生物制药股份有限公司2024年度持续督导跟踪报告
2025-05-08 09:16
2 中国国际金融股份有限公司 关于苏州泽璟生物制药股份有限公司 2024 年度持续督导跟踪报告 根据《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票上市规则》 和《上海证券交易所上市公司自律监管指引第 11 号——持续督导》等相关规定,中 国国际金融股份有限公司(以下简称"中金公司"、"保荐机构")作为苏州泽璟生物制 药股份有限公司(以下简称"泽璟制药"、"公司")持续督导工作的保荐机构,开展其 上市后的持续督导工作,并出具 2024 年度(以下简称"本报告期"、"持续督导期") 持续督导跟踪报告。 一、持续督导工作情况 | 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度,并针对具体 的持续督导工作制定相应的工作计划 | 保荐机构已建立健全并有效执行 | | | | 了持续督导制度,并制定了相应的 | | | | 工作计划 | | 2 | 根据中国证监会相关规定,在持续督导工作开始前, | 保荐机构已与泽璟制药签订承销 持续督导期间的权利和义务,并报 | | | 与上市公司或相关当事人签署持续督导协议,明确双 | 与保 ...
泽璟制药(688266) - 泽璟制药2024年年度股东大会会议资料
2025-05-08 09:15
苏州泽璟生物制药股份有限公司 2024年年度股东大会会议资料 证券代码:688266 证券简称:泽璟制药 苏州泽璟生物制药股份有限公司 2024 年年度股东大会会议资料 二〇二五年五月 1 苏州泽璟生物制药股份有限公司 2024年年度股东大会会议资料 | | | 苏州泽璟生物制药股份有限公司 2024 年年度股东大会会议须知 | | 年年度股东大会会议须知 3 | 2024 | | --- | --- | --- | | | 年年度股东大会会议议程 5 | 2024 | | | 年年度股东大会会议议案 7 | 2024 | | 议案一 | 关于公司《2024 年年度报告》及摘要的议案 7 | | | 议案二 | 关于公司《2024 年度董事会工作报告》的议案 8 | | | 议案三 | 关于公司《2024 年度监事会工作报告》的议案 16 | | | 议案四 | 关于公司《2024 年度财务决算报告》的议案 20 | | | 议案五 | 关于公司《2025 年度财务预算报告》的议案 26 | | | 议案六 | 关于公司《2024 年度独立董事述职报告》的议案 29 | | | 议案七 | 关于公司 2024 ...
5月7日工银前沿医疗股票A净值下跌1.77%,近6个月累计下跌0.07%
Sou Hu Cai Jing· 2025-05-07 12:17
Core Insights - The latest net value of ICBC Frontier Medical Stock A (001717) is 2.8300 yuan, reflecting a decrease of 1.77% [1] - The fund has shown a one-month return of 5.28%, ranking 400 out of 471 in its category; a three-month return of 8.06%, ranking 71 out of 471; and a year-to-date return of 7.56%, ranking 113 out of 469 [1] Fund Holdings - The top ten holdings of ICBC Frontier Medical Stock A account for a total of 59.05%, with the largest positions being: - Heng Rui Medicine (10.11%) - Kelun Pharmaceutical (8.01%) - WuXi AppTec (7.72%) - BeiGene (6.85%) - Xinlitai (4.90%) - Zai Lab (4.77%) - Yuyue Medical (4.60%) - New Horizon Health (4.36%) - East China Pharmaceutical (4.20%) - Haizhi Pharmaceutical (3.53%) [1] Fund Overview - ICBC Frontier Medical Stock A was established on February 3, 2016, and as of March 31, 2025, it has a total scale of 9.081 billion yuan [1] - The fund manager is Zhao Bei, who has extensive experience in the healthcare sector [2]