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攻坚脱发难题,泽璟制药重度斑秃新药上市申请获受理
Zheng Quan Shi Bao Wang· 2025-05-13 13:27
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
Core Viewpoint - Zai Jian Pharmaceutical has received acceptance for its new drug application (NDA) for JAK inhibitor, Jika Xitini Hydrochloride Tablets, aimed at treating severe alopecia areata, marking the second indication for this drug [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the NDA submitted by Zai Jian Pharmaceutical [1] - Jika Xitini Hydrochloride is a novel JAK inhibitor that significantly inhibits all four subtypes of JAK kinases: JAK1, JAK2, JAK3, and TYK2 [1] - This is the second indication for Jika Xitini Hydrochloride Tablets, with no domestic JAK inhibitors currently approved for treating severe alopecia areata in China [1]
5月12日富国精准医疗混合A净值下跌3.50%,近1个月累计下跌2.01%
Sou Hu Cai Jing· 2025-05-12 12:40
简历显示:赵伟先生:中国,硕士研究生。历任葛兰素史克(上海)医药研发有限公司药物化学部助理研究 员、广发证券股份有限公司投资自营部医药研究员、招商基金管理有限公司研究部医药组组长及招商基 金管理有限公司国际业务部基金经理助理。现任农银汇理基金管理有限公司基金经理。2019年11月8日 至2021年3月5日担任农银汇理中小盘混合型证券投资基金基金经理。2020年1月13日至2021年3月5日担 任农银汇理行业成长混合型证券投资基金基金经理。2020年1月21日至2021年3月5日任职农银汇理创新 医疗混合型证券投资基金基金经理。2017年6月20日至2021年3月5日担任农银汇理医疗保健主题股票型 证券投资基金基金经理。曾任农银汇理中国优势灵活配置混合型证券投资基金基金经理。2021年03月加 入富国基金管理有限公司,2021年7月6日起担任富国精准医疗灵活配置混合型证券投资基金基金经理。 2024年04月23日起担任富国科创板两年定期开放混合型证券投资基金基金经理。 金融界2025年5月12日消息,富国精准医疗混合A(005176) 最新净值2.6542元,下跌3.50%。该基金近1个 月收益率-2.01%, ...
上证G60战略新兴产业成份指数上涨1.23%,前十大权重包含江淮汽车等
Jin Rong Jie· 2025-05-12 12:40
Core Points - The Shanghai G60 Strategic Emerging Industries Index (G60 Index) rose by 1.23% to 935.77 points, with a trading volume of 15.724 billion yuan [1] - Over the past month, the G60 Index has increased by 7.95%, while it has decreased by 4.89% over the last three months and has seen a year-to-date increase of 0.49% [1] - The G60 Index includes up to 50 of the largest strategic emerging industry companies listed in the Shanghai Stock Exchange from the Yangtze River Delta G60 nine cities, reflecting the overall performance of these companies [1] Index Composition - The top ten weighted companies in the G60 Index are: Jianghuai Automobile (9.64%), Huayou Cobalt (7.32%), Hengsheng Electronics (6.32%), Hengtong Optic-Electric (4.84%), Zhongkong Technology (4.77%), Silan Microelectronics (4.53%), China Jushi (4.47%), Jingfang Technology (2.95%), Naxin Micro (2.73%), and Zejing Pharmaceutical (2.61%) [1] - The G60 Index is fully composed of companies listed on the Shanghai Stock Exchange, with a 100% market share [1] Industry Breakdown - The industry composition of the G60 Index includes: Industrial sector (36.53%), Information Technology (30.24%), Materials (14.25%), Communication Services (9.67%), and Healthcare (9.31%) [2] - The index samples are adjusted biannually, with adjustments occurring on the next trading day after the second Friday of June and December [2] Fund Tracking - Public funds tracking the G60 Index include the Shenwan Hongyuan G60 Strategic Emerging Industries ETF [3]
重组蛋白概念下跌0.94%,主力资金净流出27股
Zheng Quan Shi Bao Wang· 2025-05-12 08:39
截至5月12日收盘,重组蛋白概念下跌0.94%,位居概念板块跌幅榜前列,板块内,迈威生物、泽璟制 药、阿拉丁等跌幅居前,股价上涨的有16只,涨幅居前的有*ST万方、百普赛斯、*ST苏吴等,分别上 涨2.73%、2.69%、2.58%。 今日涨跌幅居前的概念板块 | 代码 | 简称 | 今日涨跌幅(%) | 今日换手率(%) | 主力资金流量(万元) | | --- | --- | --- | --- | --- | | 688166 | 博瑞医药 | -3.34 | 3.24 | -9247.96 | | 688266 | 泽璟制药 | -7.80 | 2.14 | -5042.00 | | 300723 | 一品红 | -1.36 | 2.96 | -4614.17 | | 002584 | 西陇科学 | 0.56 | 10.62 | -2062.55 | | 688136 | 科兴制药 | -2.77 | 1.52 | -1992.98 | | 688068 | 热景生物 | -5.39 | 4.08 | -1842.96 | | 600223 | 福瑞达 | -1.08 | 1.40 | -1498.6 ...
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]
5月9日工银医疗保健股票净值增长0.72%,今年来累计上涨9.87%
Sou Hu Cai Jing· 2025-05-09 12:28
Group 1 - The core viewpoint of the news is the performance and holdings of the Industrial and Commercial Bank of China Medical Healthcare Stock Fund, which has shown positive returns in recent months and has a diversified portfolio in the healthcare sector [1][3] - As of May 9, 2025, the latest net value of the fund is 2.5040 yuan, with a growth of 0.72%. The fund's return over the past month is 5.17%, ranking 504 out of 783 in its category; over the past three months, the return is 9.06%, ranking 88 out of 778; and year-to-date, the return is 9.87%, ranking 103 out of 773 [1] - The top ten holdings of the fund account for a total of 39.79%, with significant investments in companies such as Heng Rui Pharmaceutical (8.90%), WuXi AppTec (5.12%), and Mindray Medical (2.80%) [1] Group 2 - The fund was established on November 18, 2014, and as of March 31, 2025, it has a total scale of 2.724 billion yuan. The fund managers are Zhao Bei and Ding Yang [1] - Zhao Bei has extensive experience in the healthcare sector, having served as the fund manager for various healthcare-related funds since 2014, while Ding Yang joined the company in 2017 and currently serves as a fund manager [2]
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 ...