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新药获批 长春高新迎来第二个生长激素
Jing Ji Guan Cha Wang· 2025-07-02 15:02
Core Viewpoint - Changchun High-tech has received approval for its innovative drug Jinbeixin, marking a significant milestone in its transformation efforts after facing declining revenues and profits due to market pressures and reliance on a single product [1][2][3] Group 1: Company Performance - Changchun High-tech's stock price has dropped from a peak of 515.9 yuan per share in 2021 to 98.8 yuan per share currently, resulting in a total market capitalization of 40.3 billion yuan [1] - The company is experiencing its first dual decline in revenue and net profit in nearly 20 years, with significant pressure from the market environment and competition [1] - Revenue from its subsidiary Baike Biotech, which launched a shingles vaccine, peaked at over 1.8 billion yuan in 2023 but fell to 1.23 billion yuan in 2024, with net profit decreasing to 230 million yuan [1] Group 2: Research and Development - Under the leadership of General Manager Jin Lei, Changchun High-tech has increased its R&D investment from 1.66 billion yuan to nearly 2.7 billion yuan over the past three years [3] - The company has developed 23 research pipelines, with 6 classified as Class 1 new drugs, including Jinbeixin, which is seen as a key product for the company's transition [3] - Jinbeixin is the first Class 1 new drug in China for the treatment of acute gouty arthritis, with market potential estimated to reach 1 to 2 billion yuan, although it may not match the performance of its flagship growth hormone product [3]
长春高新(000661) - 关于子公司注射用伏欣奇拜单抗在境内获批上市的公告
2025-07-02 13:00
长春高新技术产业(集团)股份有限公司 关于子公司注射用伏欣奇拜单抗在境内获批上市的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 证券代码:000661 证券简称:长春高新 公告编号:2025-067 近日,长春高新技术产业(集团)股份有限公司(以下简称"公司")从国 家药品监督管理局网站获悉,控股子公司长春金赛药业有限责任公司(以下简称 "金赛药业")申报的注射用伏欣奇拜单抗已经国家药品监督管理局批准上市。 现就相关情况公告如下: 一、药品的基本情况 产品名称:注射用伏欣奇拜单抗(曾用名注射用金纳单抗) 商品名称:金蓓欣 获批适应症:适用于对非甾体类抗炎药和/或秋水仙碱禁忌、不耐受或缺乏 疗效的,以及不适合反复使用类固醇激素的成人痛风性关节炎急性发作。 二、药品的其它情况 注射用伏欣奇拜单抗是公司研发的一款新型全人源抗 IL-1β 单克隆抗体药 物,属于治疗用生物制品 1 类新药,可特异性结合人 IL-1β,阻断 IL-1β 诱导的 炎性介质产生,用于成人痛风性关节炎急性发作患者。 痛风性关节炎是一种单钠尿酸盐沉积在关节所致的晶体相关性关节病,是我 国 ...
长春高新:子公司注射用伏欣奇拜单抗获批上市
news flash· 2025-07-02 12:57
Core Viewpoint - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the injection of Fushen Qibai monoclonal antibody (trade name: Jinbeixin), which is indicated for acute attacks of gouty arthritis in adults who are intolerant to or have contraindications for non-steroidal anti-inflammatory drugs and/or colchicine, as well as those unsuitable for repeated use of steroid hormones [1] Group 1 - The newly developed Fushen Qibai monoclonal antibody is a fully human anti-IL-1β monoclonal antibody that specifically binds to human IL-1β, blocking the production of inflammatory mediators induced by IL-1β [1] - Key clinical trial results indicate that Fushen Qibai can take effect within 6 hours, with pain relief comparable to steroids at 72 hours, and a nearly 90% reduction in the risk of first recurrence within 6 months, demonstrating good safety [1] - The approval of this product is expected to enrich the company's product portfolio in the adult autoimmune field and enhance its competitiveness in the pharmaceutical market [1]
医药生物企业赴港IPO热度持续升温 长春高新启动H股上市筹备
Zheng Quan Ri Bao Wang· 2025-07-02 12:46
Core Viewpoint - Changchun High-tech aims to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international brand image [1][2] Group 1: Company Strategy - The company is a leading player in the domestic biopharmaceutical sector, focusing on the research, production, and sales of biopharmaceuticals and traditional Chinese medicine, along with real estate development [1] - Changchun High-tech is advancing its international strategy by building innovative platforms and exploring diverse development methods such as License-out to collaborate with large international pharmaceutical companies [1][2] - The company reported a significant increase in overseas sales revenue from its subsidiary, Changchun Jinsai Pharmaceutical, which grew by 454% year-on-year, with emerging markets like Algeria becoming key growth drivers [1] Group 2: Market Context - The trend of A-share companies listing in Hong Kong is increasing, with 7 A-share companies successfully listing in 2023, contributing to the growing "A+H" model [3] - The Hong Kong IPO market has seen a surge, with 43 new stocks listed and total fundraising of 1,067 million HKD, marking a 43% increase in quantity and a 708% increase in scale compared to the previous year [3] - The biopharmaceutical sector is particularly active, with 6 companies successfully listing in Hong Kong this year, surpassing the total from the previous year [3][4] Group 3: Regulatory Environment - The introduction of the 18A listing rule in 2018 has made Hong Kong a preferred destination for biotech companies, allowing those without revenue or profit to list [4] - The ongoing policy benefits and improvements in the listing process have created favorable conditions for biopharmaceutical companies, which typically face long R&D cycles and high capital consumption [4]
7月2日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-02 10:18
Group 1 - CITIC Construction Investment has received approval from the China Securities Regulatory Commission to issue perpetual subordinated bonds with a total face value of no more than 20 billion yuan [1] - Bluefocus Technology has received a loan commitment of up to 900 million yuan from CITIC Bank for stock repurchase [1] - Huaren Pharmaceutical's subsidiary has received approval for the listing of Bumetanide raw materials, which are used to treat severe heart failure and hypertension emergencies [3] Group 2 - Betta Pharmaceuticals has received approval for the listing of Enasidenib capsules in Macau, aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer [4] - Juewei Food plans to use 110 million yuan of idle fundraising for cash management, with an expected annual yield of 1.00%-1.89% [6] - China Huadian has successfully completed the issuance of 1 billion yuan medium-term notes with a coupon rate of 1.95% [9] Group 3 - Fosun Pharma's subsidiary has received a GMP certificate from the Belgian Federal Agency for Medicines and Health Products for the production facilities of two monoclonal antibodies [11] - China Nuclear Engineering has signed a civil engineering contract for the Taishan Nuclear Power Units 3 and 4 [13] - Kanglongda has faced administrative regulatory measures from the Zhejiang Securities Regulatory Bureau due to the failure of performance commitment parties to fulfill compensation obligations [15] Group 4 - Gaoling Information has received three invention patent certificates in the second quarter, covering various technological fields [16] - Weimais plans to use 190 million yuan of excess fundraising to increase capital in its subsidiary for building a new energy vehicle powertrain production base [17] - Huazhong Technology has received a project designation notice from a leading eVTOL manufacturer for the development and supply of an intelligent cockpit multimedia display system [19] Group 5 - Madi Technology expects a net profit of 25 million to 27 million yuan for the first half of 2025, marking a turnaround from a loss in the previous year [19] - Dazhong Mining's subsidiary has obtained a mining license for the Zhouyoufang Iron Mine, increasing production capacity to 6.5 million tons per year [20] - Zhongguancun's subsidiary has had its application for the listing of Arolol hydrochloride tablets accepted by the National Medical Products Administration [21] Group 6 - Tianhong Co. has signed a property management contract worth 15 million yuan with a local company [22] - Dong'an Power has secured nine new market designation agreements in the second quarter, with a projected total sales volume of 1.5 million units [24] - Zhujiang Co. has appointed Zhao Kun as the new deputy general manager [25] Group 7 - Jinyi Industrial has won a bid for a project worth 335 million yuan from the China Railway Shanghai Bureau Group [26] - Kangchen Pharmaceutical has received a clinical trial notification for its innovative drug KC1086, aimed at treating advanced solid tumors [27] - Changhua Group has received a project designation notice from a new energy vehicle company, with an expected total sales amount of 970 million yuan [29] Group 8 - Lingxiao Pump Industry plans to use 60 million yuan of idle funds to purchase financial products [31] - Mould Technology has received a project designation for exterior parts from a well-known North American electric vehicle company, with an expected total sales of 1.236 billion yuan [34] - Fulongma has pre-bid for five sanitation service projects in June, with a total contract amount of 181 million yuan [35] Group 9 - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange [36] - *ST Yuancheng is under investigation by the CSRC for suspected false financial disclosures [37] - Beilu Pharmaceutical's subsidiary has received approval for the listing of Iopamidol raw materials [38] Group 10 - Zhejiang Liming's shareholder plans to reduce their stake by up to 2.93% [39] - Zhejiang Liming's actual controller has committed not to reduce their holdings within a year [40] - SAIC Motor reported a total vehicle sales of 2.0526 million units in the first half of 2025, a year-on-year increase of 12.35% [41] Group 11 - Xinhongcheng expects a net profit increase of 50%-70% for the first half of 2025 [42] - Xianhe Co. plans to invest 11 billion yuan in a bamboo pulp paper integrated project [42] - Great Wall Motors reported a total vehicle sales of 569,800 units in the first half of 2025, a year-on-year increase of 1.81% [43] Group 12 - Dongfeng Co. received a government subsidy of 10 million yuan [44] - Zhongke Environmental Protection has acquired two water environmental companies in Guangxi for a total of 353 million yuan [45] - Anji Food's H-share public offering is priced at 60 Hong Kong dollars per share [46]
拟港股上市,“东北药茅”长春高新加码海外市场
Core Viewpoint - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy, accelerate internationalization, and improve overseas financing capabilities [1] Group 1: Financial Performance - In 2024, Changchun High-tech reported a revenue of 13.466 billion yuan, a year-on-year decrease of 7.55% [1] - The net profit attributable to the parent company was 2.583 billion yuan, a significant decline of 43.01% year-on-year [1] - The pharmaceutical sector, which is the core business, generated a revenue of 12.666 billion yuan, accounting for 94.07% of total revenue [1] Group 2: Cost Analysis - R&D expenses increased to 2.690 billion yuan, up 11.20% year-on-year, with R&D costs specifically rising by 25.75% to 2.167 billion yuan due to accelerated new product development and talent acquisition [2] - Sales expenses reached 4.439 billion yuan, an increase of 11.81% year-on-year, aimed at enhancing sales team recruitment and compliance [2] - Management expenses rose to 1.202 billion yuan, a 25.59% increase year-on-year, attributed to adjustments in the management structure of its subsidiary, Jinsai Pharmaceutical [2] Group 3: Subsidiary Performance - Jinsai Pharmaceutical, a key subsidiary, achieved a revenue of 10.671 billion yuan in 2024, a decrease of 3.73% year-on-year, and a net profit of 2.678 billion yuan, down 40.67% year-on-year [2] - The decline in Jinsai Pharmaceutical's performance directly impacted Changchun High-tech's overall financial results [2] Group 4: Strategic Intent - The move to seek a listing in Hong Kong may also be a strategy to alleviate cash flow issues caused by the declining performance of Jinsai Pharmaceutical, aiming to secure new development opportunities through financing [3]
长春高新拟启动H股上市 首季及去年净利均下降4成
Zhong Guo Jing Ji Wang· 2025-07-02 03:21
Core Viewpoint - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international financing capabilities [1][2]. Group 1: Company Announcement - The company announced the authorization for management to initiate preparations for the overseas issuance of H-shares and listing on the Hong Kong Stock Exchange [1]. - The board has started communication and cooperation with relevant intermediaries for the H-share listing process, although specific details are yet to be determined [1]. Group 2: Regulatory Requirements - The H-share listing will require approval from the company's board and shareholders, as well as regulatory approval from the China Securities Regulatory Commission and the Hong Kong Stock Exchange [2]. - There is significant uncertainty regarding the approval and implementation of the H-share listing [2]. Group 3: Financial Performance - In 2024, the company reported a revenue of 13.47 billion yuan, a decrease of 7.55% year-on-year [2][3]. - The net profit attributable to shareholders was 2.58 billion yuan, down 43.01% compared to the previous year [2][3]. - The net profit after deducting non-recurring gains and losses was 2.83 billion yuan, a decline of 37.32% year-on-year [2][3]. - The net cash flow from operating activities was 3.10 billion yuan, down 39.18% from the previous year [2][3]. Group 4: Q1 2025 Financial Results - In the first quarter of 2025, the company achieved a revenue of 2.99 billion yuan, a decrease of 5.66% year-on-year [4]. - The net profit attributable to shareholders was 472.70 million yuan, down 44.95% compared to the same period last year [4]. - The net profit after deducting non-recurring gains and losses was 492.17 million yuan, a decline of 41.87% year-on-year [4]. - The net cash flow from operating activities was 571.07 million yuan, down 49.72% from the previous year [4].
两部门印发《支持创新药高质量发展的若干措施》;长春高新拟发行H股并在香港联交所上市丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-02 00:12
Group 1: Policy Support for Innovative Drugs - The National Healthcare Security Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, focusing on five areas and sixteen specific measures [1] - The measures aim to create a clinical value-oriented environment for innovative drug research and development, establish a diversified payment system, and enhance the accessibility of innovative drugs [1] Group 2: Longhua High-Tech's H-Share Listing - Changchun High-Tech announced plans to issue H-shares and list on the Hong Kong Stock Exchange to deepen its global strategy and accelerate internationalization [2] - The move aligns with the trend of domestic pharmaceutical companies pursuing both domestic and international growth, potentially enhancing the company's international financing capabilities and brand image [2] Group 3: IPO Approval for He Yuan Bio - Wuhan He Yuan Bio's IPO was approved by the Shanghai Stock Exchange, marking the first company to pass under the newly restarted fifth set of listing standards for the Sci-Tech Innovation Board [3] - The company focuses on recombinant human albumin, with its core product expected to be the first recombinant human albumin drug approved in China [3] Group 4: Clinical Trial Acceptance for Microchip Bio - Microchip Bio announced that its clinical trial application for CS231295, a selective Aurora B inhibitor for advanced solid tumors, was accepted by the FDA [4] - This drug is the first of its kind to enter clinical trials globally, showcasing the company's technological strength in innovative drug development [4] Group 5: Angli Kang's Innovation Drug Pipeline - Angli Kang reported that it currently has only one innovative drug project, ALK-N001, which is in the I phase of clinical trials as of the announcement date [5][6] - The company highlighted the long cycle, high investment, and uncertainty associated with innovative drug development, which may temper market speculation [6]
长春高新拟发行H股;杭州高新实控人拟变更丨公告精选
Group 1: Company Announcements - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international brand image [1] - Saisir reported June sales of 46,086 new energy vehicles, a year-on-year increase of 4.44%, with a total of 172,100 units sold in the first half of the year, down 14.35% year-on-year [1] - Hangzhou High-tech announced a change in controlling shareholder to Jirong Weiye, with stock resuming trading on July 2, 2025 [1] Group 2: Financial Performance - Guomai Technology expects a net profit of 125 million to 156 million yuan for the first half of 2025, a year-on-year increase of 60.52% to 100.33% [2] - Kid King anticipates a net profit of 120 million to 160 million yuan for the first half of 2025, representing a year-on-year growth of 50% to 100% [2] - Mould Technology received a project from a well-known North American electric vehicle company, with expected total sales of 1.236 billion yuan over five years [3] Group 3: Regulatory and Compliance - *ST Yuancheng is under investigation by the China Securities Regulatory Commission for suspected false disclosures in financial reports [4] - The company received a notice of investigation on July 1, 2025, which may lead to significant penalties and potential delisting [4] Group 4: Market Activity - Changcheng Military Industry's stock has experienced significant volatility, with a cumulative price deviation exceeding 20% over three trading days, indicating potential irrational speculation [5] - Anglikang has only one innovative drug project, ALK-N001, currently in Phase I clinical trials, highlighting the long and uncertain nature of drug development [6] Group 5: Sales and Contracts - Beiqi Blue Valley's subsidiary reported a 139.73% year-on-year increase in sales for the first half of the year [7] - Dong'an Power's engine sales in June increased by 82.79% year-on-year [7] - Pudong Construction's subsidiary won multiple major projects with a total bid amount of 1.964 billion yuan [7]
7月2日上市公司重要公告集锦:长春高新拟发行H股并在香港联交所上市
Zheng Quan Ri Bao· 2025-07-01 13:03
Group 1 - The controlling shareholder of Upwind New Materials is planning a change in control, leading to a suspension of trading from July 2, expected to last no more than 2 trading days [1] - Great Wall Motors reported a total vehicle sales of 569,800 units in the first half of the year, representing a year-on-year increase of 1.81% [9] - Yanghe Distillery's chairman Zhang Liandong has resigned due to work adjustments, and the company will proceed with the necessary procedures for board member replacement [11] Group 2 - Zhenhua Environmental announced a 354 million yuan acquisition of 100% equity in Guigang Environmental and Pingnan Environmental, enhancing its waste treatment business in Guangxi [12] - New and improved sales in the nutrition segment are expected to drive Xinhecheng's net profit for the first half of 2025 to between 3.3 billion and 3.75 billion yuan, a year-on-year increase of 50% to 70% [13] - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange, with management authorized to initiate preparatory work [14] Group 3 - Longxin Co. announced that shareholders and executives plan to collectively reduce their holdings by no more than 2% of the company's shares [5] - Sailyus reported a 4.44% year-on-year increase in new energy vehicle sales in June, with total sales for the year so far at 172,100 units, down 14.35% year-on-year [6] - Hainan Huatie intends to publicly issue bonds not exceeding 2 billion yuan to optimize its financing structure [8]