百诚医药公告，近日获悉，公司自主研发的创新药BIOS-0623-Z4片获得国家药品监督管理局（NMPA） 临床试验批准通知书。BIOS-0623-Z4片是由公司自主研发的一种非阿片类靶点机制应用于成人癌痛治 疗的药物，目前无同靶点且同适应症药品上市。药品名称：BIOS-0623-Z4片，注册分类：1类，适应 症：缓解成人癌痛，申请人：杭州百诚医药科技股份有限公司，受理号：CXHL2500675、 CXHL2500676，目前所处审批阶段：IND批准（临床试验获批），审批结论：根据《中华人民共和国药 品管理法》及有关规定，经审查，2025年7月10日受理的BIOS-0623-Z4片临床试验申请符合药品注册的 有关要求，同意本品开展缓解成人癌痛的临床试验。 ...

Core Viewpoint - Changchun High-tech has submitted a listing application to the Hong Kong Stock Exchange, aiming to expand its market presence after being listed on the Shenzhen Stock Exchange. The company is recognized as a leading innovation-driven pharmaceutical group in China, with a comprehensive product portfolio across various drug categories [1]. Group 1: Company Overview - Changchun High-tech is a prominent pharmaceutical group in China, focusing on therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with capabilities in R&D, production, and commercialization across all major drug registration types [1]. - The company has established a competitive and diversified product matrix driven by a differentiated innovation strategy, leading to strong financial performance and sustainable growth [1]. Group 2: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has successfully launched 13 new drug products, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [2]. - The company is actively expanding the indications of its approved products to cover a broader patient population, such as the approval of Jin Sai Zeng for ISS and Turner syndrome in 2024, which addresses approximately 82.3% of the pediatric short stature population in China [2]. Group 3: Financial Performance - The company reported revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the fiscal years 2022, 2023, 2024, and the six months ending June 30, 2025, respectively. Corresponding profits for these periods were approximately RMB 42.15 billion, RMB 47.76 billion, RMB 27.08 billion, and RMB 9.32 billion [3].

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Construction Investment International as the sole sponsor, indicating its intention to expand its market presence after being listed on the Shenzhen Stock Exchange [1][3]. Group 1: Company Overview - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with comprehensive capabilities in R&D, production, and commercialization across all major drug registration types [3][4]. - The company has established a strong and diversified product portfolio in various therapeutic areas, including endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [4]. Group 2: Financial Performance - The sales revenue of Changchun High-tech's pharmaceutical products reached RMB 12.7 billion in 2024, maintaining over RMB 10 billion for four consecutive years [3]. - The company has consistently ranked among the "Top 100 Pharmaceutical Enterprises in China" for eight consecutive years since 2017 [3]. - Revenue figures for the fiscal years 2022 to 2025 show a growth trajectory, with revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the first half of 2025 [5][7]. Group 3: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has over 40 candidate drugs in clinical stages or submitted for IND applications, including 14 in Phase III clinical trials or NDA stages and 15 first-class innovative drugs [5]. - The company has successfully launched 13 new drug products during the historical record period, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [4][5].

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Construction Investment International as the sole sponsor, while already being listed on the Shenzhen Stock Exchange [1]. Group 1: Company Overview - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with capabilities across all major drug registration types in China [4]. - The company has established a competitive and diversified product matrix through a differentiated innovation strategy, leading to strong financial performance and a solid foundation for sustainable growth [4]. - In 2024, the sales revenue from pharmaceutical products is projected to reach RMB 12.7 billion, maintaining over RMB 10 billion for four consecutive years [4]. Group 2: Product Development and Pipeline - Changchun High-tech has developed a strong and diversified product portfolio in areas such as endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [5]. - The company has successfully launched 13 new drug products, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [5]. - As of September 23, 2025, the company has over 40 candidate drugs in clinical stages or submitted for IND applications, including 14 in Phase III clinical trials or NDA stages, showcasing potential for global first-in-class or best-in-class drugs [6]. Group 3: Financial Performance - For the fiscal years 2022 to 2025, the company reported revenues of approximately RMB 12.63 billion, RMB 14.57 billion, RMB 13.47 billion, and RMB 6.64 billion for the first half of 2025, respectively [6][8]. - The net profit for the same periods was approximately RMB 4.22 billion, RMB 4.78 billion, RMB 2.71 billion, and RMB 0.93 billion for the first half of 2025, indicating fluctuations in profitability [6][8].

截至2025年9月29日 13:04，恒生医疗保健指数强势上涨1.22%，成分股映恩生物-B上涨7.03%，晶泰控 股上涨6.33%，阿里健康上涨4.51%，巨子生物，微创机器人-B等个股跟涨。恒生医疗ETF(513060)上涨 0.14%，最新价报0.71元。拉长时间看，截至2025年9月26日，恒生医疗ETF近1月累计上涨4.55%，涨幅 排名可比基金1/3。 流动性方面，恒生医疗ETF盘中换手10.9%，成交7.84亿元，市场交投活跃。拉长时间看，截至9月26 日，恒生医疗ETF近1月日均成交22.95亿元，排名可比基金第一。 截至2025年9月29日 13:04，恒生港股通创新药精选指数上涨0.95%，成分股映恩生物-B上涨7.03%，荣 昌生物上涨5.78%，三生制药上涨3.44%，康诺亚-B上涨3.13%，先声药业上涨2.80%。港股创新药精选 ETF(520690)下跌0.20%，最新报价1元。拉长时间看，截至2025年9月26日，港股创新药精选ETF近1月 累计上涨2.99%，涨幅排名可比基金1/2。 流动性方面，港股创新药精选ETF盘中换手16.1%，成交6826.52万元，市场交投活跃。拉 ...

Core Viewpoint - Tianfeng Securities has revised down the revenue and net profit forecasts for Green Leaf Pharmaceutical for 2025 to 2026 due to intense market competition and centralized procurement impacts, while maintaining a "Buy" rating [1] Group 1: Financial Performance - The revenue forecast for Green Leaf Pharmaceutical has been adjusted from 85.29 billion and 102.79 billion to 66.38 billion and 74.47 billion for 2025 and 2026 respectively, with an expected revenue of 81.62 billion for 2027 [1] - The net profit forecast has been revised down from 13.73 billion and 16.78 billion to 6.72 billion and 8.31 billion for 2025 and 2026 respectively, with an expected net profit of 9.16 billion for 2027 [1] - In the first half of 2025, the company reported revenue of 31.81 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 3.13 billion, a year-on-year decrease of 19.3% [1] Group 2: Business Focus and Product Development - The company is focusing on two major areas: CNS (Central Nervous System) and oncology, with multiple new products beginning commercialization and an increasing sales proportion of new products (up 32% year-on-year) [1] - In the oncology treatment sector, revenue reached 12.95 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 8.68 billion, up 5.4%. Cardiovascular treatment revenue was 6.93 billion, down 9.2%, and metabolic treatment revenue was 1.80 billion, down 7.9% [1] Group 3: New Product Commercialization - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance directory, showing over 4 times year-on-year sales growth [2] - ERZOFRI, a product for treating schizophrenia, entered the U.S. market in April 2025, being the first of its kind developed by a Chinese company with independent intellectual property rights [2] - ERZOFRI has a long patent period until 2039 and is currently in a favorable competitive landscape with only two companies in the market [2] Group 4: Innovation Pipeline - The company has a rich pipeline of innovative drugs in development, actively seeking business development collaborations with multinational corporations [3] - LY03017, aimed at treating Parkinson's disease psychosis and Alzheimer's disease psychosis, is expected to complete Phase I clinical trials in China by the end of 2025, with IND approval anticipated in Q3 2025 [3] - Other innovative drugs, including LY03015 for tardive dyskinesia and Huntington's disease, are in Phase II clinical trials, with data expected in the first half of 2026 [3]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Shiyao Group, forecasting revenue and net profit growth from 2025 to 2027 despite a decline in 2025H1 performance due to comprehensive procurement execution and pressure on traditional medicine sales [1] Group 1: Financial Performance - In 2025H1, the company reported revenue of 13.273 billion yuan, a year-on-year decrease of 18.5%, and a net profit of 2.548 billion yuan, down 15.6% [1] - The traditional medicine business revenue was 10.248 billion yuan, including 1.075 billion yuan from licensing income, representing a year-on-year decline of 24.4% [2] - Excluding licensing income, product sales revenue fell by 32.3%, with significant declines in various therapeutic areas [1][2] Group 2: Licensing Income and Business Development - Licensing income has become a strong source of revenue and profit for the company, with a 120 million USD upfront payment for SYH2086 expected to contribute to future income [2] - The company has successfully executed six business development projects in 2024, highlighting the value of its eight R&D platforms [2] Group 3: Clinical Developments and Drug Approvals - SYS6010 has initiated overseas Phase III clinical trials, with positive early data recognized by regulatory authorities in both China and the U.S. [2] - The first domestic HER2 bispecific antibody, KN026, has had its new drug application accepted by the Chinese National Medical Products Administration, showing promising clinical trial results [3] - Multiple clinical data readouts are expected in 2025, with several ongoing trials across various cancer types [4]

EGFRADCSYS6010海外已启动EGFR mu III期临床，wtNSCLC注册路径积极沟通中 EGFRADCSYS6010早期数据得到中美药品监管认可，已拿到多项认证，期待后续注册临床进度。 SYS6010已获得美国FDA授予的三项快速通道资格(FTD)，分别为覆盖EGFR突变阳性、EGFR高表达鳞 状型以及不伴EGFR突变的非鳞状NSCLC患者。SYS6010已获得NMPA的BTD，适应症为单药用于经 EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期NSCLC患者。 首个国产HER2双抗KN026申报上市 公司与康宁杰瑞合作开发的HER2双抗KN026(安尼妥单抗注射液)的新药上市申请于2025年9月获中国国 家药监局受理，适应症为联合化疗用于至少接受过一种系统性治疗(必须包含曲妥珠单抗联合化疗)失败 的HER2阳性局部晚期、复发或转移性的胃/胃食管结合部腺癌。本次上市申请主要是基于一项关键II/III 期临床试验(KC-WISE)。III期临床研究的首次期中分析结果显示，与目前的标准治疗相比，KN026联合 化疗可显著提高临床疗效，延长无进展生存期和总生存期，且在安全性方面无新发安全性风险 ...

金新制药的主要推荐逻辑基于三点。首先是其主业的企稳回升。在 2020 年和 2021 年医药集采最为激烈时，金新制药作为传统仿制药企业，许多品种如瑞 舒伐他汀、匹伐他汀、舍曲林等已完成集采。公司通过拓展院外市场，实现了 收入和利润的稳定增长。2024 年，公司扣非归母净利润约为 6.3 亿元，未来 几年仍有望实现双位数增长。今年（2025 年），预计扣非净利润可达 7 亿元， 总利润约 8 亿元，对应市值支撑在 100-120 亿元。 第二点是蒂达西尼，这是 一款从海外引进的创新失眠药物，在 2024 年 11 月成功进入医保，其价格远 超市场同类仿制药。今年（2025 年）放量迅速，预计可达到 1.8-2 亿元，而 市场预期仅为 5-8 亿元。未来有望突破 20 亿销售额，对应市值可达 60 亿。 第三点是口服 LPA 小分子研发进度领先全球，目前正在与海外 MNC 进行深度 谈判。如果按恒瑞交易估值八折计算，其 BD 交易估值至少在 15-20 亿美元， 对应市值约 100 亿。因此，如果这三步逻辑逐步兑现，金新制药市值有望达到 300 亿。 蒂达西尼在市场中的表现如何？ 京新药业 20250926 摘要 ...

贝恩资本、维梧资本、先进制造基金、春华等为机构股东。 本文为IPO早知道原创 作者｜ 罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，9月26日，北京鞍石生物科技股份有限公司（下称"鞍石生物"）科创板IPO申请获受理。 鞍石生物此次公开发行股票不超过76,004,323股（行使超额配售选择权之前），占发行后总股本的比例不 超过15%且不低于10%。公司选择以"科创板第五套标准"申报上市。 鞍石生物为一家迈入商业化阶段的创新生物医药企业，专注于肿瘤等存在重要未满足临床需求的疾病领域。 公司围绕MET、EGFR、ROS1、NTRK、HER2、RAS等重要肿瘤驱动基因通路，构建了具有"同类首 创"或"同类最佳"潜力的多层次创新药物管线。 目前，公司已有一款产品（万比锐®，伯瑞替尼）在国内获批上市，一款产品（安达艾替尼）处于新药上市 审评阶段，两款产品（ANS01、ANS03）处于临床研究阶段，并正在全球多地开展多项临床研究试验，包 括四项III期临床研究。 | 通用名/ | 靶点 | 治疗方式 | 适应症 | 武装地区 | 药品特殊审评资格 | 研发进展/ | | --- | --- | --- | ...