Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients [1] Group 1 - The company plans to conduct an international multicenter clinical trial in the United States once conditions are met [1]

Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. once conditions are met [1] Group 1 - The company is focused on developing HLX13, a recombinant anti-CTLA-4 fully human monoclonal antibody injection [1] - The IND application for HLX13 has been approved by the U.S. Food and Drug Administration (FDA) [1] - The company aims to initiate the clinical trial in the U.S. when conditions allow [1]

Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. [1] Group 1 - HLX13 is a biosimilar of ipilimumab, targeting multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The mechanism of HLX13 involves blocking CTLA-4 to enhance immune response against tumors [2] - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023, and further approvals for other cancers were granted in November 2023 [2] Group 2 - In April 2025, the company signed a licensing agreement with Sandoz AG, granting exclusive rights for the commercialization of HLX13 in the U.S., certain European regions, Japan, Australia, and Canada [2]

Investment Rating - The industry investment rating is "Strong Outperform" [2] Core Insights - The report emphasizes the potential of TSLP-targeted bispecific antibodies in addressing unmet needs in the autoimmune sector, particularly in asthma and atopic dermatitis [4][6] - The success of Dupilumab (Dupi) illustrates the demand for long-acting, multi-indication therapies in a market characterized by high patient numbers and chronic conditions [5][15] - The report identifies a significant market opportunity driven by high disease prevalence and the need for new therapeutic options [5][15] Summary by Sections High Disease Prevalence Creates Market Opportunities - The report highlights the large patient populations for conditions like asthma and atopic dermatitis, with millions affected, indicating a substantial market for new treatments [14][15] - Existing therapies have unmet needs, particularly in terms of long-acting formulations and improved efficacy [18][19] Focus on Bispecific Antibodies - The report suggests prioritizing bispecific antibodies that target TSLP and IL-13, as they have shown clinical promise in enhancing efficacy and expanding patient populations [6][22] - Companies such as 康诺亚, 信达生物, 荃信生物, and 联邦制药 are identified as key players in this space [6] Respiratory Diseases and Bispecific Antibodies - In the respiratory disease sector, particularly asthma and COPD, the report notes the need for long-term management and the potential of bispecific antibodies to address this challenge [25][37] - The market for asthma biologics is projected to reach approximately $7.5 billion by 2023, with significant growth expected [25][28] Clinical Data and Efficacy - The report discusses the clinical efficacy of various biologics, noting that Dupilumab and Tezepelumab have shown significant improvements in asthma control and quality of life [34][35] - The combination of TSLP and IL-4R is highlighted as a promising therapeutic strategy, with early clinical data supporting its potential [37][47]

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 【深度】麦济生物IPO：8年烧8亿商业化进程仍无时间表 核心产品市场竞争激烈且专利曾陷权属纠纷 近日，麦济生物收到证监会关于本次境外上市的备案反馈意见，具体反馈如下，请你公司就以下事项补 充说明，请律师核查并出具明确的法律意见： 一、关于股权变动。（1）请说明你公司及前身麦济有限历次增资及股权转让定价依据，是否实缴出 资，是否存在未履行出资义务、出资方式存在瑕疵的情形，并就历次股权变动是否合法合规出具明确结 论性意见；（2）请说明控股股东麦康克合伙人变更相关工商登记办理进展。 二、根据法律意见书，你公司现有直接持股股东不存在代持；请按照《监管规则适用指引—境外发行上 市类第2号》关于股份代持的核查要求进行核查。 三、你公司及子公司经营范围包含"医学研究和试验发展"，请说明是否实际开展相关业务及具体经营情 况，是否已取得必要的资质许可，你公司经营范围及实际业务开展是否涉及外资禁止或限制领域。 四、请说明张江科投国有股东标识办理进展。 五、关于本次发行上市及"全流通"。（1）请说明全额行使超额配售选择权后的预计募集规模；（2）请 说明本次拟 ...

Core Viewpoint - The company plans to allocate a total of 160 million yuan from the "South China Biological Large-Scale Suspension Culture Workshop Construction Project" and 115 million yuan from the surplus funds of the "Zhong'an Biological Renovation and Expansion Project" to the "Biomanufacturing Industrialization Engineering Construction Project" [1] Group 1 - The total investment for the new project is 679 million yuan, with 296 million yuan sourced from raised funds [1] - The implementation entities for the new investment project are the company and its wholly-owned subsidiary, Tianjin Ruishi Biotechnology Co., Ltd [1] - The project will be located in the Tianjin Port Free Trade Zone, Lingang area [1] Group 2 - The raised funds include 20.8231 million yuan from financial management income and interest income [1] - The remaining investment will be funded through the company's own funds or self-raised funds [1]

绒促卵泡激素αN02注射液是金赛药业研发的一款长效重组人促卵泡激素—CTP融合蛋白注射液(FSH- CTP)，是经基因工程技术将人促卵泡激素(hFSH)基因与人绒毛膜促性腺激素(hCG)的β亚基羧基末端肽 (CTP)基因通过中国仓鼠卵巢(CHO)细胞表达得到的绒促卵泡激素，1次皮下注射代替7天促卵泡激素 (FSH)的使用，属于治疗用生物制品3.2类。 智通财经APP讯，长春高新(000661.SZ)发布公告，近日，公司子公司长春金赛药业有限责任公司(以下 简称"金赛药业")收到国家药品监督管理局核准签发的《药品注册证书》，其申报的绒促卵泡激素αN02 注射液已在境内获批上市。 ...

Core Viewpoint - The company is initiating a shareholder return activity in collaboration with Zhejiang Hexin Tonghuashun Network Information Co., Ltd. to express gratitude to shareholders for their long-term support [1] Group 1: Shareholder Return Activity - The activity is named "Listed Company Shareholder Festival" and will take place from September 29, 2025, to October 17, 2025, at 17:00 [1] - Prizes for the event include products such as Lingjiangxian Red Yeast Rice Wine, Red Yeast Dan Shen Sanqi Soft Capsules, Jiacheng Red Yeast Tea, and Manjianghong Red Yeast Rice Wine [1]

Core Viewpoint - WuXi AppTec's CAR-T product, Benodida, along with four other CAR-T therapies, has successfully passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, signaling a positive regulatory shift towards improving access to cutting-edge therapies [1] Group 1: Stock Performance - WuXi AppTec-B (02126) saw a nearly 7% intraday increase, currently up 6.1% at HKD 4.35, with a trading volume of HKD 7.2867 million [1] Group 2: Regulatory Developments - The National Healthcare Security Administration announced the completion of expert review for the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory adjustments [1] - The inclusion of CAR-T therapies in the review indicates a commitment from regulators to enhance the accessibility of advanced treatments [1] Group 3: Market Context - CAR-T therapies have not been included in the basic medical insurance directory due to their high cost, often exceeding one million yuan per injection [1] - Currently, CAR-T therapy payment structures are diversified, relying primarily on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1] Group 4: Company Response - WuXi AppTec has stated that its CAR-T products will actively participate in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] - Over 70 commercial health insurance products have already included WuXi AppTec's Benodida [1]

Core Viewpoint - WuXi AppTec's CAR-T product, Benauda, has passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, signaling a positive regulatory shift towards improving access to advanced therapies [1] Group 1: Company Updates - WuXi AppTec's stock rose nearly 7% during trading, closing up 6.1% at HKD 4.35, with a trading volume of HKD 7.2867 million [1] - The company has confirmed that its CAR-T product, Benauda, is included in over 70 commercial health insurance products [1] - WuXi AppTec plans to actively participate in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The National Healthcare Security Administration has completed the expert review for five CAR-T drugs, including Benauda, which is seen as a positive signal for the accessibility of cutting-edge therapies [1] - CAR-T therapies have not yet entered the basic medical insurance directory due to their high pricing, often exceeding one million yuan per injection [1] - The current payment structure for CAR-T therapies is diverse, primarily relying on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1]