声明：市场有风险，投资需谨慎。本文为AI基于第三方数据生成，仅供参考，不构成个人投资建议。 本文源自：市场资讯 有投资者在互动平台向诺诚健华提问："请问贵公司近两年是否出口欧盟国家？" 针对上述提问，诺诚健华回应称："尊敬的投资者，您好！截至目前公司暂无自研药品于欧盟范围内获 批及销售。感谢您的关注！" 作者：公告君 ...

格隆汇11月28日丨诺诚健华(688428.SH)在投资者互动平台表示，截至目前公司暂无自研药品于欧盟范 围内获批及销售。 ...

Core Insights - Nocera Biopharma announced the completion of the first patient dosing in the global Phase II clinical trial of its novel TYK2 inhibitor Soficitinib (ICP-332) for the treatment of nodular prurigo [1][2] - Soficitinib is a highly selective oral TYK2 inhibitor developed for various T-cell related autoimmune diseases, with a strong focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The global market for nodular prurigo treatment is projected to grow from $2 billion in 2024 to $3 billion by 2034, with approximately 10 million patients affected worldwide [1] Company Developments - Nocera Biopharma's product pipeline covers ten autoimmune diseases, with a significant emphasis on dermatological diseases [2] - Soficitinib has demonstrated excellent efficacy and safety in Phase II clinical studies for moderate to severe atopic dermatitis, and the related research was featured in a prominent oral presentation at the American Academy of Dermatology annual meeting [2] - The company is accelerating global clinical development to provide innovative treatment solutions for more autoimmune patients [2]

Core Insights - Nocare Biopharma announced the completion of the first patient dosing in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib, for the treatment of nodular prurigo [1][2] - Soficitinib is designed to treat various T-cell related autoimmune diseases, with a strong focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The global market for nodular prurigo treatment is projected to grow from $2 billion in 2024 to $3 billion by 2034, with approximately 10 million patients affected worldwide [1] Company Developments - Nocare Biopharma's product pipeline covers ten autoimmune diseases, with a significant emphasis on dermatological diseases [2] - Soficitinib has demonstrated excellent efficacy and safety in Phase II clinical studies for moderate to severe atopic dermatitis, and the research was selected for a prominent oral presentation at the American Academy of Dermatology annual meeting [2] - The company is accelerating its global clinical development to provide innovative treatment solutions for more autoimmune patients [2]

Core Viewpoint - The Hong Kong stock market opened slightly higher on November 28, with the Hang Seng Index at 25,959 points, reflecting a 0.05% increase [1]. Company Developments - Avita Technology (Chongqing) Co., Ltd. submitted its listing application to the Hong Kong Stock Exchange on the evening of November 27, with CITIC Securities and CICC as joint sponsors. The funds raised will primarily be used for product development, platform and technology development, brand building, sales service network construction, and operational funding to enhance core competitiveness [5]. - Avita, established in 2018, aims to create a high-end smart electric vehicle brand with independent technology and international presence. It has received support from Changan Automobile, Huawei, and CATL in various fields [5]. - From 2021 to 2024, Avita completed four rounds of financing, totaling approximately 19 billion yuan, with a valuation of around 30 billion yuan [5]. Market Trends - The Hang Seng Technology Index reported a 0.29% increase, reaching 5,613 points [3]. - The new consumption sector continues to strengthen, with Pop Mart rising over 2% and Dongfang Zhenxuan increasing over 4% [5]. - Other sectors showed positive movement, including tech stocks like Bilibili and Alibaba, which both opened higher, and innovative drug concepts with companies like Innovent Biologics rising over 1% [5]. - Gold stocks also performed well, with Shandong Gold and Lingbao Gold both increasing over 2% [5]. - The semiconductor sector was active, with companies like SMIC and Huahong Semiconductor both rising over 1% [5]. - The new energy vehicle sector showed mixed results, with NIO rising over 1% while Seres fell over 6% [5]. Market Outlook - Brokerage firms suggest that the Hong Kong stock market will maintain a volatile pattern, advising investors to be patient and focus on whether the Hang Seng Index can break through key moving average resistance with volume [5]. - Analysts indicate that the market is currently driven by sentiment, with risk appetite not fully restored. Although the index has rebounded, it relies heavily on a few large-cap stocks, while small and mid-cap stocks remain weak [5]. - In an uncertain environment, sectors such as energy, telecommunications, public utilities, and state-owned banks are viewed as "ballast" for funds due to their low valuations and high dividends [5].

Core Viewpoint - InnoCare Pharma has initiated a global Phase II clinical trial for its TYK2 inhibitor, Soficitinib, targeting prurigo nodularis in China, marking a significant step in its development pipeline for autoimmune diseases [1][5]. Company Overview - InnoCare Pharma is a biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs both in China and globally [6]. Product Development - Soficitinib is a selective TYK2 inhibitor aimed at treating various T-cell related autoimmune disorders, including prurigo nodularis, atopic dermatitis, and vitiligo, among others [2][5]. - The drug works by blocking cytokine signaling pathways associated with itching and inflammation, thereby alleviating symptoms of prurigo nodularis [3]. Market Potential - There are approximately 10 million patients suffering from prurigo nodularis globally, with the market for this condition valued at US$2 billion in 2024 and projected to grow to US$3 billion by 2034 [4].

Core Viewpoint - The company announced the completion of the first patient dosing in a global Phase II clinical trial for its novel TYK2 inhibitor Soficitinib (ICP-332) aimed at treating nodular prurigo [1] Group 1: Product Development - Soficitinib is a highly efficient and selective oral TYK2 inhibitor developed by the company [1] - The drug is being developed for various T-cell related autoimmune diseases, with a strong focus on dermatological indications [1] Group 2: Market Potential - The current development strategy includes a deep focus on a wide range of skin-related conditions, including atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1]

Core Viewpoint - Nocera Biopharma has seen significant stock price growth this year, with a 112.95% increase, indicating strong market performance and investor interest [2]. Company Overview - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, is based in Beijing and focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [2]. - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and R&D services [2]. Stock Performance - As of November 27, the stock price reached 26.15 CNY per share, with a market capitalization of 46.145 billion CNY [1]. - The stock has experienced a recent increase of 8.19% over the last five trading days and a 14.69% increase over the last 20 days, although it has declined by 8.28% over the past 60 days [2]. Financial Performance - For the period from January to September 2025, Nocera Biopharma reported a revenue of 1.115 billion CNY, reflecting a year-on-year growth of 59.85%, while the net profit attributable to shareholders was -64.4149 million CNY, showing a 76.61% increase in losses compared to the previous period [3]. - As of September 30, 2025, the number of shareholders increased by 8.66% to 16,500, indicating growing investor interest [3]. Institutional Holdings - As of September 30, 2025, notable institutional shareholders include: - Fuguo Precision Medical Flexible Allocation Mixed A, holding 12.1549 million shares, down 427,100 shares from the previous period [3]. - Wanjia Preferred, a new shareholder with 10 million shares [3]. - Ping An Medical Health Mixed A, also a new shareholder with 8.6266 million shares [3].

高研发投入和高成长性一直是科创板公司的鲜明特征。近日，随着中芯国际、诺诚健华2家多地上市的 红筹公司完成三季报业绩披露，科创板592家公司的三季度"成绩单"正式揭晓。数据显示，"硬科技"企 业研发投入持续加码，集成电路、人工智能等重点产业加速培育新质生产力。 近年来，科创板公司研发投入力度持续加大。前三季度，板块研发投入总额高达1197.45亿元，是板块 净利润的2.4倍，研发强度中位数高达12.4%，持续大幅领跑A股各板块。 今年6月，科创板"1+6"改革启动，设立科创成长层，精准支持未盈利科技型企业发展。从三季度业绩表 现看，35家科创成长层未盈利企业用"时间"换"空间"，用"研发"换"未来"，发展势头喜人。35家公司前 三季度营收同比增长39%，净利润同比大幅减亏65%；在增收缩亏的同时，研发强度中位数高达 44.3%。 在近日召开的上海证券交易所国际投资者大会上，上交所副总经理傅浩介绍，自设立之初，科创板便突 破传统盈利门槛，允许未盈利企业、红筹企业及特殊股权架构企业上市，开辟科创企业专属融资通道。 近2年来，监管层不断完善制度供给。发行端，推出科创板"1+6"政策组合，并将第五套上市标准进一步 扩围 ...

Investment Rating - The report indicates a positive outlook for the Chinese biopharmaceutical industry, highlighting significant advancements in drug development efficiency and global collaboration strategies. Core Insights - Chinese biopharmaceutical companies have significantly shortened drug development cycles through streamlined decision-making processes and enhanced research capabilities, with some drugs taking only four years from clinical trials to NDA acceptance [1][2] - External licensing has become a crucial strategy for Chinese companies to globalize, with many firms actively building business development teams to foster collaborations with large multinational pharmaceutical companies [1][5] - There is a strong interest in emerging drug modalities such as ADCs, small nucleic acid drugs, and in vivo CAR-T therapies, which are becoming integral parts of the R&D pipeline and are expected to drive next-generation product innovation [1][6] - Global investors are particularly focused on weight loss products and Lipoprotein A (Lp(a)) projects, indicating substantial growth potential in cardiovascular disease-related products [1][4] Summary by Sections Drug Development Efficiency - Chinese companies like Heng Rui have demonstrated impressive development timelines, with processes from GLP E Tox to IND taking only six months and clinical trials to NDA acceptance completed in four years [2] Globalization Strategies - Chinese biopharmaceutical firms are addressing globalization challenges by collaborating with multinational pharmaceutical companies, moving from traditional licensing to co-development models [5] Emerging Drug Modalities - The report emphasizes the enthusiasm of Chinese companies in exploring new drug forms, particularly ADCs and small nucleic acid drugs, which are becoming key components of their R&D pipelines [2][6] Market Focus Areas - Investors are keenly interested in weight loss products and Lp(a) projects, with significant attention on cardiovascular disease collaborations, indicating a robust growth trajectory in these areas [4] Company-Specific Developments - He Yu Pharmaceutical's Pimiatinib is projected to capture a 25% global market share in key indications, with peak sales potentially reaching $1.6 billion [7] - Kangnuo's Sluqi monoclonal antibody is expected to exceed RMB 5 billion in peak sales by 2035, with promising prospects in multiple indications [10] - Hanlin Pharmaceutical is recognized for its high-margin biosimilar business, supporting its innovative pipeline, with the PD-L1 ADC HLX43 expected to achieve peak sales of $3.8 billion [11][12]