在京东金融主办的投资策略会上，工银瑞信研究部联席总经理赵蓓表示，中国当前创新药总规模为2000 亿元至3000亿元，未来市场潜力巨大。近十年政策全面支持创新药产业发展。中国成为全球创新药的研 发中心，美国市场授权引入的产品中已经有23％来自中国药企，且这个比例在过去5年逐年提升。欧美 的MNC也面对大量的专利到期问题，急需更多的产品补充管线，国产创新药的出海机会有希望继续增 多。 ...

Group 1: Industry Overview - The innovative drug development sector in China is experiencing significant growth, with 43 innovative drugs approved in the first half of 2025, a 59% increase year-on-year, nearing the total of 48 approved in 2024 [1] - The industry is transitioning from a quantity-focused model to a quality-driven approach, enhancing its competitiveness against global pharmaceutical companies [1][2] - The average time for drug approval has decreased from 420 working days in 2017 to 235 days, reflecting improved efficiency in the review process [2] Group 2: Rare Disease Drug Development - The Chinese government has implemented measures to accelerate the review and approval of rare disease drugs, addressing previous accessibility issues [2] - Several rare disease drugs, such as those from Beihai Kangcheng and Fosun Pharma, received approval in the first half of 2025, indicating progress in this area [2] Group 3: International Collaboration and Licensing - Chinese pharmaceutical companies are increasingly engaging in licensing agreements and collaborations with multinational firms, enhancing their global presence [8][10] - Notable partnerships include the licensing of a PD-1/VEGF dual antibody product to Pfizer and a collaboration with GSK to develop up to 12 innovative drugs [9][10] - These collaborations are expected to improve the international recognition and market access of Chinese innovative drugs [10][12] Group 4: Clinical Trial and Regulatory Advancements - Companies like Dizhe Pharma have successfully navigated the FDA approval process for their innovative drugs, showcasing the potential for Chinese drugs in international markets [15] - The establishment of a national-level public technology platform and global clinical trial network is essential for supporting the internationalization of Chinese innovative drugs [21] Group 5: Challenges and Future Directions - Despite advancements, challenges remain in achieving global competitiveness, particularly in areas such as original innovation and compliance with international standards [18][20] - The industry must focus on enhancing commercialization capabilities and addressing the gap between clinical benefits and market access strategies [20][21] - Continuous investment in R&D and the cultivation of talent with international expertise are critical for the future success of Chinese innovative drug companies [21][22]

证券代码：002653 证券简称：海思科 公告编号：2025-089 海思科医药集团股份有限公司 关于获得创新药 HSK47977 片 一、 研发项目简介 HSK47977是公司自主研发的一种口服BCL6（人B细胞淋巴瘤因子 瘤细胞的发生和发展，拟用于非霍奇金淋巴瘤的治疗。根据国家药品 监督管理局关于发布《化学药品注册分类及申报资料要求》的通告 （2020年第44号）中化学药品注册分类的规定，本品属于化学药品1 类。 本品国内尚无同靶点药物进入临床阶段，是潜在的First-In- Class产品。同时，本品已于2025年7月完成与FDA的Pre-IND沟通，并 于同月完成向FDA的IND申报递交，正在审评中，未来有望实现中美同 步开发。 在多项临床前研究中，HSK47977均展现出强效的抗肿瘤活性以及 较强的靶点选择性和理想的安全窗，并且与BCL2抑制剂联合使用时可 实现协同抗癌效果，是一款极具开发潜力的药物。 二、风险提示 创新药研发周期长、环节多、风险高，容易受到一些不确定性因 素的影响，敬请广大投资者谨慎决策，注意防范投资风险。公司将根 据该项目的后续进展及时履行信息披露义务。 《药物临床试验批准通知书 ...

Investment Rating - The industry investment rating is "Outperform the Market" [1][47]. Core Insights - The white spot market for vitiligo treatment is vast, with a potential market size expected to reach 21.7 billion yuan by 2030, driven by an increasing number of patients and the need for effective treatments [3][15][39]. - Current treatment options are inadequate, with no approved products specifically for vitiligo in China, highlighting a significant gap in the market that innovative drugs could fill [3][26]. - The competitive landscape is favorable, with several small pharmaceutical companies and leading firms vying for market share, and key products expected to receive approval soon [3][39]. Summary by Sections Part 1: Patient Demographics and Health Risks - The prevalence of vitiligo is significant, with approximately 22.83 million patients in China, of which 54.01% are receiving treatment [3][15]. - The condition is associated with severe psychological impacts, including a higher incidence of depression among patients [3][10]. Part 2: Current Treatment Limitations - Existing treatments, primarily involving drug therapy and phototherapy, have shown limited effectiveness, necessitating the introduction of new drugs with higher repigmentation rates [3][24]. - The current market lacks approved medications specifically for vitiligo, with existing drugs primarily approved for other conditions [3][26]. Part 3: Competitive Landscape and Drug Development - The vitiligo treatment sector is characterized by a lack of approved products, with several drugs in various stages of clinical trials, including one in Phase III and six in Phase II [3][39]. - JAK inhibitors are identified as key targets in drug development, with the first approved topical JAK1/JAK2 inhibitor, Ruxolitinib cream, showing promising sales growth [3][32][39]. - The innovative drug market for vitiligo is projected to reach 10 billion yuan, with significant interest in companies like Kangzheng Pharmaceutical and TianKang [3][39]. Part 4: Investment Recommendations - The report suggests focusing on the progress of drug development in the vitiligo sector and monitoring companies involved, including Kangzheng Pharmaceutical, TianKang, Huadong Medicine, and others [3][39].

Core Viewpoint - The company received approval from the National Medical Products Administration for its drug "HSK47977," which is a novel oral BCL6 PROTAC small molecule formulation aimed at treating non-Hodgkin lymphoma [1] Group 1 - The drug HSK47977 is developed in-house by the company and targets the degradation of the BCL6 protein, which is crucial in the development and progression of tumor cells [1] - The approval signifies a significant step forward in the company's oncology pipeline, potentially enhancing its market position in cancer treatment [1]

HSK47977是公司自主研发的一种口服BCL6(人B细胞淋巴瘤因子6)PROTAC小分子制剂，可以靶向结合 和降解BCL6蛋白，进而抑制肿瘤细胞的发生和发展，拟用于非霍奇金淋巴瘤的治疗。 海思科（002653）(002653.SZ)发布公告，公司于近日收到国家药品监督管理局下发的《药物临床试验 批准通知书》，涉及药品："HSK47977"。 ...

每经AI快讯，8月12日，海思科（002653）(002653.SZ)公告称，公司近日收到国家药品监督管理局下发 的《药物临床试验批准通知书》，同意HSK47977片开展临床试验。该药品为公司自主研发的口服 BCL6PROTAC小分子制剂，用于治疗非霍奇金淋巴瘤。HSK47977片国内尚无同靶点药物进入临床阶 段，是潜在的First-In-Class产品。此外，该药品已完成与FDA的Pre-IND沟通和IND申报递交，正在审评 中，未来有望实现中美同步开发。创新药研发周期长、风险高，存在不确定性，投资者需谨慎决策。 ...

来源：金融界 金融界8月12日消息，有投资者在互动平台向盘龙药业提问：国家医保局首次公开确认制定"新上市药品 首发价格机制"，"新上市药品首发价格形成机制"推出后将给予高质量创新药更高的定价自由度、效率 更高的挂网流程以及更长的首发价格稳定周期。新靶点/新机制的高质量创新药研发产商有望迎来更快 的现金流回报，创新药企业有望持续享受到监管政策在真支持创新、支持真创新、支持差异化创新等方 向的全链条支持。2025年以来医药政策环境向好，全面支持创新药发展。贵司有创新药提供什么。 公司回答表示：尊敬的投资者您好！公司将紧紧把握好国家医药政策的支持力度和发展机遇，加快推进 公司产品的创新研发工作。感谢您的关注！ ...

Core Viewpoint - He Yu-B (02256) has seen its stock price rise over 4%, reaching a historical high of 13.67 HKD, with a year-to-date increase of nearly 100% [1] Financial Performance - For the first half of the year, the company reported revenue of 612 million RMB, representing a year-on-year growth of 21.5% [1] - The net profit attributable to shareholders was 328 million RMB, showing a significant year-on-year increase of 58.8% [1] Research and Development - The company has increased its R&D expenses by 6% year-on-year, indicating a commitment to innovation [1] - Management expenses have decreased by 13%, contributing to improved profitability [1] Financial Guidance - The company has guided that its operating cash consumption for the year will remain within 570 million RMB, with expectations of maintaining profitability [1] Market Valuation and Future Prospects - Citigroup believes the current valuation of He Yu-B is low, considering the high certainty of its two late-stage drug candidates, pimicotinib and irpagratinib [1] - The success rate of the phase III clinical trial for irpagratinib in second-line liver cancer is expected to be very high, which should be factored into its valuation [1] - Key catalysts are anticipated in 2025 and 2026, including the approval and commercialization of pimicotinib, phase III data for irpagratinib, and updates on other candidates like ABSK043 and ABSK061 [1]

Group 1 - The National Smart Medical Insurance Competition reflects the government's supportive attitude towards the development of innovative drugs, with open medical insurance data empowering drug research and development [1] - Medical insurance data covers a large population and has rich dimensions, providing substantial real-world data support for innovative drug development, helping teams accurately target clinical needs and determine research directions, thereby improving research efficiency [1] - The competition promotes cross-industry resource integration among pharmaceutical companies, technology firms, and research institutions, with big data analysis and artificial intelligence technologies from tech companies combining with drug research to create new research models and accelerate the transition of innovative drugs from the lab to clinical application [1] Group 2 - Long-term, the deepening application of medical insurance data in innovative drug development is expected to enhance both the quantity and quality of innovative drugs, indicating high growth potential and investment value in this sector [1] - The Science and Technology Innovation and Entrepreneurship ETF (588360) tracks the Science and Technology Innovation 50 Index (931643), which can fluctuate by up to 20% in a single day, reflecting the overall performance of listed companies in high-tech industries such as new-generation information technology, biomedicine, and high-end equipment manufacturing [1] - Investors without stock accounts can consider the Guotai Zhongzheng Science and Technology Innovation and Entrepreneurship 50 ETF Initiated Link C (013307) and Link A (013306) [1]