HTD1801是君圣泰医药核心产品，也是本次合作开发主要产品。它是一种靶向肠－肝系统的口服抗炎 及代谢调节剂，具有全球首创的激活AMPK并抑制NLRP3炎症小体的独特双机制。全球开展的十余项临 床试验显示，HTD1801可同步改善血糖、血脂、肾功能、体重、肝功能、心血管、炎症等指标，展现 出对2型糖尿病、慢性肾病、肥胖、血脂异常、脂肪肝等多个适应症的共病治疗潜力。 中国医学科学院成立于1956年，是我国最高医学研究机构和领衔医学教育机构。以引领我国医学科技与 教育发展和维护人民健康为己任，医疗领衔行业，为我国现代科学医学体系的建立和发展做出了重要贡 献。 医药生物技术研究所(药生所)是中国医学科学院的直属研究所，其重点领域是微生物药物、抗感染药 物、与生物技术药物研究，在国内一直保持相关学科和领域的研究优势。药生所具备综合的新药研究体 系，在抗感染、抗代谢综合徵、及抗癌等领域的新药研发方面均取得重要进展，已成为不可替代的国家 战略科技力量。 格隆汇8月12日丨君圣泰医药-B(02511.HK)公告，集团的全资附属公司深圳君圣泰生物技术有限公司与 中国医学科学院医药生物技术研究所("药生所")共同开展课题合作， ...

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]