Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has launched its self-developed innovative anti-cancer drug, Dihydro-Enzalutamide soft capsule, marking a significant milestone in its development journey [2][3] Group 1: Product Launch and Clinical Significance - Dihydro-Enzalutamide soft capsule is recognized as a new type of androgen receptor antagonist (ARi) and has shown significant clinical value, particularly in treating metastatic castration-resistant prostate cancer (mCRPC) [2] - Clinical studies indicate that Dihydro-Enzalutamide significantly improves disease progression and survival rates while demonstrating excellent safety profiles, with no adverse events such as falls or seizures reported [2] - Experts suggest that Dihydro-Enzalutamide has the potential to be moved forward in treatment protocols for metastatic hormone-sensitive prostate cancer (mHSPC) [2][3] Group 2: Company Development and Future Plans - The inauguration of Haichuang Pharmaceutical's headquarters and the rapid nationwide supply of Dihydro-Enzalutamide signify a critical leap from research innovation to industrial empowerment [3] - The company focuses on developing innovative drugs for cancer and metabolic diseases and plans to accelerate the global rollout of multiple anti-cancer and metabolic disease drugs [3] - Haichuang Pharmaceutical's chairman emphasized the importance of patient-centered research and the collective effort of employees and partners in achieving this milestone [3]

此前，海创药业在5月末公告称，氘恩扎鲁胺软胶囊获得国家药监局批准上市。 6月下旬，公司的微信公众号发文表示，氘恩扎鲁胺软胶囊首批产品从广州装车发货，并于20日开出全 国首张处方。该胶囊正式开启全国供应，患者凭医生开具的处方即可在全国各大省会城市DTP药店购买 到这款产品。在公司看来，该药首方的开出距离该药获批上市仅半月余，充分展现了其重要的临床价值 和紧迫的临床需求。 据公开资料，前列腺癌是常见的泌尿系统恶性肿瘤，位居全球男性癌症发病率的第二位和癌症死亡率的 第五位。2022年，全球前列腺癌新发病例数达到146.7万例。近年来，中国前列腺癌的发病率呈现上升 趋势，2022年中国前列腺癌新发病例数达到13.4万例。 对于转移性去势抵抗性前列腺癌，内分泌治疗仍是推荐的首选治疗方式。氘恩扎鲁胺软胶囊是国内第一 款针对该类患者人群获得批准上市的创新药物。 （原标题：我国自主研发的1类抗癌新药氘恩扎鲁胺发布上市） 7月4日，海创药业(688302)在成都天府国际生物城举行了总部基地启用盛典，并宣布我国自主研发的1 类抗癌新药氘恩扎鲁胺软胶囊发布上市。 海创药业董事长陈元伟表示，该产品的成功上市，离不开各方的鼎力支持，更 ...

行业深度分析 行业评级：领先大市-A 创新出海引领投资主线，复苏改善接踵而至 2025年7月3日 证券研究报告 目录 | 1 | 创新药引领医药板块行情,估值有望持续修复 | | --- | --- | | 2 | 创新出海趋势加速，有望持续引领主线行情 | | • | 创新药：创新药出海加速，BD陆续兑现可期 | | • | 家用器械：海外市场突破打开国产龙头成长空间 | | 3 | 部分细分边际改善，有望逐步迎来修复机会 | | • | CXO：GLP-1和ADC药物研发和销售持续火热，有望推动相关CDMO公司经营边际改善 | | • | 设备/高耗/IVD：压制因素有序出清，可系统性把握改善节奏 | | • | 中药：多因素共振积蓄板块修复势能，把握创新探索与国改深化的窗口机遇 | | • | 零售药房：持续优化门店经营，业绩有望加速改善 | | 4 | 医疗新浪潮：手术机器人、AI+医疗、脑机接口有望持续取得突破 | | 5 | 建议关注标的汇总 | | 6 | 风险提示 | 2 2025Q1医药板块业绩有所承压，期待后续修复 2025年医药中期策略 李奔： S1450523110001 分析师 冯俊 ...

Group 1: Healthcare Legislation and Regulation - The draft of the Medical Security Law aims to establish a comprehensive basic medical insurance system and protect the rights of insured individuals [1] - The National Medical Products Administration (NMPA) held a meeting to enhance monitoring and management of medical device sales online, emphasizing risk governance and public safety [2] - Tianjin's health authorities issued a notice to promote the implementation of centralized procurement results, ensuring that selected drugs and consumables are procured within three months [3] Group 2: Medical Data and Technology - Hubei province launched a new feature for its medical insurance information platform to enable nationwide sharing of medical imaging data by 2026 [4] - The Gates Foundation announced a commitment to donate $1.6 billion to the Global Vaccine Alliance over the next five years, contributing to vaccine development and delivery [6] Group 3: Pharmaceutical Developments - Lizhu Group received approval for clinical trials of YJH-012 injection, a new siRNA drug aimed at long-term suppression of uric acid production [5] - Haisheng Pharmaceutical's HSK47388 tablet for autoimmune diseases has had its clinical trial application accepted by the NMPA [6] - Baiyue Shenzhou announced the clinical use of its bispecific HER2 inhibitor in China, targeting patients with HER2-positive biliary tract cancer [8] - Haichuang Pharmaceutical's new anti-cancer drug, Dihengzalu, has been prescribed in multiple cities, marking its entry into clinical practice [9] - Fuhong Hanlin completed the first patient dosing in Japan for its drug Hanshuang in a trial for extensive-stage small cell lung cancer [10] Group 4: Corporate Actions - Wantai Biological Pharmacy responded to investor concerns regarding the efficacy data of its 9-valent HPV vaccine, stating that the circulating data is inaccurate [12] - A senior executive at Kew Flower Pharmaceutical resigned due to retirement, effective immediately [13]

海创药业(688302)的微信公众号6月20日下午发文称，公司自主研发的Ⅰ类抗癌新药氘恩扎鲁胺软胶囊 首批产品从广州装车发货，并于今日开出全国首张处方。该胶囊正式开启全国供应，患者凭医生开具的 处方即可在全国各大省会城市DTP药店购买到这款产品。 氘恩扎鲁胺软胶囊是海创药业自主研发的、用于治疗接受醋酸阿比特龙及化疗后出现疾病进展，且既往 未接受新型雄激素受体抑制剂的转移性去势抵抗性前列腺癌成人患者的Ⅰ类新药。 据公开资料，前列腺癌是常见的泌尿系统恶性肿瘤，位居全球男性癌症发病率的第二位和癌症死亡率的 第五位。2022年，全球前列腺癌新发病例数达到146.7万例。近年来，中国前列腺癌的发病率呈现上升 趋势，2022年中国前列腺癌新发病例数达到13.4万例。 对于转移性去势抵抗性前列腺癌，内分泌治疗仍是推荐的首选治疗方式。氘恩扎鲁胺软胶囊是国内第一 款针对该类患者人群获得批准上市的创新药物。 据称，相较于其他新型内分泌药物，氘恩扎鲁胺软胶囊在安全性方面表现优异，可显著降低中枢神经系 统不良事件（如癫痫、跌倒等）发生率，且无皮疹相关不良反应，同时减少老年患者常见并发症风险。 海创药业曾在5月末公告称，氘恩扎鲁胺软胶 ...

Core Viewpoint - The implementation of the "K8 Measures" has led to a renewed focus on the fifth listing standard for unprofitable biotech companies on the STAR Market, aiming to enhance the financing environment for innovative drug firms and shift A-share valuation logic towards "technological value" and "commercial prospects" [1][5][15] Group 1: K8 Measures and STAR Market - The "K8 Measures" were introduced by the China Securities Regulatory Commission (CSRC) to support high-quality, unprofitable tech companies with key technologies and market potential to list on the STAR Market [1] - Since the introduction of the K8 Measures, two unprofitable hard tech companies have been accepted for listing, but the specific "Standard Five" for unprofitable innovative drug companies has yet to be activated [1][3] - The CSRC has reiterated its commitment to promoting the new cases under the fifth listing standard, which is expected to accelerate the financing pace for biotech companies [1][3] Group 2: Impact on Biotech Companies - Biotech companies, particularly innovative drug firms, face longer investment periods and greater uncertainty due to strict approval processes, making them highly dependent on capital [1][5] - The fifth listing standard has previously allowed 20 unprofitable biotech companies to list, with 19 of them successfully bringing 45 self-developed drugs/vaccines to market [3][5] - The introduction of the fifth standard has significantly shortened the capital cycle for these companies and has contributed to the prosperity of the biopharmaceutical primary market [3][5] Group 3: Commercialization and Financial Performance - As of 2024, the 20 companies that listed under the fifth standard collectively achieved revenues of 14.21 billion yuan, a year-on-year increase of 44.17%, with four companies expected to surpass 1 billion yuan in revenue in the coming years [12] - Companies like Ailis and Shenzhou Cell have reported significant revenue growth and profitability, attributing their success to continuous R&D investment and effective commercialization strategies [12][13] - The revised "STAR Market Attribute Evaluation Guidelines" for 2024 emphasize the importance of commercialization capabilities and revenue growth for companies seeking to list [11] Group 4: Future Prospects and Challenges - The market is keenly observing which companies will benefit first from the reactivation of the fifth listing standard, with five companies currently under review [14] - Companies with strong technological innovation capabilities and significant market potential are expected to be the first beneficiaries of the new standard [14][15] - The fifth listing standard presents both opportunities and challenges for unprofitable companies, requiring them to demonstrate their technological strengths and market potential despite not being profitable [15]

截至10:09，港股通创新药ETF(159570)标的指数前十大权重股多数飘绿：药明生物跌超5%，消息面上，主要股东WuXi Biologics Holdings Limited拟每股26.6 港元配售8294万股现有股份，占股约2.04%，涉资约22.07亿港元。配售价较上周五收市价28港元折让5%。百济神州、中国生物制药跌超1%，信达生物微 跌，康方生物涨超5%。 【创新药催化不断！持续看好创新药投资机会】 随着国产创新药的临床数据和临床进度在全球范围内的竞争力越来越强，创新药出海的趋势不断加强。继5月20日三生制药与辉瑞就PD-1/VEGF双抗 （SSGJ-707）达成的交易首付款再次刷新国产创新药出海纪录（首付款）后，石药集团于5月30日公告，3项潜在交易正在进行磋商，每项潜在交易项目的 总交易额均可能达到50亿美元。 今日，港药大幅波动，港股通创新药ETF(159570)早盘一度跌1.5%后快速拉起转为涨超2%，随后冲高回落涨幅收窄，成交额已大幅爆量超15亿元，规模和 流动性大幅领先同类！资金面持续火热，港股通创新药ETF(159570)盘中再获净流入近2亿元，截至6月13日近9日已累计"吸金"18 ...

春争日，夏争时。全力冲刺二季度之际，初夏时节的蓉城大地各重点项目建设正酣，产业新貌加速呈现。 日前，在位于成都高新区和双流区合作共建的成都天府国际生物城（以下简称生物城），GE医疗中国精准医疗产业基地（一期）项目顺利通过并联验收， 正式投入使用。这是全球医疗器械巨头GE医疗近年来在中国西部新增布局的首个精准医疗产业化基地项目。 值得关注的是，通过不断提升医药健康产业专业服务体系、推进政务服务增值化改革，生物城助力该项目从完工到通过并联竣工验收仅用时40个工作日，较 从前压缩至少2个月，实现了"竣工即验收、验收即投用"。 不久前，作为四川省开展政务服务增值化改革试点地区，生物城在全省首批次发布《成都天府国际生物城建设项目"开工一件事"服务手册》（以下简称《手 册》）。一本手册将原本分散在12个部门的审批事项整合为"一件事"办理流程，集成40余项服务细则，成为政务服务增值化改革的突破性注脚。 从"便捷办理"到"增值赋能"，当政务服务不再被动承接诉求，转而成为生产力创新的助燃剂，生物城的产业生态正获得向上突围的核心竞争力。 12个部门审批事项"归一" 项目开工前准备周期缩短45% 医药健康产业项目建设素以生产工艺复 ...

Group 1 - The innovative drug sector has recently become a leader in both A-shares and H-shares, with significant market activity observed, particularly on June 9, where the STAR 200 Index rose by 1.79%, reaching a new high since March 24 [1][2] - The current market focus on innovative drug companies is primarily on those in clinical phases I and II, indicating that the profitability of some companies remains uncertain despite rising valuations [1][5] - The Wind Innovative Drug Index has increased by 27.62% year-to-date, with over 20 stocks in the sector rising more than 10% [2][5] Group 2 - Recent large-scale business development (BD) transactions and positive data from the ASCO conference have stimulated strong performance in the innovative drug sector, with significant cross-border collaborations reported [2][4] - The low interest rate environment is beneficial for innovative drug companies, as it reduces financing costs and allows for increased investment in research and development [4][5] - The majority of innovative drugs currently in development are in the clinical I phase, which accounts for 58% of the pipeline, suggesting a long timeline before potential market entry [5][6] Group 3 - Companies like HaiChuang Pharmaceutical and YiFang Bio have seen significant stock price increases, with HaiChuang's stock rising by 13.3% and YiFang reaching a historical high of 32.8 yuan [5][6] - The innovative drug sector's active market has led to increased trading volumes and a spillover effect into related sub-sectors such as in vitro diagnostics and raw materials [6][7] - Analysts note that while some non-innovative drug companies have experienced volatility due to the hype around individual innovative drug pipelines, core innovative drug stocks have remained relatively stable [7]

Core Viewpoint - The pharmaceutical sector in both A-shares and Hong Kong has shown significant performance, with innovative drug stocks being a key driver of growth, particularly due to external licensing transactions and favorable policies supporting the industry [4][13]. Group 1: Market Performance - The A-share pharmaceutical and biotechnology sector rose by 1.13%, ranking 17th among 31 industries [4]. - In the Hong Kong market, the healthcare index increased by 4.11%, and the biotechnology index rose by 4.52%, outperforming the Hang Seng Index, which gained 2.16% [4]. - The innovative drug sector has seen a substantial increase in external licensing transactions, with a total of $45.5 billion in transactions from January to May 2025, accounting for over 30% of the global total [4][5]. Group 2: Company Developments - The company reported potential transactions that could yield up to $5 billion in upfront and milestone payments, with one transaction expected to complete by June [5]. - The innovative drug sector has been active since a record licensing deal by a major pharmaceutical company on May 20, which has led to increased activity in the sector [4]. Group 3: ETF and Fund Performance - The largest pharmaceutical ETFs in China include the Huabao Medical ETF with a size of 25.9 billion yuan and the E Fund Medical ETF with 20.8 billion yuan, with respective year-to-date gains of 0.92% and 3.32% [9][11]. - The largest innovative drug ETFs are the GF Fund Hong Kong Innovative Drug ETF, the Yinhua Fund Innovative Drug ETF, and the Bosera Fund Hang Seng Medical ETF, with sizes of 9.889 billion yuan, 9.662 billion yuan, and 8.436 billion yuan respectively [9][11]. Group 4: Future Outlook - The innovative drug sector is expected to maintain its growth momentum, driven by policy support, global competitiveness, and the realization of commercial profits [13]. - The demand for innovative drugs is anticipated to recover by 2025, with improvements expected in the medical services and OTC sectors [13].