Core Viewpoint - Junshi Bioscience has announced a new H-share placement, which has led to a decline in its stock prices in both A-share and Hong Kong markets, indicating market concerns about the company's financial strategies and performance [1][2]. Group 1: Stock Performance - On June 17, Junshi Bioscience's A-share closed at 34.64 CNY, down 3.10%, while its Hong Kong share closed at 23.50 HKD, down 9.09% [1]. - The stock had previously closed at 36.08 CNY and 25.65 HKD on June 13, reflecting a decline of 6.65% and 10.47% respectively [1]. Group 2: H-share Placement Details - The company plans to issue 41,000,000 new H-shares at a price of 25.35 HKD per share, which represents approximately 18.70% of the total issued H-shares and 4.16% of the total issued shares as of the announcement date [2]. - The expected total proceeds from the placement are approximately 1,039 million HKD, with a net amount of about 1,026 million HKD after deducting commissions and estimated expenses [2]. Group 3: Use of Proceeds - The company intends to allocate 70% of the net proceeds from the placement towards innovative drug research and development, including projects like JS207, JS212, and JS213 [3]. - The remaining 30% of the net proceeds will be used to supplement working capital and other general corporate purposes [3]. Group 4: Historical Financial Performance - Since its listing on July 15, 2020, Junshi Bioscience has experienced a significant decline in stock price, with the highest price reaching 220.40 CNY on the first trading day [5][6]. - The company has not declared any dividends or stock transfers since its IPO, and its cumulative fundraising from two rounds amounts to 8.613 billion CNY [7]. - The net profit attributable to shareholders has been negative for several years, with figures ranging from -1.35 billion CNY in 2016 to -12.81 billion CNY in 2024 [7].

Market Overview - The Hong Kong stock market for innovative drugs has seen a strong rebound in 2023, with the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index (HSSCPB) achieving a year-to-date increase of 71.83%, contrasting sharply with a decline of 20.74% in the same period last year [1] - The Hong Kong innovative drug ETF (159567) also recorded a significant growth of 67.16% [1] - The ongoing recovery in the secondary market has created new opportunities for numerous pharmaceutical companies seeking to go public, leading to a surge in IPO activity in Hong Kong [1] IPO Activity - In June alone, seven local pharmaceutical companies, including Hansai Aitai, Weili Zhibo, Yinnuo Pharmaceutical, Dongyangguang Pharmaceutical, Changfeng Pharmaceutical, Hemei Pharmaceutical, and Xuanzhu Biological, have submitted applications for listing in Hong Kong [1] - Notably, several of these companies, such as Hansai Aitai, Weili Zhibo, Yinnuo Pharmaceutical, Hemei Pharmaceutical, and Xuanzhu Biological, are still in a loss-making state [1] - The trend of companies transitioning from A-share IPO attempts to Hong Kong listings is evident, as seen with Changfeng Pharmaceutical and Xuanzhu Biological [1] Financial Performance of IPO Candidates - Hansai Aitai reported revenues of 6.664 million yuan and 7.681 million yuan for 2023 and 2024, respectively, with losses of 85.16 million yuan and 116.92 million yuan [2] - Weili Zhibo's revenue for 2023 was 8.865 million yuan, with losses of 36.2249 million yuan and 30.1216 million yuan for 2023 and 2024 [2] - Yinnuo Pharmaceutical generated revenues of 16.849 million yuan and 20.055 million yuan for 2023 and 2024, with losses of 73.3376 million yuan and 17.469 million yuan [2] Industry Trends - The Hong Kong IPO market is becoming increasingly attractive for Chinese pharmaceutical companies due to more flexible and lenient listing conditions compared to the A-share market [2] - The introduction of the "18A" listing rule in 2018 has opened doors for unprofitable biotech companies, fueling the IPO wave among innovative drug companies [3] - The current phase of the pharmaceutical industry is characterized by a "structural thaw," where companies with genuine innovation are beginning to attract financing [3] Challenges for Innovative Drug Companies - Many companies, including Hansai Aitai, face significant challenges due to high R&D costs and prolonged timelines for drug development [4] - The average success rate for drug development from Phase I to FDA approval is only 7.9%, with a lengthy average timeline of 10.5 years [4] - Companies like Weili Zhibo are also navigating uncertainties, having lost significant business development (BD) projects just before their IPO [6] Competitive Landscape - Companies with commercialized products, such as Yinnuo Pharmaceutical and Xuanzhu Biological, are also facing intense market competition and product iteration pressures [8] - Yinnuo Pharmaceutical's flagship product, approved for treating type 2 diabetes, has not yet turned the company profitable, with losses of 73.3 million yuan and 17.5 million yuan projected for 2023 and 2024 [8] - Dongyangguang Pharmaceutical, despite its market leadership, is confronting risks associated with expiring patents, particularly for its key product [9] Strategic Focus - Dongyangguang Pharmaceutical aims to enhance operational efficiency and explore new growth avenues through the integration of its R&D platform and product pipeline [9] - Changfeng Pharmaceutical plans to invest raised funds into the full-cycle R&D and commercialization of inhalation formulations, as well as upgrading production facilities [9] - The overall expectation is that both loss-making and established companies will leverage the Hong Kong listing to navigate the competitive landscape of the biopharmaceutical industry [10]

南都讯 6月10日，广州国家实验室举办了昂拉地韦成果发布会。共和国勋章获得者、中国工程院院士、 广州国家实验室主任钟南山介绍，昂拉地韦是全球首款靶向甲型流感病毒RNA聚合酶PB2亚基的创新 药，具有快速、强效、低耐药等优点。 创新 瞄准全新靶点，为流感防控提供"中国方案" 发布会上，广州国家实验室会同该药联合研发单位广州医科大学附属第一医院、国家呼吸医学中心、国 家呼吸系统疾病临床医学研究中心、广东众生睿创生物科技有限公司以及行业专家解锁该药研发历程、 创新特点及临床疗效。 钟南山介绍，昂拉地韦是全球首款靶向甲型流感病毒RNA聚合酶PB2亚基的创新药，已于5月20日获国 家药监局批准上市，昂拉地韦片III期临床试验结果已发表。 钟南山介绍，流感病毒RNA聚合酶中有三个靶点，昂拉地韦是首个以其中的PB2亚基为靶点的药物，为 国际首创。 它所使用的"抢帽"(抢抓宿主细胞的mRNA帽子)机制与玛巴洛沙韦的"酶切"(切断宿主mRNA)机制不同， 此前国外机构曾尝试利用该机制研发药物，但临床研究未获最终成功。 特点 能较快缓解症状，耐药发生率低 关于该新药特点，钟南山介绍，该药可以较快缓解症状，"一两天、两三天就可以让 ...

Group 1: Company Developments - Banu International Holdings Limited submitted its listing application to the Hong Kong Stock Exchange, reporting revenues of 5.639 billion RMB in Q1 2024 and 7.087 billion RMB in Q1 2025, with adjusted net profits of 575 million RMB and 767 million RMB respectively [1] - Midea Group announced a share repurchase plan with a maximum amount of 10 billion RMB and a minimum of 5 billion RMB, aiming to repurchase up to 1 billion shares, which is approximately 1.30% of the total issued shares [6] - *ST Zhongdi plans to transfer its real estate development assets and liabilities to its controlling shareholder for 1 RMB, focusing on property services and asset management for strategic transformation [7] - Muyuan Foods announced that its application for H-share issuance has been accepted by the China Securities Regulatory Commission [8] - *ST Jiuyou's stock will be delisted, with the Shanghai Stock Exchange initiating the delisting process due to significant reporting violations, including a fine of 8.5 million RMB [10] - Weir Shares will change its name to Haowei Group, effective June 20, 2025 [11] - Three squirrels terminated the acquisition of Hunan Ailing Food Technology due to failure to reach agreement on core terms [12] - Bohai Automobile plans to acquire stakes in four automotive parts companies through a combination of share issuance and cash payments [13] - Zhujiang Beer elected a new chairman, Huang Wensheng, following the retirement of the previous chairman [14] Group 2: Industry Trends - The National Medical Products Administration announced measures to support innovative drug development, including a 30-day review process for clinical trial applications [3] - Guangdong Province aims to cultivate 3-5 leading enterprises in the nuclear medicine industry by 2030, enhancing innovation capabilities and establishing a competitive industry cluster [5] - The National Radio and Television Administration is implementing regulations to improve user experience in internet television services, addressing issues related to automatic renewal and user complaints [4] - Shanshui Technology plans to invest 6 billion RMB in a new chemical materials project, expected to generate an annual output value of 8 billion RMB upon completion [19]

每经记者｜陈星 每经编辑｜陈俊杰 ｜ 2025年6月17日 星期二 ｜ 南模生物公告，由于公司第四届董事会非独立董事候选人、独立董事候选人均还需要进一步讨论，公司 董事会同意取消2024年度股东大会第8项至第12项议案，并同意第三届董事会延期换届。 点评：此前因董事反对及弃权，南模生物两项事关董事候选人的议案未获通过。第10项议案为选举严惠 敏为非独立董事候选人，第15项为选举陈开伟为独立董事候选人。此次延期换届选举为前序事项的延 续。 NO.3 奥精医疗创始人、实控人之一崔福斋逝世 奥精医疗公告，公司创始人、实控人之一崔福斋因病不幸逝世，享年80岁。崔福斋作为生物材料领域的 知名专家，为世界生物材料和再生医学事业的进步与发展，为我国生物材料医疗器械相关产业跻身世界 前列作出突出贡献。 点评：企业需检视是否已建立科学的决策授权体系、核心技术的制度化传承机制，以及接班人计划。若 早期布局充分，即使创始人离世，公司仍可依托成熟的治理架构平稳过渡。 免责声明：本文内容与数据仅供参考，不构成投资建议，使用前请核实。据此操作，风险自 担。 NO.1 国家药监局公开征求《关于优化创新药临床试验审评审批有关事项的公告（征求 ...

先声药业（02096）与NextCure达成重磅合作。根据协议条款，先声药业有望获得最高达7.45亿美元的 款项，其中包括首付款、开发及销售里程碑付款。此外，先声药业还将享有基于该产品在大中华区以外 市场净销售额的分级特许权使用费，比例最高可达双位数。 上周五，国务院常务会议研究优化药品和耗材集采有关举措。 另外，近期医药依然存在事件驱动，ADA大会（美国糖尿病协会年会）将于6月20日至23日举行，该会 议是代谢类疾病领域的风向标，多项GLP-1RA前沿研究方向及对应重点药品的临床进展将在会议上报 告。 智通财经APP获悉，国家药品监督管理局发布公告称，为落实《国务院办公厅关于全面深化药品医疗器 械监管改革促进医药产业高质量发展的意见》有关要求，支持创新药研发，国家药监局在开展优化创新 药临床试验审评审批试点工作经验基础上，组织起草了《关于优化创新药临床试验审评审批有关事项的 公告（征求意见稿）》，现向社会公开征求意见。 其中提到，为进一步支持以临床价值为导向的创新药研发，提高临床研发质效，对符合要求的创新药临 床试验申请在30个工作日内完成审评审批。 药物临床试验申请审评审批30日通道支持国家重点研发品种， ...

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days for core innovative drug varieties, which may reshape China's innovative drug development landscape [1][3][4]. Summary by Sections Clinical Trial Review and Approval Optimization - The draft aims to significantly enhance the efficiency of drug development, marking a key step towards establishing China as a global hub for innovative drug research [3][4]. - The 30-day review and approval channel will support national key research varieties and encourage early global synchronized research and international multi-center clinical trials [3][4]. Categories of Supported Drugs - The drugs eligible for the expedited review include: 1. Nationally supported key innovative drugs with significant clinical value. 2. Drugs included in the NMPA's Children's Drug Star Program and Rare Disease Care Program. 3. Globally synchronized research varieties, including Phase I, II clinical trials, and international multi-center clinical trials led by Chinese principal investigators [3][4][5]. Impact on Clinical Trial Efficiency - The reduction of the approval timeline from the conventional 60 working days to 30 days (and even 18 days in some regions) is expected to significantly enhance the initiation efficiency of clinical trials, thereby accelerating the pace of research and reducing costs and risks for companies [4][5]. - For instance, a typical oncology drug could see its Phase III multi-center clinical trial approval time reduced by 55 days, potentially allowing for market entry six months earlier [4][5]. Encouragement for Global Collaboration - The inclusion of global synchronized research in the priority channel is anticipated to increase China's attractiveness as a key site for international multi-center clinical trials, motivating multinational pharmaceutical companies to incorporate China into their early global plans [5][8]. Regulatory and Operational Requirements - The draft emphasizes the responsibility of applicants to engage with clinical trial institutions before submitting applications, ensuring that they have the capacity for risk assessment and management [8][9]. - A commitment to initiate clinical trials within 12 weeks post-approval is mandated, which aims to prevent resource idling and compel companies to enhance their clinical operational capabilities [10][12]. Focus on Rare Diseases and Children's Drugs - The draft specifically addresses the needs of "niche" diseases, highlighting the importance of children's drugs and rare disease medications, which have historically faced a lack of systematic policy support in China [10][11]. - The inclusion of these drugs in the fast-track channel is seen as a critical incentive to address the insufficient research motivation in these areas [10][11]. Challenges and Considerations - While the draft presents opportunities, it also raises the bar for companies, requiring them to establish robust risk management and drug safety systems to align with the accelerated timelines [12]. - The implementation of this draft will necessitate careful attention to regional disparities in institutional capabilities and the prevention of local protectionism in the regulatory process [12].

Group 1 - The Ministry of Commerce of Guangdong Province has issued an action plan to accelerate the research and development of radioactive therapeutic drugs, supporting enterprises, medical institutions, and research institutes in enhancing investment in new types of radioactive drugs [5] - Chongqing Steel has signed an asset transfer contract worth 1.081 billion yuan with Chongqing Heavy Industry Group [6] - Muyuan Foods has had its H-share filing materials accepted by the China Securities Regulatory Commission [6] Group 2 - Feitian Integrity's Vice General Manager Li Wei plans to reduce his stake by no more than 0.96% [7] - Fengshan Group's shareholders plan to collectively reduce their holdings by no more than 983,000 shares [7] - Weier Technology will change its stock name to "Haowei Group" starting June 20 [7] Group 3 - Oriental Shenghong's controlling shareholder's concerted action party intends to increase its stake in the company by 500 million to 1 billion yuan [7] - China Bank's Vice President Zhang Xiaodong has left due to job transfer [7] - CITIC Securities has been approved to issue up to 6 billion yuan in technology innovation bonds [7]

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days, which could significantly enhance the efficiency of drug development in China [1][2]. Group 1: Approval Process Changes - The new draft aims to compress the clinical trial review and approval period for key innovative drugs to 30 working days, with some regions like Beijing potentially reducing it to 18 days [2]. - The draft supports the development of drugs that are classified as traditional Chinese medicine, chemical drugs, and biological products, specifically focusing on three categories: nationally supported innovative drugs, drugs for children and rare diseases, and globally synchronized research products [1][4]. Group 2: Impact on Drug Development - The reduction in approval time is expected to significantly improve the efficiency of clinical trial initiation, allowing companies to accelerate their research and capture global market opportunities [2]. - The new policy is anticipated to lower research and development costs and risks, reduce waiting times for companies, and ultimately enhance the international competitiveness of China's pharmaceutical industry [2][3]. Group 3: Focus on Rare Diseases and Children's Drugs - The draft emphasizes the inclusion of drugs for rare diseases and children's medications, addressing unmet clinical needs in these areas [6]. - Currently, only about 10% of the over 800 rare disease drugs available globally have been approved in China, indicating a substantial market opportunity for new drug development in this sector [6]. Group 4: Responsibilities and Compliance - The draft introduces a requirement for applicants to demonstrate their capability in risk assessment and management, ensuring that clinical trials can commence within 12 weeks post-approval [3][4]. - Companies must establish robust drug safety monitoring and risk control systems to align with the expedited review process, ensuring quality and safety standards are maintained [7][8]. Group 5: Global Collaboration and Market Positioning - The inclusion of global synchronized research in the priority review channel is expected to enhance China's attractiveness as a key site for international multi-center clinical trials [2][5]. - Domestic innovative pharmaceutical companies, such as BeiGene and Innovent Biologics, are likely to benefit from this new policy, as it allows them to expedite the development of their first-class new drugs that align with national support directions [5].

南方财经全媒体记者林汉垚 北京报道 近日，多款创新药密集上市，创新药板块关注度持续提升。中邮证券研报指出，创新药板块近期具备较 多催化，海外BD、ASCO大会等事件持续提高板块热度。国内创新药企迎来估值重塑，有望成为贯穿 全年的投资主线。 在此背景下，保险资金作为"长期资金"也将目光投向生物医药、创新药领域，21世纪经济报道记者通过 Wind统计，今年以来，险资共调研医疗健康领域上市公司112家，其中西药行业上市公司50家。 业内人士表示，随着中国医疗健康产业的蓬勃发展，保险资金正以其长期性和稳定性，成为推动创新药 研发的重要力量。 创新药板块强势增长 据了解，上海医药是沪港两地上市的大型医药公司，在医药商业与医药工业板块均处于国内领先地位。 上海医药工业板块覆盖全面，在生物药、化药、中药和罕见病药物等领域积极开展创新转型。其中，中 随着人口老龄化程度的加深、恶性肿瘤和慢性疾病的增加，以及居民健康意识的提高，民众对创新药和 医疗健康管理服务的需求也逐步增强。 2024年7月5日,国务院召开国务院常务会议审议通过《全链条支持创新药发展实施方案》，会议指出， 发展创新药关系医药产业发展，关系人民健康福祉。要全链条 ...