来源：问董秘 投资者提问： 你好。1.HIE是由新生儿脑组织缺氧和脑血流量减少引起的一种新生儿脑损伤疾病，对发育中的大脑有 严重影响，并可能导致显著的死亡率和长期神经系统后遗症，如脑瘫、癫痫、智力障碍等，给家庭社会 带来沉重负担。目前，全球尚无获批的HIE治疗药物。亚低温（therapeutic hypothermia，TH）是目前唯 一被批准的HIE神经保护治疗，用于中重度HIE，但效果有限。WP103可以为全球患儿提供一种全新的 主动干预手段。 2.HIE是一个需求广阔的蓝海市场。全球范围每年约有数十万婴儿罹患中重度HIE，市 场容量有望达到百亿美金。WP103已获得FDA的孤儿药（ODD）和罕见儿科疾病（RPDD）双认定，不 仅体现了创新价值，也意味着药物上市后可能获得7年的市场独占权、新药申请的优先评审、注册费用 免除等一系列政策支持，为后续商业化提供了有力保障。 3.近期完成的大动物药效学研究显示，WP103 在多个关键指标上表现出良好的治疗效果，同步改善行为学、神经评分及脑组织病理变化。试验动物与 人类大脑有相似的生理结构和脑回，提示WP103有望对HIE患儿降低残疾水平、改善认知、记忆损伤。 4 ...

和誉 20251119 摘要 FGFR 4 项目目前进展如何？ FGFR 4 项目在研发日提供的数据和进展超出预期。目前二线加丹药的注册性 临床试验已于今年（2025 年）6 月开始患者入组，进展比原计划更快。预计明 年（2026 年）此时将完成试验并获得 ORR 数据，以便向 CDE 递交 NDA 申请。 这意味着 FGFR 4 可能在 2027 年四季度至 2028 年上半年进入商业化状态。 此外，一线加 Combo FURTHER 研究方案已与 FDA 初步沟通完毕，计划明年 上半年确定方案并开展全球多中心 MRCT 试验。 匹米替尼预计 2026 年下半年在中美欧实现商业化，有望带来可持续现 金流。美国市场销售峰值预计 5-6 亿美元，欧洲 4-5 亿欧元，中国 10- 15 亿人民币，加拿大和日本市场也将贡献增量。 FGFR 4 项目二线加丹药注册性临床试验提前至 2025 年 6 月启动患者 入组，预计 2026 年完成试验并获得 ORR 数据，有望 2027 年四季度至 2028 年上半年商业化。一线加 Combo FURTHER 研究方案已与 FDA 初步沟通，计划明年上半年开展全球多中心 M ...

Financial Performance - Revenue for 1-9/2025 was RMB 19,891 million, a decrease of 12.3% compared to RMB 22,686 million in 1-9/2024[27] - Gross profit for 1-9/2025 was RMB 13,049 million, down 18.4% from RMB 15,985 million in 1-9/2024[27] - Gross profit margin decreased by 4.9 percentage points, from 70.5% in 1-9/2024 to 65.6% in 1-9/2025[27] - R&D expenses increased by 7.9%, from RMB 3,880 million in 1-9/2024 to RMB 4,185 million in 1-9/2025[27] - Reported profit attributable to shareholders decreased by 7.1%, from RMB 3,778 million in 1-9/2024 to RMB 3,511 million in 1-9/2025[27] - Underlying profit attributable to shareholders decreased by 23.0%, from RMB 3,999 million in 1-9/2024 to RMB 3,079 million in 1-9/2025[27] - Finished drugs revenue decreased by 17.2%, from RMB 18,670 million to RMB 15,450 million[28] - Revenue from oncology decreased significantly by 56.8%, from RMB 3,809 million to RMB 1,645 million[29] - Revenue from nervous system decreased by 21.6%, from RMB 7,234 million to RMB 5,669 million[29] - License fee revenue was RMB 1,540 million in 1-9/2025, compared to no revenue in 1-9/2024[29] R&D and Regulatory Updates - 3 new drugs were approved[5] - 5 breakthrough therapy designations were received[5] - 12 new pivotal clinical trials were initiated[7] - 52 IND approvals were obtained, including 42 in China and 10 in North America[7] BD and Shareholder Returns - License-out agreements were made for SYS6005, Irinotecan Liposome Injection, SYH2086 and strategic collaboration with AstraZeneca[9, 115] - A total of HK$300 million worth of shares have been repurchased this year[8] - The 2025 interim dividend is HK14 cents per share[8] R&D Pipeline Highlights - Anbenitamab injection co docetaxel treatment of 1L HER2+ relapse/metastasis breast cancer was published in Cancer Communications, with ORR of 76.4% and mPFS of 27.7m[37] - SYS6091 for injection has been granted as BTD by NMPA for the treatment of platinum resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or whole population of patients with fallopian tube cancer and HER2-positive advanced colorectal cancer[45] - JMT101+ Irinotecan has been granted as BTD by NMPA for the treatment of RAS, RAF, EGFR ECD and PIK3CA exon 20 wild-type advanced colorectal cancer after failure of standard treatment in second-line or beyond[51] - The company has approximately 200 innovative drugs and new formulations[4, 96]

会上，白云山稀核健康与全球医疗科技巨头GE医疗签署战略合作协议，双方将致力在精准医疗与核医 学领域的发展与创新，为充分发挥白云山稀核健康在放射性药物研发、生产与管理专业优势，以及GE 医疗深厚的技术沉淀，推动医学影像前沿技术的提升及转化，共同引领核医学诊疗一体化的发展。此次 合作既是广药集团"科技化""国际化"战略的具体实践，也是跨界资源整合、推动产业升级的重要探索。 白云山稀核健康此次发布的完全自主知识产权医用放射性核素一体化解决方案，成功攻克固体靶系统与 分离纯化技术壁垒，构建了从辐照到核素制备的全链条技术体系；同步推出的镓-68、锆-89、铼-186与 铜-64四大核心医用核素，涵盖精准诊断、靶向治疗及诊疗一体化方向，标志着广药集团已能完全自 主、稳定地制备上述四种关键医用放射性核素以及在多核素药物研发平台的建设上取得了决定性突破。 中证报中证网讯（王珞）11月18日，2025年广药集团、广药白云山（600332）战略合作研讨会在南京举 办。大会汇聚合作伙伴、行业专家及企业代表等430余位嘉宾，搭建起覆盖医药大健康全产业链的高端 对话与资源对接平台，集中发布了广药集团创新战略、创新成果与合作规划，其中核 ...

Group 1 - The core viewpoint emphasizes the importance of encouraging the development of innovative drugs to enhance clinical medication technology and improve public health, while also supporting the self-reliance and technological innovation of the biopharmaceutical industry [1] - The provincial medical insurance bureau and health committee have jointly issued a notice to support high-quality development of innovative drugs across the entire chain, aiming to better meet the public's needs for disease prevention, treatment, and medication [1] - The notice outlines measures to support the inclusion of innovative drugs in the basic medical insurance drug list and to establish a dynamic adjustment mechanism for this list based on the capacity of the insurance fund and clinical advancements [1] Group 2 - Local medical insurance and health departments are required to focus on key issues and develop targeted measures to ensure effective implementation of policies, including evaluating the impact of support measures [2] - There is an emphasis on improving data sharing and monitoring related to drug usage among relevant departments to provide data support for dynamically improving policies that support innovative drug development [2] - To strengthen fund supervision, local areas are encouraged to innovate regulatory methods, enhance big data analysis, and integrate online and offline inspections to combat fraud in medical insurance [2]

Core Viewpoint - The announcement by BaiLi TianHeng regarding its innovative drug izabren achieving dual primary endpoints in the Phase III clinical trial for advanced esophageal squamous cell carcinoma marks a significant breakthrough, indicating strong potential for meeting clinical needs in post-line treatment and reshaping market valuation perceptions of the company [1][2]. Group 1: Clinical Trial Results - Izabren has achieved both progression-free survival (PFS) and overall survival (OS) as dual primary endpoints in its Phase III clinical trial, a first for an ADC drug in this indication [2][3]. - The drug demonstrated a 39.6% objective response rate (ORR) and a median PFS of 5.4 months in earlier Phase Ib studies, reinforcing its therapeutic potential [3]. Group 2: Market and Commercialization Potential - Izabren's unique mechanism of action positions it favorably for commercialization across multiple cancer types, with significant advancements noted in nasopharyngeal carcinoma and non-small cell lung cancer [4][5]. - The drug's potential annual peak sales are projected to exceed $20 billion, supported by its broad indication coverage and the absence of similar products in the market [6]. Group 3: Strategic Decisions and Financial Position - The decision to delay the Hong Kong IPO reflects a strategic retreat in response to market conditions, allowing the company to focus on its robust pipeline and clinical data [7][8]. - BaiLi TianHeng has a strong cash position of 6.086 billion RMB, ensuring operational and developmental sustainability for the coming years [8].

Core Insights - The strategic cooperation seminar held by Guangzhou Pharmaceutical Group and Guangzhou Baiyunshan Pharmaceutical Group focused on the theme "New Journey Without Boundaries, Together Towards the Future" and gathered over 430 guests from various sectors [1][2] - Guangzhou Pharmaceutical Group aims to achieve modernization, digitalization, technological advancement, and internationalization as part of its "14th Five-Year Plan" to accelerate the goal of "recreating a new Guangzhou Pharmaceutical" [1] Group 1 - Guangzhou Pharmaceutical Group's capital operations are robust, with a fund subscription scale of 4.7 billion yuan and actual contributions of 2.4 billion yuan, focusing on innovative drugs and high-end medical devices [1] - The company is advancing its technological innovation with nearly 20 new drugs under research and 26 new product projects added this year [1] - International expansion is entering a new phase, with ongoing efforts to explore markets in Southeast Asia, the Middle East, and South America [1] Group 2 - A key highlight of the seminar was the announcement of the nuclear medicine industry layout and the innovative achievements of Guangzhou Baiyunshan's nuclear health pharmaceutical company [2] - A strategic cooperation agreement was signed between Baiyunshan and GE Healthcare to empower the high-quality development of the nuclear medicine industry through cross-industry collaboration [2] - The launch of the "China Innovative Drug R&D and Industry Development Research Report Project" aims to integrate resources across the industry chain and address challenges in innovative drug development, supporting China's transition from a major pharmaceutical country to a strong pharmaceutical nation [2]

Group 1 - The core viewpoint of the news is that the innovative drug sector is experiencing a short-term adjustment, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index down by 1% and the CSI Innovative Drug Industry Index down by 0.8% as of 14:40 [1] - Despite the recent decline, there is a strong willingness among investors to allocate funds to the innovative drug sector, with net inflows exceeding 6 billion yuan in Hong Kong and over 3 billion yuan in A-shares since November [1] - Significant advancements in global innovative drug research have been reported, including successful Phase III studies for Roche's new oral SERD drug and FDA approval for Arrowhead's first long-acting lipid-lowering siRNA therapy [1] Group 2 - The Hang Seng Hong Kong Stock Connect Innovative Drug Index is one of the first "pure" innovative drug indices with 100% purity, focusing on leading innovative drug companies in Hong Kong [2] - The CSI Innovative Drug Industry Index targets the A-share innovative drug sector, consisting of no more than 50 leading companies primarily engaged in innovative drug research and development [2] - The Hang Seng Innovative Drug ETF (159316) and the E Fund Innovative Drug ETF (516080) track these indices, providing investors with convenient tools to invest in cutting-edge innovative drug companies [2]

Core Insights - The company focuses on sustainable development through R&D innovation and internationalization, enhancing its presence in "strong advantages" and "high potential chronic disease" sectors, particularly in digestion, mental health, cardiovascular, metabolism, and autoimmune fields [1] Investment Highlights - The company maintains a "buy" rating and raises the target price to CNY 49.13 per share from CNY 43.96. Projected revenues for 2025-2027 are CNY 120.36 billion, CNY 123.95 billion, and CNY 130.29 billion, with growth rates of 1.9%, 3.0%, and 5.1% respectively. Net profits are forecasted at CNY 22.21 billion, CNY 22.95 billion, and CNY 23.91 billion, with growth rates of 7.7%, 3.4%, and 4.2%. EPS is expected to be CNY 2.46, CNY 2.54, and CNY 2.64 [2] R&D Pipeline Progress - The company reports significant advancements in its R&D pipeline. In the digestion sector, the P-CAB product JP-1366 tablet has been submitted for market approval, and the injection form has completed the first patient enrollment in Phase II. In the autoimmune sector, the IL-17A/F psoriasis and ankylosing spondylitis indications have completed Phase III trials, with psoriasis expected to be submitted for approval this year. In the mental health sector, the NS-041 tablet for epilepsy has completed Phase II enrollment, and the IND application for depression has been accepted. The new indication for Triptorelin microspheres for central precocious puberty has completed Phase III enrollment. Additionally, a new oral GnRH antagonist project for assisted reproduction is preparing for Phase II trials, and a quadrivalent influenza recombinant protein vaccine has completed Phase I enrollment. The semaglutide diabetes indication is expected to be approved this year, with the weight loss indication in late Phase III trials [3] International Expansion - The company is enhancing its overseas business layout, particularly in Vietnam, where a company acquisition is under approval. The target company, Imexpharm, has shown stable performance with over 20% growth in revenue, profit, and EBITDA. Imexpharm has the largest EU-GMP product line in Vietnam, and both companies are planning product and process transfers to leverage Imexpharm's established market channels and EU-GMP certification for expanding innovative drug products into overseas markets [3] Catalysts - Key catalysts include the ramp-up of new product volumes, clinical data from innovative drug pipelines, and external collaborations for licensing innovative drug pipelines [4]

Market Overview - On November 17, U.S. interest rate cut expectations cooled, leading to a decline in technology stocks, with major Asia-Pacific markets generally falling. The Hang Seng Index closed at 25,930 points, down 454 points (1.7%), breaching the psychological level of 26,000 points [1] - The Hang Seng Technology Index fell by 111 points (1.9%), closing at 5,645 points, with total market turnover increasing to 242.1 billion HKD [1] Company Specifics - Xpeng Motors (9868 HK) reported a total revenue of 20.38 billion HKD for Q3, a year-on-year increase of 102%. However, the company’s Q4 revenue guidance of 21.5 billion to 23 billion HKD, representing a year-on-year growth of 33.5%-42.8%, was below market expectations, leading to a 10.5% drop in its stock price [4] - Alibaba (9988 HK) saw a brief increase in stock price due to the launch of its Qianwen APP but ultimately closed down 0.2% [1] - Tencent (700 HK) and Kuaishou (1024 HK) also experienced declines of 2.0% and 3.2%, respectively [1] Industry Dynamics - The automotive sector saw a broad decline, particularly affecting Xpeng Motors due to concerns over future delivery growth amid the phasing out of new energy vehicle subsidies [4] - The healthcare sector, represented by the Hang Seng Healthcare Index, fell by 1.7%, but major companies did not experience significant declines. Notably, BeiGene (6160 HK) saw a 1.0% increase in stock price following positive clinical research results for its HER2-targeted therapies [5] - The renewable energy and utility sectors also faced declines, with stocks like Xinyi Solar (968 HK) and GCL-Poly Energy (3800 HK) dropping between 2.9% and 8.6% [5]