致：香港交易及結算所有限公司 公司名稱: 和黃醫藥（中國）有限公司 呈交日期: 2025年8月1日 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00013 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 1,500,000,000 | USD | | 0.1 | USD | | 150,000,000 | | 增加 / 減少 (-) | | | | 0 | | | USD | | | | 本月底結存 | | | 1,500,000,000 | USD | | 0.1 | USD | | 150,000,000 | 本月底法定/註冊股本總額： USD 1 ...

Core Insights - The Chinese life sciences industry is undergoing rapid transformation driven by policy relaxation, technological innovation, the rise of domestic companies, and the development of specialized real estate ecosystems [9][18][39] - The report "Trends in China's Life Sciences" provides a comprehensive overview of current market dynamics, regulatory changes, and future development directions [9] Policy Environment - Nationally, China has relaxed foreign investment restrictions in gene and cell therapy, allowing foreign-owned hospitals in major cities [10][20] - Local governments in cities like Beijing, Shanghai, and Shenzhen are offering targeted subsidies and fast-track approval processes to support biotechnology development [10][27] Industry Innovation and Company Growth - Chinese life sciences companies are shifting from generic drug production to innovative therapies, with firms like CanSino Biologics and BeiGene leading in CAR-T cell therapy and bispecific antibodies [11][29] - These companies are attracting international investment and licensing agreements, enhancing China's position in the global life sciences sector [11][39] Real Estate Development and Regional Hubs - Innovation hubs such as Suzhou BioBay and Shanghai Zhangjiang Hi-Tech Park provide end-to-end support, including shared laboratories and GMP-compliant facilities [12][35] - Second-tier cities like Chengdu and Ningbo are emerging as new growth centers, expanding the life sciences ecosystem [12][35] Owner Perspective - Real estate developers are adapting to industry-specific needs through light-asset models and flexible leasing arrangements [14][45] - While first-tier cities face saturation, demand remains robust in central and western regions, with a focus on sustainability and compliance [14][45] Tenant Perspective - Life sciences tenants are responding to regulatory reforms and increased compliance requirements, seeking flexibility and proximity to talent and infrastructure [15][46] - The highest demand is for GMP-certified laboratories and modular production facilities, emphasizing location advantages and sustainability certifications [15][46] Future Outlook - Growth opportunities lie in AI-driven drug development, personalized medicine, and advanced therapies, supported by government policies [16][39] - Life sciences real estate is evolving from generic parks to specialized, digitally-enabled facilities with high compliance and flexibility [16][39]

7月29日，和黄医药(US ADR)(HCM)开盘上涨5.62%，截至21:30，报18.99美元/股，成交9.37万美元，总 市值33.12亿美元。 财务数据显示，截至2024年12月31日，和黄医药(US ADR)收入总额6.3亿美元，同比减少24.8%；归母 净利润3772.9万美元，同比减少62.56%。 本文源自：金融界 作者：行情君 8月7日，和黄医药(US ADR)将于(美东)盘前披露2025财年中报（数据来源于纳斯达克官网，预计披露日 期为美国当地时间，实际披露日期以公司公告为准）。 资料显示，和黄医药(中国)有限公司(原名:和黄中国医药科技有限公司)是中国首家专注于全球市场的创 新型医药研发企业之一。在过去的20年里,公司建立了具有世界一流的发现和开发能力的全面整合的研 发创新平台。自成立以来,公司致力于将自主发现的抗肿瘤候选药物带向全球患者,首三个药物现已在中 国上市,其中首个药物亦于美国上市。公司还在中国市场建立了深入的具盈利的商业平台,在中国生产、 营销及经销自主研发的创新肿瘤药物,以及处方药和消费保健产品。和黄医药于纳斯达克全球精选市 场、香港交易所以及伦敦证交所的AIM市场上市(纳 ...

在生物医药领域，"授权合作"是常见的模式，并从去年以来加速。 今年创新药行情由跨国药企高额交易驱动。 国际投行Jefferies认为，中国创新药研发性价比高、临床研发成本高，双方BD（商务开发）合作是强强联合，中国药企可借此提升全球商业化能力，但目前 仍处于起步阶段。 继人工智能、新消费等行业后，今年以来中国医药行业迎来了三年低迷后的逆袭。 创新药行情是由跨国药企高额交易所驱动的，美国大药企更是疯狂"扫货"中国管线，超过10亿美元的海外授权（Licensing-out）订单常态化。当前，创新药 行情热度依旧不减，众多生物医药企业排队等待港股IPO。 所谓"授权合作"，即中国药企将候选药物的部分权利（如全球开发、生产、商业化权利）授权给美国药企。中国药企通常仍然保留药物的专利权归属，并无 需建设自主全球商业化能力。美国药企拥有在协议范围内的独占许可权，有权在相关市场开展后续开发与销售，而中国企业则可获得里程碑付款（临床、注 册、销售等），并按药物在美国或全球的销售额获得一定比例（如5%~15%）。 根据港交所披露的数据，截至7月中旬，约有288家企业排队等待IPO，其中不乏生物医药企业试图通过18A规则上市。在 ...

Core Viewpoint - CICC maintains its profit forecast for Hutchison China MediTech (00013) at $360 million for 2025 and $100 million for 2026, with a target price of HKD 30, indicating a 20.5% upside from the current stock price [1] Group 1: Drug Approval and Market Potential - The recently approved indication for Savolitinib is the largest for the drug to date [2] - Approximately 10-25% of non-small cell lung cancer (NSCLC) patients in the US and Europe have EGFR mutations, while the rate is as high as 30-40% in Asian patients [2] - MET amplification is a major mechanism of acquired resistance in EGFR-mutant NSCLC patients, with 15-50% of patients showing MET abnormalities after third-generation EGFR TKI treatment [2] Group 2: Clinical Trial Results - The approval is based on the SACHI Phase III study, which showed significant progression-free survival (PFS) benefits compared to platinum-based chemotherapy [3] - In the SACHI intent-to-treat population, the median PFS for the Savolitinib + Osimertinib combination was 8.2 months and 7.2 months, compared to 4.5 months and 4.2 months for the chemotherapy group, reducing the risk of disease progression by 66% and 60% respectively [3] Group 3: Ongoing Clinical Trials and Regulatory Progress - The SAFFRON Phase III clinical trial is ongoing, focusing on regulatory registration progress overseas [4] - The combination therapy received Fast Track designation from the FDA in 2023, with AstraZeneca conducting the SAFFRON trial to evaluate its effectiveness against platinum-based doublet chemotherapy in MET-overexpressing NSCLC [4] - Attention is recommended on the data readout from SAFFRON in 2026 and the overseas application status [4]

Core Points - HUTCHMED will announce its interim results for the six months ended June 30, 2025, on August 7, 2025, at 7:00 am EDT [1] - The company will host two webcast presentations for analysts and investors to discuss the interim results, with the English session at 8:00 am EDT and the Chinese session at 8:30 am HKT on August 8, 2025 [2] - Both webcasts will be available live on the company website, with a replay accessible shortly after the events [3] Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, global development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [4] - The company has successfully marketed its first three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4]

Core Insights - AstraZeneca announced the approval of the combination therapy of Savolitinib (brand name: Worishe) and Osimertinib (brand name: Taris) by the National Medical Products Administration of China for treating locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients with EGFR gene mutations and MET amplification after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - Savolitinib is the first selective MET inhibitor approved in China, developed in collaboration with Hutchison China MediTech, and is indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 alterations [1] - Osimertinib is an irreversible third-generation EGFR-TKI with confirmed clinical activity in treating NSCLC patients, including those with central nervous system metastases [1][2] Group 2 - The approval is based on the SACHI Phase III clinical trial data, which achieved the predefined primary endpoint of progression-free survival (PFS) in a pre-specified interim analysis [2] - The combination therapy was included in the breakthrough therapy designation by the National Medical Products Administration in 2024 and received priority review for its new drug application in 2025 [2] - The approval marks the third indication for Savolitinib in China, highlighting its significance in addressing complex challenges in lung cancer treatment [2]

Summary of the Conference Call for Hehuang Pharmaceutical Company Overview - Hehuang Pharmaceutical is a biopharmaceutical company focused on innovative oncology drugs, established in 2000 with over 20 years of history [4][6]. Key Products and Sales Projections - **Fuqingti**: - First innovative drug launched by Hehuang, targeting third-line colorectal cancer. - Expected domestic sales in China for 2024: **$115 million**. - Expected overseas sales (managed by Takeda) for 2024: **$290 million**, with a growth forecast of over **20%** in 2025 [2][4][6]. - Second indication (endometrial cancer) approved in December 2024, contributing limited revenue initially [4][6]. - Third indication (second-line renal cancer) expected to be approved by mid-2026 [2][4]. - **Saiwo**: - Targeting second-line small cell lung cancer after EGFR resistance, expected approval in Q3 2025, with AstraZeneca responsible for domestic sales [2][4][5]. - Ongoing clinical research for first-line MET overexpressing small cell lung cancer, with global filing planned for 2027 [2][4][6]. - **Sofan**: - Sales for neuroendocrine tumors reached nearly **$5 million** last year, with ongoing development for first-line pancreatic cancer [2][8][21]. - **Stata**: - Unique drug for follicular lymphoma, expected approval in H1 2025, aiding in building experience in blood product promotion [2][8]. Collaborations and Market Strategy - Hehuang collaborates with Takeda for overseas sales of Fuqingti and with AstraZeneca for Saiwo in China, with AstraZeneca receiving **30%** of terminal sales [2][7]. - Both companies share responsibilities in different regions and stages of commercialization to enhance product development [7]. Clinical Research and Development Pipeline - Multiple ongoing clinical studies, including: - Saiwo for MET overexpressing gastric cancer, NDA submission planned for late 2025 [8]. - Sofan for neuroendocrine tumors and potential expansion into pancreatic cancer [8][21]. - ATTC antibody-drug conjugate platform with two molecules entering R&D stage, with the first expected to enter clinical trials by the end of the year [9][26]. Financial Overview - Projected revenue from oncology products in 2024: **$270 million**, with over **$90 million** from licensing-related income [27]. - Anticipated new projects for 2025 include NDA submissions for various indications, including renal cancer and gastric cancer [28]. Market Dynamics and Competitive Landscape - Saiwo's market potential is limited due to a small patient population for its current indication, but new indications could significantly enhance its market size [13]. - The introduction of new treatments like Sofan and the SYK inhibitor (Sole) addresses unmet needs in autoimmune diseases, providing long-term treatment options [23][24]. Conclusion - Hehuang Pharmaceutical is positioned for growth with a robust pipeline of innovative oncology drugs and strategic collaborations, aiming to expand its market presence both domestically and internationally. The company is actively pursuing new indications and leveraging partnerships to maximize its product offerings and revenue potential [2][4][6][7][9].

Core Viewpoint - The approval of the combination therapy of Savolitinib (ORPATHYS®) and Osimertinib (TAGRISSO®) by the National Medical Products Administration of China represents a significant advancement in the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations and MET amplification after prior EGFR TKI therapy [1][2]. Company Summary - Hutchison China MediTech Limited (和黄医药) announced the approval of its combination therapy, which is a milestone in addressing the challenges faced by NSCLC patients in China [2]. - The approval will trigger a milestone payment of $11 million from AstraZeneca, which is responsible for the sales of both drugs in China [1]. - The CEO of Hutchison China MediTech emphasized the importance of collaboration with AstraZeneca in achieving this significant progress in treating MET-driven resistance in NSCLC patients [2]. Industry Summary - The combination therapy provides a new oral treatment option for NSCLC patients who develop MET amplification after treatment with EGFR inhibitors, addressing a critical resistance mechanism [2]. - The approval marks the third indication for Savolitinib in China, highlighting the ongoing development and expansion of treatment options for lung cancer patients [2].

Core Insights - The combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) has been approved by the China National Medical Products Administration (NMPA) for treating patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR TKI therapy [1][2][3] - This combination treatment is the only all-oral option available for these patients, providing a chemotherapy-free approach [1][3] - The SACHI Phase III trial demonstrated a 66% reduction in the risk of disease progression or death compared to platinum-based chemotherapy, with a median progression-free survival (PFS) of 8.2 months for the combination versus 4.5 months for chemotherapy [1][3][12] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [15] - The approval of the ORPATHYS and TAGRISSO combination marks a significant milestone in HUTCHMED's mission to address MET-driven progression in NSCLC patients [3][15] - AstraZeneca collaborates with HUTCHMED to market both ORPATHYS and TAGRISSO in China, enhancing the reach of this new treatment option [3][15] Industry Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases [5] - Approximately 30-40% of NSCLC patients in Asia have EGFR mutations, highlighting the need for effective treatment options [5][6] - MET amplification is a common mechanism of acquired resistance to EGFR TKI therapy, affecting 15-50% of patients who experience disease progression [11][12]