Core Viewpoint - The Hong Kong innovation drug sector is experiencing a downturn, with the Hong Kong Stock Connect Innovation Drug ETF (520880) declining over 2% and major stocks like Kangfang Biotech and 3SBio dropping more than 5% [1][9]. Group 1: Market Performance - The Hong Kong innovation drug sector has entered a phase of adjustment since early September, with the ETF index retreating over 19%, indicating that previous high risks have been sufficiently released [3][12]. - There is a surge in "bottom-fishing" capital, with over 56 million yuan entering the Hong Kong Stock Connect Innovation Drug ETF recently [1][9]. Group 2: Investment Opportunities - The National Healthcare Security Administration released the first version of the "Medical Insurance + Commercial Insurance Dual Directory," which may boost investment enthusiasm for innovative drugs in the short term [2][11]. - The 2025 National Medical Insurance Drug List successfully added 114 new drugs, including 50 innovative drugs, with an overall success rate of 88%, significantly higher than the 76% in 2024 [4][11]. - Analysts suggest that the current market conditions may present a favorable opportunity for long-term investment in core innovative drug assets [3][12]. Group 3: ETF Characteristics - The Hong Kong Stock Connect Innovation Drug ETF (520880) is the largest in its category, with a scale of 2.142 billion yuan and an average daily trading volume of 458 million yuan since its inception [7][15]. - The ETF's index has three unique advantages: it is purely focused on innovative drug companies, has a high concentration of leading firms with over 72% weight in the top ten stocks, and employs measures to control risks associated with less liquid stocks [5][6][13].

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Core Viewpoint - The recent adjustments to the national basic medical insurance directory and the introduction of the commercial insurance innovative drug directory mark significant steps towards enhancing access to innovative treatments in China, particularly for high-cost therapies like CAR-T drugs [2][6]. Summary by Sections National Basic Medical Insurance Directory Adjustments - A total of 114 new drugs were added to the basic medical insurance directory, including 50 first-class innovative drugs [2]. - The total number of drugs in the basic medical insurance directory has increased to 3,253, comprising 1,857 Western medicines and 1,396 traditional Chinese medicines [3]. - New inclusions cover various fields such as oncology, chronic diseases, mental health, and pediatric medications, with several rare disease treatments also added [3]. Commercial Insurance Innovative Drug Directory - The commercial insurance innovative drug directory aims to include high-innovation drugs that exceed the basic insurance scope but offer significant clinical value and patient benefits [6]. - A total of 121 drugs underwent formal review for the commercial insurance directory, with 24 entering price negotiation, ultimately resulting in 19 drugs from 18 companies being included [6]. - Notable inclusions are five CAR-T therapies, which previously cost over one million yuan per injection, making them unaffordable for many patients [6]. Performance of Pharmaceutical Companies - Several leading pharmaceutical companies have reported their successes in the 2025 national medical insurance negotiations, with Heng Rui Pharmaceutical having 20 drugs included, contributing 7.554 billion yuan to their total revenue [5]. - Innovent Biologics announced that 7 of its new drugs were included in the updated national medical insurance directory, with 12 of its 17 innovative drugs now covered [5]. Specific Drug Inclusions - The directory includes drugs for Alzheimer's disease, such as the monoclonal antibodies from Eisai and Eli Lilly, and several rare disease treatments [7]. - Some high-profile drugs, like Novo Nordisk's semaglutide and Bristol-Myers Squibb's nivolumab, were not included despite passing the formal review [8]. Implementation Timeline - The new directory is set to be officially implemented nationwide on January 1, 2026 [9].

Core Viewpoint - 康方生物's five approved drugs have been successfully included in the latest version of the National Medical Insurance Drug List (2025) in China, which will take effect on January 1, 2026 [1][2] Group 1: Drug Approvals and Indications - 开坦尼 (卡度尼利, PD-1/CTLA-4) has successfully renewed its existing indication for recurrent or metastatic cervical cancer and added new indications for first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer, as well as first-line treatment for persistent, recurrent, or metastatic cervical cancer [1] - 依达方 (依沃西, PD-1/VEGF) has renewed its existing indication for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFRTKI treatment and added a new indication for first-line treatment of PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC [1] - 安尼可 (派安普利, PD-1) is included for the treatment of second-line and above classical Hodgkin lymphoma, first-line locally advanced or metastatic squamous NSCLC, second-line or above nasopharyngeal carcinoma, and first-line nasopharyngeal carcinoma [2] - 伊喜宁 (伊努西, PCSK9) is included for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, as well as heterozygous familial hypercholesterolemia [2] - 爱达罗 (依若奇, IL-12/IL-23) is included for the treatment of moderate to severe plaque psoriasis [2] Group 2: Company Commitment and Future Plans - The company is dedicated to providing more globally innovative and best-in-class treatment options, continuously improving patient accessibility and affordability [2] - The company aims to deepen its focus in various disease areas and promote the inclusion of more innovative drugs and new indications in the National Medical Insurance Drug List to benefit more patients [2]

Core Viewpoint - 康方生物's five approved drugs have been successfully included in the latest version of the National Medical Insurance Drug List (2025) in China, which will be implemented from January 1, 2026 [1][2][3] Group 1: Drug Approvals and Indications - 开坦尼® (卡度尼利, PD-1/CTLA-4) has renewed its original indication for recurrent or metastatic cervical cancer and added new indications for first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer, as well as first-line treatment for persistent, recurrent, or metastatic cervical cancer [1] - 依达方® (依沃西, PD-1/VEGF) has renewed its original indication for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFRTKI treatment and added a new indication for first-line treatment of PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC [1] - 安尼可® (派安普利, PD-1) is included for the treatment of second-line and above classical Hodgkin lymphoma, first-line locally advanced or metastatic squamous NSCLC, second-line or above nasopharyngeal carcinoma, and first-line nasopharyngeal carcinoma [2] - 伊喜宁® (伊努西, PCSK9) is included for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, as well as heterozygous familial hypercholesterolemia [2] - 爱达罗® (依若奇, IL-12/IL-23) is included for the treatment of moderate to severe plaque psoriasis [3] Group 2: Company Commitment and Future Plans - The company is dedicated to providing more innovative and best-in-class treatment options for patients and aims to continuously improve patient accessibility and affordability [3] - The company plans to deepen its focus in various disease areas and advance more innovative drugs and new indications into the National Medical Insurance Drug List to benefit more patients [3]

Core Insights - 康方生物's five approved drugs have been successfully included in the latest National Medical Insurance Drug List (2025) by the National Healthcare Security Administration of China, effective from January 1, 2026 [1][2][3] Group 1: Drug Approvals and Indications - 开坦尼 (卡度尼利, PD-1/CTLA-4) has renewed its existing indication for recurrent or metastatic cervical cancer and added new indications for first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer, as well as first-line treatment for persistent, recurrent, or metastatic cervical cancer [1] - 依达方 (依沃西, PD-1/VEGF) has renewed its existing indication for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFR TKI treatment and added a new indication for first-line treatment of PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC [1] - 安尼可 (派安普利, PD-1) is included for the treatment of second-line and above classical Hodgkin lymphoma, first-line locally advanced or metastatic squamous NSCLC, second-line or above nasopharyngeal carcinoma, and first-line nasopharyngeal carcinoma [2] - 伊喜宁 (伊努西, PCSK9) is included for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, as well as heterozygous familial hypercholesterolemia [2] - 爱达罗 (依若奇, IL-12/IL-23) is included for the treatment of moderate to severe plaque psoriasis [3] Group 2: Company Commitment and Future Plans - The company is dedicated to providing more globally innovative and best-in-class treatment options, continuously improving patient accessibility and affordability [3] - The company aims to deepen its focus in various disease areas and promote more innovative drugs and new indications to be included in the National Medical Insurance Drug List, benefiting more patients [3]

Akeso, Inc. 康 方 生 物 科 技（ 開 曼 ）有 限 公 司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） （股 份 代 號：9926） 香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 之 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 伊喜寧®（ 伊努西，PCSK 9 ）新藥納入2025版目錄，用於治療原發性高膽固醇血症 和混合型高脂血症，及雜合子型家族性高膽固醇血症。 愛達羅®（ 依若奇，IL -12 / IL -23 ）新藥納入2025版目錄，用於治療中度至重度斑塊 型銀屑病。 本公司致力於為患者帶來更多全球首創、同類最佳的治療選擇，並持續提高患者 的可及性和可負擔性。本公司將深耕各大疾病領域，推進更多創新藥物、新適應 症納入國家醫保藥品目錄，惠及更多患者。 自願公告 康方生物5款已上市藥物所有獲批適應症均被成功納入 最新版國家醫保藥品目錄 康方生物科技（ 開曼 ）有限公司（「本公司」，連同其附屬公司統 ...

Core Viewpoint - Kangfang Biopharma successfully negotiated all indications for its five self-developed new drugs to be included in the national medical insurance catalog, marking a significant achievement for the company in expanding access to its innovative therapies [2] Group 1: Drug Development and Approval - All five self-developed new drugs from Kangfang Biopharma have received approval for their respective indications and are now included in the national medical insurance catalog [2] - The newly negotiated dual-antibody drug, Cardunili, and Yivosi have added multiple first-line indications, enhancing their market potential [2] - Three drugs that participated in negotiations for the first time successfully secured inclusion for all their indications in the national medical insurance catalog [2]

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11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 康方生物科技（開曼）有限公司 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 | 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) | 09926 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | 本月底法定/ ...

Core Viewpoint - The innovative drug concept stocks have shown a rebound, with notable increases in share prices for several companies, driven by recent developments in the healthcare policy landscape in China [1]. Group 1: Stock Performance - Gilead Sciences-B (01672) increased by 10.26%, reaching HKD 13.11 [1] - Kangfang Biotech (09926) rose by 4.15%, reaching HKD 123.1 [1] - Zai Lab (09688) saw a 3.36% increase, reaching HKD 15.69 [1] - Xiansheng Pharmaceutical (02096) grew by 2.9%, reaching HKD 13.48 [1] Group 2: Policy Developments - In November, the National Healthcare Security Administration initiated negotiations for the 2025 National Basic Medical Insurance Drug List and the pricing consultation for the commercial insurance innovative drug list [1] - The fourth batch of traditional Chinese medicine centralized procurement was launched nationwide [1] - Beijing introduced policies related to medical devices, and the State Council meeting outlined the promotion of provincial-level coordination for basic medical insurance [1] Group 3: Market Insights - Bohai Securities highlighted the importance of the upcoming release of the new basic medical insurance drug list and the first commercial insurance innovative drug list in early December, indicating potential investment opportunities for related pharmaceutical companies [1] - Zhongyou Securities noted that despite a temporary vacuum in domestic BD (business development) transactions, there have been multiple collaborations with multinational corporations (MNCs) since Q4, reflecting recognition of the innovative research capabilities of domestic companies [1] - The strong competitive advantages of China's innovative drug industry, including the capacity of the industry chain, pipeline quantity and quality, and research efficiency, are expected to foster long-term positive trends [1]