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]

Core Viewpoint - The innovative pharmaceutical stocks have shown a rebound, with notable increases in share prices for several companies, driven by recent policy developments and market dynamics [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, and new policies regarding medical devices were introduced in Beijing [1] - The State Council meeting outlined plans to promote provincial-level coordination of 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 in related pharmaceutical companies [1] - Zhongyou Securities noted that despite a temporary vacuum in domestic BD outbound transactions, several collaborations with multinational corporations (MNCs) have emerged since Q4, reflecting the recognition of domestic innovative drug companies' R&D capabilities [1] - The strong competitive advantages of China's innovative drug industry, including the capacity of the industry chain, pipeline quantity and quality, and R&D efficiency, are expected to drive long-term industry trends [1]

Core Viewpoint - The Hong Kong innovative drug concept stocks have shown a rebound today, indicating a positive market sentiment towards this sector [1] Company Performance - Gilead Sciences-B (01672.HK) increased by 10.26%, reaching HKD 13.11 [1] - CanSino Biologics (09926.HK) rose by 4.15%, trading at HKD 123.1 [1] - Zai Lab (09688.HK) saw a gain of 3.36%, with a price of HKD 15.69 [1] - Ascletis Pharma (02096.HK) grew by 2.9%, priced at HKD 13.48 [1]

Core Viewpoint - The innovative drug sector is experiencing a rebound, with notable stock price increases for several companies following recent policy developments in China's healthcare system [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%, priced at HKD 123.1 [1] - Zai Lab (09688) saw a 3.36% increase, trading at HKD 15.69 [1] - Xiansheng Pharmaceutical (02096) grew by 2.9%, now at 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 of innovative drugs for commercial insurance [1] - The fourth batch of traditional Chinese medicine procurement has commenced, and new policies regarding medical devices have been introduced in Beijing [1] - The State Council has outlined plans to advance provincial-level coordination of basic medical insurance [1] Group 3: Investment Opportunities - 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, suggesting potential investment opportunities in related pharmaceutical companies [1] - Zhongyou Securities noted that despite a temporary lull in domestic BD (business development) transactions, there have been multiple collaborations with multinational corporations (MNCs) since Q4, indicating ongoing interest in domestic innovative drug companies [1] - The purchasing behavior of overseas MNCs is seen as a validation of the innovative research capabilities of domestic companies, reflecting China's strong competitive advantages in the global innovative drug industry [1]

Group 1 - The core viewpoint is that the innovative drug sector is expected to remain the most important investment theme in the pharmaceutical sector for the upcoming year, with significant positive catalysts emerging [2] - The Hong Kong pharmaceutical ETF (159718.SZ) has seen a 0.74% increase, with notable gains in constituent stocks such as Kangfang Biopharma (4.57%), MicroPort Scientific (4.15%), and Zai Lab (3.95%) [1] - The U.S. job market showed a significant decline in November, with private sector jobs decreasing by 32,000, the largest drop in two and a half years, which has heightened expectations for a Federal Reserve interest rate cut [1] Group 2 - The pharmaceutical sector has experienced a 2-3 month adjustment period, leading to a relative low in stock prices, market expectations, and institutional allocations, thus enhancing investment safety margins [2] - Multiple favorable policies are set to be released, including December's medical insurance negotiations and international conferences, which are expected to positively impact the industry [2] - The U.S. biotechnology index (XBI) has risen by 2.84%, reflecting a strong performance in the healthcare sector, with expectations of a gradual recovery in global innovative drug financing and demand [1][2]

Group 1 - The core viewpoint of the news is that after a four-day decline, the Hong Kong innovative drug sector has rebounded, with leading stocks like Kangfang Biotech and Rongchang Biotech showing significant gains [1][7] - The Hong Kong Stock Connect Innovative Drug ETF (520880) has over 70% of its holdings in leading innovative drug stocks, indicating strong market confidence [1][7] - The innovative drug sector is expected to be a major upward trend in the cross-year market, supported by China's pharmaceutical industry entering a critical phase of "innovation realization + global layout" [3][9] Group 2 - The Hong Kong Stock Connect Innovative Drug ETF (520880) has a total scale of 2.142 billion yuan and an average daily trading volume of 458 million yuan since its listing, making it the largest and most liquid ETF tracking the same index [5][10] - The index tracked by the ETF, the Hang Seng Stock Connect Innovative Drug Select Index, has a high concentration of leading stocks, with the top ten stocks accounting for 72.57% of the total weight, showcasing the strength of the innovative drug sector [3][10] - The ETF is designed to cover pure innovative drug companies without including CXO, ensuring a comprehensive representation of the innovative drug research and development sector [4][9]

Core Viewpoint - The launch of the China Drug Price Registration System marks a significant step towards a globalized pricing framework for innovative drugs, enhancing market-oriented pricing capabilities for pharmaceutical companies and supporting the development of a new pricing ecosystem that aligns drug prices with innovation value and market demand [1][2][6]. Group 1: Drug Price Registration System - The new system allows domestic and international pharmaceutical companies to independently register drug prices, ensuring accountability for price authenticity [1][3]. - The system operates under the principle of "one location acceptance, nationwide sharing, global openness," and is managed by a state-owned enterprise in Beijing [1][3]. - The first batch of companies to register prices includes major players such as China National Pharmaceutical Group, Beijing Tongrentang, and Roche, indicating strong industry participation [3]. Group 2: Impact on Pharmaceutical Industry - The system is expected to enhance the pricing strategies of pharmaceutical companies, allowing them to adjust prices based on clinical value, supply-demand dynamics, and competitive landscape [3][4]. - The dual mechanism of registration and query will promote transparency in drug pricing, moving away from previous opaque practices [4]. - The establishment of this system is anticipated to create a comprehensive pricing structure that encompasses innovative drugs, insurance payment prices, and generic drug prices, benefiting the innovative drug sector [5]. Group 3: Global Market Development - The China Drug Price Registration System is designed to facilitate the international expansion of Chinese innovative drugs and attract high-quality foreign drugs into the Chinese market [2][5]. - Data indicates that the total amount of overseas licensing transactions by Chinese pharmaceutical companies exceeded $92 billion in the first three quarters of 2025, highlighting the growing global presence of Chinese innovative drugs [2]. - The system aims to address significant price discrepancies between domestic and international markets, influenced by factors such as currency exchange rates and pricing mechanisms [5]. Group 4: Long-term Industry Implications - The implementation of the drug price registration system is expected to enhance the global competitiveness of China's biopharmaceutical industry and drive high-quality innovation within the sector [6].