自願公告 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，概不對因本公告全部或任何部份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 他克莫司緩釋膠囊獲藥品註冊批件 主席 蔡東晨 香港，2025年10月13日 – 1 – 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「董 事 會 」）欣 然 宣 佈，本集團開發的他克莫司緩釋膠囊（ 0.5 mg、1mg ）（「該產品」）已獲得中華人民共和國國家 藥品監督管理局頒發的藥品註冊批件，並視同通過仿製藥質量和療效一致性評價。 他 克 莫 司 是 一 種 大 環 內 酯 類 免 疫 抑 制 劑 ， 屬 於 鈣 調 神 經 磷 酸 霉 抑 制 劑 。 體 內 外 研 究 均 證 實，他克莫司具有強效的免疫抑制作用，能抑制引起移植物排斥反應的細胞毒淋巴細胞的 形成， ...

自願公告 依達格魯肽α注射液的新藥上市申請 獲國家藥品監督管理局受理 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 佈，本公司附屬公司石藥集團百克（ 山東 ）生物製藥股份有限公司開發的依達格魯肽α注射 液（「該產品」）的新藥上市申請已獲中華人民共和國國家藥品監督管理局受理。該產品按照 治 療 用 生 物 製 品 1 類 新 藥 申 報 ， 其 適 應 症 為 在 控 制 飲 食 和 增 加 運 動 的 基 礎 上 ， 用 於 超 重 或 肥胖成人的長期體重管理。 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的內容概不負責，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份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 主席 蔡東晨 香港，2025年10月13日 該產品為一款重組人源胰高血糖素樣肽-1 (h ...

Core Insights - The Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index has decreased by 3.79% as of October 13, 2025, with notable declines in stocks such as Junshi Biosciences down 10.01% and Innovent Biologics down 7.08% [3] - The Hong Kong Innovative Drug Selection ETF (520690) has also fallen by 3.54%, currently priced at 0.95 yuan, indicating a challenging market environment for innovative drug companies [3] - The European Society for Medical Oncology (ESMO) conference is set to take place from October 17 to 21, 2025, in Berlin, where breakthrough data from various Chinese innovative drug companies is anticipated [3] Company Developments - Rongchang Biopharmaceutical's Taitasip has been proposed for priority review by China's drug regulatory authority, targeting adult patients with IgA nephropathy [4] - Innovent Biologics has initiated Phase III clinical trials for IBI363, aimed at squamous non-small cell lung cancer [4] - SystImmune, a wholly-owned subsidiary of Bai Li Tianheng, has entered a global strategic collaboration with Bristol-Myers Squibb for the dual antibody ADC project, triggering an initial payment of $250 million [4] Market Trends - The trend of Chinese innovative drugs entering international markets is expected to continue, with 72 license-out transactions recorded in the first half of 2025, surpassing the total for 2024 [4] - The total transaction amount for these deals has increased by 16% compared to the entirety of 2024, with 16 transactions exceeding $1 billion [4] - Despite concerns over trade tensions and potential decoupling, the shift of global innovative research and development towards China is viewed as an unstoppable trend [4] ETF Performance - The Hong Kong Innovative Drug Selection ETF has reached a new high with 431 million shares outstanding [5] - Recent net inflows into the ETF amount to 3.01 million yuan, with a total of 75.52 million yuan net inflow over the past 14 trading days [5] - The ETF closely tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index, which reflects the performance of Hong Kong-listed companies involved in innovative drug research, development, and production [5]

Investment Rating - The report maintains an investment rating of "Outperform" with a target of "A" [5] Core Insights - The report highlights the upcoming ESMO conference as a significant catalyst for the innovative drug sector, with multiple domestic companies expected to disclose important data [3][21] - The report suggests focusing on several key companies and products that are likely to benefit from upcoming catalysts, including academic conferences, business development (BD) realizations, and negotiations for medical insurance [20] Summary by Sections Weekly New Drug Market Review - From October 6 to October 12, 2025, the top five gainers in the new drug sector were Yongtai Bio (+13.47%), Fuhong Hanlin (+3.06%), Keji Pharma (+2.77%), Betta Pharma (+1.57%), and Aidi Pharma (+0.83%). The top five losers were Rongchang Bio (-20.97%), Nuocheng Jianhua (-14.83%), Chuangsheng Group (-11.23%), Yifang Bio (-9.77%), and Kelun Botai (-9.08%) [16][17] Recommended Focus Stocks - The report recommends attention on products with high overseas market potential, including: 1. PD-1 upgraded products: Sanofi Pharma 2. GLP-1 assets: Lianbang Pharma 3. ADC assets: Kelun Botai, Baile Tianheng - Potential heavyweights for overseas licensing include: 1. PD-1 upgraded products: Kangfang Bio, Innovent Biologics 2. Breakthroughs in autoimmune fields: Yifang Bio, China Antibody 3. Innovative target ADCs: Fuhong Hanlin, Shiyao Group - Products likely to benefit from medical insurance negotiations include: Hengrui Medicine, Kangnuo Pharma, Maiwei Bio, Zhixiang Jintai, and Haichuang Pharma [20] New Drug Approval and Acceptance Status - No new drug or new indication applications were approved this week, but one new drug application was accepted [25] - A total of 117 new drug clinical applications were approved, and 22 new drug clinical applications were accepted this week [10][27]

Core Viewpoint - The article discusses the significant advancements in AI drug development, highlighting a transformative shift in the pharmaceutical industry where AI is moving from enhancing existing processes to enabling the creation of entirely new drug candidates through innovative design techniques [5][8][9]. Group 1: AI Drug Development Trends - AI drug development is gaining momentum, with several companies achieving substantial business development (BD) transactions, amounting to billions of dollars, indicating renewed investor confidence in the sector [6][7]. - Companies like YuanSi ShengTai and HuaShen ZhiYao have successfully navigated stringent selection processes of multinational pharmaceutical firms, demonstrating the effectiveness of AI in improving drug development success rates [6][7]. Group 2: Technological Advancements - The emergence of advanced AI models, such as AlphaFold 2, has revolutionized protein structure prediction, allowing for the rapid identification of protein structures that were previously difficult to obtain [10][11]. - New AI models, including Chai-2 and ESM3, have shown significant improvements in generating novel protein designs, enhancing the efficiency of drug discovery processes [11][12]. Group 3: Paradigm Shift in Drug Discovery - The traditional drug discovery process, characterized by extensive screening and empirical methods, is being replaced by a more rational and design-focused approach enabled by AI [9][13]. - AI's ability to design drugs from scratch (de novo design) is expected to unlock new therapeutic targets that were previously considered difficult to address, potentially leading to breakthroughs in treating chronic diseases [14][13]. Group 4: Industry Dynamics and Future Outlook - The article outlines three main types of players in the AI drug development space: tech giants with substantial resources, startup teams led by top AI and biological scientists, and traditional pharmaceutical companies leveraging AI for drug development [15][16]. - The future of drug development is anticipated to be heavily influenced by AI, with a focus on delivering viable drug candidates that meet market needs, thereby reshaping the competitive landscape of the pharmaceutical industry [17].

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Views - The in vivo CAR-T technology is emerging as a new hotspot in cell therapy, with significant investment opportunities in the domestic market. Major pharmaceutical companies are actively entering this field, with multiple high-value transactions occurring in 2025 [5][14] - Compared to traditional CAR-T, in vivo CAR-T offers advantages such as reduced manufacturing costs, shortened processing times, and improved accessibility for patients, making it applicable in various diseases including B-cell malignancies and autoimmune diseases [6][15] - The report highlights the performance of various sub-sectors within the pharmaceutical industry, noting that the hospital sector showed the highest increase, while the medical R&D outsourcing sector experienced the largest decline [7][24] Summary by Sections Section 1: In Vivo CAR-T Transactions - Numerous significant transactions in the in vivo CAR-T space have occurred in 2025, indicating strong interest and investment potential. Notable deals include AstraZeneca's acquisition of EsoBiotech for $1 billion and BMS's agreement to acquire Orbital Therapeutics for $1.5 billion [5][14] Section 2: Market Performance - In the second week of October 2025, the pharmaceutical sector declined by 1.20%, underperforming the CSI 300 index by 0.69 percentage points, ranking 25th among 31 sub-industries. The hospital sector saw the largest increase at 1.79% [7][18] - The report provides a detailed analysis of sub-sector performance, with the hospital sector leading gains and the medical R&D outsourcing sector facing the most significant losses [24][28] Section 3: Recommended Stocks - The report recommends several stocks for investment, including Shiyao Group, Sunshine Nuohuo, and Yuekang Pharmaceutical, among others [8][16]

Core Insights - Health insurance is becoming an essential supplement to basic medical insurance, particularly in the context of rising health risk awareness among the public [1] - The introduction of cardiovascular-specific medical insurance by Aixin Life and Hebei Mayo Cardiovascular Hospital aims to address the challenges faced by patients with chronic diseases, particularly those with cardiovascular conditions [1][2] Group 1: Product Launch and Impact - Aixin Life has launched a cardiovascular-specific disease medical insurance product that focuses on prevention, treatment, and rehabilitation for cardiovascular disease patients [1] - The product fills a gap in the insurance market for cardiovascular diseases in Hebei province, providing targeted health protection for the local population [1] - A case study of a patient who benefited from this insurance highlights its effectiveness, as the patient received significant financial support for treatment costs, demonstrating the product's value [2] Group 2: Future Directions and Strategy - Aixin Life plans to enhance its health management services by collaborating with local hospitals, health check-up centers, and pharmaceutical companies to offer a range of health management products targeting chronic and specific diseases [2] - The company aims to transition its business model towards "preventive management healthcare," integrating health insurance with health management to improve patient outcomes [2] - Aixin Life's chairman emphasizes the importance of disease prevention and management, indicating a commitment to expanding coverage for various diseases and creating a comprehensive health management service system [3]

Market Overview - The overall valuation of the market has increased, with the Wind All A Index leading the rise, up by 2.9 percentage points in PE-TTM historical percentile[5] - The PB-LF historical percentile also saw an increase across indices, with the CSI 300 leading at a rise of 4.4 percentage points[5] Industry Insights - In the automotive sector, PE valuation increased by 1.1 percentage points, leading among industries[6] - The non-ferrous metals sector saw a significant rise in PB valuation, up by 14.0 percentage points, indicating strong performance[6] Trading Activity - Trading activity has increased, with the turnover rate rising by 26.0% for the SSE 50 index, while total transaction volume decreased by 1.25%[6] - As of September 30, 2025, the margin trading balance was 2.39 trillion yuan, reflecting a decrease of 1.25% compared to September 26, 2025[6] Company Performance - The company reported a revenue growth from 678,800 yuan in 2022 to 1,908,800 yuan in 2024, with a compound annual growth rate of 67.7%[12] - The gross profit margin improved significantly from 19.9% in 2022 to 32.7% in 2024, maintaining at 32.4% in the first half of 2025[12] Risk Factors - Risks include uncertainties in overseas economic conditions and geopolitical factors that may impact market stability[8] - Potential risks in the pharmaceutical sector include uncertainties in original IP incubation and fluctuations in consumer demand[13]

Investment Rating - The report rates the industry as "Overweight" [4] Core Insights - The siRNA drug industry is entering a new era with the maturation of technology platforms and the expansion of indications, focusing on the commercial value of siRNA drugs for common diseases [2][3] - siRNA drugs have transitioned from rare diseases to common diseases, showcasing strong target expansion capabilities, robust research and development extensibility, long-lasting effects, and low resistance [4][12] - The industry is witnessing a surge in business development (BD) transactions, particularly among multinational corporations (MNCs), indicating a vibrant market for siRNA technology [4][31] Summary by Sections 1. Dawn of a New Era for Small Nucleic Acid Drugs - Small nucleic acid drugs, including siRNA and ASO, are becoming a significant path for drug development, with a focus on their ability to regulate protein production [7] - The global approval of small nucleic acid drugs has reached 23, with siRNA drugs leading the way in rare disease applications [12][13] - Alnylam and other leading companies have demonstrated significant market capitalization differences due to their innovative drug development technologies [14][16] 2. Platform Characteristics and Focus on Indications - The siRNA drug industry is characterized by high barriers in modification and delivery, with a focus on breakthroughs in extrahepatic delivery systems [6][29] - The commercialization of siRNA drugs is accelerating, with multiple common diseases nearing market readiness [6][29] - The GalNAc delivery system has become the mainstream strategy for liver-targeted siRNA delivery, while breakthroughs in extrahepatic delivery are still needed [6][29] 3. Related Companies - Listed companies in the siRNA space include Yuyuan Pharmaceutical, Hengrui Medicine, and others, while unlisted companies include Bewang Pharmaceutical and others [4][12]

Core Insights - AstraZeneca has signed a $555 million collaboration agreement with Algen Biotechnologies to leverage Algen's AI platform for discovering new therapeutic targets in immunology [1] - The partnership aims to utilize CRISPR gene regulation technology and AI-driven drug discovery methods to develop next-generation immunotherapy [1][5] - AI technology is becoming a crucial driver in the pharmaceutical industry, expected to generate over $350 billion annually, especially as companies face a patent cliff of approximately $236 billion by 2030 [2][5] Group 1: AstraZeneca's AI Strategy - AstraZeneca's collaboration with Algen is its third significant partnership this year, reflecting its commitment to AI in drug development [5] - The company has a historical advantage in AI, with 50% of its small molecule pipeline derived from AI research as of 2021 [5][6] - AstraZeneca has established its own AI-CRO, Evinova, to enhance clinical drug development through AI digital solutions [5][6] Group 2: AI in Drug Development - AI is expected to reduce drug development timelines by 50% to 66% and lower costs by 10%, while increasing success rates [5] - The company has previously engaged in high-value collaborations, including a $5.3 billion partnership with CSPC and a $200 million collaboration with Tempus AI and Pathos AI for cancer treatment [7] - AI applications in oncology are particularly emphasized, with one-third of all AI collaborations in the pharmaceutical sector focused on cancer treatment [18][20] Group 3: Industry Trends and Investments - The pharmaceutical industry is witnessing a significant shift towards AI integration, with major companies committing billions to AI-driven research and manufacturing facilities [14][15] - Eli Lilly has risen to the top of the AI readiness rankings among pharmaceutical companies, highlighting the competitive landscape [12] - The need for AI in drug discovery is underscored by the increasing complexity of cancer data and the urgent demand for personalized treatment solutions [18][19]