Market Performance - The pharmaceutical and biotechnology index rose by 0.83% from August 18 to August 22, underperforming the Shanghai Composite Index by 0.62 percentage points [1] - The innovative drug sector saw a mixed performance, with stocks rising by 0.11% during the week [1] - Among 140 innovative drug stocks in A-shares, 96 stocks increased, an increase of 62 stocks compared to the previous week [1] New Drug Approvals - Xuan Bamboo Biotechnology's ALK inhibitor, Dirocitinib (brand name: Xuanfining), received approval from the National Medical Products Administration (NMPA) for treating ALK-positive advanced non-small cell lung cancer [4] - The TROP2ADC (Derdabomab) developed by Daiichi Sankyo and AstraZeneca was approved for treating HR-positive, HER2-negative breast cancer in patients who have previously undergone endocrine therapy and at least one line of chemotherapy [5][9] Market Trends and Projections - The market for drugs treating Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) is projected to exceed $10 billion by 2025, with the approval of semaglutide marking a significant milestone [6] - Semaglutide showed a 36.8% improvement in liver fibrosis among treated patients, compared to 22.4% in the placebo group [6] - In 2024, online pharmacy sales in China are expected to reach 71.513 billion yuan, with a year-on-year growth of 31.69% [7] Company Highlights - Beihai Kangcheng's stock price has surged over 1700% this year, attributed to the approval of its first self-developed rare disease drug and strategic investments [10] - The company aims to highlight the value of rare disease drug development, indicating a shift in market and policy support [10]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The AI drug discovery industry is expected to experience rapid growth, with key milestones anticipated in 2023-2024 and around 2026 [3][22] - The report highlights the significant order received by JingTai Holdings, indicating the initial success of its AI-driven drug discovery platform [18][19] - The pharmaceutical sector has shown varied performance, with A-share pharmaceutical index increasing by 2.2% this week and 26.3% year-to-date, while the Hang Seng Biotechnology Index has surged by 101.6% year-to-date [3][8] Summary by Sections Industry Trends - The A-share pharmaceutical index has outperformed the CSI 300 index by 2.68% this week, but underperformed by 15.07% year-to-date [3][8] - The report notes a weak performance in the pharmaceutical sector this week, with significant gains in medical devices and traditional Chinese medicine, while medical services and raw materials saw declines [3][8] AI Drug Discovery - JingTai Holdings has secured a substantial order worth $58.9 billion, demonstrating the potential of its AI technology in drug discovery [18][19] - AI drug discovery is revolutionizing traditional drug development processes through enhanced efficiency and innovative methodologies [22][25] - The report emphasizes the importance of data in the AI drug discovery industry, highlighting the need for specialized databases and processing tools [25][26] Research and Development Progress - Recent approvals include the ALK inhibitor "Dirocitinib" by XuanZhu Biotech and a new anesthetic drug application by Enhua Pharmaceutical [3] - The report provides a detailed overview of recent drug approvals and clinical trial applications, showcasing the dynamic nature of the pharmaceutical R&D landscape [3][11] Market Insights - The report ranks preferred sub-sectors as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [9][10] - Specific stock recommendations include JingTai Holdings and Chengdu XianDao from the AI drug discovery perspective, and various companies from GLP1 and PD1/VEGF dual antibody sectors [11][12][13]

Major Events - Xianjian Technology (01302) has entered the special review process for innovative medical devices for its nickel-titanium alloy arterial duct occluder [1] - Sunny Optical Technology (02382) signed a memorandum of understanding with GoerTek (002241.SZ) and GoerTek Optical to promote complementary advantages [1] - Fuhong Hanlin (02696) completed the first patient dosing in the U.S. for its HLX43 (targeted PD-L1 antibody conjugate) in an international multi-center Phase II clinical study for advanced non-small cell lung cancer [1] - Shanghai Pharmaceuticals (02607) received drug registration certificates for oxytocin injection and octreotide acetate injection in the Philippines [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYS 6036 injection in China [1] - Kaisa Group (01638) reached a strategic cooperation with CITIC City Construction for the Shenzhen Futian Jiayuan project [1] - Conant Optical (02276) has been included in the Hang Seng Composite Index [1] - China Railway (00390) is investigating the cause of the Qianzhazhuang Yellow River Bridge accident, which has resulted in 12 fatalities and 4 missing persons [1] - Dongfeng Motor Group (00489) plans to be privatized at a premium, while Lantu Automobile has applied for a listing introduction [1] - Baize Medical (02609) has been included in the Hang Seng Index series [1] - Zhongmiao Holdings (01471) plans to acquire 55% of Beijing Kechuang Rongxin Technology Co., Ltd. for 165 million yuan [1] - Huaxing Capital Holdings (01911) intends to establish a strategic cooperation framework with YZi Labs to support the application of Binance Coin and the BNB Chain ecosystem [1] - Sihuan Pharmaceutical (00460) received approval from the National Medical Products Administration for its self-developed innovative drug, Dirocitin [1] - China Tongru (01763) successfully obtained a radiation safety license for its radiation source R&D and production base [1] Operating Performance - Cathay Pacific (00293) and Hong Kong Express carried approximately 3.2 million passengers in July, setting a new monthly record for the year [2] - CSPC Pharmaceutical Group (01093) reported a mid-year profit attributable to shareholders of 2.548 billion yuan, a decrease of 15.64% year-on-year [2] - TCL Electronics (01070) reported a mid-year net profit of 1.09 billion HKD, an increase of 67.78% year-on-year [2] - Chongqing Bank (01963) reported a mid-year net profit of 3.19 billion yuan, a year-on-year increase of 5.39%, indicating stable profitability [2] - Shenwan Hongyuan Hong Kong (00218) reported a mid-year profit attributable to ordinary shareholders of 60.134 million HKD, turning from loss to profit [2] - Times Electric (03898) reported a mid-year net profit of 1.6715 billion yuan, a year-on-year increase of 12.93% [2] - CIFI Holdings Group (00884) reported mid-year revenue of 12.281 billion yuan, delivering approximately 15,000 property units in the first half of the year [2] - CRRC (01766) reported a mid-year net profit of 7.246 billion yuan, a year-on-year increase of 72.48% [2] - China Tobacco Hong Kong (06055) reported a mid-year profit attributable to shareholders of 706 million HKD, an increase of 9.79% year-on-year [2] - Vanke Enterprises (02202) reported mid-year revenue of 105.323 billion yuan, maintaining operational efficiency among industry peers [2] - Greentown Management Holdings (09979) reported a mid-year profit attributable to shareholders of 256 million yuan [2] Additional Operating Performance - Goldwind Technology (02208) reported a mid-year profit attributable to shareholders of 1.488 billion yuan, an increase of 7.26% year-on-year [3] - Zhouliufu (06168) reported a mid-year net profit of 415 million yuan, an increase of approximately 11.9%, with a mid-year dividend of 0.45 yuan per share [3] - Zhejiang Huhangyong (00576) reported a mid-year profit attributable to shareholders of 2.787 billion yuan, a year-on-year increase of 4% [3] - Dongfeng Motor Group (00489) reported a mid-year profit attributable to shareholders of 55 million yuan, a decrease of 91.96% year-on-year [3] - Zhaojin Mining (01818) reported a mid-year profit attributable to shareholders of approximately 1.44 billion yuan, a year-on-year increase of approximately 160.44% [3]

Core Viewpoint - The approval of the innovative ALK inhibitor, Dirocitinib (formerly known as "Dazatinib"), by the National Medical Products Administration (NMPA) in China marks a significant advancement for the company in the oncology field, particularly for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2]. Group 1: Product Approval and Significance - The product is the third class 1 innovative drug approved for the company and the second innovative oncology drug, showcasing the company's continuous progress in targeted therapies from breast cancer to lung cancer [1]. - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1]. Group 2: Clinical Breakthroughs - Dirocitinib successfully addresses clinical challenges by controlling brain metastases and ensuring safety, effectively penetrating the blood-brain barrier [2]. - The safety profile of Dirocitinib shows significant advantages, with adverse reactions primarily being mild gastrointestinal issues, which can be managed through symptomatic treatment or dose adjustments [2].

Core Viewpoint - The approval of the innovative ALK inhibitor drug, Dirocitinib (formerly known as "Dahisitinib"), by the National Medical Products Administration (NMPA) in China marks a significant advancement for the company in the oncology field, particularly for treating ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Approval and Significance - The drug Dirocitinib is the third innovative drug approved for market by the company's subsidiary, Xuan Zhu Bio-Tech, and the second innovative oncology drug, showcasing the company's continuous progress in targeted therapies from breast cancer to lung cancer [1] - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1] Group 2: Clinical Breakthroughs - Dirocitinib successfully addresses clinical challenges by controlling brain metastases and ensuring safety, effectively penetrating the blood-brain barrier and compensating for existing therapies' shortcomings in central nervous system protection [2] - The drug demonstrates significant safety advantages, with adverse reactions primarily being mild gastrointestinal issues, which can be managed through symptomatic treatment or dose adjustments, leading to improved long-term medication adherence among patients [2]

Core Viewpoint - The approval of the innovative ALK inhibitor, Dirocitinib (formerly known as "Dahitinib"), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Xuan Bamboo Biotechnology and provides a breakthrough treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Approval and Significance - Dirocitinib is the third innovative drug approved for Xuan Bamboo Biotechnology and the second innovative oncology drug, showcasing the company's continuous advancement in targeted therapies from breast cancer to lung cancer [1] - The approval represents an important research and development milestone for Xuan Bamboo's innovative drug pipeline, contributing to the acceleration of cancer prevention and treatment goals under the "Healthy China 2030" initiative [2] Group 2: Drug Advantages - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1] - The drug effectively penetrates the blood-brain barrier, addressing existing therapies' shortcomings in central nervous system protection, while demonstrating a favorable safety profile with manageable side effects [2] Group 3: Clinical Impact - In pivotal Phase III clinical trials, Dirocitinib showed significant efficacy compared to existing first- and second-generation ALK inhibitors, particularly against resistant mutations such as G1202R and I1171N [1] - The drug's safety profile includes primarily mild gastrointestinal reactions, with reduced risks of pleural effusion and hepatotoxicity, enhancing long-term medication adherence among patients [2]

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。 自願公告 軒竹生物自研創新藥地羅阿克片獲國家藥監局上市批准 四 環 醫 藥 控 股 集 團 有 限 公 司（「本公司」或「四環醫藥」，連 同 其 附 屬 公 司，統 稱 為 「本集團」）董 事 會（「董事會」）欣 然 宣 佈，本 集 團 旗 下 非 全 資 附 屬 公 司 軒 竹 生 物 科 技 股 份 有 限 公 司（「軒竹生物」）自 主 研 發 的ALK抑制劑1類 創 新 藥 地 羅 阿 克 片（曾 用 名「達 希 替 尼」，XZP-3621，商 品 名：軒 菲 寧®）獲 得 中 國 國 家 藥 品 監 督 管 理 局 (NMPA)批 准 上 市，用 於 治 療 間 變 性 淋 巴 瘤 激 酶(ALK)陽性的晚期非小細胞肺癌 (NSCLC)。該產品是軒竹生物第三個獲批上市的1類 創 新 藥，同 時 也 是 軒 竹 生 物 第二個獲批上市的1類 ...