Group 1 - The Hong Kong pharmaceutical sector is experiencing a strong rebound, with the Hong Kong Stock Connect Innovation Drug ETF (159570) rising nearly 2% and achieving a transaction volume exceeding 700 million yuan in a short period [1] - The ETF has seen a cumulative net inflow of over 430 million yuan in the past five days, with its latest scale surpassing 25.1 billion yuan, leading in its category [1] - The majority of the weighted stocks in the ETF's index have shown positive performance, including Kangfang Biopharma and Kelun-Botai, which both rose over 4% [3][4] Group 2 - Kangfang Biopharma announced that its new humanized anti-IL-17A monoclonal antibody, AK111, has received acceptance for a new drug application for treating active ankylosing spondylitis (AS) by the National Medical Products Administration (NMPA) [3] - This new drug is expected to provide a new treatment option for nearly 4 million AS patients in China [3] - The JPMorgan Healthcare Conference highlighted the achievements of Chinese innovative drug companies, with expectations for significant revenue growth and multiple drug approvals in the coming years [5][6] Group 3 - The domestic pharmaceutical industry is witnessing rapid technological advancements and an acceleration in globalization, with significant transactions exceeding 10 billion USD occurring [6][7] - The industry is entering a critical period of validation for innovative drug performance, with many companies expected to launch global registration studies and new product applications [6][7] - A domestic innovative drug company projected a revenue increase of 15.84% for 2025, with a substantial net profit growth of 102.65% [7]

智通财经APP获悉，康方生物(09926)涨超5%，截至发稿，涨5.16%，报118.1港元，成交2.31亿港元。 据介绍，古莫奇单抗是康方生物继伊努西单抗(PCSK9)、依若奇单抗(IL-12/IL-23)之后，第三个进入上 市阶段的非肿瘤重磅产品。随着伊努西单抗、依若奇单抗相继上市并纳入国家医保目录，古莫奇单抗、 曼多奇单抗等产品逐步迈入商业化阶段，以及IL-4R/ST2双抗、神经退行性病变等非肿瘤创新靶点药物 针对多适应症深度开发的高效推进，公司产品组合力愈发强劲，非肿瘤板块的竞争力持续增强。 消息面上，据康方生物官微消息，近日，公司宣布，其自主研发的新型人源化抗IL-17A单克隆抗体古莫 奇单抗(AK111)用于治疗活动性强直性脊柱炎(AS)的新药上市申请(sNDA)，已获得国家药品监督管理局 药品审评中心(NMPA CDE)受理。这标志着该药有望为中国近400万AS患者带来新的治疗选择。 ...

Core Viewpoint - Kangfang Biopharma's innovative drug, Gumokimab injection, has submitted a new indication application for active ankylosing spondylitis, which has been accepted by the National Medical Products Administration (NMPA) [1][4]. Group 1: Drug Information - Gumokimab is a humanized IL-17 monoclonal antibody targeting key inflammatory factors, playing a crucial role in diseases like psoriasis and ankylosing spondylitis [4][7]. - The drug is currently in the application stage for both moderate to severe plaque psoriasis and active ankylosing spondylitis [5][12]. Group 2: Research and Development Progress - The first application for Gumokimab was accepted by the CDE on January 16, 2025, marking a significant milestone in its development [8][11]. - In August 2025, Gumokimab achieved positive results in a pivotal Phase III clinical trial for active ankylosing spondylitis, demonstrating significant clinical improvements for patients [11]. Group 3: Industry Position - Gumokimab is the eighth innovative drug submitted for market approval by Kangfang Biopharma, highlighting the company's commitment to drug development [13]. - It is the third innovative drug in the non-oncology field to reach the market application stage, showcasing Kangfang Biopharma's strong research capabilities and innovation in addressing autoimmune diseases [13].

Core Viewpoint - The Chinese innovative drug sector is experiencing rapid growth, positioning itself as a global leader in drug development, with significant investments and collaborations from major pharmaceutical companies [2][8][30]. Group 1: Market Dynamics - The price of experimental monkeys has surged from 3,000 yuan to 100,000 yuan, indicating a high demand in the innovative drug sector [1]. - By 2025, China is projected to rank second globally in new drug clinical trials, with its pipeline accounting for 30% of the global total [2]. - In 2024, Chinese innovative drug companies completed 94 overseas licensing transactions, representing 44% of the national total, with over 100 transactions exceeding $100 billion in the first ten months of 2025 [6][30]. Group 2: Challenges in Traditional Pharmaceutical Sector - The generic drug sector is facing significant challenges, with a projected 5.5% decline in revenue for 2024 and over 30% of companies experiencing losses [5]. - Major pharmaceutical companies are increasingly collaborating with Chinese innovative drug firms to mitigate the risks associated with patent expirations, which could lead to a revenue gap exceeding $300 billion in the next five years [10][30]. Group 3: Advantages of Chinese Innovative Drugs - China offers a cost-effective and efficient environment for drug development, with clinical trial costs significantly lower than in the U.S. [20][21]. - The average time for clinical trial approvals in China has been reduced from 60 to 30 working days, and the average new drug application approval time has decreased to approximately 130 days [14]. - Chinese pharmaceutical companies are increasingly moving from "me-too" and "me-better" drugs to original innovations, with a notable increase in the number of innovative drug projects [27]. Group 4: Global Positioning and Future Outlook - Despite the rapid growth of Chinese innovative drugs, the overall market value of Chinese biotech companies remains significantly lower than their U.S. counterparts, capturing only 5% to 10% of global new drug revenues [30][31]. - Chinese companies are establishing commercial centers in global pharmaceutical hubs to enhance their commercialization capabilities, marking a shift towards becoming major players in the global market [37][38]. - The transition from biotech firms to large multinational pharmaceutical companies is seen as a critical step in the global battle for market share and innovation [38].

Core Viewpoint - Bank of America Securities initiates coverage of Kangfang Biopharma (09926) with a "Buy" rating and a target price of HKD 162.8, citing strong clinical trial data for the key drug ivonescimab in China as a solid reference for global trial results [1] Group 1 - The company is expected to reveal multiple global and China Phase III clinical trial data this year [1] - The inclusion in the national medical insurance directory, expansion of indications, and new drug approvals are accelerating the company's commercialization process in China, with a potential to achieve breakeven this year [1] - The company's rich R&D pipeline provides long-term growth momentum and new licensing opportunities [1]

Core Viewpoint - The Hang Seng Index Company will announce the results of the Hang Seng Index adjustments on February 13, 2026, with implementation on March 9, 2026. This adjustment will affect the investment scope of the Stock Connect program between Shanghai, Shenzhen, and Hong Kong [1][7]. Group 1: Hang Seng Index Adjustments - Companies such as Zijin Mining International, BeiGene, Yum China, Xpeng Motors, China Pacific Insurance, CanSino Biologics, and Laopuqin Gold are potential candidates for inclusion in the Hang Seng Index based on market capitalization and industry representation [2][3]. - Historical data indicates that actual results may differ from quantitative predictions, as seen with Yum China and BeiGene, which were previously forecasted to be included but were not due to subjective criteria in the index inclusion standards [2][3]. Group 2: Impact on Stock Connect - The adjustments to the Hang Seng Index will directly influence the investment scope of the Stock Connect program, with an estimated 44 stocks expected to be eligible for inclusion, including JD Industrial, East Asia Bank, and Dippu Technology [4][6]. - The methodology for calculating the average market capitalization for index adjustments has been optimized, which may affect the eligibility of stocks for inclusion in the Stock Connect [4][5]. Group 3: Exclusions from Stock Connect - Approximately 25 stocks may be removed from the Stock Connect due to low market capitalization or other factors, including Youbao Online and Automotive Street [6]. - Companies expected to delist from the Hong Kong Stock Exchange will also be removed from the Stock Connect trading [6].

Core Viewpoint - Bank of America Securities initiates coverage of Kangfang Biopharma with a "Buy" rating and a target price of HKD 162.8, citing strong clinical trial data for the key drug ivonescimab in China as a solid reference for global trial results [1] Group 1 - The company is expected to reveal multiple global and China Phase III clinical trial data this year [1] - The inclusion in the national medical insurance directory, expansion of indications, and new drug approvals are accelerating the commercialization process in China, with expectations of reaching breakeven this year [1] - The company's rich R&D pipeline provides long-term growth momentum and new licensing opportunities [1]

Core Insights - The announcement of a $5.6 billion licensing agreement between Rongchang Biopharma and AbbVie marks a significant milestone for Chinese innovative drugs entering the global market, indicating a shift from follower to leader in the dual antibody space [1][3] - Concurrently, Kangfang Biopharma's partner, Summit Therapeutics, submitted a Biologics License Application (BLA) for Ivoris monoclonal antibody to the FDA, further highlighting the progress of Chinese dual antibodies on the international stage [1][4] - However, the termination of a licensing agreement by Yiming Oncology with Instil Bio serves as a cautionary tale for the challenges faced by Chinese companies in global expansion [1][10] Group 1: Major Developments - Rongchang Biopharma's agreement with AbbVie includes an upfront payment of $650 million and potential milestone payments of up to $4.95 billion, along with double-digit royalties on net sales outside Greater China [3] - Kangfang Biopharma's Ivoris monoclonal antibody is positioned to address a significant unmet clinical need in treating EGFR-mutant non-small cell lung cancer, with the FDA expected to make a decision by Q4 2026 [4][5] - The competitive landscape for PD-1/VEGF dual antibodies is intensifying, with major pharmaceutical companies increasingly focusing on a few validated "winners" in the market [2][9] Group 2: Industry Trends - The recent high-value transactions in the dual antibody space reflect a growing recognition of the clinical and commercial potential of Chinese innovative drugs, with transaction amounts reaching new heights [9] - The competitive dynamics are shifting, as the number of potential international buyers decreases due to the concentration of capital and interest in a limited number of validated products [10][13] - The success of PD-1/VEGF dual antibodies is seen as pivotal for the future of cancer treatment, with ongoing clinical trials exploring their combination with other therapies to enhance efficacy [14]

Market Overview - On January 13, the Hang Seng Index rose by 0.90%, with total southbound trading amounting to HKD 137.35 billion, including buy transactions of HKD 69.32 billion and sell transactions of HKD 68.03 billion, resulting in a net buying amount of HKD 1.30 billion [1] Southbound Trading Activity - The southbound trading through Stock Connect (Shenzhen) recorded a total trading amount of HKD 54.86 billion, with buy transactions of HKD 28.00 billion and sell transactions of HKD 26.85 billion, leading to a net buying amount of HKD 1.15 billion [1] - The southbound trading through Stock Connect (Shanghai) had a total trading amount of HKD 82.49 billion, with buy transactions of HKD 41.32 billion and sell transactions of HKD 41.17 billion, resulting in a net buying amount of HKD 0.15 billion [1] Active Stocks - Alibaba-W was the most actively traded stock with a total trading amount of HKD 139.06 billion and a net buying amount of HKD 10.71 billion, closing with a price increase of 3.63% [1][2] - Tencent Holdings followed with a total trading amount of HKD 52.93 billion and a net buying amount of HKD 7.56 billion, closing with a price increase of 0.72% [1][2] - Xiaomi Group-W had a total trading amount of HKD 49.62 billion and a net buying amount of HKD 6.07 billion, closing with a price decrease of 1.96% [1][2] Continuous Net Buying and Selling - Three stocks experienced continuous net buying for more than three days, with Xiaomi Group-W, Tencent Holdings, and Kuaishou-W having net buying days of 9, 5, and 3 respectively [2] - Tencent Holdings had the highest cumulative net buying amount of HKD 69.99 billion, followed closely by Xiaomi Group-W with HKD 69.33 billion [2] - Two stocks faced continuous net selling, with China Mobile and Meituan-W having net selling amounts of HKD 52.84 billion and HKD 11.67 billion respectively [2]

Core Insights - The article highlights significant advancements in China's biopharmaceutical sector, particularly in the PD-1/VEGF dual antibody space, marked by major deals and regulatory submissions that indicate a shift from follower to leader status for Chinese companies in the global market [1][2][3]. Group 1: Major Developments - Rongchang Biopharma announced a $5.6 billion licensing agreement with AbbVie for its PD-1/VEGF dual antibody RC148, with an upfront payment of $650 million and potential milestone payments of up to $4.95 billion [2]. - Summit Therapeutics, a partner of Kangfang Biopharma, submitted a Biologics License Application (BLA) for Ivoris monoclonal antibody to the FDA, targeting EGFR-mutant non-small cell lung cancer, with a decision expected in Q4 2026 [3]. Group 2: Market Dynamics - The PD-1/VEGF dual antibody market is becoming increasingly competitive, with major pharmaceutical companies investing heavily, indicating the high commercial value of this therapeutic area [5][6]. - The termination of a collaboration between Yiming Biotech and Instil Bio serves as a cautionary tale, highlighting challenges faced by Chinese innovative drug companies in global markets, including the need for strong financial backing and execution capabilities [1][7]. Group 3: Future Outlook - The success of Kangfang's Ivoris monoclonal antibody in clinical trials could position it as a leading product in the market, potentially capturing significant market share if it demonstrates strong overall survival data [4][10]. - The increasing number of PD-1/VEGF products in clinical stages, with 14 products linked to Chinese companies, suggests a crowded competitive landscape, which may complicate future business development opportunities for companies like Yiming Biotech [8][9].