如何在强生跌倒的地方站起来？众生药业在研发过程中多次面 临这样的拷问。陈小新的策略是从分子结构设计和临床试验适 应证两方面着手。 作者：张英 刘晓诺 封图：图虫创意 编者按 自2015年启动药政改革以来，经过十年的"国药维新"，中国生物医药产业已在重大药物研发前沿领 域取得了长足进步，甚至在个别领域实现了领先。多个新老明星药企的实验室纷纷发现了价值不菲 的药物分子。 这些珍贵的药物分子，正不断突破曾被欧美跨国公司垄断的创新药物市场，未来将支撑中国药企创 造出巨大的经济和社会价值。同时，以创新分子达成的中外企业权益合作，也在提升全球药物市场 的价值和信心。 作为见证者和记录者，经济观察报将持续关注中国重磅药物的诞生及其背后的中国明星药企，从商 业、科技、人文角度全方位观察中国创新药行业的演变。 本文为【中国分子】系列报道第五篇，记录国产创新药昂拉地韦PK流感"神药"奥司他韦的故事。 " 如 果 我 们 的 分 子 连 奥 司 他 韦 都 PK 不 了 ， 也 没 有 上 市 的 必 要 了 。 "5 月 29 日 ， 众 生 药 业 （002317.SZ）子公司众生睿创总裁陈小新在接受经济观察报采访时说。 他口 ...

Group 1 - The research achievements of Chinese innovative pharmaceutical companies are increasingly attracting the attention of multinational pharmaceutical giants, with approximately 31% of innovative drug candidates introduced by large multinational companies in 2024 coming from China, compared to zero in 2019 [1][3] - At the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, over 70 studies from Chinese innovative pharmaceutical companies were selected for oral presentations, with a focus on bispecific antibodies and ADC drug research [1] - Kangfang Biopharma and its partner Summit Therapeutics released the first global Phase 3 clinical trial results for the PD-1/VEGF bispecific antibody ivonescimab, showing a 48% reduction in the risk of disease progression or death for previously treated patients with EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) [1] Group 2 - IBI363, a globally innovative PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics, showed clinical data for treating immune-treated advanced melanoma at ASCO, along with a comparison study against Merck's Keytruda [2] - Kelun-Biotech presented six clinical research results at ASCO, including the ADC drug sac-TMT for previously treated advanced EGFR-mutant non-small cell lung cancer patients [2] - In the previous month, Zai Lab announced that the FDA granted fast track designation for its potential ADC drug ZL-1310 for the treatment of extensive-stage small cell lung cancer (ES-SCLC), with updates expected at ASCO [2] Group 3 - I-Mab presented preliminary results of its ADC drug DB-1310 for treating advanced solid tumors at ASCO, focusing on safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity [3]

Core Viewpoints - In 2024, the company's R&D expenses are projected to be 215 million RMB, remaining stable compared to 2023, indicating robust cost control and alignment with overall development expectations [1] - The company has approximately 800 million RMB in cash and cash equivalents, ensuring sufficient cash flow for future operations [1] - The Phase I SAD trial results for the core product LAE102 are promising, laying a solid foundation for the upcoming Phase I MAD trial, and collaboration with Eli Lilly enhances international influence [1][4] - The clinical trial for LAE002 is progressing, with the Phase III trial for breast cancer being particularly noteworthy [1] Financial Performance - The company reported a total loss of 254 million RMB for the year, a reduction of 31.05% year-on-year, indicating improved financial health [1] - Administrative expenses decreased by 2.4% year-on-year to 74 million RMB, reflecting effective management [1] Research and Development - The company has established a global R&D team of 61 employees, covering the entire drug discovery and development cycle, with innovation centers in Shanghai and New Jersey [2] - LAE102, a monoclonal antibody targeting ActRIIA, shows potential for effective weight management by promoting muscle gain and reducing fat [2] - The Phase I SAD clinical study for LAE102 began in June 2024, with 64 healthy participants recruited, demonstrating good safety and efficacy results [3] Clinical Trials and Collaborations - The collaboration with Eli Lilly involves conducting a Phase I trial for LAE102 in the U.S., expected to start in Q2 2025 [4] - The company is also advancing LAE002 in multiple cancer clinical trials, with significant results reported for various combinations [5][6] Pipeline and Future Prospects - The company maintains a balanced pipeline focused on cancer and metabolic diseases, with several candidates in various stages of development [7] - LAE002 has shown efficacy in multiple clinical trials, with ongoing efforts to expand its indications [6][7] - The company anticipates commercial potential for LAE102 and LAE002, with projected revenues of 0 million RMB in 2025 and 169 million RMB in 2027 [7]

Core Insights - The article discusses the approval of a new influenza drug, Anglatavir, by China's drug regulatory authority, which is the first innovative drug to outperform the widely used Oseltamivir in head-to-head trials [1][3] - The drug targets the PB2 protein of the influenza virus and has been in development for 10 years, with expectations of capturing a market share of 2 billion yuan [1][10] Company Overview - Zhongsheng Pharmaceutical's subsidiary, Zhongsheng Ruichuang, is responsible for the development of Anglatavir, which has been a significant shift from traditional pharmaceutical practices to innovative drug development [2][8] - The company faced challenges during the development process, particularly after Johnson & Johnson's failure in clinical trials for a similar drug, VX-787, which raised doubts among investors [6][9] Market Context - The influenza drug market in China has evolved significantly, with Oseltamivir and the newer drug, Marbofloxacin, dominating the market [2][3] - The market for antiviral drugs in China is approaching 20 billion yuan, with projections indicating growth to 26.91 billion yuan by 2028 [9][10] Clinical Trial Results - Phase III clinical trial results showed that Anglatavir significantly reduced the time to symptom relief and viral load compared to Oseltamivir, indicating its potential effectiveness [3][4] - Anglatavir demonstrated superior efficacy against strains resistant to both Oseltamivir and Marbofloxacin, suggesting a strong competitive advantage [3][4] Future Prospects - The company plans to explore licensing opportunities for Anglatavir in international markets, particularly in the U.S. and Belt and Road countries, despite facing challenges in conducting large-scale clinical trials abroad [9][10] - The drug is currently approved for adults with uncomplicated influenza, and a pediatric formulation is in the pipeline, which could further expand its market reach [10]

百利天恒(688506.SH)公告称，公司计划向特定对象发行A股股票并募集资金不超过37.64亿元，扣除发 行费用后，实际募集资金将全部用于 创新药研发项目。 ...

Core Insights - The 2025 American Society of Clinical Oncology (ASCO) annual meeting will take place in Chicago, showcasing cutting-edge clinical oncology research and treatment outcomes, with significant participation from Chinese companies [1][2]. Group 1: Participation and Research Highlights - Chinese researchers have submitted over 70 original studies for oral presentations, surpassing last year's 55 studies, indicating a growing contribution to global oncology research [2]. - Companies like Dizal Pharmaceutical and China National Pharmaceutical Group will present their latest research on innovative therapies, including PD-1 monoclonal antibodies and antibody-drug conjugates (ADCs) [1][3]. Group 2: Specific Company Developments - Dizal Pharmaceutical will present two innovative products, DZD8586 and DZD6008, focusing on B-cell non-Hodgkin lymphoma and non-small cell lung cancer (NSCLC), with DZD8586 showing an objective response rate (ORR) of 84.2% in heavily pre-treated CLL/SLL patients [3]. - China National Pharmaceutical Group will unveil preliminary data from the first-in-human phase I clinical study of TQB2102, an HER2 bispecific antibody-drug conjugate, reporting an ORR of 51.3% in HER2-positive breast cancer patients [4]. Group 3: Focus on Lung Cancer - Lung cancer remains the leading cause of cancer incidence and mortality, with NSCLC accounting for 80%-85% of cases, prompting multiple companies to target this area for research [5]. - Kelun Pharmaceutical will present six clinical studies, including results for sac-TMT in advanced EGFR-mutant NSCLC, demonstrating significant efficacy compared to docetaxel [5][6]. - Dizal's DZD6008 has shown promising results in a phase I/II study for advanced NSCLC, with an 83.3% tumor reduction rate among previously treated patients [7]. Group 4: Innovation and Market Trends - As of December 31, 2024, China leads globally with 3,575 active innovative drug candidates, and the proportion of domestically approved innovative drugs has increased from under 10% in 2015 to 42% in 2024 [8]. - Large multinational pharmaceutical companies have increasingly sought to acquire Chinese innovative drug candidates, with 31% of new drug candidates sourced from China in 2024, up from 0% in 2019 [8].

Core Viewpoint - The innovative drug industry is experiencing a "triple resonance" of policy support, industrial upgrades, and performance recovery, leading to a rapid restructuring of capital market valuation logic [1] Group 1: ASCO Conference Highlights - The 2025 ASCO annual meeting in Chicago showcased a record number of presentations from Chinese experts, with 71 original research results selected for oral presentations, including 11 major studies [2] - Chinese pharmaceutical companies such as Hengrui Medicine, Innovent Biologics, and Rongchang Biopharmaceutical had significant research entries, with Hengrui reporting 69 studies, including 67 on innovative drugs [2][3] - The number of clinical studies from Chinese companies at ASCO has been increasing, with notable advancements in ADCs (antibody-drug conjugates), bispecific antibodies, and new small molecules [2][5] Group 2: Development of Chinese Innovative Drugs - Over the past decade, Chinese pharmaceutical companies have transitioned from being "followers" to "leaders" in the global pharmaceutical ecosystem, particularly in oncology [3] - The ASCO meeting highlighted significant clinical research from companies like Shijiazhuang Pharmaceutical and China Biologic Products, with China Biologic achieving a record of 12 oral presentations [3] Group 3: Market Trends and Projections - Antibody drugs, particularly PD-(L)1 inhibitors, remain a focal point at ASCO, with global sales projected to exceed $50 billion in 2024 and continue to grow [4] - The market for PD-(L)1/VEGF bispecific antibodies is expected to reach nearly $70 billion by 2028, driven by ongoing innovations and clinical trials [4] Group 4: Investment and R&D Growth - China's pharmaceutical R&D investment has been growing at an average annual rate of over 20%, with total spending reaching $32.6 billion in 2022, accounting for 13.5% of global pharmaceutical R&D expenditures [6] - By 2030, China's pharmaceutical R&D spending is projected to reach $67.5 billion, with a compound annual growth rate of 9.5% from 2022 to 2030 [6] Group 5: Globalization and Business Development - Chinese innovative drug companies are increasingly exploring global markets through various business development models, including licensing agreements [7][8] - A recent licensing deal between 3SBio and Pfizer for a PD-1/VEGF bispecific antibody reached a total value of over $6 billion, setting a record for upfront payments for Chinese innovative drugs [7][8]

Core Insights - The National Medical Products Administration approved 11 innovative drugs recently, with 10 coming from listed companies, indicating a significant advancement in China's pharmaceutical sector [1][4] - The approval of these drugs marks a pivotal moment for the industry, as it transitions into a phase of realizing the results of extensive research and development efforts [7][8] Group 1: Drug Approvals and Innovations - Among the approved drugs, several are the first of their kind in China, including Bai Jie Shen Zhou's injection of Zhenida Monoclonal Antibody, which is the first HER2 dual-target drug approved for cholangiocarcinoma [4][5] - Heng Rui Pharmaceutical's Apixaban is a multi-target tyrosine kinase inhibitor approved for use in advanced solid tumors, showcasing innovative treatment mechanisms [4][5] - The approval of Zai Jing Pharmaceutical's Jikaxitinib marks the first domestic JAK inhibitor for treating myelofibrosis, providing new options for patients with rare blood cancers [5][6] Group 2: Market Trends and Investment Opportunities - The innovative drug sector has seen a strong market performance, with 53 stocks hitting the daily limit up, indicating heightened investor interest [2][7] - Analysts predict that 2025 will be a transformative year for the pharmaceutical industry, characterized by increased revenue, profitability, and valuation improvements [1][7] - The Hong Kong innovation drug index has seen significant capital inflow, with over 200 million yuan in net inflow over the past 20 trading days, reflecting strong market sentiment [2][8] Group 3: Challenges and Future Outlook - Despite the positive developments, the innovative drug industry faces challenges such as high uncertainty in commercialization and intense competition among similar products [7][8] - The industry is supported by favorable policies and the growth of commercial health insurance, which enhances the payment environment for innovative drugs [8]

Market Overview - The last trading day before the Dragon Boat Festival saw a volume contraction in the two markets, with the pharmaceutical sector experiencing a broad rally, particularly in Alzheimer's, innovative drugs, and CROs [1] - Several stocks, including Ruizi Pharmaceutical, Wanbangde, and Hainan Haiyao, hit the daily limit up [1] - The pork and chicken sectors also saw a rise, while bank stocks remained active, with Hangzhou Bank and Chengdu Bank reaching new historical highs [1] Banking Sector - Despite the strong performance of bank stocks, a sell-off occurred in multiple bank stocks towards the end of the trading session, indicating a potential profit-taking behavior ahead of the holiday [8] - Regional banks like Hangzhou Bank and Chengdu Bank attracted end-of-day funds due to their earnings elasticity, but this was not enough to offset the selling pressure from larger state-owned banks [8] - The banking sector has been a focus for investors this year, driven by increasing risk aversion, and is expected to remain a key market theme post-holiday [8] Pharmaceutical Sector - On May 29, the National Medical Products Administration approved 11 innovative drugs for market entry, a notably rare occurrence [10] - Among these, five were from innovative companies listed on the Sci-Tech Innovation Board, indicating a supportive policy environment for the innovative drug sector [10] - The current valuation of the innovative drug industry stands at a price-to-earnings ratio (TTM) of 27.74, with a 150% premium over the CSI 300 index, suggesting a stable growth outlook despite recent net outflows from the sector [10] Social Security Fund Holdings - A summary of the latest holdings by the Social Security Fund highlights several pharmaceutical stocks, including Wo Wu Biological, Jiuzhou Pharmaceutical, and others, with varying market capitalizations and price-to-earnings ratios [12] - The data indicates a focus on companies with strong growth potential and established market positions within the pharmaceutical sector [12]

Group 1 - The National Medical Products Administration approved the listing of the innovative drug Deuteroenzalutamide capsules (brand name: Hainaanan®) developed by Haichuang Pharmaceutical, providing a new treatment option for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after receiving abiraterone acetate and chemotherapy [1][4][6] - The approval marks a significant milestone for Haichuang Pharmaceutical, representing 12 years of innovative research and development, and is the first small molecule innovative drug approved in Chengdu Tianfu International Bio-city [2][3][4] - Deuteroenzalutamide is an androgen receptor (AR) inhibitor developed based on Haichuang's core deuterated drug platform and has received support from the National Major New Drug Creation Technology Major Project [4][6] Group 2 - Prostate cancer is the fifth most common cancer among men in China, with an increasing incidence rate. It is estimated that by 2024, there will be 160,000 new cases of mCRPC in China, rising to 176,000 by 2030 [6] - The launch of Deuteroenzalutamide fills a clinical gap as there were no approved AR inhibitors for this indication in China prior to its approval [6][11] - Haichuang Pharmaceutical plans to enhance academic promotion efforts to increase awareness of the product among doctors and patients, aiming to improve patient survival rates and quality of life [7][11] Group 3 - Chengdu Tianfu International Bio-city has established a complete biopharmaceutical ecosystem from research and development to industrialization, supporting the growth of innovative pharmaceutical companies [2][8] - The bio-city provides comprehensive lifecycle services for enterprises, including streamlined approval processes, financial and market activities, and shared facilities to reduce collaboration costs [8][10] - The bio-city has also implemented green energy solutions, such as distributed photovoltaic projects, to ensure stable energy supply for biopharmaceutical enterprises [10] Group 4 - Haichuang Pharmaceutical has six additional products in various stages of clinical trials and several in preclinical research, indicating a robust product pipeline [11] - The company emphasizes sustainable and healthy development, focusing on long-term strategic planning to benefit more patients with new drug developments [11][12] - Chengdu Tianfu International Bio-city aims to continue fostering high-level innovation and support the biopharmaceutical industry’s high-quality development through comprehensive policy guarantees and resource mobilization [12][13]