近日，江苏省创新药械产品目录（第一批）发布，全省共收录149款创新药械产品，苏州共有60款 产品入选，占全省40%，数量位居全省第一。据悉，此次苏州入选产品全面覆盖1类创新药、2类改良型 新药和第三类创新医疗器械、第二类创新医疗器械等四大核心领域，形成了多维度、全链条的创新产品 矩阵，精准对接临床需求痛点。 另据了解，苏州市场监管部门推出的一系列服务举措，也为创新产品研发上市加速了进程。 聚焦创新项目顺利开展，市场监管部门组建市生物医药产业审评审批服务专班，建立重点企业、重 点项目清单，梳理企业诉求，跟踪服务保障；每月召开专班例会，协调解决重点项目在注册申报、研发 生产中遇到的难点堵点，助力一批创新产品上市提速。 聚焦医药企业发展提升，市场监管部门推动成立市医药产业服务中心，积极对接国家、省级部门， 探索建立人才交流与培训机制；选派业务骨干赴上级部门交流学习，邀请国家药监局医疗器械技术审评 检查长三角分中心、省药监局审评及核查中心等单位专家来苏开展专题培训和"面对面"服务，通过"请 进来"指导与"送出去"学习，提升产业服务能力和企业注册申报质效。 聚焦产业园区和基层服务升级，我市建成运行省药监局审评核查张家港 ...

Core Viewpoint - The approval of the BCL-2 inhibitor Sotorakra by BeiGene marks a significant advancement in the treatment of hematologic malignancies, with potential implications for the competitive landscape of BCL-2 inhibitors in the market [1][3]. Company Developments - BeiGene's Sotorakra has received approval for two indications: treatment of adult patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) [1]. - The approval came just eight months after the new drug application was accepted by the NMPA, indicating a rapid development timeline [1]. - Sotorakra is positioned as a next-generation BCL-2 inhibitor, designed to block the BCL-2 protein that aids tumor cell survival, and has shown strong efficacy and specificity in clinical trials [1][2]. Clinical Trial Results - Early clinical trials of Sotorakra combined with Zebutini have demonstrated unprecedented rates of undetectable minimal residual disease in treatment-naive CLL patients [2]. - Recent data from five clinical studies indicate significant clinical benefits for Sotorakra, suggesting its potential as a cornerstone therapy for various B-cell malignancies [2]. Market Landscape - The global BCL-2 inhibitor market is projected to reach $5.2 billion by 2028, with the Chinese market expected to reach 1.4 billion yuan [5]. - The approval of Sotorakra follows the approval of another BCL-2 inhibitor, Lisatoclax, from Ascentage Pharma, indicating a growing presence of Chinese companies in the BCL-2 space [3][5]. - The competitive landscape is intensifying as multiple Chinese pharmaceutical companies, including Innovent Biologics and Zai Lab, are developing BCL-2 inhibitors [3][4]. Financial Performance - BeiGene's Zebutini has become a significant revenue driver, with global sales reaching $1.3 billion in 2023, marking a 129% year-over-year increase [6]. - In the first half of 2025, BeiGene reported a revenue of 17.52 billion yuan, a 46% increase year-over-year, largely driven by Zebutini sales [6][7]. - The company is under pressure to identify the next blockbuster product as Zebutini's growth may slow down in the future [7].

2026 年度医药策略观点更新 20260105 摘要 医药板块经历 2025 年调整后，机构持仓和估值均处于左侧布局阶段， 具备向上弹性，创新药及其产业链是 2026 年确定性最强且具进攻性的 方向，受益于中国创新竞争力持续加强。 创新竞争力增强的动因包括 BD 落地、海外临床进展和商业化兑现，以 及 XDC、双抗、小核酸等新技术突破，和潜在 IPO 公司登陆港股市场等 催化剂。 创新思路包括关注信达生物、博泰生物、英恩生物等核心资产，重磅数 据读出或潜在 BD 带来的短期催化剂，以及 XDC、双抗、小核酸等新技 术方向。 创新产业链全面复苏，CDMO 订单与业绩从 2024 年开始复苏，2025 年进一步全面复苏，预计 2026 年持续，凯莱英与博腾等公司具有较高 估值性价比。 内需复苏趋势明确，2025 年逐季度加强，驱动力包括国内创新 BD 创新 高、一级市场和二级市场回暖，A 股和港股 IPO 数量增加，推动一级市 场融资触底反弹。 Q&A 2026 年医药行业的投资机会主要集中在哪些方面？ 2026 年医药行业依然充满投资机会，主要集中在全球有竞争力的资产，包括 创新药、创新药产业链和高端制造。同 ...

中国战略新兴产业融媒体记者 李子吉 在上半年，创新药板块迎来爆发式增长，在A股与港股市场均取得显著超额收益。2月，百济神州A股市 值突破3107亿元，其以27亿元的微弱优势超越传统巨头恒瑞医药，晋升为新的"医药一哥"。截至6月17 日，中证创新药指数年内涨幅为13.43%，恒生港股通创新药指数更是大涨60%，均远超同期大盘表现。 而时间到了9月，创新药板块持续调整。同花顺数据显示，截至12月28日，港股通创新药指数9月以来跌 幅超过20%，其指数成分股中，不少未盈利的生物科技公司跌幅已超过40%。 资本市场的风云变幻，代表着整个生物医药行业的底层逻辑正在重构。 2025 这一年的变革，更像是一场"净化"。 支付环境持续优化，集采政策在扩大覆盖范围的同时也开始"反内卷"，而商业健康保险的落地，也为高 价值、高成本的创新药提供了更有利的价值实现空间。 2025年的生物医药行业像是坐上了跳楼机，"突然地升空又急速落地"。 增长"引擎"已完成转型，传统仿制药的规模红利逐渐消退，而真正具备临床价值的创新药正批量涌现， 以技术驱动取代渠道驱动成为核心增长力。 9月12日，国家药监局发布并实施《关于优化创新药临床试验审评审 ...

Core Insights - The Chinese innovative drug sector is poised for significant growth, with the National Medical Insurance Administration announcing that new drugs approved in May 2025 will be reimbursed by January 2026, indicating a rapid support for innovative drugs [2][3] - The 2025 National Basic Medical Insurance Drug List includes 114 new drugs, with an 88.19% success rate in negotiations, highlighting the government's commitment to supporting innovative drug development [2][5] - The global market for innovative drugs is also expanding, with record-breaking business development transactions, such as the $11.4 billion deal between Innovent Biologics and Takeda, and a potential $12 billion collaboration between Hengrui Medicine and GSK [2] Group 1: Policy and Support - The Chinese government is providing comprehensive support for innovative drug development through policies that facilitate research, market entry, clinical application, and multi-tiered payment systems [3][10] - The 2026 implementation of the innovative drug directory reflects a careful selection process, with only 19 innovative drugs included, indicating strict criteria to meet various stakeholder needs [5][10] - The CAR-T therapy, a prominent innovative drug, has been included in the 2025 innovative drug directory, although its high cost remains a barrier for basic medical insurance coverage [5][6] Group 2: Market Dynamics - The commercial success of innovative drugs is heavily reliant on a mature payment system, which is crucial for ensuring accessibility to high-value therapies like CAR-T [7][10] - In the global CAR-T market, Gilead leads with significant sales, while Chinese companies like Legend Biotech are leveraging partnerships to expand their market presence [8][9] - The disparity in sales between innovative drugs in China and their global counterparts is evident, with the top-selling innovative drug in China generating only 44 million yuan, significantly lower than leading global products [9][12] Group 3: Financial Viability - Despite the growth in innovative drug approvals, many companies continue to face financial losses, underscoring the challenges of achieving profitability in the sector [11][25] - The investment landscape for innovative drugs has shifted, with a focus on sustainable growth and the need for companies to demonstrate potential for future profitability [27][30] - The success of companies like BeiGene, which has achieved significant market capitalization and revenue through strategic product development, highlights the importance of long-term investment strategies in the innovative drug space [19][23]

Core Insights - Strong One Co., Ltd. (688809.SH) officially listed on the Sci-Tech Innovation Board, becoming the 600th company, marking a significant milestone in the board's growth since its inception in 2019 [1] - The Sci-Tech Innovation Board has established itself as a key platform for empowering hard-tech enterprises, reflecting China's commitment to innovation-driven development and the cultivation of new productive forces [1] Financial Performance - In the first three quarters of 2025, companies on the Sci-Tech Innovation Board achieved a total operating revenue of 1,105.01 billion yuan, representing a year-on-year growth of 7.9% [2] - Net profit reached 49.27 billion yuan, with an 8.9% year-on-year increase, while the net profit after deducting non-recurring items was 31.97 billion yuan, up 5.5% [2] - R&D investment totaled 119.75 billion yuan, 2.4 times the net profit, with a median R&D intensity of 12.4%, indicating a strong focus on technological innovation [2] Industry Development - The Sci-Tech Innovation Board has formed a distinctive hard-tech industry cluster, particularly in the semiconductor sector, which includes over 100 companies, accounting for about 60% of the total in the A-share market [3] - Revenue in the integrated circuit industry grew by 25% year-on-year, with net profit increasing by 67% [3] - The biopharmaceutical sector saw the approval of nine Class 1 new drugs and potential total transaction amounts exceeding 13 billion USD from 16 outbound BD deals, enhancing industry competitiveness [3] Future Outlook - The emergence of the 600th company is seen as both a summary of past achievements and a starting point for future development [3] - The Sci-Tech Innovation Board aims to deepen reforms and enhance support for hard-tech enterprises, fostering the growth of high-quality tech companies through capital [3] - The board is expected to attract and cultivate more world-class technology enterprises, leading to the emergence of more innovative company stars in the future [3]

Group 1: Market Outlook - The equity market is expected to continue its upward trend due to clear domestic policy, strong economic growth momentum, and relatively loose market liquidity[3] - Investors are advised to actively position for the spring market, focusing on sectors with improving performance and benefiting from policies[3] Group 2: Recommended Stocks - BeiGene (688235.SH): Global sales of its core product, Zanubrutinib, reached $2.78 billion in the first three quarters of 2025, a year-on-year increase of 53.2%[4] - Beijing Junzheng (300223.SZ): The storage cycle is on the rise, and the company is expected to benefit from the L3 autonomous driving market[11] - Haiguang Information (688041.SH): The company is a leading domestic computing power provider, with revenue maintaining rapid growth in the first three quarters of 2025[18] - Daotong Technology (688208.SH): The company has seen rapid revenue growth and is advancing its AI strategy[26] - Penghui Energy (300438.SZ): The company ranks among the top three globally in household storage cell shipments in the first three quarters of 2025[32] - Goldwind Technology (002202.SZ): The gross margin for wind turbine and component business reached 7.97% in the first half of 2025, showing significant improvement[39] - Chifeng Gold (600988.SH): The company is expected to benefit from rising gold prices and increased production from new mining projects[46] - Luoyang Molybdenum (603993.SH): The company is positioned to benefit from rising copper prices and increased production[52] - Huaxin Cement (600801.SH): The company reported a 120.7% year-on-year increase in net profit attributable to shareholders in Q3 2025[57] - China Pacific Insurance (601601.SH): The company has maintained a high dividend yield, exceeding 3% since 2018[65]

Group 1: Overview of the Pharmaceutical Industry - The pharmaceutical industry maintained stable revenue around 2.45 trillion yuan from 2023 to 2025, with quarterly revenue stabilizing at approximately 600 billion yuan [1][15] - The biotech sector is expected to achieve over 100 billion yuan in sales by 2025, marking it as a significant growth segment within the pharmaceutical industry [2] - The overall revenue for the pharmaceutical industry in the first three quarters of 2025 was 1.83 trillion yuan, reflecting a year-on-year decline of 1.5% [15][19] Group 2: Innovation in Pharmaceuticals - The innovation drug sector has shown remarkable performance, with biotech companies experiencing over 70% revenue growth in 2023 and 2024, and maintaining around 42% growth in the first three quarters of 2025 [20][21] - The CXO industry is the fastest-growing sub-sector in terms of profit, with a year-on-year increase of 33.4% [20] - The total transaction value for license-out deals in the innovation drug sector reached 920 billion USD in the first three quarters of 2025, providing significant cash flow for domestic innovation drug companies [3][20] Group 3: International Expansion - The global market for innovative drugs is expanding, with license-out transactions expected to exceed 100 billion USD in 2025, capturing nearly half of the global pharmaceutical business development transaction volume [2] - The export of medical devices from China has shown a recovery trend, with a total export value of 355.3 billion yuan in 2024, marking a year-on-year growth of 9.8% [4][7] Group 4: Blood Products Sector - The blood products industry is characterized by high barriers to entry and a stable pricing structure, with the top six companies accounting for 80% of domestic plasma collection [8] - Despite short-term supply-demand disturbances, the blood products sector remains a stable segment within the pharmaceutical industry [8][22] - The industry is currently experiencing a wave of mergers and acquisitions, leading to increased market concentration [8] Group 5: Medical Devices - The domestic medical device bidding market showed a significant recovery, with a total market size exceeding 80 billion yuan in the first half of 2025, reflecting a year-on-year growth of 62.75% [4] - The recovery in international markets has also contributed to the growth of medical device exports, which are expected to continue their upward trend [4][7]

Core Viewpoint - The 20th Central Committee's Fourth Plenary Session emphasizes the strategic importance of developing new quality productivity to accelerate the construction of a modern industrial system, positioning it as a new engine for high-quality development in China and offering global opportunities [1]. Group 1: Innovation and Economic Growth - The third industrial revolution's impact on global economic growth is diminishing, necessitating a shift to higher levels of productivity to rejuvenate economic growth [2]. - By 2029, strategic emerging industries in China are projected to account for over 20% of GDP, indicating significant growth opportunities for global tech companies in areas like AI and biotechnology [2]. - PwC forecasts that global opportunities from business model transformation will reach $7.1 trillion by 2025, with the Chinese market contributing $1.66 trillion [2]. Group 2: Technological Advancements and Global Leadership - China's high-tech manufacturing sector is expected to see a 9.2% year-on-year increase in value added by November 2025, with smart consumer device manufacturing growing by 7.6% [3]. - China is leading in setting global standards for industrial 5G, contributing to the digital transformation of global manufacturing [3]. - China is a major player in the green energy sector, exporting over 80% of the world's photovoltaic components and 70% of wind power equipment, aiding global sustainable development [3]. Group 3: International Cooperation and Development - China's new quality productivity is becoming a key term in global South cooperation, with various countries expressing interest in collaborative efforts to avoid traditional modernization pitfalls [5][6]. - The establishment of cooperation mechanisms, such as the China-Vietnam railway, and significant agreements like the $22 billion high-tech industrial park project with Malaysia, highlight China's commitment to fostering international partnerships [5]. - China's approach to innovation and cooperation is seen as a model for developing countries to achieve sustainable development [6]. Group 4: Open Cooperation and Global Governance - China advocates for inclusive technological cooperation, sharing the benefits of new quality productivity with other nations to promote a more inclusive global economy [7]. - The country positions artificial intelligence as a global public good, inviting global South countries to collaborate in its development [7]. - Through initiatives like the Belt and Road, China is sharing its development experiences in satellite navigation and e-commerce with the world [7]. Group 5: Future Directions - China is committed to advancing new quality productivity through technological innovation, aiming for higher quality and more inclusive development that contributes to global economic growth [8].

作者 | 余强 桑晓东 中国生物医药产业的真正崛起，不仅体现在获批新药的数量上，更反映在创新质量的提升和创新生态的 成熟 2015年的夏天，中国医药行业经历了一场"刮骨疗毒"式的变革。"722临床核查"风暴席卷全国，临床虚 假数据的泡沫被彻底戳破。彼时，中国创新药在全球医药市场的占比不足5%，大部分的药品市场被仿 制药占据。 十年后的2025年，仅上半年国内便有43款创新药获批上市，同比增长59%，其中国产创新药占比高达 93%，且新药的临床开发周期已跃居国际前列。与此同时，在资本市场，医药股在经历了一轮"寒冬"之 后，又如遇夏日的阳光，火热起来。 这一戏剧性转变的背后，是中国生物医药产业历经政策破冰、资本沉浮与技术攻坚的艰辛十年。而未 来，产业还需直面地缘政治的重重挑战，在供应链安全、国际合作壁垒等现实考验中，踏上向创新药强 国稳步突围的新征程。 地缘政治挑战下的全球定位 正当中国生物医药产业加速发展之时，全球地缘政治格局的剧烈变动为产业发展增添了不确定性。目 前，美国政府通过加征关税、升级药品监管壁垒、扩大生物技术实体清单等手段，挤压中国生物医药产 业的发展空间。面对这一挑战，中国生物医药产业需要寻找到合 ...