Core Insights - The approval of Zeshuo Pharmaceutical's injection of human thyroid-stimulating hormone beta (Zesuning) marks a significant milestone as it becomes China's first innovative product approved for precise assessment post-surgery for differentiated thyroid cancer [1][2] - The Chinese innovative drug industry is experiencing robust growth, with multiple new drugs receiving approval since the beginning of 2026, including innovative drugs from companies like Hengrui Medicine and BeiGene [1][2] - The National Medical Products Administration (NMPA) is enhancing support for innovative drugs, focusing on new mechanisms and targets, and aims to facilitate the "China first launch" of innovative drugs [3][4] Company Developments - Hengrui Medicine's innovative drug, the dual-specific antibody fusion protein Ruilafuzumab α injection, has been approved as the world's first anti-PD-L1/TGF-βRII dual-specificity antibody fusion protein for advanced gastric cancer [1][2] - BeiGene's innovative drug, Sotorasib tablets, has received conditional approval for treating chronic lymphocytic leukemia/small lymphocytic lymphoma and is the first and only BCL2 inhibitor approved for treating mantle cell lymphoma in China [2] - The approval of multiple innovative drugs reflects a significant increase in the number of innovative drugs approved in China, with 76 approved in 2025, surpassing the 48 approved in 2024 [2] Industry Trends - Approximately 20 major new drugs are expected to receive approval in 2026, covering various therapeutic areas such as oncology, infectious diseases, rare diseases, autoimmune diseases, and neurological disorders [3] - The Chinese innovative drug industry is transitioning from a follower to a competitor, with many domestic companies accelerating the development and market entry of groundbreaking innovative drugs [2][3] - The NMPA is implementing reforms to enhance the drug approval process, including the introduction of a data protection system for drug trials and a market exclusivity system for pediatric and rare disease medications [4][5] Policy Support - The NMPA is set to provide comprehensive support across the entire chain of communication, clinical trials, registration, and review processes for innovative drugs [4] - The new medical insurance directory has been implemented, facilitating the inclusion of innovative drugs in hospitals, which alleviates initial payment challenges for high-value innovative drugs [4] - The NMPA is also optimizing the review process for urgently needed foreign drugs, encouraging global simultaneous research and application in China [4][5]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical industry [4] Core Insights - The pharmaceutical index rose by 7.81% from January 5 to January 9, outperforming the CSI 300 index by 5.03%. The brain-machine interface and AI medical sectors are expected to remain active in Q1 2026, with a strong rebound in innovative drugs, particularly small nucleic acids [5][25] - The report highlights the potential for significant advancements in small nucleic acids in 2026, driven by breakthroughs in liver-targeted delivery technologies and a surge in clinical data readouts [8][22] - The report emphasizes the importance of selecting innovative drug stocks with strong fundamentals and suggests focusing on companies that have undergone sufficient adjustments [5][49] Summary by Sections Industry Performance - The pharmaceutical index saw 443 stocks rise and 25 fall during the week, with notable gainers including Innovative Medical (+61.04%) and Sanbo Brain Science (+56.15%). Conversely, Baohua Pharmaceutical saw a decline of -21.65% [5][26][27] Small Nucleic Acids - 2026 is projected to be a pivotal year for the small nucleic acid sector, with advancements in liver-targeted delivery technologies and a high frequency of clinical data readouts expected [8][22] - Arrowhead's delivery platform has shown promising results in clinical trials, validating the feasibility of RNAi therapies for obesity and other conditions [9][11] Investment Recommendations - The report suggests focusing on companies with leading platform capabilities and differentiated pipeline layouts, such as Rebio Biotech, Yuyuan Pharmaceutical, and Frontier Biotech [20][24] - It also recommends a diversified investment approach, including innovative drugs, brain-machine interfaces, and AI medical technologies [47][48] Market Trends - The report notes that the aging population and increasing healthcare demands are driving growth in the pharmaceutical sector, with a focus on chronic diseases and innovative medical technologies [47] - The report highlights the ongoing trend of domestic companies enhancing their capabilities in the global market, particularly in innovative drug development and medical devices [46][47] Key Companies to Watch - Recommended stocks include China National Pharmaceutical Group, Rebio Biotech, Shanghai Yizhong, and Yuyuan Medical [49]

Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its self-developed injectable recombinant human thyroid-stimulating hormone beta (rhTSH), marking it as the first innovative product approved in China for precise assessment post-surgery in differentiated thyroid cancer patients [2][3]. Drug Basic Information - Injectable human thyroid-stimulating hormone beta (rhTSH) is a biopharmaceutical developed by the company, belonging to the category of therapeutic biological products. It mimics the endogenous thyroid-stimulating hormone in humans and is designed to stimulate iodine uptake and the synthesis and release of thyroid hormones [3]. Clinical Research Results - A Phase III clinical study demonstrated that the consistency rate of whole-body imaging scan (WBS) results after rhTSH administration was 88.2%. In patients with negative thyroglobulin antibodies, the consistency rate for two-stage thyroglobulin assessment was 90.4% [4]. - The study also indicated that rhTSH administration significantly reduced symptoms of hypothyroidism compared to stopping thyroid hormone therapy, improving the quality of life for patients [4]. Market Collaboration - In June 2025, the company entered into a collaboration agreement with Merck, granting them exclusive marketing rights for rhTSH within mainland China, excluding Hong Kong, Macau, and Taiwan [5]. Impact on Company - The approval of rhTSH is expected to enrich the company's product line and positively impact its future operating performance [5].

Core Viewpoint - Zai Jing Pharmaceutical, the first innovative drug company to list on the STAR Market under the "Fifth Set of Standards," has struggled to achieve profitability since its IPO in 2020, despite launching several products and transitioning from a clinical biotech firm to a commercial pharmaceutical company [4][6][9]. Financial Performance - Since its listing, Zai Jing Pharmaceutical has reported continuous losses, with a net loss of 1.5 billion RMB in 2024 and a net loss of 1.38 billion RMB [6][10]. - As of the end of Q3 2025, the company reported revenues of 5.93 billion RMB, surpassing the total revenue for 2024 [10][11]. - The company's debt ratio exceeded 60% by Q3 2025, with total liabilities reaching 18.64 billion RMB, primarily driven by short-term debts [17][18]. Product Development and Sales - Zai Jing Pharmaceutical's product portfolio includes multiple drugs, with its main revenue source being Donafenib, which has been approved for use in over 2,200 hospitals [20][21]. - The company has launched several products, including Donafenib, Recombinant Human Thrombin, and JAK inhibitor Gika Xitini, with the latter expected to enter the national medical insurance directory in January 2026 [8][21]. - Despite revenue growth, the company faces high sales and distribution expenses, which reached 3.32 billion RMB in the first three quarters of 2025, indicating a sales expense ratio of over 56% [9][21]. Strategic Moves - Zai Jing Pharmaceutical is pursuing a dual listing on the Hong Kong Stock Exchange to raise funds for international expansion and brand establishment [11][12]. - The company recently announced a licensing deal with AbbVie for its drug ZG006, which could provide up to 1 billion USD in milestone payments, marking its first overseas licensing agreement [16][24]. - The cancellation of its U.S. subsidiary, Gensun Biopharma, was aimed at optimizing resource allocation and enhancing R&D efficiency, although it raised questions about the rationale behind the acquisition of a loss-making asset [12][15]. Market Sentiment - The stock price of Zai Jing Pharmaceutical saw a nearly 50% increase in the first half of 2025, but market sentiment has shifted, with concerns about the company's ability to achieve profitability and manage high sales expenses [22][23]. - As of January 8, 2026, the stock price was reported at 97.25 RMB per share, reflecting a decline, indicating market skepticism regarding the company's future performance [23][24].

Core Viewpoint - Zaiqiang Pharmaceutical has received approval from the National Medical Products Administration for its innovative drug, injection human thyroid-stimulating hormone beta, marking a significant advancement in the treatment of differentiated thyroid cancer [1] Group 1: Company Announcement - Zaiqiang Pharmaceutical announced the approval of its new drug application for injection human thyroid-stimulating hormone beta, previously known as injection recombinant human thyroid-stimulating hormone [1] - The approved indication is for use in the collaborative diagnosis of patients with differentiated thyroid cancer following total or near-total thyroidectomy, facilitating serum thyroglobulin (Tg) testing, with or without radioactive iodine (131I) whole-body scan (WBS) [1] - This product is the first of its kind in China approved for precise assessment post-surgery for differentiated thyroid cancer [1]

证券代码：688266 证券简称：泽璟制药 公告编号：2026-002 苏州泽璟生物制药股份有限公司 关于自愿披露注射用人促甲状腺素β 获批上市的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 2026 年 1 月 8 日，苏州泽璟生物制药股份有限公司（以下简称"公司"）收 到国家药品监督管理局核准签发的《药品注册证书》，公司自主研发的注射用人 促甲状腺素β（曾用名：注射用重组人促甲状腺激素，商标：泽速宁®）的新药 上市申请获得批准，本次获批的适应症为："用于分化型甲状腺癌患者在甲状腺 全切或近全切除术后随访中的协同诊断，以进行血清甲状腺球蛋白（Tg）检测， 伴或不伴放射性碘（131I） 全身显像（WBS）检查"。注射用人促甲状腺素β是 我国首个获批用于分化型甲状腺癌术后精准评估的创新产品。 由于医药行业的特点，药品上市后的具体销售情况受政策环境、市场需求及 竞争状况等多种因素的影响，存在一定的不确定性，公司将及时根据后续进展履 行信息披露义务。敬请广大投资者谨慎决策，注意防范投资风险。 现将相关情况 ...

人民财讯1月8日电，泽璟制药(688266)1月8日公告，2026年1月8日，公司收到国家药品监督管理局核准 签发的《药品注册证书》，公司自主研发的注射用人促甲状腺素β(曾用名：注射用重组人促甲状腺激 素，商标：泽速宁)的新药上市申请获得批准。注射用人促甲状腺素β是我国首个获批用于分化型甲状腺 癌术后精准评估的创新产品。 ...

智通财经APP讯，泽璟制药(688266.SH)发布公告，2026年1月8日，公司收到国家药品监督管理局核准 签发的《药品注册证书》，公司自主研发的注射用人促甲状腺素β(曾用名：注射用重组人促甲状腺激 素，商标：泽速宁®)的新药上市申请获得批准，本次获批的适应症为："用于分化型甲状腺癌患者在甲 状腺全切或近全切除术后随访中的协同诊断，以进行血清甲状腺球蛋白(Tg)检测，伴或不伴放射性碘 (131I)全身显像(WBS)检查"。注射用人促甲状腺素β是我国首个获批用于分化型甲状腺癌术后精准评估 的创新产品。 ...

Summary of Zai Lab's Conference Call Company Overview - Zai Lab is transitioning from a biotech company to a biopharma company, with significant potential for market capitalization growth. The company is listed in Hong Kong and is pursuing internationalization and an innovative pipeline to create more development opportunities [3][8]. Key Projects and Developments Project 006 (Small Cell Lung Cancer) - **Market Position**: The median progression-free survival (PFS) for the 10mg dose in third-line and later treatment is 7 months, outperforming DL3 CD3 dual antibody TARA and comparable to in-development ADC products, positioning it as a potential best-in-class option [2][4]. - **Domestic Market**: There are approximately 150,000 to 160,000 new small cell lung cancer patients annually in China. With upgraded treatment methods extending survival, Project 006 is expected to capture a significant market share, with peak sales potentially exceeding expectations of 2-3 billion [5][6]. - **International Market**: Currently in Phase I clinical trials, Project 006 has excellent safety and efficacy data. The company is exploring combination therapies with AbbVie, aiming to establish it as a cornerstone treatment for extensive-stage small cell lung cancer [6][18]. Project 005 (Cervical Cancer) - **Clinical Efficacy**: Demonstrated strong efficacy in second-line cervical cancer treatment and superior results when combined with bevacizumab in first-line treatment compared to PD-1 and PD-1 CTLA-4 dual antibodies [2][7]. - **Future Data**: Anticipated data release at the 2026 ASCO conference for first-line liver cancer treatment combined with bevacizumab, indicating growing commercial value [7][16]. Strategic Collaborations - The partnership with AbbVie is deemed highly valuable due to AbbVie's extensive experience in small cell lung cancer and ongoing clinical trials. This collaboration may lead to innovative combination therapies that could capture significant market share globally [13][17]. Financial Outlook - Zai Lab's current market capitalization is below 30 billion, reflecting only a fraction of its product pipeline and domestic market expectations. The company aims to enhance its valuation through international expansion and further financing [3][8]. Research and Development - Zai Lab is actively exploring various combinations of its drugs, including GS18 and 006 for small cell lung cancer, and 005 with GS18 for non-small cell lung cancer. The company has a robust internal asset base, allowing for flexible early data exploration [15][17]. Clinical Trial Performance - In the 2025 ASCO conference, Project 005 reported an overall response rate (ORR) of 40% in second-line cervical cancer, significantly higher than competitors. In first-line treatments, the 20mg group showed an unconfirmed OR of 82%, indicating strong performance compared to existing therapies [16]. Conclusion - Zai Lab is positioned for significant growth with its innovative drug pipeline and strategic partnerships. The company is focusing on expanding its market presence both domestically and internationally, with promising clinical data supporting its product offerings [2][3][8].

1月7日，泽璟制药涨5.37%，截至发稿，报98.39元/股，成交1.22亿元，换手率0.48%，总市值260.45亿 元。 资料显示，苏州泽璟生物制药股份有限公司位于江苏省昆山市玉山镇晨丰路262号,香港湾仔皇后大道东 183号合和中心46楼，成立日期2009年3月18日，上市日期2020年1月23日，公司主营业务涉及化学新药 及生物新药的研发、生产及销售。主营业务收入构成为：药品99.97%，医药中间体及原辅料0.02%，资 产租赁0.00%。 从基金十大重仓股角度 截至发稿，丁天宇累计任职时间5年10天，现任基金资产总规模2.31亿元，任职期间最佳基金回报 13.55%， 任职期间最差基金回报-25.34%。 风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建 议。 责任编辑：小浪快报 数据显示，中金基金旗下1只基金重仓泽璟制药。中金新医药A（006981）三季度减持3.65万股，持有股 数2.95万股，占基金净值比例为3.15%，位居第十大重仓股。根据测算，今日浮盈赚取约1 ...