2026年1月23日，国家药监局官网显示，华辉安健全球首创靶向乙肝和丁肝病毒PreS1区域的立贝韦塔单 抗(HH-003)获得附条件批准，用于治疗慢性丁型肝炎病毒(HDV)感染的成年患者。 立贝韦塔单抗是一款在肝病患者群体、中国新药创制领域同时备受期待的药物。它既是中国第一款丁肝 治疗药物、全球病毒性肝炎领域第一款单抗药物，也是中国第一款彻底的原创新药——从发现病毒感染 机制、作用靶点到药物研发，全都是中国原创。 经济观察报记者张铃 李文辉曾告诉经济观察报，从靶点选择、安全性，到防止病毒逃逸和突变，再到临床使用验证，他们为 立贝韦塔单抗设计的每一个关键点最终都变成了现实。在九死一生的创新药研发战场上，这很难，也很 幸运。 慢性乙肝病毒(HBV)和丁肝病毒(HDV)合并感染是最严重的慢性病毒性肝炎，其显著加速肝脏相关死亡 及肝细胞癌的进展。HDV是HBV的"卫星"病毒，需依赖HBV包膜蛋白完成其生命周期，因此HDV感染 仅见于合并HBV感染的人群。慢性HBV和HDV合并感染比HBV单一感染更容易导致肝硬化或肝癌，导 致全球乙肝感染者中有约六分之一的肝硬化病例和五分之一的肝癌病例。 据世卫组织报告，全球慢性丁型肝 ...

作为新中国第一家化学合成制药企业，新华制药已发展成为全球重要的解热镇痛药生产和出口基地，并深度布局心脑血管、抗感染、神经系统等关键治疗 领域，拥有26个市场占有率第一或独家品种，产品行销全球。正是基于如此坚实的产业基础与持续的研发投入，新华制药得以牵头联合中国医学科学院、 沈阳药科大学、首都医科大学宣武医院等八家顶尖单位，组建了"山东省神经退行性药物研发创新联合体"。 该联合体的成立，直指阿尔茨海默病等神经退行性疾病这一全球医学难题。联合体旨在构建从疾病机制研究到临床转化的全链条平台，集中力量攻 坚。"我们全力攻坚全球首个靶向Aβ清除的多靶点小分子抗AD药物，加速推进OAB-14的临床试验和上市进程，争取早日为患者带来新的希望。"新华制 药相关负责人介绍。目前，治疗阿尔茨海默病的在研药物OAB-14已完成I期临床试验，安全性良好，II期临床试验已顺利开展，标志着公司在原创新药领 域迈出了关键一步。 创新的背后，是"四链"深度融合提供的系统性支撑。新华制药以数智化转型为抓手，构建了"人才引领创新、创新驱动产业、产业反哺教育"的闭环生态。 公司打造了由10名院士领衔、500余名硕博士支撑的高端人才梯队；与山东大学 ...

每经记者｜甄素静 每经编辑｜黄博文 12月23日晚间，微芯生物（SH688321，股价28.72元，市值117.12亿元）公告称，拟聘任在公司任职超 20年的黎建勋为总经理，全面负责日常经营管理；董事长XIANPING LU（中文名为"鲁先平"）辞任公 司总经理及法定代表人，仍保留董事长职务，工作重心转向企业战略规划、国际业务拓展等事务。 同日，微芯生物披露股份回购实施结果，以1500万元资金完成回购，达到方案上限，回购股份拟用于员 工持股计划或股权激励。 《每日经济新闻》记者注意到，此次人事调整与资本动作同步落地，正值微芯生物两款原创新药规模化 销售、业绩扭亏为盈的阶段。 对于此次人事调整和任命，微芯生物在接受记者采访时表示，本次任命是公司在前期探索基础上，为适 应新发展阶段需求而做出的制度化安排，旨在保障公司长期、稳健、高质量的发展。今后的分工将更为 专业、聚焦，决策链条更为清晰，执行效率有望进一步提升。 根据公告，微芯生物第三届董事会第十九次会议审议通过相关议案，同意聘任黎建勋为公司总经理，任 期自本次董事会审议通过之日起至第三届董事会任期届满之日为止。 对此，微芯生物表示，鲁先平不存在应履行而未履行的 ...

Core Viewpoint - Microchip Biotech (688321.SH) reported a significant increase in revenue and profit for Q3 2025, driven by strong sales of its innovative drugs, particularly Sidabone and Siglitazone [1] Financial Performance - For the first three quarters of 2025, the company achieved a revenue of 674 million yuan, representing a year-on-year growth of 40.12% [1] - In Q3 2025, the company generated a revenue of 268 million yuan, showing a year-on-year increase of 50% and a quarter-on-quarter growth of 10% [1] - The quarterly profit expanded to 41.18 million yuan, with total profit for the first three quarters reaching 70.77 million yuan [1] Product Performance - The growth in revenue is primarily attributed to the sales of Sidabone, which saw a year-on-year revenue increase of 18.76%, and Siglitazone, which experienced a remarkable year-on-year revenue growth of 136.13% [1] - Microchip Biotech has successfully launched two first-in-class innovative drugs, Sidabone (Aipusha®) and Siglitazone (Shuangluoping®), in multiple markets including mainland China, Japan, and Taiwan [1] Industry Recognition - The company has been recognized as a leading biotech firm at the 2025 China Pharmaceutical Decision-Makers Summit and received an award for Siglitazone as an industry-leading innovative drug [1]

Core Insights - He Yuan Bio became the first project to be approved after the resumption of the fifth set of standards on the Sci-Tech Innovation Board, officially listing on October 28 [1] - The investment firm Yifeng Capital has been supporting He Yuan Bio for over nine years since its investment in 2016, focusing on the development of innovative drugs in the medical health sector [1][2] - Yifeng Capital's CEO, Zhu Pai, emphasizes the importance of value investment and patience in supporting companies through various cycles, particularly in the context of China's pharmaceutical industry [1][6] Company Development - He Yuan Bio has developed a recombinant human serum albumin extraction technology from rice, successfully transitioning from pilot production to commercialization [2][3] - The company faced significant challenges during its industrialization phase, including financial pressure and sales difficulties, which are common in the "valley of death" for tech startups [2][3] - After nine years of support, He Yuan Bio achieved significant milestones, including the approval of its core product in July 2025 and its listing on the Sci-Tech Innovation Board in October [3] Investment Strategy - Yifeng Capital has invested in over a hundred projects, focusing on innovative drugs and high-end medical devices, avoiding investments in heavy asset hospitals and ordinary consumables [4][5] - The firm employs a professional team with extensive experience in the medical field, enabling it to identify trends and assess project value effectively [4] - Zhu Pai outlines three key dimensions for selecting investment projects: technological and clinical progress, innovation in drug formulation, and sustained R&D capabilities [5] Industry Trends - The Chinese pharmaceutical industry is experiencing a surge in collaboration with major global pharmaceutical companies, leading to explosive growth in overseas licensing deals [6] - Chinese pharmaceutical companies are increasingly recognized in the global market, enhancing their competitiveness and profitability through international expansion [6] - Yifeng Capital remains optimistic about the long-term development opportunities in the Chinese pharmaceutical sector, focusing on value investment and supporting companies in their R&D breakthroughs [6]

Core Viewpoint - Microchip Biotech (688321) reported significant growth in revenue and profitability for the first half of 2025, indicating a strong performance in the innovative drug sector [1] Financial Performance - The company achieved a revenue of 407 million yuan, representing a year-on-year increase of 34.56% [1] - Net profit attributable to shareholders was 29.59 million yuan, marking a substantial turnaround from losses [1] - Net cash flow from operating activities reached 62.06 million yuan, an increase of 299.15% compared to the end of the previous year [1] Product Portfolio and Market Presence - Microchip Biotech has two innovative drugs with multiple indications globally marketed, focusing on oncology, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral fields [1] - The sales revenue for the drug Sidabamine grew by 15.14%, while the drug Siglitazone saw a remarkable increase of 125.7% [2] - Sidabamine has been included in the national medical insurance catalog for eight consecutive years and has received approvals for various indications in China, Japan, and Taiwan [1] - Siglitazone is also included in the national medical insurance catalog and has shown efficacy and safety in treating type 2 diabetes and fatty liver disease [1][2] Production Capacity and Expansion - The company is actively expanding its production capacity to meet growing market demand, with its subsidiary Chengdu Microchip Pharmaceutical passing GMP compliance checks for the production line of Siglitazone [2] - The construction of the Pengzhou Microchip Innovative Drug Manufacturing Base is progressing as planned, with a new capacity of 1.2 billion tablets for Siglitazone expected [2] Future Growth Catalysts - Future revenue growth is anticipated from the continuous launch of new indications for Sidabamine, increased sales of Siglitazone, and the approval of the drug Xioloni for pancreatic cancer [3] - Key catalysts include the market expansion of Siglitazone, data from Xioloni for pancreatic cancer, and presentation of Sidabamine data at ESMO [3]

Core Insights - Shenzhen Micron Biotechnology Co., Ltd. reported a revenue of 407 million yuan for the first half of 2025, representing a year-on-year growth of 34.56% and a net profit of 29.59 million yuan, marking a turnaround from losses [1] - The growth in performance is primarily attributed to increased sales of its innovative drugs, namely Sidabenan and Siglecatin [1] Company Overview - Micron Biotechnology is a pioneer in China's original innovative drug sector, focusing on creating globally competitive product lines driven by core technologies [1] - The company adheres to the philosophy of "original, safe, effective, and Chinese," aiming to provide revolutionary therapeutic drugs that meet clinical needs [1] - It has established a complete industrial chain from early exploratory discovery to commercialization, offering original innovative drugs to global patients [1] Product Pipeline - The company has developed two innovative drugs that are globally marketed, with multiple indications in areas such as malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral treatments [1] - Sidabenan is the world's first subtype-selective histone deacetylase (HDAC) inhibitor, approved for multiple indications in China and Japan, and is undergoing clinical trials for additional indications globally [2] - Siglecatin is the first PPAR full agonist globally, included in the national medical insurance catalog, and shows efficacy in treating type 2 diabetes and fatty liver disease [2] Sales Performance - Sales revenue for Sidabenan and Siglecatin increased by 15.14% and 125.7% year-on-year, respectively [3] - Sidabenan has achieved coverage in major cities and hospitals across the country, while Siglecatin is available in over 5,300 hospitals and 6,700 pharmacies nationwide [3] - The company is accelerating its online channel presence through platforms like JD, Alibaba, and Meituan in response to changes in the pharmaceutical industry [3] Research and Development - Micron Biotechnology has multiple original innovative drug product lines, including several in clinical development and preclinical research stages, covering various disease areas with global first-in-class or differentiated advantages [3]

Core Insights - Micron Biotechnology focuses on developing innovative molecular entities for major diseases with global patent protection and unique clinical effects [1][3] - The company has successfully launched two First-in-Class drugs, Sidaben and Siglitazone, targeting oncology and metabolic diseases, while also addressing unmet clinical needs in neurodegenerative and autoimmune diseases [1][2] Drug Development and Technology - The company utilizes an AI-assisted design and chemical genomics integrated technology platform to enhance drug development processes, improving success rates, accelerating research, and reducing costs [1][3] - Micron Biotechnology has a diverse portfolio of treatment options for complex tumor characteristics, including new generation immune-activating antibody-drug conjugates and small molecule PD-L1 inhibitors [2][4] Clinical Research and Market Potential - The company is conducting clinical studies for its drug Westoroni, which selectively inhibits key proteins related to tumor development, in combination with AG therapy for advanced pancreatic ductal adenocarcinoma [2][4] - The global pancreatic cancer mortality rate is significant, with nearly 470,000 deaths annually, highlighting the urgent need for effective treatments [2] Metabolic Disease Focus - Siglitazone, the world's first PPAR pan-agonist, shows promise in treating diabetes and metabolic-associated fatty liver disease, positioning it as a cornerstone drug for metabolic diseases [4] - The company is also developing First-in-Class small molecules for weight management that do not affect appetite, addressing unmet needs in the obesity treatment landscape [4]

Core Viewpoint - The company is experiencing a turning point in performance due to the significant sales growth of innovative drugs, including Sidabenan (Aipush) and Siglitazone (Shuangluoping), which are addressing clinical needs and differentiating in the market [1][2]. Group 1: Financial Performance - The company achieved a revenue of 660 million yuan in 2024, representing a 26% year-on-year increase, driven by the substantial sales growth of Sidabenan and Siglitazone [1]. - The company's expenses amounted to 640 million yuan, with the expense-to-revenue ratio decreasing by 28% [1]. - Operating cash flow turned positive with a net inflow of 76.13 million yuan, marking a 148% year-on-year increase [1]. - As of the end of the period, the company had cash and cash equivalents totaling 470 million yuan and net assets of 1.58 billion yuan [1]. - For the first half of 2025, the company anticipates revenue of approximately 410 million yuan, an increase of 110 million yuan (+35%) compared to the same period last year [1]. Group 2: Product Pipeline and Market Potential - The company has a comprehensive oncology portfolio, with Sidabenan approved for multiple indications, including MYC/BCL2 double-expressing diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL), and breast cancer, with several other indications under research [2]. - Sidabenan is expected to activate cold tumors and has the potential to achieve peak sales exceeding 3 billion yuan, with ongoing Phase III clinical trials for colorectal cancer and melanoma [2]. - Siglitazone is projected to surpass 4 billion yuan in peak sales, as it improves metabolic diseases through various mechanisms, including blood sugar reduction and anti-inflammatory effects [3]. - The company forecasts continued revenue growth driven by the launch of new indications for Sidabenan, increased sales of Siglitazone, and potential approval of the pancreatic cancer treatment, Xioroni [3]. - Revenue projections for 2025-2027 are estimated at 907 million yuan, 1.447 billion yuan, and 2.507 billion yuan, with growth rates of 37.87%, 59.5%, and 73.25% respectively [3].

Company Overview - Microchip Biotech is a pioneer in original innovative drugs in China, focusing on providing clinically needed revolutionary mechanism drugs for patients [7][38] - The company has established a complete industrial chain layout from early exploratory discovery to commercialization, offering original innovative drugs globally [38] Financial Performance - For the fiscal year 2024, the company reported a net profit attributable to shareholders of -114.57 million yuan, with the parent company achieving a net profit of -88.42 million yuan [5] - The board decided not to distribute cash dividends or issue bonus shares for the fiscal year 2024, despite having positive undistributed profits [5] Product Pipeline - The company has developed two innovative drugs, with multiple indications approved for sale globally, including in the fields of malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral treatments [7][39] - Key products include: - **Sida Benamide (西达本胺)**: A first-in-class HDAC inhibitor with multiple indications approved in China and Japan, including for peripheral T-cell lymphoma and breast cancer [8][9][39] - **Siglitazone (西格列他钠)**: A first-in-class PPAR agonist approved for type 2 diabetes and recently for combination therapy with metformin [12][13][40] Research and Development - The company employs a team of experienced scientists to drive drug development, focusing on understanding disease mechanisms and optimizing drug design [22] - The R&D pipeline includes several promising candidates targeting various cancers and metabolic diseases, with ongoing clinical trials demonstrating significant efficacy [17][21][40] Industry Context - The biopharmaceutical industry in China is rapidly evolving, with increasing participation in global biotech innovation and a focus on meeting domestic healthcare needs [26][30] - Despite a low-risk appetite in global financing, Chinese companies are becoming significant players in licensing transactions, with a notable increase in outbound licensing activities [29][41] - The market for innovative drugs in China is projected to grow significantly, with a forecasted market size of approximately $197 billion by 2025 [30]