Core Viewpoint - Zhejiang Borui Biopharmaceutical Co., Ltd. (Borui Biopharma) has submitted its IPO application to the Hong Kong Stock Exchange, standing out in the biotech industry by achieving profitability for three consecutive years amidst a challenging financing environment [3][4]. Financial Performance - In 2024, Borui Biopharma is projected to generate revenue of 1.623 billion RMB, with a net profit of 91.295 million RMB, maintaining a high gross margin of 79.5% [3][27]. - The company reported a revenue of 1.379 billion RMB and a net profit of 155 million RMB for the first three quarters of 2025, indicating a strong growth trajectory [28]. Product Development - The company's first self-developed innovative drug, Anruixi (Zebetuzumab), is expected to generate revenue of 277 million RMB in 2024, a significant increase from 10.65 million RMB in 2023, marking a growth of over 2500% [4][26]. - Borui Biopharma has a portfolio of eight commercialized products, including two innovative drugs and six mature products, with over 70% of its revenue coming from these established lines [27][28]. Investment and Financing - Borui Biopharma has completed four major financing rounds, raising over 2.04 billion RMB, with its valuation increasing from 6.6 billion RMB to 13.5 billion RMB [4][19]. - The company attracted significant investment from PAG, which acquired a 58% stake in 2019, marking one of the largest private equity investments in the biotech sector that year [16][17]. Management and Strategy - The management team has been strengthened with the appointment of Liu Min as CEO, who brings over 25 years of experience in the biopharmaceutical industry [12][14]. - The company plans to allocate 80% of its R&D investment towards innovative drugs, with over 400 million RMB spent on R&D in 2024 and 2025 [30][31]. Market Position and Competition - Borui Biopharma operates in a highly competitive market for autoimmune and oncology drugs, facing challenges from both multinational and domestic pharmaceutical companies [33][34]. - The company aims to differentiate itself through innovative drug development and has already established a strong market presence with its biosimilars [21][35].

Core Viewpoint - Hansoh Pharmaceutical (03692) has seen a stock price increase of over 4%, currently trading at HKD 42.12, following the announcement of a new indication for its innovative drug, Amelot (Ametinib Mesylate Tablets) [1] Group 1: Regulatory Approval - On January 8, Hansoh Pharmaceutical announced that the National Medical Products Administration (NMPA) of China has issued a drug registration certificate for Amelot, approving it for use in combination with pemetrexed and platinum-based chemotherapy for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations [1] - This marks the fifth indication approved for Amelot [1] Group 2: Research Findings - Recent research results published in the prestigious oncology journal, Lancet Oncology, indicate that Amelot significantly improves disease-free survival (DFS) in patients with completely resected stage II-III B EGFR-mutant NSCLC, with good safety profiles [1]

京新药业 20260112 摘要 金鑫药业传统业务聚焦仿制药、原料药和医疗器械，仿制药涵盖精神神 经、心脑血管等领域，集采影响已逐步消除，原料制剂一体化布局具备 成本优势，收购深圳巨峰进入医用显示器市场，巩固了其在传统制药领 域的地位。 地达西尼作为新一代抗失眠创新药，通过独特机制规避了传统苯二氮卓 类药物的安全性问题，起效迅速且半衰期短，适合多病共存患者，上市 后已进入医保目录，2025 年前三季度销售额达 1.1 亿人民币，超出市 场预期，预计未来两年将迎来快速放量。 JX2,201 是一款靶向降脂的新靶点创新小分子药物，目前处于二期临床 阶段，虽然短期内难以贡献显著业绩，但其 BD 潜力巨大，有望成为公 司远期估值弹性的关键因素，为金鑫药业提供持续增长动力。 金星药业在降脂领域的小分子 LPA 创新药与礼来的莫法贝林结构相似， 后者已进入三期临床，若莫法贝林成功上市，金星的 2,201 也有较高成 药潜力，具备较高的 BD 交易潜力。 Q&A 金鑫药业的业务架构和发展逻辑是什么？ 金鑫药业的业务主要分为传统制药和创新药两大部分。传统业务包括仿制药、 原料药和医疗器械，其中仿制药对营收影响最大。尽管过去由 ...

Core Insights - In 2025, Wuhan achieved a historic breakthrough in innovative pharmaceuticals with three Class I innovative drugs receiving "National Drug Approval" [1][17] - This achievement reflects a two-decade commitment to innovation, showcasing a deep integration of government, industry, academia, research, and medical sectors [1][5] Group 1: Innovation Journey - The journey of innovation is marked by perseverance, as exemplified by Yang Daichang, who led a team for 20 years to develop the world's first plant-derived recombinant human serum albumin [2][5] - The extraction efficiency of human serum albumin from rice improved from 2.75 grams per kilogram to 30 grams, with purity increasing from 99.9% to 99.9999% over 20 years [2][5] - The development of the "Children's Bovine Gallstone Heat-Reducing Patch" by Jianmin Pharmaceutical Group took 20 years, emphasizing the modernization of traditional Chinese medicine [5][6] Group 2: Ecosystem and Support - Wuhan is building a robust ecosystem for life and health industry innovation, supported by top medical education resources from institutions like Huazhong University of Science and Technology and Wuhan University [6][9] - The region hosts 32 tertiary hospitals and over 7,000 health institutions, facilitating a deep integration of clinical needs, technological research, and industrial innovation [7][9] - The "Optics Valley Biocity" has attracted over 4,200 enterprises, focusing on strengthening the biopharmaceutical and high-end medical equipment industry clusters [9][12] Group 3: Government and Regulatory Support - The local government has played a crucial role in supporting innovative companies, providing financial assistance and facilitating connections for funding [12] - The Hubei Provincial Drug Administration has implemented reforms to expedite the approval process for innovative drugs, significantly reducing the time to market [14][16] - A modernized regulatory framework, including the establishment of a smart drug supervision platform, enhances the stability and predictability of the industry [16]

复宏汉霖HLX43的含金量还在不断上升。 作为广谱抗肿瘤、兼具IO疗效的潜在同类最优PD-L1 ADC，HLX43已在非小细胞肺癌、胸腺癌、宫颈癌等多个瘤种中验证治疗潜力，并在持续拓展治疗版 图。 就在近日举办的2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）上，复宏汉霖首次公布了HLX43末线治疗复发/转移性食管鳞癌（ESCC）的II期概 念验证（POC）数据：在3 mg/kg剂量组的13例疗效可评估的患者中，8例患者达到了部分缓解，ORR为61.5%，DCR为100.0%，确认的ORR（cORR）为 38.5%，初步临床疗效优异且安全性良好，优势人群获益潜力显著。 值得注意的是，复宏汉霖在实体瘤领域打出的王牌，不只有HLX43。 01 HLX43的护城河 具有广谱抗肿瘤潜力，是HLX43具备大药潜质的重要体现之一。 目前，复宏汉霖已累计开展约10项HLX43治疗多项实体瘤中的临床研究，广泛覆盖肺癌、宫颈癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管 交界部癌、胰导管腺癌等，在全球入组超过500例患者。 这种"广撒网"式的临床布局，体现了复宏汉霖的研发实力。尤其HLX43已在多个瘤种中读 ...

Core Viewpoint - The termination of the licensing and collaboration agreement between Yiming Anke (01541.HK) and Instil Bio (TIL.US) for the development of two cancer drugs, IMM2510 and IMM27M, is a significant setback for Yiming Anke, which had potential revenues exceeding $2 billion from this deal [2][3][5]. Group 1: Agreement Details - The collaboration agreement, established in August 2024, allowed Yiming Anke to retain rights in Greater China while granting Axion Bio exclusive global development and commercialization rights [2][3]. - Yiming Anke received a total of $35 million in payments from the collaboration, including a $5 million upfront payment and milestone payments [3][5]. - The agreement was initially seen as a major milestone for Yiming Anke's international strategy, particularly as PD-(L)1/VEGF dual antibodies were highly sought after in the international business development market [3][5]. Group 2: Reasons for Termination - The primary reason for the termination was the slow progress of clinical trials, with only three patients enrolled in the U.S. clinical trial as of January 2026, which was significantly below expectations [3][4]. - Yiming Anke's founder indicated that the choice of collaboration partner had limitations, contributing to the slow development pace [4][5]. Group 3: Future Strategy and Market Reaction - Following the termination, Yiming Anke plans to regain control over the global rights to the two drugs, which may accelerate their development pace [5][6]. - The market reacted negatively to the news, with Instil Bio's stock price dropping over 50% following the announcement [2]. - Yiming Anke aims to pursue new business development opportunities with multinational companies and is considering partnerships with mid-sized firms for further development [6].

在初始治療的T2DM患者以及二甲雙胍單藥治療血糖控制不佳的T2DM患者中開展的Ⅲ期臨 床試驗證實，普盧格列汀具有良好的有效性和安全性。與二甲雙胍單藥治療相比，普盧格 列 汀 聯 合 二 甲 雙 胍 具 有 顯 著 且 持 久 的 降 糖 作 用 ， 低 血 糖 發 生 率 較 低 ， 且 安 全 性 良 好 。 此 外，該產品與其他藥物發生相互作用的可能性較低，輕中度腎功能不全患者服用該產品時 無需調整劑量。與兩種單方製劑聯合應用相比，複方製劑可簡化治療方案、顯著提高患者 依從性，從而更有效地控制血糖。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 普盧格列汀二甲雙胍緩釋片的上市申請 獲國家藥監局受理 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 ...

Core Viewpoint - The collaboration between Haixiang Pharmaceutical and Wanbangde Pharmaceutical Group focuses on developing innovative drugs for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, leveraging each company's strengths to enhance their market competitiveness [1] Group 1: Collaboration Details - Haixiang Pharmaceutical signed an "Innovative Drug Cooperation Agreement" with Wanbangde Pharmaceutical on January 12, 2023 [1] - The initial collaboration will focus on the WP205 product, which has received orphan drug designation, and its research and commercialization [1] - Future cooperation will involve small molecule cyclic peptide agonists targeting melanocortin receptors (MCR) in areas such as raw materials and formulations [1] Group 2: Strategic Implications - The partnership aims to effectively integrate resources and complement each other's strengths in the innovative drug sector [1] - Haixiang's involvement in the neurodegenerative disease drug development will expand and deepen its presence in the peptide drug field [1] - This collaboration is expected to enhance Haixiang's existing research pipeline and positively impact its innovative development, thereby improving future market competitiveness [1]

Core Viewpoint - Haishang Pharmaceutical has signed an innovative drug cooperation agreement with Wanbangde Pharmaceutical to collaborate on the research and commercialization of the WP205 product for amyotrophic lateral sclerosis (ALS) [1] Group 1: Agreement Details - The agreement involves Haishang Pharmaceutical providing 150 million yuan in funding for the development of the WP205 product [1] - Haishang Pharmaceutical will receive 15% of the revenue rights from the commercialization of the product [1] - The agreement is subject to approval by the shareholders' meeting of Wanbangde Pharmaceutical [1] Group 2: Risks - There are risks associated with regulatory policies and market environment that could impact the collaboration [1] - The high-risk nature of drug development is highlighted as a potential concern [1]

Core Viewpoint - The company,艾力斯 (688578.SH), emphasizes its commitment to innovation as a core competitive advantage and outlines its strategic focus on the development of its key product,伏美替尼, along with other innovative drug candidates [2]. Group 1: Product Development - The company is conducting in-depth research on伏美替尼, exploring multiple application scenarios beyond the already approved indications for second-line and first-line treatments [2]. - Ongoing clinical registrations for伏美替尼 include auxiliary treatment for classic EGFR mutations, second-line and first-line treatments for 20 exon mutations, PACC mutation indications, brain metastasis indications, and auxiliary treatment for non-classic EGFR mutations [2]. - The NDA application for the second-line treatment of the 20 exon mutation has been accepted and prioritized for review, while the PACC mutation NSCLC first-line treatment indication is expected to be classified as a breakthrough therapy by December 2025 [2]. Group 2: New Product Introductions - In August 2024, the company introduced the KRAS G12C inhibitor,戈来雷塞, and the SHP2 inhibitor, taking full responsibility for their subsequent development [2]. - The second-line treatment indication for戈来雷塞 in NSCLC was officially approved in May 2025, and ongoing studies are being conducted for its use in pancreatic cancer and other solid tumors [2]. - Clinical trials are progressing smoothly for the combination of戈来雷塞 with the SHP2 inhibitor for first-line treatment of KRAS G12C mutation non-small cell lung cancer [2]. Group 3: Research and Development Enhancements - The company is advancing its new drug discovery platform, enhancing its capabilities in both large and small molecule research, and strengthening team development [2]. - Several innovative drugs are currently in the preclinical research stage, indicating a robust pipeline for future growth [2]. - The company is committed to promoting the internationalization of its products, aiming to make innovative drugs accessible to patients worldwide [2].