杭州生物医药产业活力迸发。日前，派格生物医药（杭州）股份有限公司自主研发的1类创新药"维 培那肽注射液"（药名"派达康"）获国家药品监督管理局批准上市，成为杭州今年获批上市的第五个1类 创新药。全市1类创新药上市申请量占全省75%，多项核心指标领跑全省。 维培那肽凭借创新的定点PEG化技术，可以有效抵御DPP-4酶的降解，并显著降低肾脏清除率。这 一技术既确保了药物与GLP-1受体的高效结合，发挥药物生物活性，使其能够快速达到较高的暴露浓 度，又可明显减少免疫应答和清除、降低胃肠道副作用、避免因分子量过大可能引发的体内蓄积的风 险，使其在临床治疗时能够达到更长久的暴露时间，最终实现疗效与安全的理想平衡。 "杭州市市场监管局的工作人员主动上门服务，帮我们预判并解决问题，节省了大量时间和精 力。"派格生物相关负责人对这种"想在企业前面"的"杭州服务"模式印象深刻。在破解企业实际难题 上，杭州市场监管部门在全省率先开展贵重仪器设备委托检验备案，为企业缓解资金压力；针对跨省委 托生产等共性难题，组织专题讨论，推动指导原则落地，使相关咨询量显著下降。此外，积极搭建资源 对接桥梁，协助企业申报产业专项资金，确保惠企政策精 ...

Core Viewpoint - Zhijiang Biotech (stock code: 688317) has received overwhelming support from shareholders to engage in foreign exchange derivative trading to mitigate currency risk associated with its international business operations [1][2]. Group 1: Shareholder Meeting and Approval - The second extraordinary general meeting of Zhijiang Biotech was attended by 112 shareholders, representing approximately 72.82 million shares, or 37.9% of the total share capital [1]. - The proposal to conduct foreign exchange derivative trading was approved with a high vote of 99.52% [1]. - The company plans to engage in foreign exchange derivatives with a limit of up to $20 million (or equivalent in other currencies) within 12 months of the approval [1]. Group 2: Business Strategy and Rationale - The company aims to hedge against currency fluctuations due to its import and export operations, which often involve foreign currencies like the US dollar [1][2]. - Although current overseas revenue is modest at around 2.3 million yuan, the company is in a critical phase of expanding its international presence, including markets like Japan [2]. - Zhijiang Biotech is also exploring overseas acquisition targets to diversify its business strategy [2]. Group 3: Financial Performance - For the first three quarters of the year, Zhijiang Biotech reported revenue of 90.43 million yuan, a year-on-year decline of 34.27%, with a net loss attributable to shareholders of 29.38 million yuan [3]. - Despite the revenue drop, the company increased its R&D investment, which accounted for 46.51% of revenue, up 18.11 percentage points from the previous year [3]. - The company has effectively managed its inventory levels, which have returned to normal after previous adjustments [4]. Group 4: Innovation and Drug Development - Zhijiang Biotech has signed a strategic cooperation agreement with Sanyou Biotech to enhance drug development automation, aiming to shorten R&D cycles and improve efficiency [5]. - The company is focusing on innovative drug development, particularly in infectious diseases and oncology, with ongoing preclinical studies [6][7]. - The company is leveraging its expertise in materials science and chip technology to develop organoid technology for personalized medicine and drug screening [6]. Group 5: Future Plans and Financial Strategy - The company plans to establish an independent platform for innovative drug development, indicating a strategic shift towards this area [7]. - Zhijiang Biotech is evaluating various projects for investment, with a focus on synergy with its core business [7]. - The company has over 2 billion yuan in cash, which will be strategically utilized for future investments [7].

证券日报网讯健康元11月18日在互动平台回答投资者提问时表示，创新药研发是一项周期长、风险高、 投入大的系统工程，公司的创新转型正处于持续推进阶段。从靶点布局、临床前研究到临床试验，每一 步都需要时间沉淀，期间也必然面临诸多不确定性。目前，公司已在创新药研发上持续投入并取得阶段 性进展。 （文章来源：证券日报） ...

Core Viewpoint - The company emphasizes the importance of innovation in drug development for oncology, autoimmune diseases, and neurobiology, highlighting unmet clinical needs and significant market demand in these areas [1] Group 1: Oncology - Oncology remains a key focus for innovative drug development, with ongoing clinical demand for breakthroughs in immunotherapy, targeted therapy, and personalized medicine due to increasing drug resistance [1] Group 2: Autoimmune Diseases - Autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease are critical areas of interest for biopharmaceutical companies, particularly as they affect the younger workforce and have lower treatment efficacy and adherence [1] Group 3: Neurobiology - Neurodegenerative diseases like Alzheimer's, Parkinson's, and diabetic neuropathy are gaining significant attention from global pharmaceutical companies and research institutions, driven by the rapid increase in patient numbers due to global aging [1] Group 4: Company Pipeline - The company has established multiple self-developed drug pipelines in neurobiology, autoimmune diseases, and oncology, having obtained three IND approvals for Class I new drugs and ten IND approvals for Class II new drugs [1]

11月18日早间，四川百利天恒药业股份有限公司（以下简称"百利天恒"）发布公告称，公司自主研发的 全球首创（First-in-class）、新概念（Newconcept）且唯一进入Ⅲ期临床阶段的EGFR×HER3双抗ADC （iza-bren）在食管鳞癌Ⅲ期临床试验中取得重磅突破。 公告显示，该研究针对既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌患 者。经独立数据监查委员会（iDMC）判断，iza-bren在预设的期中分析中达到无进展生存期（PFS）和 总生存期（OS）双主要终点。特别的是，该研究是全球首个ADC药物在食管癌治疗中取得PFS/OS双阳 性结果的Ⅲ期临床研究。 值得关注的是，这已是iza-bren第2项达到主要终点的确证性注册Ⅲ期临床研究。今年7月，iza-bren在鼻 咽癌Ⅲ期临床试验的期中分析中同样达到主要研究终点，显示出该药物在多种肿瘤治疗中的广泛应用前 景。9月，该药物被国家药品监督管理局药品审评中心纳入优先审批品种名单，上市进程进一步加速。 公告还显示，iza-bren正在中国和美国进行40余项针对多种肿瘤类型的临床试验。截至目前，iza-bren已 有7 ...

Group 1: Product Performance and Market Strategy - The company’s Loxoprofen Sodium Gel Patch was selected in the 11th batch of national drug centralized procurement with prices set at ¥17.88 for 4 patches, ¥26.82 for 6 patches, and ¥35.76 for 8 patches, with a planned selection quantity of 30.122605 million patches [2] - The company anticipates a certain growth in sales for the Loxoprofen Sodium Gel Patch post-price reduction due to the ongoing growth in the chronic pain treatment market, with actual performance feedback expected after next year's procurement execution [2][3] - The company plans to expand its sales channels and enhance brand building in response to the centralized procurement, leveraging its established multi-channel coverage system [4] Group 2: Financial Impact and Adjustments - The centralized procurement is expected to lead to a phase adjustment in profit margins for the Loxoprofen Sodium Gel Patch, impacting short-term revenue and profit performance [3] - The company is facing pressure to meet its annual targets due to market challenges, prompting a focus on promoting new products and enhancing market penetration through education and optimized product positioning [9] Group 3: Innovation and R&D Initiatives - The company is transitioning towards innovative drug development, establishing multiple R&D centers and focusing on various drug forms and collaboration models [5] - The R&D team consists of over 40 experts with experience in drug design and clinical research, focusing on oncology and chronic disease treatments using small molecules, peptides, and other drug forms [5] - The JIJ02 gel is expected to complete Phase I clinical trials in the first half of next year, with Phase II trials to follow [6] Group 4: Corporate Governance and Employee Engagement - The company is implementing a share repurchase plan to support future equity incentive programs, aiming to align the interests of the company, shareholders, and core team members [7]

Core Viewpoint - The Hong Kong stock market for innovative drugs has seen a recent rebound, driven by positive developments from leading companies like BeiGene, 3SBio, and Innovent Biologics, while several innovative drug companies are seeking IPOs in Hong Kong, including Libang Pharmaceutical [1] Group 1: Company Overview - Libang Pharmaceutical was founded in 2018 by Dr. Gavin Xia and Dr. Jin Tian, and it became a joint-stock company in October 2025, headquartered in Yangzhou, Jiangsu Province [2][3] - The company has completed multiple rounds of financing totaling approximately 2 billion RMB, with a post-investment valuation of about 3.779 billion RMB as of October 2025 [3] - Major investors include Tencent, Guojin Group, and several venture capital firms [3] Group 2: Product Pipeline - Libang Pharmaceutical focuses on the renal disease sector, with a product portfolio that includes seven candidate products, three of which are in clinical stages, and one commercialized product [6] - The core product, AP301, is a phosphate binder for treating hyperphosphatemia, a common complication of chronic kidney disease (CKD), and has completed Phase III clinical trials in China [7][8] - AP306, another key product, is a first-in-class phosphate transporter inhibitor, which received breakthrough therapy designation from the Chinese National Medical Products Administration in June 2024 [10][11] Group 3: Market Potential - The global market for hyperphosphatemia drugs is projected to reach 1.5 billion USD by 2024, with the Chinese market expected to reach 2.4 billion RMB [14] - Hyperphosphatemia affects approximately 95% of dialysis-dependent CKD patients and about 15% of non-dialysis-dependent CKD patients, indicating a significant unmet medical need [13][14] Group 4: Financial Performance - Libang Pharmaceutical reported revenues of 0, 6.5 million, and 12.11 million RMB for the years 2023, 2024, and the first half of 2025, respectively, all derived from the sales of its commercial product, Meixinlu (AP601) [19][21] - The company has incurred total losses of 910 million RMB over two and a half years, primarily due to R&D expenditures [20] - As of June 2025, the company had cash and cash equivalents of 171 million RMB, with sufficient operating funds to cover at least 125% of its costs for the next 12 months [22]

Core Viewpoint - Real Bio Technology Co., Ltd. has submitted a main board listing application to the Hong Kong Stock Exchange, showcasing its innovative research-driven approach in the fields of viral infections, tumors, and cardiovascular diseases, with significant development potential and strategic depth [1] Group 1: Product Pipeline and Development - The core product Azvudine has received conditional approval for treating HIV in July 2021 and COVID-19 in July 2022, marking it as the first oral antiviral drug developed by a Chinese company for COVID-19 [2] - Other key products include CL-197, a long-acting HIV treatment candidate currently in Phase II clinical trials, and Doxitinib, a third-generation EGFR-TKI targeting unmet needs in advanced non-small cell lung cancer, with Phase I results showing efficacy similar to Osimertinib but better safety [2][3] - Azvudine also holds significant potential in oncology, being the only nucleoside drug with dual mechanisms to inhibit tumor cell DNA synthesis and enhance immune response [2] Group 2: Research and Development Capabilities - The company is expanding its oncology applications, developing both monotherapy and combination therapies for multiple cancers, with IND approval for Azvudine/Doxitinib in non-small cell lung cancer expected by September 2025 [3] - Real Bio has established a comprehensive R&D system, including platforms for high-selectivity nucleoside anti-tumor drug development and drug target discovery, ensuring systematic support for continuous innovation [4] - The company has regained exclusive commercialization rights for Azvudine from Fosun Pharma, indicating the drug's potential value and expansion opportunities [4] Group 3: Commercialization and Market Position - Azvudine's successful commercialization is evidenced by its inclusion in the National Reimbursement Drug List (NRDL) in 2023, with over 10 million bottles sold and coverage across more than 50,000 medical terminals [5] - The company has established a GMP-certified production base with an annual capacity of approximately 3 billion tablets, supporting current and future product supply [5] - Real Bio's pipeline strategically targets high-prevalence disease areas, with a focus on unmet clinical needs in HIV and oncology, providing a unique clinical differentiation advantage [6]

每经记者｜陈星 每经编辑｜黄博文 在创新药研发的竞技场上，Ⅲ期临床的"期中大考"是检验药物价值的试金石。 11月18日，百利天恒宣布其核心产品——全球首创的EGFR×HER3双抗ADC药物iza-bren，在晚期食管鳞 癌Ⅲ期临床试验的预设期中分析中，同时达到无进展生存期和总生存期双主要终点。这不仅意味着该药 物有望满足食管鳞癌后线治疗的巨大临床需求，更标志着百利天恒的研发管线迎来关键性突破。 在临床捷报传来前夕，百利天恒做出暂缓港股IPO的决策。这一"进"一"退"之间，折射出中国创新药企 的价值新逻辑：当优质资产的价值足够坚实，企业便拥有了与市场博弈定价权的底气。从食管鳞癌、鼻 咽癌到肺癌，iza-bren展现出的"大癌种""泛疗效"潜力，正在重塑市场对百利天恒的估值认知。双终点 确证疗效：食管鳞癌治疗格局生变 食管鳞癌的后线治疗是临床上面临的主要挑战。一旦一线免疫联合化疗方案失败，患者的治疗选择便急 剧收窄。此时，传统的单药化疗虽是可选项之一，但其客观缓解率（ORR）多在30%以下，中位总生存 期（OS）也难以令人满意，且患者耐受性差，预后不佳。 11月18日，百利天恒公布其自主研发的EGFR×HER3双 ...

Core Insights - Shenzhen Hanyu Pharmaceutical Co., Ltd. has appointed Tang Yangming and Shen Yaping as executive presidents to enhance management structure and achieve complementary advantages [1][2] Group 1: Management Changes - Tang Yangming has over 20 years of experience in peptide drug research and has been a senior vice president at Hanyu Pharmaceutical, ensuring effective execution of company strategies [1] - Shen Yaping brings extensive experience from his tenure at Hengrui Medicine, focusing on international market strategies and commercialization, which aligns with Hanyu Pharmaceutical's expansion into overseas markets [1][2] Group 2: Strategic Implications - The addition of Shen Yaping is expected to infuse Hanyu Pharmaceutical with innovative drug development strategies, particularly in peptide drugs, enhancing clinical progression and commercialization efforts [2] - Tang Yangming's promotion reflects the company's commitment to internal talent development, ensuring continuity in core technologies and stable operations [2]