2025年，就在国内Biotech还沉浸在大额BD频发、港股重新开闸的热闹之时，大洋彼岸的美国Biotech却在经历一场劫难。 | 序号 | रूना | 关停时间 | 倒闭原因 | 创立时间 | 专注领域 | | --- | --- | --- | --- | --- | --- | | 1 | Velia Therapeutics | 2025年1月 | 临床研究失败,资金链断裂 | 2021 | 自身免疫病和肿瘤领域靶点 | | 2 | Viracta Therapeutics | 2025年2月 | 股价低于1美元,退市 | 1998 | 肿瘤领域小分子药物研发 | | 3 | kojin Therapeutics | 2025年2月 | 技术过于创新,融资困难 | 2019 | 专注铁死亡药物研发 | | 4 | spotlight Therapeutics | 2025年2月 | 临床研究失败,合作被终止 | 2017 | 致力于体内CRISPR基因编辑疗法 | | 5 | HC Bioscience | 2025年3月 | 技术过于创新,融资困难 | 2021 | tRNA技术研发 | | 6 ...

Core Viewpoint - Shimai Pharmaceutical has submitted an application to the Hong Kong Stock Exchange for its main board listing, with Huatai International acting as the sole sponsor [1] Industry Summary - The T-cell engaging (TCE) therapy market is projected to grow significantly, from $3 billion in 2024 to $121.1 billion by 2035, representing a compound annual growth rate (CAGR) of 40.0% [1] Company Summary - As of November 5, 2025, Shimai Pharmaceutical has four self-developed clinical-stage candidate drugs, including DNV3 targeting LAG3, SMET12 for intravenous use targeting EGFR×CD3, CMD011 targeting GPC3×CD3, and the next-generation cloaked TCE CMDE005 [1] - The company is also developing two preclinical next-generation multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [1] - Shimai Pharmaceutical emphasizes that its TCE therapies feature selective activation, zero immune cell toxicity, precise tumor recognition, and prevention of tumor recurrence, aiming to become a cornerstone therapy in future tumor immunotherapy [1]

Core Insights - Merck's PD-1 monoclonal antibody, Keytruda, has achieved over $20 billion in annual sales for both 2023 and 2024, solidifying its position as a leading drug in the lung cancer treatment market [2] - A competitive race is underway among pharmaceutical companies to establish the next generation of immune therapies for lung cancer, with significant advancements being made in the field [3][4] Group 1: Company Developments - Jun Zhu, CEO of Junshi Biosciences, announced promising results for their PD-L1 ADC HLX43 in treating non-small cell lung cancer (NSCLC), with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients [3] - HLX43 demonstrated even better efficacy in non-squamous patients, achieving an ORR of 48.6% and a DCR of 94.3% [3] - Junshi plans to advance at least eight Phase III clinical trials for HLX43 in the lung cancer domain [3] Group 2: Industry Trends - Lung cancer remains the leading malignancy globally, with 2.4 million new cases annually, and is a critical area for pharmaceutical breakthroughs [4] - The rise of targeted and immune therapies has transformed the treatment landscape for lung cancer, with new modalities such as ADCs, bispecific antibodies, and tumor vaccines expanding treatment options [4] - Several domestic companies, including Junshi Biosciences, CanSino Biologics, and Innovent Biologics, are competing to develop next-generation immune therapies, focusing on PD-(L)1 combinations with ADCs or PD-1 bispecific antibodies [4][5] Group 3: Clinical Research and Development - CanSino Biologics is conducting eight Phase III clinical trials for their PD-1/VEGF bispecific antibody, Ivoris, in lung cancer [6] - Innovent Biologics announced a collaboration with Takeda Pharmaceutical to co-develop a new generation immune therapy, IBI363, which targets PD-1 and IL-2α-bias [7] - Junshi's HLX43 is currently leading in global development for PD-L1 ADCs, with plans for clinical studies in cervical cancer, esophageal squamous cancer, and colorectal cancer [8]

Core Insights - Merck's PD-1 monoclonal antibody, Keytruda, has achieved global sales exceeding $20 billion in both 2023 and 2024, solidifying its position as the leading drug in the lung cancer market [1] Industry Overview - Lung cancer remains the leading cause of cancer globally, with 2.4 million new cases each year, and China reporting significantly higher new cases than other countries [3] - The rise of targeted and immunotherapy treatments has transformed the treatment landscape for lung cancer, with new therapies such as ADCs, bispecific antibodies, and tumor vaccines expanding treatment options [3] Competitive Landscape - A race is underway among pharmaceutical companies to establish the next generation of immunotherapy leaders in lung cancer, with companies like Junshi Biosciences, Kintor Pharmaceutical, and Innovent Biologics actively competing [2][3] - Junshi Biosciences has reported promising results for its PD-L1 ADC, HLX43, showing an objective response rate (ORR) of 33.3% in squamous non-small cell lung cancer (NSCLC) patients and 48.6% in non-squamous patients [2] - Kintor Pharmaceutical's PD-1/VEGF bispecific antibody, Ivoris, is currently undergoing eight pivotal phase III clinical trials [5] - Innovent Biologics has announced a collaboration with Takeda Pharmaceutical to co-develop a new generation of immunotherapy, IBI363, which targets PD-1 and IL-2α [6] Clinical Development - Junshi Biosciences plans to initiate at least eight phase III clinical trials for HLX43 in the lung cancer space, with additional studies planned for cervical cancer, esophageal squamous cancer, and colorectal cancer [2][7] - The cost of each global phase III clinical trial is estimated to be around $200 million, presenting a significant financial challenge for companies [7] Financial Performance - Junshi Biosciences reported revenue of 2.82 billion yuan in the first half of the year, a year-on-year increase of 2.7%, with net profit remaining stable at 390 million yuan [7]

Market Overview - The domestic market indices showed a decline, with the Shanghai Composite Index closing at 3,954.79, down 0.81% [2] - The Shenzhen Component Index and the CSI 300 also experienced declines of 1.14% and 1.47% respectively [2] Agricultural Sector - The company "Juxing Agriculture" reported a continuous increase in pig output, with a total of 293,000 pigs sold in the first three quarters of 2025, generating sales revenue of 5.153 billion [6] - The company aims to control breeding costs through various efficiency measures, despite a decline in pig prices leading to a drop in profitability in Q3 [6] New Materials Sector - "Jundingda" achieved a revenue of 728 million in the first three quarters of 2025, marking a year-on-year growth of 23.43% [5] - The company reported a net profit of 137 million, up 18.82%, with a gross margin of 40.38% and a net margin of 18.86% [5] Military Industry - "Inner Mongolia Yijian" reported a revenue of 7.894 billion in the first three quarters of 2025, a year-on-year increase of 11.07% [10] - The net profit reached 386 million, up 6.18%, driven by improvements in profit margins and growth in unmanned and military trade sectors [10][11] Technology Sector - "Dameng Data" reported a revenue of 2.167 billion in Q3 2025, a decrease of 6.59% year-on-year, but with an improved gross margin of 14.77% [16] - The company is focusing on expanding its military trade market and enhancing its position in high-tech weaponry [16] Energy Sector - "Baofeng Energy" achieved a revenue of 35.54 billion in the first three quarters of 2025, a year-on-year increase of 46.4% [27] - The net profit reached 8.95 billion, up 97.3%, driven by capacity release and steady progress on ongoing projects [27] Chemical Sector - "Zanyu Technology" reported a revenue of 9.676 billion in the first three quarters of 2025, with a year-on-year growth of 27.92% [20] - The net profit for the same period was 151 million, reflecting a 24.96% increase, attributed to the recovery in palm oil prices [20] Textile and Apparel Sector - "Weixing Co." reported a revenue of 36.33 billion in the first three quarters of 2025, a slight increase of 1.46% [24] - The net profit was 5.83 billion, down 6.46%, but the company is optimistic about future growth due to new factory efficiencies [24] Clinical Data Update - The clinical data for HLX43 shows promising safety advantages and potential as a cornerstone drug for tumors, with an overall response rate of 47.4% in specific patient groups [33][35]

Core Viewpoint - The company's performance in the first three quarters of 2025 aligns with expectations, showing significant revenue growth and reduced net loss compared to the previous year [1][2]. Financial Performance - Revenue for 1-3Q25 reached 1.806 billion yuan, representing a year-on-year increase of 42.1% [1]. - The net profit attributable to the parent company was -596 million yuan, reflecting a year-on-year reduction in loss of 35.7% [1]. Development Trends - The core product, Tuoyi, continues to see strong sales growth, with domestic market revenue of 1.495 billion yuan in 1-3Q25, up approximately 40% year-on-year [1]. - Tuoyi has received approval for 12 indications in China, with a new indication for HER2-expressing urothelial carcinoma under review by NMPA [1]. - Tuoyi has been approved in 40 countries and regions globally, including Hong Kong, the US, the EU, India, and the UK, with expectations for continued revenue contribution as more indications are approved [1]. Clinical Research and Innovation - The FDA has approved the initiation of clinical research for JS207, a PD-1/VEGF dual-target drug, marking a significant step in its development for operable patients [1]. - The company showcased over 20 research studies at the 2025 ESMO conference, with two studies selected for oral presentations, indicating strong engagement in international academic forums [2]. - Upcoming data updates for JS107 and JS207 at the 2025 ESMO Asia conference highlight the company's commitment to advancing cancer immunotherapy [2]. Profit Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at -917 million yuan and -315 million yuan, respectively [2]. - The company retains an "outperform" rating based on DCF valuation, with a target price of 36.98 HKD, indicating a potential upside of 47.6% from the current stock price [2].

Financial Performance - The overall performance of the formulation business has shown signs of stabilization and recovery this year, with key products like Zuo Yi maintaining stability and selected varieties from centralized procurement achieving growth [1] - The raw material drug business has experienced fluctuations, primarily due to a sluggish antibiotic market and decreased market share for key clients affected by centralized procurement [1] Product Development - The injection drug ALK-N001/QHL-1618 received clinical trial approval in April 2025 and is currently in the dose escalation phase of clinical I trials, progressing as planned [2] - The company is exploring potential tumor types for ALK-N001, which theoretically has broad tumor treatment potential, and will base future clinical trial directions on observed clinical signals [2] Sales and Revenue Structure - The company has licensing rights for ALK-N001 in mainland China, Hong Kong, Macau, and Taiwan, with a sales commission structure of 6%-12% based on agreements with partners [2] - If the partner successfully licenses the product to third parties outside the target regions, the company will receive 3% of the net income from those licensing fees [2] Innovation Strategy - The second innovative drug, ALK-N002/IMD-1005, is a novel CD47-targeting antibody that aims to provide new immunotherapy options for cancer patients, showing promising efficacy and safety in preclinical studies [4] - The company plans to optimize its R&D team structure to focus more on innovative drug development as the output from generic drug projects begins to materialize [7] R&D Investment - R&D investments are expected to shift focus from generic drugs to innovative drug projects starting in 2026, with a gradual reduction in generic drug-related R&D expenditures [8] - The company has established criteria for capitalizing R&D expenditures based on the stage of clinical trials, with specific thresholds for new and generic drug development [8]

Core Insights - Junshi Bioscience (688180.SH) reported a significant increase in revenue and a reduction in net loss for the first three quarters of 2025, with total revenue reaching 1.806 billion yuan, a year-on-year growth of 42.06%, and a narrowed net loss of 596 million yuan, a decrease of 35.72% [1] - The company's core product, Toripalimab, has shown continuous growth in sales, achieving 1.495 billion yuan in revenue for the first three quarters, a 40% increase year-on-year, and has maintained a sequential growth for six consecutive quarters since 2024 [1][2] Financial Performance - For Q3 2025, Junshi Bioscience reported revenue of 637 million yuan, reflecting a year-on-year increase of 31.40% [1] - The company had a strong cash position with a total of 3.270 billion yuan in cash and financial assets as of the end of Q3 2025 [1] Product Development and Clinical Recognition - Toripalimab's clinical value has been recognized internationally, particularly highlighted at the 2025 ESMO annual meeting, where its combination therapy with ADC drug was presented, showing significant improvements in overall survival and progression-free survival compared to traditional chemotherapy [2] - The new indication for Toripalimab has been accepted for review by the NMPA in China, marking the 13th indication application for the drug [2] Global Commercialization and Market Expansion - Toripalimab has been approved in over 40 countries and regions across four continents, including major markets like the US and EU, with recent approvals in Pakistan and Canada [3] - The company has established a global commercialization network covering over 80 countries through partnerships with various pharmaceutical companies [3] R&D Pipeline and Future Prospects - Junshi Bioscience has developed over 50 drug candidates, with a focus on accelerating R&D in innovative pipelines, including next-generation therapies [3][4] - The company is preparing to submit a marketing application for its anti-IL-17A monoclonal antibody, JS005, which has shown positive results in a Phase III study for psoriasis [4] - A new equity incentive plan was introduced, indicating the company's confidence in achieving revenue targets of at least 2.4 billion yuan in 2025 [4]

Core Insights - Junshi Biosciences (688180.SH/1877.HK) reported a continuous increase in commercial revenue and accelerated R&D of differentiated innovative pipelines, showcasing improved sustainable operational capabilities [1][2]. Financial Performance - For the first three quarters, Junshi Biosciences achieved operating revenue of 1.806 billion yuan, a year-on-year increase of 42.06%, while narrowing its net loss to 596 million yuan, a reduction of 35.72% [1]. - In Q3 alone, the company recorded operating revenue of 637 million yuan, reflecting a year-on-year growth of 31.40% [2]. Product Performance - The core product, Tuoyi® (Tremelimumab), generated sales of 1.495 billion yuan in the first three quarters, marking a 40% year-on-year increase [2]. - Tuoyi® has seen six consecutive quarters of sequential growth since 2024, driven by enhanced sales efficiency and the inclusion of more indications in medical insurance [2]. Global Expansion - As of the end of Q3, Tuoyi® has been approved for marketing in over 40 countries and regions across four continents, including major markets like the U.S. and EU, with ongoing expansion into emerging regions [2][6]. - The global commercialization network has been established through partnerships with companies like Coherus and Dr. Reddy's, covering over 80 countries [2][6]. R&D and Pipeline Development - Junshi Biosciences is focusing on next-generation therapies, with high-potential pipelines such as JS207 (PD-1/VEGF), JS212 (HER3/EGFR dual antibody ADC), and JS015 (DKK1 monoclonal antibody) advancing rapidly [2][8]. - The company has developed over 50 drug candidates, including four commercialized products and nearly 30 in clinical stages, indicating strong product iteration capabilities [8]. Clinical Achievements - At the recent ESMO conference, Tuoyi® was highlighted for its combination therapy with ADC drug Vadisizumab, achieving significant clinical results, including an overall survival extension to 31.5 months compared to traditional chemotherapy [5][6]. - The company has also received positive results from its ongoing studies, including the registration study for JS005 (anti-IL-17A monoclonal antibody) in treating moderate to severe plaque psoriasis, which is expected to lead to a market application [11]. Strategic Initiatives - In September 2025, Junshi Biosciences launched an equity incentive plan with performance targets, reflecting strong confidence in future performance [3]. - The company is actively exploring combination therapies for its products, enhancing its competitive edge in the oncology market [9][10].

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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 此為本公司刊發的自願性公告。本集團無法保證ABK-CDK-1以及ABK-SM2-1最 終將成功獲批上市。本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 和譽開曼有限責任公司 徐耀昌博士 主席 上海，2025年10月27日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥在第37屆AACR-NCI-EORTC大會公佈新型CDK4/2抑制劑和 SMARCA2 PROTAC降解劑臨床前研究成果 2025年10月27日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，公司在 第37屆AACR-NCI-EORTC國際分子靶標與癌症治療大會（「AACR-NCI-EORTC 大會 ...