Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' drug Hansizhuang® has received recognition from the NMPA, indicating a significant step in its development for gastric cancer treatment [1] - The inclusion in the breakthrough therapy designation process suggests potential expedited review and approval, which could enhance the drug's market entry timeline [1]

Core Viewpoint - The company has received official inclusion of its innovative anti-PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), in the breakthrough therapy drug program by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Hanshuo has been approved for multiple indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has also received approvals in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

Core Viewpoint - The announcement highlights the inclusion of Hanshuo (Sruilumab injection) in the National Medical Products Administration (NMPA) breakthrough therapy program for the neoadjuvant/adjuvant treatment of gastric cancer, indicating a significant advancement for the company in the oncology sector [1] Group 1: Product Development - Hanshuo is an innovative anti-PD-1 monoclonal antibody developed by the company, which has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The product has also received approvals in multiple countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] Group 2: Clinical Trials - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its drug Hansizhuang® (sulunatuzumab injection) has been officially included in the breakthrough therapy designation process by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Junshi Biosciences' Hansizhuang® has received recognition from NMPA's Center for Drug Evaluation (CDE) [1]

（於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 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而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | 漢斯狀®+化療 | 廣泛期小細胞肺癌 | 於美國處於橋接試驗中 | | | | 於日本處於橋接試驗中 | | | 胃癌新輔助/輔助 | 於中國境內處於3期臨 | | | | 床試驗中，已達到主要 | | | | 研究終點 | | | 局限期小細胞肺癌（漢 | 於中國境內、美國、澳 | | | 斯狀®聯合化療同步放 | 大利亞及歐盟國家處於 | | | 療） | 3期臨床試驗中（國際 | | | | 多中心試驗） | | 漢斯狀®+貝伐珠單抗+化 | 轉移性結直腸癌 | 於中國境內、日本、印 | | 療 | | 度尼西亞處於2/3期臨 | | ...

Group 1 - Maosheng Holdings (00022) saw a rise of over 14% due to a 75.4% year-on-year increase in revenue for the six months ending September 30, 2025, attributed to the final stages of renovation construction services [1] - Emperor Capital (00717) increased by over 3.8% as net profit rose significantly due to a large reduction in impairment provisions for margin loans and other loans, alongside an increase in group revenue [1] - Ginkgo BioWorks-B (01167) rose over 5.4% following the approval of its self-developed KRAS G12C inhibitor, Goresir, for commercialization in China, with a partnership established with Ailida [1] - Maoyan Entertainment (01896) fell over 2% as reports indicated an increase in the ticket refund rate for "Demon Slayer" [1] - Fuhong Hanlin (02696) increased by over 4.3% after announcing FDA approval for its biosimilar to PERJETA, making it the first and only biosimilar of its kind in the U.S. [1] Group 2 - Trip.com Group-S (09961) dropped over 3.4% despite reporting a net operating revenue of 18.3 billion RMB for Q3 2025, a 16% year-on-year increase driven by sustained global travel demand [2] - Gushengtang (02273) rose over 2.2% after announcing a share transfer agreement with DA ZHONG TANG PTE. LTD. [2] - XPeng Motors-W (09868) fell over 4.6% amid market speculation about plans to produce thousands of autonomous taxis annually from 2026-2027 [2] - Techtronic Industries (00669) increased by over 4.7% as Home Depot's Q3 results indicated a positive outlook for the U.S. consumer market, benefiting Techtronic's professional segment [2] Group 3 - Guofu Quantum (00290) rose over 2.8% as it projected a net profit of approximately 200 million to 210 million HKD for the six months ending September 30, compared to a net loss of about 10.9 million HKD in the same period last year [3] Group 4 - Circle (CRCL.US) fell 8.98% as its stock price continued to decline since late October, with a significant insider sale reported [4] - The U.S. optical communication sector saw gains, with Lumentum (LITE.US) up 8.69% and other companies in the sector also rising [4] - Storage stocks in the U.S. rose, with Seagate Technology (STX.US) up 2.08% following a report on NVIDIA's shift to low-power memory chips for AI servers [5] - MP Materials (MP.US) increased by 8.61% after announcing a joint venture with the U.S. Department of Defense and Saudi Arabia's Maaden to build a rare earth refining plant [5] - Google (GOOGL.US) rose 3% as its new AI model Gemini 3 Pro topped the LMArena leaderboard, highlighting AI's role in its growth [6] - Nokia (NOK.US) fell over 9.19% as it focuses on AI-related infrastructure [6] - Block (XYZ.US) rose 7.56% after announcing a $5 billion increase in its stock buyback plan [6] - NetEase (NTES.US) fell 4.15% following the global launch of its new game [6] - Lowe's (LOW.US) rose 4.03% after reporting Q3 revenue of $20.81 billion, slightly below market expectations [6]

Core Viewpoint - Fuhong Hanlin's biosimilar drug POHERDY has received FDA approval, making it the first interchangeable biosimilar of PERJETA in the U.S. market, covering all indications approved for the original product [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 4.58%, reaching HKD 67.40, with a trading volume of HKD 40.6885 million [1] - The FDA approval allows POHERDY to be used interchangeably with the original PERJETA, marking a significant milestone for the company [1] - POHERDY is the first biosimilar of pertuzumab approved in the U.S. and the first interchangeable biosimilar for cancer treatment [1] Group 2: Market Position - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Company Summary - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved POHERDY, a biosimilar of pertuzumab, allowing it to be used interchangeably with the original product PERJETA, covering all indications previously approved for the original drug in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted for review [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved the biosimilar injection of pertuzumab, POHERDY, which can be used interchangeably with the original product PERJETA, covering all indications approved for the original product in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] Group 2: Market Position - Fuhong Hanlin has submitted marketing applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those products receiving approval in the U.S. [1]

Market Overview - The pharmaceutical and biotechnology index increased by 2.19%, outperforming the Shanghai Composite Index by 2.65 percentage points, ending a nearly two-month period of sluggish performance [4] - The innovative drug index (BK1106) rose by 4.93%, while the Hang Seng Healthcare Index (HSCICH) surged by 7.18%, and the Hong Kong innovative drug ETF (513120) increased by 5.90% [4][5] Investment Insights - The recent rebound in the pharmaceutical sector indicates a recovery in market sentiment, with a notable increase in risk appetite [5] - Investors are advised to focus on two main themes: capitalizing on valuation recovery opportunities in innovative drugs and medical devices, and being cautious of concept stocks lacking fundamental support [5] - Companies with strong global innovation capabilities and progress in international markets are highlighted as key investment targets [5] Company Developments - Fuxiang Pharmaceutical, primarily engaged in the development and sales of anti-infection drug raw materials, has seen its stock performance closely tied to the rising prices of lithium battery electrolyte additives, rather than traditional pharmaceutical concepts [5] - The company is expanding into synthetic biology and microbial protein businesses [5] Clinical Trials and Approvals - A total of 94 new clinical trial registrations were disclosed, with 37 in Phase II or above [9] - Notable clinical trials include the evaluation of HLX43 for late-stage pancreatic cancer, which has commenced its Phase II study [15] - The approval of innovative drugs includes the launch of Vepaglutide by Paig Biological, aimed at improving blood sugar control in adults with type 2 diabetes [13][14] IPO and M&A Activity - Jiahe Biopharma is pursuing a reverse merger with Yiteng Pharmaceutical, marking the first reverse acquisition case under the Hong Kong 18A listing rules for biotech companies [7][8] - Jiahe Biopharma reported a revenue of 32.245 million yuan, a year-on-year increase of 122.84%, despite a loss of 54.373 million yuan during the same period [7]