Core Viewpoint - The company, Fuhong Hanlin (02696), has received FDA approval for the IND application of its self-developed biosimilar HLX18, a recombinant anti-PD-1 humanized monoclonal antibody, for the treatment of various solid tumors [1] Group 1: Clinical Development - The company plans to conduct Phase 1 clinical trials in the United States once conditions are met [1] - HLX18 targets multiple potential indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1] Group 2: Mechanism of Action - The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, which can inhibit T cell proliferation and cytokine production [1] - Some tumor cells upregulate PD-1 ligands, leading to the suppression of activated T cell immune surveillance through this signaling pathway [1] - Nivolumab, a human immunoglobulin G4 (IgG4) monoclonal antibody, binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby inhibiting the immune suppressive response mediated by the PD-1 pathway, including anti-tumor immune responses [1]

Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX18, a recombinant anti-PD-1 humanized monoclonal antibody, for use in various solid tumors, indicating a significant advancement in its clinical development pipeline [1] Group 1: Product Development - HLX18 is a biosimilar to nivolumab, with potential indications including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma [1] - The company plans to conduct Phase 1 clinical trials in the United States once conditions are met [1] Group 2: Mechanism of Action - The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, which can inhibit T cell proliferation and cytokine production [1] - Tumor cells can upregulate PD-1 ligands, leading to the suppression of activated T cells' immune surveillance against tumors [1] - Nivolumab, as a human immunoglobulin G4 (IgG4) monoclonal antibody, binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2, thereby inhibiting the immune suppressive response mediated by the PD-1 pathway, including anti-tumor immune responses [1]

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 （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 HLX18是本公司自主研發的納武利尤單抗生物類似藥，潛在適應症包括黑色 素瘤、非小細胞肺癌、惡性胸膜間皮瘤、腎細胞癌、經典型霍奇金淋巴瘤、 頭頸部鱗狀細胞癌、尿路上皮癌、胃癌、胃食管連接部癌或食管腺癌、食管 癌、結直腸癌、肝細胞癌等原研藥已獲批的適應症。T細胞中表達的PD-1受 體與其配體PD-L1和PD-L2結合，可以抑制T細胞增殖和細胞因子生成。部 分腫瘤細胞的PD-1配體上調，通過這個通路信號傳導可抑制激活的T細胞對 腫瘤的免疫監視。納武利尤單抗是一種人類免疫球蛋白G4(IgG4)單克隆抗體 (HuMAb)，可與PD-1受體結合，阻斷其與PD-L1和PD-L2之間的相互作用， 阻斷PD1通路介導的免疫抑制反應，包括抗腫瘤免疫反應 ...

Market Overview - The US CPI annual rate decline has led to a rise in US stocks, boosting risk market sentiment [1] - The Hang Seng Index opened higher and closed up 0.75%, with the Hang Seng China Enterprises Index and Hang Seng Tech Index rising by 0.68% and 1.12% respectively [1][2] Sector Performance - Major technology stocks saw collective gains, with Tencent up 1.49%, Kuaishou up 1.45%, and Meituan up 1.28% [4] - Pharmaceutical stocks were active, with WuXi AppTec and other related stocks rising [2] - Gaming stocks continued to rise, with MGM China leading with a 6.6% increase [2][5] - AI-driven demand boosted optical fiber and cable stocks, with Yangtze Optical Fiber rising 12% [2] - Automotive, wind power, education, photovoltaic, insurance, and Apple-related stocks also experienced gains [2] Notable Stock Movements - Xpeng Motors rose 7.65%, Horizon Robotics up 7.04%, and Li Auto up 3.81% [4][10] - Electronic cigarette stocks saw significant increases, with China Tobacco Hong Kong up 6.68% [5] - Chinese brokerage stocks rose, with China International Capital Corporation up over 4% [7] - Intelligent driving concept stocks surged, with Youjia Innovation up 31.22% [8] Weak Performers - Heavy machinery stocks faced declines, with China National Heavy Duty Truck Group down over 6% [13] - Gold and precious metal stocks were weak, with several companies experiencing declines of over 2% [16] - Oil stocks also fell, with China Petroleum & Chemical Corporation down 1.52% [15] Capital Flows - Southbound funds recorded a net purchase of HKD 3.371 billion, with net selling from Shanghai-Hong Kong Stock Connect and net buying from Shenzhen-Hong Kong Stock Connect [18] Market Outlook - CITIC Securities suggests that after a strong performance in September, Hong Kong stocks are undergoing a mid-term adjustment, with quality assets entering a high-value zone [18]

Core Viewpoint - The report from China Galaxy Securities highlights the strong performance and growth potential of Fuhong Hanlin, a leading player in the biosimilar drug market in China, with a recommendation for a "buy" rating [1] Group 1: Business Performance - In 2023, the company achieved profitability with a projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, up 50% year-on-year [1] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [1] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer, with significant efficacy results reported [2] - HLX22, in combination with trastuzumab, shows improved efficacy and safety for HER2-positive gastric cancer, with ongoing global Phase III trials [2] - The company is leading in the ES-NCLC segment with its differentiated strategy, achieving major clinical endpoints in perioperative gastric cancer [2] Group 3: Market Strategy and Valuation - The company has expanded its global market coverage, with its core biosimilar products driving profitability [3] - A proposal for full circulation of H-shares is expected to enhance liquidity, as currently, only 30.07% of shares are tradable in Hong Kong [3] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan, respectively, with corresponding PE ratios of 39, 43, and 28 [3]

Core Viewpoint - Fuhong Hanlin (复宏汉霖) is positioned as a leading player in the biosimilar drug market in China, focusing on hematological malignancies, solid tumors, and autoimmune diseases, with a strong emphasis on international collaboration and product commercialization [1][2] Group 1: Business Performance - In 2023, the company achieved profitability with projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, reflecting a 50% increase compared to the previous year [2] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [2] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer and gastric cancer, showing significant efficacy in clinical trials with an overall response rate (ORR) of 33.3% for squamous NSCLC and 48.6% for non-squamous NSCLC [3] - HLX22, in combination with trastuzumab, has shown improved efficacy and safety in treating HER2-positive gastric/gastroesophageal junction cancer, with ongoing global Phase III trials [3] - The company is also advancing the development of Surulitinib, which aims to replace postoperative chemotherapy in gastric cancer with immunotherapy, having met primary clinical endpoints [3] Group 3: Market Strategy and Valuation - The company has established a global presence with its biosimilar products, which are key drivers of revenue growth, and is considering implementing full circulation of H-shares to enhance liquidity [4] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan respectively, with corresponding price-to-earnings ratios of 39, 43, and 28, suggesting a total market valuation between 52.1 billion and 67.9 billion yuan [4]

Core Insights - GIC Private Limited increased its stake in Fuhong Hanlin (02696.HK) by purchasing 88,200 shares at an average price of HKD 64.7061 per share, totaling approximately HKD 5.71 million [1] - Following this transaction, GIC's total shareholding in Fuhong Hanlin rose to 8,208,400 shares, which represents an increase in ownership from 4.97% to 5.02% [1] Company Summary - Fuhong Hanlin is a biotechnology company listed on the Hong Kong Stock Exchange under the stock code 02696 [2] - The recent share purchase by GIC Private Limited indicates a positive outlook on the company's performance and potential growth [1][2]

Group 1 - The core viewpoint of the article highlights that GIC Private Limited, the Singapore government investment company, has increased its stake in Fuhong Hanlin (2696.HK) by acquiring 88,200 H-shares at an average price of HKD 64.7061 per share, amounting to approximately HKD 5.7071 million [1] - Following the investments from Point72 Associates, Boyu Capital, and Taikang Insurance, GIC's acquisition reflects international investors' confidence in the company's operational stability and growth potential, as its shareholding percentage increased from 4.97% to 5.02% [1]

Market Overview - The Hong Kong stock market experienced fluctuations and adjustments, with the Hang Seng Index down 0.92% to 25,737.85 points, the Hang Seng Tech Index down 1.79% to 5,537.11 points, the National Enterprises Index down 1.2% to 8,970.29 points, and the Red Chip Index down 0.3% to 4,137.97 points due to the significant drop in US stocks last Friday [1] - Major technology stocks saw declines, with Alibaba down 2.73%, Tencent Holdings down 1.54%, JD Group down 1.12%, Xiaomi down 2.28%, NetEase down 0.18%, Meituan down 1.07%, Kuaishou down 3.85%, and Bilibili down 1.12% [1] - Insurance stocks performed well, with China Ping An reaching a four-year high, while the biopharmaceutical sector weakened, with Baijiazhensheng down over 6% [1] - Semiconductor stocks faced significant declines, with Huahong Semiconductor down over 6% [1] Company News - China Merchants Energy (01138.HK) signed shipbuilding contracts with Dalian China Merchants Heavy Industry, Yangzhou China Merchants Heavy Industry, and Guangdong China Merchants Heavy Industry for the construction of one ethylene ship and eighteen oil tankers, with a total cost of RMB 7.882 billion [2] - ZhongAn Online (06060.HK) reported a cumulative original insurance premium income of approximately RMB 32.904 billion for the first eleven months [3] - R&F Properties (02777.HK) achieved total sales revenue of approximately RMB 12.7 billion in the first eleven months, representing a year-on-year increase of 24.63% [4] - Yida China (03639.HK) reported a contract sales amount of approximately RMB 681 million for the first eleven months, a year-on-year decrease of 23.22% [5] - Kason International (00496.HK) signed a steel structure procurement contract with suppliers, involving an investment of RMB 43.5366 million [5] Clinical and Regulatory Updates - Boke Vision Cloud-B (02592.HK) successfully held a meeting after the second phase of clinical trials for CBT-004 [6] - Fuhong Hanlin (02696.HK) received acceptance from the National Medical Products Administration for the listing registration application of Hanshuo® in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, which has been included in priority review [6] - Shijiazhuang Pharmaceutical Group (01093.HK) received approval for a new indication for Donyi® (liposomal irinotecan injection) for first-line treatment in patients with metastatic pancreatic cancer [6] - Hengrui Medicine (01276) received a clinical trial approval notice for HRS-1780 tablets [8] Investment Insights - Guosen Securities indicated that the short-term adjustment in the Hong Kong stock market opens up space for a market rise in 2026, with net inflows from southbound funds exceeding RMB 110 billion in November [13] - Dongwu Securities highlighted that the main focus for Hong Kong stocks is on technology and cyclical sectors, while also paying attention to innovative drugs, suggesting a barbell allocation strategy due to potential macro and political risks [13] - CITIC Securities projected that the Hong Kong stock market will benefit from internal "14th Five-Year Plan" catalysts and external fiscal and monetary easing from major economies, expecting a sustainable upward trend in revenue and profit [13] - Dongwu Securities also forecasted a continued recovery in the Hong Kong stock market in 2026, citing expected interest rate cuts by the Federal Reserve and a temporary easing of Sino-US relations [14]

Core Viewpoint - The biotechnology sector in Hong Kong is experiencing a significant decline, with several companies facing substantial stock price drops [1] Group 1: Company Performance - Gilead Sciences (歌礼制药, 01672.HK) has seen its stock price drop by over 8% [1] - Sanofi (圣诺医药, 02257.HK) has experienced a decline of more than 6% [1] - Other companies such as BeiGene (百济神州, 06160.HK) and Innovent Biologics (复宏汉霖, 02696.HK) are also following the downward trend [1]