HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发性骨髓 瘤(「MM」)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表面 表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的细 胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗还 可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作用。 2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 格隆汇2月12日丨复宏汉霖(02696.HK)宣布，近日，公司自主研发的HLX15-SC(重组抗CD38全人单克隆 抗体注射液－皮下注射)(「HLX15-SC」)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监 督管理局(NMPA)批准。 ...

根据IQVIA MIDASTM的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年 度，达雷妥尤单抗于全球范围内的销售额约为128.8亿美元。 据悉，HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发 性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表 面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的 细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗 还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 复宏汉霖(02696)公布，近日，公司自主研发的HLX15-SC(重组抗CD38全人单克隆抗体注射液-皮下注 射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局(NMPA)批准。 ...

根据IQVIA MIDAS的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年度，达 雷妥尤单抗于全球范围内的销售额约为128.8 亿美元。 智通财经APP讯，复宏汉霖(02696)公布，近日，公司自主研发的HLX15-SC (重组抗CD38全人单克隆抗 体注射液-皮下注射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局 (NMPA)批准。 据悉，HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发 性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表 面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的 细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗 还可通过降低髓源性抑制细胞和消耗CD38 表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月， HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 ...

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 HLX15-SC（重組抗CD38全人單克隆抗體注射液－皮下注射） 用於多發性骨髓瘤治療的臨床試驗申請獲國家藥品監督管理局批准 A. 緒言 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。 HLX15（重組抗CD38全人單克隆抗體）是本公司自主研發的達雷妥尤單抗生 物類似藥，擬用於多發性骨髓瘤（「MM」）等治療。達雷妥尤單抗是一種人源 化的抗CD38的IgG1κ單克隆抗體，其可與腫瘤細胞表面表達的CD38結合， 通過補體依賴的細胞毒作用(CDC)、抗體依賴的細胞毒作用(ADCC)和抗體依 賴的細胞吞噬作用(ADCP)、以及Fcγ受體等多種免疫相關機制誘導腫瘤細胞 凋亡。除此之外，達雷妥尤單抗還可通過降低髓源性抑制細胞和消耗CD38 表達陽性的免疫調節性T、B細胞來達到減少MM細胞的作用 ...

Market Overview - The Hong Kong stock market opened slightly lower, with the Hang Seng Index down 0.2% at 27,210.56 points, the Hang Seng Tech Index down 0.47% at 5,474.25 points, and the National Enterprises Index down 0.19% at 9,250.27 points [1] - Major tech stocks mostly opened lower, with Alibaba down 1.37%, Tencent down 2.01%, and Meituan down 2.48%, while AI application stocks showed strength, with Zhihui up 8.77% and MINIMAX-WP up 5.65% [1] Company Performance - NetEase reported strong performance, with a net revenue of approximately 112.63 billion yuan, a year-on-year increase of 6.96%, and a net profit of approximately 33.76 billion yuan, up 13.68% [2] - NetEase Cloud Music saw a significant profit increase of 75.4%, with a revenue of 7.76 billion yuan and a profit of 2.75 billion yuan, confirming a turning point in performance [2] Industry Trends - The hard technology and manufacturing sectors showed signs of recovery, with Qiu Tai Technology reporting a 22.8% year-on-year increase in camera module sales and an 18.4% increase in fingerprint recognition module sales, driven by demand in IoT and smart automotive sectors [3] - The renewable energy sector also saw growth, with China Resources Power reporting a 28.4% year-on-year increase in electricity sales, and solar power sales soaring by 72.3% [3] Biopharmaceutical Sector - The biopharmaceutical sector experienced significant positive developments, with Rebio Biotech announcing a global exclusive licensing agreement worth up to 4.4 billion USD, leading to a substantial increase in stock price [4] - Heng Rui Pharmaceutical's product was included in a breakthrough therapy list, with projected global sales exceeding 6.5 billion USD in 2024 [4] Capital Market Activity - Industrial capital is actively engaging in buybacks to stabilize the market, with Geely Automobile repurchasing shares worth approximately 20.30 million HKD and other companies like Kingsoft and Bai Rong Cloud also participating in buybacks [5] - Huili Group is expected to see a profit increase of over 20 times in 2025, indicating a strong performance reversal [5] Institutional Insights - There is a divergence in institutional views regarding market fluctuations, with some suggesting that the recent pullback is a liquidity shock, while others believe that valuation recovery is nearly complete [6] - Specific sectors like AI computing and surgical robots are highlighted for potential growth, with expectations for high performance in 2025 and 2026 [6]

Company News - Q Technology (01478.HK) reported a total sales volume of camera modules of 44.071 million units in January, representing a year-on-year increase of 22.8%. Fingerprint recognition module sales reached 19.741 million units, up 18.4% year-on-year, driven by increased overseas customer demand and a growing market share in the IoT and smart automotive sectors [2] - China Resources Power (00836.HK) achieved a sales volume of 23.78879 million megawatt-hours in January, a year-on-year increase of 28.4%. The sales from wind power plants increased by 7.2%, while solar power plant sales surged by 72.3% year-on-year [2] - NetEase-S (09999.HK) projected net revenue of approximately 112.626 billion yuan for 2025, a year-on-year growth of 6.96%, with net profit expected to be around 33.76 billion yuan, up 13.68% [2] - NetEase Cloud Music (09899.HK) anticipates revenue of about 7.759 billion yuan in 2025, with an expected profit of approximately 2.746 billion yuan, reflecting a significant year-on-year growth of 75.4%. The gross margin is expected to reach 35.7%, an increase from 33.7% in 2024, attributed to business scale growth, enhanced monetization capabilities, prudent cost management, and operational leverage [2] - Huitian Group (00806.HK) expects to achieve a consolidated profit attributable to shareholders of approximately 660 million HKD for the fiscal year 2025, a substantial increase from 31 million HKD in the previous year [2] Biotech Developments - Reborn Bio-B (06938.HK) entered into an exclusive global licensing agreement with Madrigal for several siRNA assets, receiving an upfront payment of 60 million USD, with potential cumulative payments of up to 4.4 billion USD upon achieving certain development, regulatory, and commercialization milestones, in addition to potential royalties on net sales [3] - Fuhong Hanlin (02696.HK) completed the first patient dosing in a Phase 1b/2 clinical study of HLX43 in combination with HLX07 or Hansizhuang® for patients with advanced or metastatic colorectal cancer in China [3] - Heng Rui Medicine (01276.HK) announced that its injection of Rukang Trastuzumab has been included in the list of breakthrough therapies, with global sales of similar products expected to reach approximately 6.557 billion USD in 2024 [3] - Saint Bella (02508.HK) made significant progress in its global strategic expansion plan, aiming to extend its reach to the eastern United States, the UK, France, Thailand, and Australia [3] - China National Biotech Group (08247.HK) signed a strategic cooperation agreement with Xiaoshou Medical to jointly promote the enhancement of quality medical resources and grassroots medical service capabilities [3] Buyback Activities - Geely Automobile (00175.HK) repurchased 1.201 million shares at a cost of 20.3042 million HKD, with repurchase prices ranging from 16.67 to 17.08 HKD [4] - Bairong Cloud-W (06608.HK) repurchased 1.66 million shares for 18.9051 million HKD, with share prices between 11.11 and 11.43 HKD [5] - Kingsoft (03888.HK) repurchased 355,200 shares at a cost of 9.9963 million HKD, with repurchase prices ranging from 27.9 HKD to 28.2 HKD [5]

格隆汇2月11日丨复宏汉霖(02696.HK)宣布，近日，注射用HLX43(靶向PD-L1抗体偶联药物) (「HLX43」)联合HLX07(重组抗EGFR人源化单克隆抗体注射液)(「HLX07」)或汉斯状®(斯鲁利单抗注 射液)(「汉斯状®」)在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国大陆完成首例患者给 药。 本研究为一项1b/2期临床研究，旨在评估HLX43联合HLX07或汉斯状®，在晚期或转移性结直肠癌患者 中的安全性、耐受性和有效性。该研究包括两个部分：第一部分包括第一阶段(安全导入期)和第二阶段 (剂量扩展)。第一阶段采用3+3剂量递增设计，患者将接受HLX43 2.5 mg/kg或3.0 mg/kg，联合固定剂量 HLX07(1000 mg)每三周一次(Q3W)静脉输注给药。第一阶段主要目的为评估不同剂量水准HLX43联合 HLX07在晚期或转移性结直肠癌患者中的安全性和耐受性，次要目的是研究HLX43的药代动力学(PK) 特徵和免疫原性、疗效、潜在药效学、潜在预测性或耐药性生物标志物。第二阶段是随机、多中心、开 放标签研究，HLX43两个剂量水准分别联合固定剂量HLX07进行扩展， ...

智通财经APP讯，复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体偶联药物) ("HLX43")联 合 HLX07(重组抗EGFR人源化单克隆抗体注射液)(" HLX07")或汉斯状®(斯鲁利单抗注射 液)("汉斯状®")在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国境内(不包括中国港澳台地 区，下同)完成首例患者给药。 ...

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 注射用HLX43（靶向PD-L1抗體偶聯藥物） 聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） 或漢斯狀® （斯魯利單抗注射液） 在晚期或轉移性結直腸癌患者中開展的1b/2期臨床研究 於中國境內完成首例患者給藥 A. 緒言 1 料，暫定HLX43的劑量水準為2.5 mg/kg和3.0 mg/kg，該階段主要目的是研究不 同劑量HLX43聯合固定劑量HLX07在轉移性結直腸癌(mCRC)患者中的有效性， 次要目的包括評價其安全性和耐受性、HLX43的PK特徵和免疫原性、並研究潛在 預測性或耐藥性生物標誌物。第二部分為一項隨機、多中心、開放標籤研究，評 估HLX43 2.0 mg/kg或2.5 mg/kg聯合固定劑量漢斯狀®(30 ...

Market Overview - The Hong Kong stock market showed initial gains but narrowed its increase, with the Hang Seng Index closing up 0.58% above 27,000 points, while the Hang Seng China Enterprises Index and Hang Seng Tech Index rose by 0.81% and 0.62% respectively [1][2]. Sector Performance - Technology stocks rebounded, driven by AI application stocks, with the stock of Reading Group surging over 15%. The film and entertainment sector remained active, and the biopharmaceutical sector saw widespread gains, led by Fuhong Hanlin [3][4]. - New consumption concept stocks, paper industry stocks, home appliance stocks, shipping stocks, and automotive stocks mostly increased. Conversely, education stocks faced declines, with gaming stocks collectively sluggish, and real estate, gas, electric, and telecom stocks also underperformed [3][4]. Notable Stocks - AI application stocks saw significant gains, with Reading Group rising 15.41%, and Zhiyun up 14.81%, reaching a new historical high during the session. Other stocks like Fubo Group and Yidu Technology also experienced increases [6][8]. - In the film sector, Orange Sky Entertainment rose over 7%, with other companies like Damai Entertainment and Ningmeng Film also following suit [10]. - The biopharmaceutical sector was buoyed by Fuhong Hanlin's increase of over 7%, with other companies like WuXi Biologics and WuXi AppTec also seeing gains [12]. Industry Insights - The real estate sector faced pressure, with Shimao Group dropping over 6% amid ongoing sales challenges in the industry. Major real estate companies are reportedly initiating organizational restructuring [13][14]. - Education stocks struggled, with Guangzheng Education falling over 5%, alongside declines in New Oriental and other educational institutions [15]. Investment Outlook - According to Everbright Securities, the current liquidity environment in the Hong Kong stock market is entering an observation period, with limited space for further tightening. Positive catalysts could lead to a recovery in market sentiment and capital inflow [22].