本报讯 （记者金婉霞）日前，记者从上海复宏汉霖生物技术股份有限公司（以下简称"复宏汉霖"）获悉，由公司自主研发 的抗PD-1单抗汉斯状已在印度获批上市。7月31日，复宏汉霖在其徐汇生产基地完成了汉斯状的首批发货，正式启航印度市 场。 （编辑 郭之宸） 资料显示，汉斯状是全球首个获批用于一线治疗广泛期小细胞肺癌（ES-SCLC）的抗PD-1单抗，迄今已在中国、英国、德 国、印度、印度尼西亚、新加坡等近40个国家和地区获批上市。在印度，汉斯状于2025年6月份获印度中央药品标准控制组织 批准上市，用于一线治疗广泛期小细胞肺癌，成为印度首个在该适应症获批的抗PD-1单抗。复宏汉霖的合作伙伴Intas将负责汉 斯状在印度的商业化推广，帮助更多患者尽早受益。 复宏汉霖总裁黄玮表示："造福全球病患，是复宏汉霖始终坚守的战略愿景。此次汉斯状完成了对印度市场的首批发货， 不仅充分验证了我们全球供应体系的高效运营能力，更是中国原研创新药持续走向世界、造福全球的又一例证。自上市以来， 汉斯状已惠及全球逾11万名患者，持续拓展全球免疫治疗的可及边界。未来，我们将继续发挥全球一体化研产销优势，将更多 优质的创新药物带给全球更广泛的患 ...

格隆汇8月1日丨复宏汉霖(02696.HK)公布，谨定于2025年8月25日(星期一)举行公司董事会会议，以考 虑及通过公司及其附属公司截至2025年6月30日止的六个月中期业绩，及派发中期股息(如有)，以及处 理其他事项。 ...

代表董事會 上海復宏漢霖生物技術股份有限公司 主席 （股份代號：2696） 董事會會議召開日期 上海復宏漢霖生物技術股份有限公司（「本公司」）董事會（「董事會」）茲通告謹定 於二零二五年八月二十五日（星期一）舉行本公司董事會會議，以考慮及通過本公 司及其附屬公司截至二零二五年六月三十日止的六個月中期業績，及派發中期股 息（如有），以及處理其他事項。 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） Wenjie Zhang 香港，二零二五年八月一日 於本公告日期，本公司董事會包括主席及非執行董事Wenjie Zhang先生，執行董 事朱俊博士，非執行董事陳啟宇先生、吳以芳先生、關曉暉女士、文德鏞先生及 Xingli Wang博士以及獨立非執行董事蘇德揚先生、陳力元博士、趙國屏博士及宋 瑞霖博士。 ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical and biotechnology industry, emphasizing the transition from "Made in China" to "Created in China" for innovative drugs [10]. Core Insights - The report highlights that domestic innovative drugs are gaining global competitiveness and are currently in the first and second stages of international expansion, primarily through licensing agreements and partnerships [10][12]. - The report identifies key areas of focus for investment, including PD-(L)1 plus, ADCs, and GLP-1 drugs, which are expected to drive future growth and business development (BD) opportunities [10][51]. Summary by Sections Section 1: Transition from "Manufacturing" to "Innovation" - The policy reforms initiated in 2015 have stimulated a shift from generic to innovative drug development in China, with significant increases in R&D investment since 2018 [19][21]. - The number of First-in-Class (FIC) drugs developed in China has risen from 9 in 2015 to 120 in 2024, indicating a substantial increase in innovation [25][26]. Section 2: Continued BD Opportunities - PD-(L)1 plus is identified as a cornerstone for next-generation cancer treatments, with significant demand and potential for new products [51]. - The report notes that ADCs are transitioning towards more differentiated targets, focusing on unmet clinical needs, with promising candidates like PD-L1, DLL3, and EGFR [51]. - The GLP-1 market is experiencing rapid growth, with a focus on multi-target, oral, combination, and long-acting formulations [51]. Section 3: Investment Recommendations - For PD-(L)1 plus, companies such as Kangfang Biotech, Shansheng Pharmaceutical, and Junshi Biosciences are recommended for investment due to their strong pipelines [5]. - In the ADC space, companies like Fuhong Hanlin and Zai Lab are highlighted for their potential in addressing unmet clinical needs [5]. - In the GLP-1 sector, firms such as Borui Pharmaceutical and Zai Lab are noted for their promising developments [5].

复宏汉霖宣布，公司自主研发和生产的抗PD-1单抗H药(商品名：汉斯状 ，斯鲁利单抗，欧洲商品名： Hetronifly )完成首批面向印度市场的供货。据介绍，H药于2025年6月获印度中央药品标准控制组织 (CDSCO)批准，用于一线治疗广泛期小细胞肺癌，成为印度首个在该适应症获批的抗PD-1单抗。 ...

港股生物医药板块午后走弱，荣昌生物(09995.HK)跌超7%，君实生物(01877.HK)跌超6%，再鼎医药 (09688.HK)、复宏汉霖(02696.HK)等跟跌。 ...

在生物医药领域，"授权合作"是常见的模式，并从去年以来加速。 今年创新药行情由跨国药企高额交易驱动。 国际投行Jefferies认为，中国创新药研发性价比高、临床研发成本高，双方BD（商务开发）合作是强强联合，中国药企可借此提升全球商业化能力，但目前 仍处于起步阶段。 继人工智能、新消费等行业后，今年以来中国医药行业迎来了三年低迷后的逆袭。 创新药行情是由跨国药企高额交易所驱动的，美国大药企更是疯狂"扫货"中国管线，超过10亿美元的海外授权（Licensing-out）订单常态化。当前，创新药 行情热度依旧不减，众多生物医药企业排队等待港股IPO。 所谓"授权合作"，即中国药企将候选药物的部分权利（如全球开发、生产、商业化权利）授权给美国药企。中国药企通常仍然保留药物的专利权归属，并无 需建设自主全球商业化能力。美国药企拥有在协议范围内的独占许可权，有权在相关市场开展后续开发与销售，而中国企业则可获得里程碑付款（临床、注 册、销售等），并按药物在美国或全球的销售额获得一定比例（如5%~15%）。 根据港交所披露的数据，截至7月中旬，约有288家企业排队等待IPO，其中不乏生物医药企业试图通过18A规则上市。在 ...

Company News - China Railway Construction (01186.HK) reported a new contract amount of approximately 1,056.17 billion yuan for the first half of the year, a year-on-year decrease of 4.04% [2] - China Metallurgical Group (01618.HK) announced a new contract amount of 548.2 billion yuan for the first half of the year, down 19.1% year-on-year [2] - Sichuan Chengyu Expressway (00107.HK) won the bid for the G5 Jingkun Expressway Chengdu to Ya'an section expansion project, with a total investment of approximately 28.548 billion yuan [2] - Road King Infrastructure (01098.HK) reported total property sales of 5.232 billion yuan for the first half of the year, a decrease of 28.37% year-on-year [2] - Amax Holdings (00880.HK) plans to acquire a property in Hengqin for 724.2 million yuan to diversify its business portfolio [2] - Chaoyue Eye Hospital (02219.HK) signed a construction contract for the first phase of its comprehensive medical facility project, with a contract value of 223 million yuan [2] - Bay Area Development (00737.HK) reported total toll revenue of 243 million yuan for June, a year-on-year decrease of 4% [2] - Decent Pharmaceuticals-B (06996.HK) received approval for its drug, Hivio®, for the second-line treatment of multiple myeloma in China [2] - Tianchen Holdings (01201.HK) plans to invest 30 million yuan to establish a joint venture in Shenzhen for new energy heavy truck charging stations [2] Performance Summary - WuXi AppTec (02359.HK) reported mid-year revenue of 20.799 billion yuan, a year-on-year increase of 20.64%, and a net profit of 8.561 billion yuan, up 101.92% year-on-year [3] Earnings Announcements - China Nonferrous Mining (01258.HK) issued a profit warning, expecting mid-term net profit of approximately 258 million USD, a year-on-year increase of about 18% [4] - Hualing Pharmaceutical-B (02552.HK) issued a profit warning, expecting mid-term net profit of approximately 1.184 billion yuan, turning from loss to profit [4] - Little Yellow Duck (02250.HK) issued a profit warning, expecting mid-term revenue to increase by over 30% year-on-year [4] - Qingci Games (06633.HK) issued a profit warning, expecting mid-term net profit to increase by approximately 78%-130% year-on-year [4] - Goodbaby International (01086.HK) issued a profit warning, expecting mid-term net profit to decrease by approximately 40%-50% year-on-year [4] - Qianhai Health (00911.HK) issued a profit warning, expecting mid-term net profit to decrease by approximately 60%-70% year-on-year [4] - Tianan Health (00383.HK) issued a profit warning, expecting mid-term net profit to decrease to approximately 7 million to 17 million HKD [4] - Pacific Network (00543.HK) issued a profit warning, expecting mid-term net loss of approximately 5 million to 15 million yuan [4] Buyback and Increase Dynamics - HSBC Holdings (00005.HK) repurchased 348,700 shares for approximately 35.487 million HKD at a price of 101.4-102 HKD [3] - China Eastern Airlines (00670.HK) repurchased 2.5 million shares for approximately 7.4983 million HKD at a price of 2.97-3.03 HKD [3] - Founder Holdings (00418.HK) canceled a total of 17.9962 million shares that had been repurchased [3]

Group 1 - The core point of the news is that HLX14, a biosimilar to Prolia, has received a positive opinion from the EMA's CHMP, recommending approval for its marketing authorization application [1] - The CHMP's positive opinion is based on data comparing HLX14 with the reference drug Prolia, including similarity studies and clinical comparisons [1][2] - If approved by the European Commission, HLX14 will be granted marketing authorization across all EU member states and EEA countries [1] Group 2 - HLX14 is developed by the company as a biosimilar for treating osteoporosis in postmenopausal women at high risk of fractures, among other indications [2] - The company has entered into an exclusive licensing agreement with Organon LLC for the commercialization of HLX14 outside of China and the Hong Kong-Macau-Taiwan region [2] - The marketing authorization applications for HLX14 have been accepted by EMA, Health Canada, and the FDA in 2024 [2]

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。 （股份代號：2696） 自願公告 地舒單抗生物類似藥HLX14（重組抗RANKL全人單克隆抗體注射液） 獲歐洲藥品管理局(EMA)人用醫藥產品委員會(CHMP)積極審評意見 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 茲提述本公司於2024年5月24日刊發的公告，內容有關本公司自主研發的 Prolia®與Xgeva® （地舒單抗）生物類似藥HLX14（重組抗RANKL全人單克隆 抗體注射液）（「HLX14」）適用於(1)骨折高風險的絕經後婦女及男性的骨質疏 鬆症治療、(2)骨折高風險的前列腺癌男性與激素消融相關的骨質流失治療、 (3)骨折高風險的成年患者中與長期全身糖皮質激素治療相關骨質流失的治 療、(4)預防成人晚期骨惡性腫瘤的骨相關事件，(5)不可手術切除或手術切除 後可能導致嚴重功能障礙的骨巨細胞瘤患者的治療，包括成 ...