Core Viewpoint - The company, Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖), has successfully launched its self-developed anti-PD-1 monoclonal antibody, Hanshuo, in India, marking a significant milestone in its global expansion strategy [1]. Group 1 - Hanshuo is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) [1]. - The drug has been approved for marketing in nearly 40 countries and regions, including China, the UK, Germany, India, Indonesia, and Singapore [1]. - In India, Hanshuo received approval from the Central Drugs Standard Control Organization in June 2025, becoming the first anti-PD-1 monoclonal antibody approved for this indication [1]. Group 2 - The company's partner, Intas, will be responsible for the commercialization of Hanshuo in India, aiming to benefit more patients [1]. - The president of the company, Huang Wei, emphasized the strategic vision of benefiting global patients and highlighted the efficient operation of their global supply system [1]. - Since its launch, Hanshuo has benefited over 110,000 patients worldwide, expanding the accessibility of global immunotherapy [1].

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].

Core Viewpoint - The company has successfully delivered the first batch of its self-developed anti-PD-1 monoclonal antibody, H drug (brand name: Hanshuang, international name: Hetronifly), to the Indian market, marking a significant milestone in its product rollout [1] Group 1 - The H drug received approval from the Central Drugs Standard Control Organization (CDSCO) in India in June 2025 for first-line treatment of extensive-stage small cell lung cancer [1] - This approval makes the H drug the first anti-PD-1 monoclonal antibody to be approved for this indication in India [1]

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。 ...

Core Insights - The Chinese pharmaceutical industry is experiencing a resurgence after three years of stagnation, driven by high-value licensing deals from multinational pharmaceutical companies [1][2] - There is a significant interest from overseas investors in Chinese biopharmaceutical companies, with a notable increase in licensing agreements and IPO activities [2][8] - The trend of "licensing out" Chinese drug candidates to foreign companies is becoming more common, providing Chinese firms with milestone payments and a share of sales revenue [4][6] Group 1: Market Dynamics - As of mid-July, approximately 288 companies are waiting for IPOs in Hong Kong, many of which are biopharmaceutical firms seeking to list under the 18A rule [1][8] - The Hong Kong medical sector has seen a 54% increase this year, significantly outperforming the MSCI China Index, which rose by 17% [8] - The average price-to-earnings (PE) ratio for the sector is around 30 times, placing it in the 15th percentile of its valuation range over the past five years [8] Group 2: Investment Trends - U.S. investment banks are playing a crucial role in facilitating these licensing deals and IPOs, with cornerstone investors contributing 42% of IPO financing this year, two-thirds of which comes from overseas [1][12] - The trend of U.S. pharmaceutical companies seeking to lower costs through partnerships with Chinese firms is expected to continue, especially in light of U.S. drug pricing policies [2][6] Group 3: Licensing Agreements - The number of licensing transactions from China has increased significantly, with 35 deals in 2023 and projected to reach 43 in 2024, alongside a total upfront payment of $2.957 billion in 2023 [3][6] - Notable licensing agreements include Akeso's ivonescimab, which was licensed to Summit Therapeutics for a total value of $5 billion, marking one of the largest overseas licensing deals in Chinese biopharmaceutical history [7][6] Group 4: Future Outlook - Chinese biopharmaceutical companies are increasingly able to produce globally recognized clinical data, particularly in competitive fields like oncology and immunology [2][6] - The shift from merely selling drug pipelines to achieving global commercialization is essential for the future growth of Chinese pharmaceutical companies [13][15] - There is a need for Chinese firms to enhance their innovation capabilities and international execution to compete effectively on a global scale [14][15]

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 ...