Group 1: Stablecoin Regulation in Hong Kong - The implementation of the Stablecoin Regulation began on August 1, with 77 applications received by the Hong Kong Monetary Authority (HKMA) by August 31, from various sectors including banks, tech companies, and e-commerce [1] - The HKMA reiterated that only a limited number of stablecoin licenses will be issued in the initial phase of the regulation [1] Group 2: Market Developments - Hong Kong Exchanges and Clearing Limited (HKEX) announced an optimization of its collateral arrangements, reducing the financing cost for non-cash collateral from 0.5% to 0.25% [3] - The total trading amount of Hong Kong Stock Connect by brokers reached HKD 12.76 trillion in the first half of 2025, with cross-border business stock reaching CNY 19.7 trillion [4] Group 3: Corporate Actions - JD Group announced a voluntary public acquisition offer for CECONOMY AG at a price of €4.60 per share [5] - New World Development's controlling shareholder is considering injecting approximately HKD 10 billion into the company, seeking partners for a joint venture [6] - Weihai Bank entered into a conditional agreement to issue up to 430 million domestic shares [7][8] - Zheshang Bank plans to invest CNY 9.94 billion to increase its stake in Zheshang Financial Leasing to 54.04% [9] Group 4: Industry Performance - BYD reported August sales of 373,600 new energy vehicles, a slight increase from 373,100 units year-on-year, with a cumulative sales growth of 23% for the first eight months [13] - Geely's total vehicle sales in August reached 250,200 units, a year-on-year increase of approximately 38% [14] - NIO delivered 31,305 vehicles in August, marking a 55.2% year-on-year growth [16] - XPeng Motors achieved a record delivery of 37,709 smart electric vehicles in August, a 169% increase year-on-year [16] Group 5: Regulatory Approvals - Fuhong Hanlin received FDA approval for two products, BILDYOS® and BILPREVDA®, for specific osteoporosis treatments, marking a significant milestone in the company's international market presence [18][19]

Core Viewpoint - The company has received FDA approval for two products, BILDYOS and BILPREVDA, which enhances its international market presence and product recognition [1][2]. Product Approvals - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women, increasing bone mass in high-risk men, and treating osteoporosis caused by glucocorticoids in both men and women [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in multiple myeloma and solid tumor patients, treating giant cell tumors of bone, and managing refractory hypercalcemia in malignancies after bisphosphonate treatment [1]. FDA Review Process - The FDA's approval was based on comprehensive reviews of comparative studies between HLX14 (the active ingredient in BILDYOS and BILPREVDA) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The production facilities for HLX14 have passed FDA pre-license inspections, confirming compliance with cGMP requirements [2]. Market Impact - With the approval of BILDYOS and BILPREVDA, the company now has six products approved overseas and three in the U.S., indicating a deepening of global commercialization efforts [2]. - This approval signifies further recognition of the company's products in international markets, enhancing their global influence [2].

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant milestone for the company, enhancing its international market presence and product recognition [1][2] Group 1: Product Approvals - The FDA has approved two products, BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), for various indications related to osteoporosis and bone-related events in cancer patients [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for patients undergoing specific cancer treatments [1] - BILPREVDA is indicated for preventing bone-related events in multiple myeloma and solid tumor patients, and for treating certain bone tumors and refractory hypercalcemia [1] Group 2: Clinical Data and Comparisons - The FDA's approval was based on comprehensive reviews of comparative studies demonstrating the similarity of HLX14 (the active ingredient in BILDYOS) to its reference drug Prolia in terms of quality, safety, and efficacy [2] - The approval aligns with FDA guidelines on demonstrating biosimilarity to reference drugs, allowing HLX14 to be used for all indications approved for Prolia and XGEVA in the U.S. [2] Group 3: Market Impact - The global sales of denosumab (the active ingredient in Prolia) are projected to be approximately $7.462 billion in 2024, indicating a substantial market opportunity for the newly approved products [2] - With the approval of BILDYOS and BILPREVDA, the company now has six products approved for international markets, with three specifically approved in the U.S., further solidifying its international commercialization efforts [2]

Core Viewpoint - The company has received FDA approval for two products, BILDYOS and BILPREVDA, which enhances its international market presence and product recognition [1][2] Product Approvals - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women, increasing bone mass in high-risk men, and treating osteoporosis in patients with glucocorticoid-induced fractures [1] - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in multiple myeloma and solid tumor patients, treating giant cell tumors, and managing refractory hypercalcemia in malignancies [1] FDA Review Process - The FDA's approval was based on comprehensive reviews of comparative studies demonstrating the similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug Prolia in terms of quality, safety, and efficacy [2] - The production facilities for HLX14 have passed FDA pre-license inspections, confirming compliance with cGMP requirements [2] Market Impact - With the approval of BILDYOS and BILPREVDA, the company has a total of six products approved overseas, including three in the U.S., indicating a deepening of global commercialization efforts [2] - This approval signifies further recognition of the company's products in international markets, enhancing their global influence [2]

Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant milestone for the company, enhancing its international market presence and product portfolio [1][2] Group 1: Product Approvals - The FDA has approved two products, BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), for various indications related to osteoporosis and bone-related events in cancer patients [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for patients undergoing specific cancer treatments [1] - BILPREVDA is indicated for preventing bone-related events in multiple myeloma and solid tumor patients, and for treating certain bone tumors [1] Group 2: Clinical Data and Comparisons - The FDA's approval was based on comprehensive reviews of comparative studies demonstrating the similarity of HLX14 (the active ingredient in BILDYOS) to its reference drug Prolia in terms of quality, safety, and efficacy [2] - The approval aligns with FDA guidelines on demonstrating biosimilarity to reference drugs, allowing HLX14 to be used for all indications approved for Prolia and XGEVA [2] Group 3: Market Impact - According to IQVIA data, the global sales of denosumab (the active ingredient in Prolia) are projected to be approximately $7.462 billion in 2024 [2] - With the approval of BILDYOS and BILPREVDA, the company has now achieved a total of six products approved for overseas markets, with three specifically approved in the U.S., indicating a deepening of its global commercialization efforts [2] - This approval is seen as a recognition from international markets, which will further advance the company's internationalization strategy and enhance the global influence of its products [2]

本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）根據香港聯合交易 所有限公司證券上市規則（「上市規則」）第13.09條及香港法例第571章證券及 期貨條例第XIVA部之內幕消息條文（定義見上市規則）而作出。 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） 內幕消息公告 美國食品藥品管理局(FDA)批准 HLX14（地舒單抗，美國商品名：BILDYOS®以及BILPREVDA®） 兩個產品用於特定人群骨質疏鬆症治療等8項適應症 A. 緒言 根據IQVIA MIDASTM的最新數據（由IQVIA提供，IQVIA是全球醫藥健康產 業專業信息和戰略諮詢服務提供商），2024年度，地舒單抗於全球範圍內的 銷售額約為74.62億美元。 2 本公司董事會（「董事會」）欣然宣佈，近日，本集團收到美國食 ...

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received FDA approval for its self-developed denosumab injection (HLX14) in two specifications, which includes five indications for osteoporosis treatment [1] Group 1: Product Approval - The FDA approved the biologics license application (BLA) for denosumab injection in two concentrations: 60mg/mL and 120mg/1.7mL [1] - The approved indications include treatment for osteoporosis in postmenopausal women, osteoporosis in male patients, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer in male patients undergoing androgen deprivation therapy, and breast cancer in women receiving aromatase inhibitor therapy [1] Group 2: Market Potential - The global sales revenue for denosumab injection is approximately $7.462 billion [1]

Group 1 - The company announced the reappointment of several members to its board committees, effective from August 29, 2025 [2] - Su Deyang was reappointed as the chairman of the Audit Committee, while Wenjie Zhang was reappointed as the chairman of the Nomination Committee [2] - The company also reappointed Chen Yuqing and Song Ruilin to the Compensation Committee, with Song Ruilin serving as the chairman [2] Group 2 - Wenjie Zhang was reappointed as the chairman of the fourth board, effective from August 29, 2025, until the term of the fourth board expires [3] - Feng Rongli was reappointed as the chairman of the fourth Supervisory Committee, effective from August 29, 2025, until the term of the fourth Supervisory Committee expires [3] - Zhu Jun was reappointed as the CEO of the company, effective from August 29, 2025, until the term of the fourth board expires [3]

Core Insights - The excitement for the company lies not in new sectors but in accelerating growth and achieving a leading position in existing sectors [1] - The company reported total revenue of 87.28 billion yuan and a net profit of 660 million yuan for the first half of 2025 [1] - The four core subsidiaries contributed 63.61 billion yuan, accounting for 73% of total revenue [1] Innovation and R&D - The company invested 3.6 billion yuan in its innovation sector during the reporting period [2] - The pharmaceutical segment is both an established industry and a driver of innovation, with multiple new drug approvals and submissions [2] - The company has a robust pipeline of innovative products with significant global market potential [2] Global Expansion - Overseas revenue reached 46.67 billion yuan, making up 53% of total revenue [4] - The company has made significant strides in global business, with overseas product profits increasing over 200% and cash inflow from business development contracts rising by 280% [4] - The company is expanding its presence in various international markets, including the Middle East and Southeast Asia [4] Financial Health - The company is executing a "slimming down" strategy, with over 8 billion yuan returned from asset exits and subsidiary dividends [6] - Total debt as a percentage of total capital stands at 53%, indicating a reasonable debt ratio [7] - The company is focused on reducing financial costs and has seen a slight decrease in interest-bearing debt [7] Strategic Vision - The company aims to enhance its global R&D, business development, and operational capabilities to become a leading global pharmaceutical enterprise [3][5] - The strategy includes a focus on "innovation + globalization" to maximize the value of its innovative products [3] - The company is committed to deepening its core business and accelerating innovation while pursuing global development [7]

Group 1: Company Performance - Renfu Pharmaceutical reported a 6.2% decline in revenue to 12.064 billion yuan, while net profit increased by 3.92% to 1.155 billion yuan [1] - Junshi Biosciences achieved a 48.64% increase in revenue to 1.168 billion yuan, with a net loss of 413 million yuan [2] - Fuhong Hanlin's revenue for the first half of 2025 was 2.8195 billion yuan, a 2.7% year-on-year increase, with a net profit of 390.1 million yuan [6] Group 2: Market Position and Product Development - Renfu Pharmaceutical holds over 60% market share in the domestic anesthetic drug market, with its subsidiary Yichang Renfu being the largest R&D and production base in Asia [1] - Junshi Biosciences' core product, Toripalimab, generated sales revenue of approximately 1.059 billion yuan, a 49.41% increase, with domestic sales reaching about 954 million yuan, up 42% [2] - Beijing Kexing's adsorbed tetanus vaccine received drug registration approval, enhancing the company's portfolio in the trauma field [3] Group 3: Strategic Partnerships and Financial Transactions - BeiGene signed a royalty transfer agreement with Royalty Pharma for Tarlatamab, potentially worth up to 950 million USD, with an initial payment of 885 million USD [4] - Lepu Medical's management expressed a desire to avoid selling potential products at low prices early in the development process, indicating a focus on maintaining financial strength [5][6] - Fuhong Hanlin reported over 1 billion yuan in cash inflow from BD contracts, with a significant increase in overseas product profits [6]