Company News - SF Holding (06936.HK) reported a total revenue of 24.787 billion yuan from its express logistics business in August, representing a year-on-year growth of 7.86% [2] - Guohao Group (00053.HK) announced its annual results for the year ending June 30, 2025, with revenue of 24.4 billion HKD, a year-on-year increase of 9%, and a net profit of 4.03 billion HKD, up 13% year-on-year [2] - Jieli Trading Treasure (08017.HK) launched the Deep Trade AI Agent, an intelligent trading system [2] - Innovent Biologics (01801.HK) received approval from the National Medical Products Administration for Masitinib to be used for blood sugar control in adult patients with type 2 diabetes [2] - Datang New Energy Group (00559.HK) issued a profit warning, expecting an annual net profit of 30 to 35 million HKD [2] - Zhonghuan New Energy (01735.HK) plans to collaborate with Ant Blockchain Technology (Shanghai) in the fields of new energy digital assets and new energy artificial intelligence ecosystem [2] - Fuhong Hanlin (02696.HK) received approval from the European Commission for the HLX14 product for the treatment of osteoporosis in specific populations [2] - Zhaoyan New Drug (06127.HK) subscribed to a financial product from Industrial and Commercial Bank of China worth 40 million yuan [2] Buyback Activities - Tencent Holdings (00700.HK) repurchased 857,000 shares at a cost of 551 million HKD, with repurchase prices ranging from 638.5 to 647 HKD [2] - HSBC Holdings (00005.HK) spent approximately 160 million HKD to buy back about 1.49 million shares, with repurchase prices between 106.9 and 107.6 HKD [3] - Shango Holdings (00412.HK) repurchased 3.7 million shares at a cost of approximately 22.623 million HKD, with repurchase prices ranging from 6.08 to 6.2 HKD [3]

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]

Core Insights - The company, Fuhong Hanlin (复宏汉霖), has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS and BILPREVDA, which are now authorized for sale in all EU member states and EEA countries [1][2] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of bone-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Product Details - BILDYOS (60mg/mL) is approved for three specific indications: 1. Treatment of osteoporosis in high-risk postmenopausal women and men 2. Treatment of bone loss in high-risk prostate cancer men related to hormone ablation 3. Treatment of bone loss in high-risk adult patients associated with long-term systemic glucocorticoid therapy [1] - BILPREVDA (120mg/1.7mL) is approved for two specific indications: 1. Prevention of bone-related events in adults with advanced bone malignancies 2. Treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Market Context - The company’s biosimilar HLX14, a denosumab product, has also received approval in the U.S. for specific osteoporosis indications, covering all indications of the original product [2] - The global sales of denosumab are projected to be approximately $7.463 billion in 2024, indicating a significant market opportunity for the company’s products [2] - The approval of BILDYOS and BILPREVDA in the EU represents a further step in the company's international expansion and enhances the global influence of its product portfolio [2]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway [1] - HLX14, the project code for these biosimilars, is developed independently by the group [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received EU approval for two denosumab injection products, BILDYOS® and BILPREVDA®, targeting osteoporosis treatment in high-risk postmenopausal women and men [1] Group 1 - The approved products are indicated for the treatment of osteoporosis in high-risk populations [1] - HLX14 has also been approved in the US for specific osteoporosis indications and its registration application in Canada has been accepted [1] - The commercialization rights for HLX14 have been granted to Organon LLC, with Fosun Pharma set to enjoy related rights under the licensing agreement [1]

Core Viewpoint - The company Fuhong Hanlin faced criticism from the Hong Kong Stock Exchange due to internal control failures and misappropriation of IPO funds, leading to a significant drop in stock price, followed by a partial recovery the next day [1][2]. Group 1: Company Actions and Consequences - On September 2, the company disclosed that it was reprimanded by the Stock Exchange, and its former CEO Liu Shigao was criticized and required to complete training on regulatory and legal issues before being eligible for future directorships [1][4]. - The investment management agreement signed by the company with Shangcheng Global, which involved the misallocation of IPO funds, was not in line with the intended use disclosed during the IPO process [3][7]. - The company approved management fees totaling $3.5 million over two years based on the investment management agreement, which was deemed inappropriate as it did not undergo proper board review [4][5]. Group 2: Financial Implications - As of the end of 2024, the company had an outstanding receivable of $66.36 million (approximately 477 million RMB) from Shangcheng Global, which has been fully impaired [5][6]. - The company reported that it had recovered $30.64 million from Shangcheng Global by the end of 2022 and an additional $20 million in the 2023 fiscal year [5]. Group 3: Governance and Management Changes - The company has experienced significant management turnover since 2019, with three CEOs and four CFOs, indicating instability within its leadership [8]. - Liu Shigao and Zhang Zidong, both involved in the investment management agreement, have since left the company, with Liu resigning in September 2020 and Zhang in December 2020 [8].

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 - Fuhong Hanlin's stock has risen over 5% following the announcement of its PD-1 inhibitor H drug's first shipment to the Indian market, marking a significant milestone for the company and its product's global reach [1] Group 1: Product Developments - Fuhong Hanlin announced the completion of the first shipment of its self-developed PD-1 monoclonal antibody H drug (brand name: Hanshuang, generic name: Surulitinib) to the Indian market, making it the first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in India [1] - The approval from the Central Drugs Standard Control Organization of India was obtained in late June, and the shipment occurred within 30 days, indicating rapid market entry [1] - The H drug has now been approved in nearly 40 countries and regions globally [1] Group 2: Regulatory Approvals - Fuhong Hanlin's biosimilar drugs Prolia and Xgeva (Dexamethasone) have received positive review opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval for their marketing authorization applications [1] - Once approved, the marketing authorization for HLX14 will be effective across all EU member states and in the European Economic Area (EEA) countries including Iceland, Liechtenstein, and Norway [1]

Core Viewpoint - The stock of Fuhong Hanlin (02696) has risen over 5%, reaching HKD 70.8, following significant regulatory approvals for its products in key markets [1] Group 1: Product Approvals - Fuhong Hanlin announced the completion of the first shipment of its self-developed anti-PD-1 monoclonal antibody, H drug (brand name: Hanshuang, generic name: Surulitinib), to the Indian market, marking the first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in India [1] - The approval from the Central Drugs Standard Control Organization of India was obtained in late June, and the shipment occurred within 30 days, indicating rapid market entry [1] - The H drug has now been approved in nearly 40 countries and regions globally [1] Group 2: European Market Developments - Fuhong Hanlin's biosimilar drugs, Prolia and Xgeva (Denosumab), have received positive review opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval for their marketing authorization applications [1] - Upon approval, the marketing authorization for HLX14 will be effective across all EU member states and in the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway [1]