Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar drug HLX14, which is a formulation of denosumab [1][3]. Product Information - HLX14 is developed as a biosimilar to treat osteoporosis in postmenopausal women at high risk of fractures and other indications consistent with the reference drug [3]. - The approved products include: - BILDYOS (60 mg/mL) for increasing bone mass in men with non-metastatic prostate cancer and women with breast cancer at high risk of fractures [2]. - BILPREVDA (120 mg/1.7mL) for treating patients with giant cell tumors and refractory hypercalcemia due to malignancy [2]. Market Impact - The approval of BILDYOS and BILPREVDA will enhance the product line of the group and strengthen its international market presence [3]. - As of September 1, 2025, Fuhong Hanlin has three products approved for the U.S. market, indicating a growing portfolio [3]. Financial Insights - The cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) as of July 2025 [3]. - The global sales of denosumab injection products are projected to be around $7.462 billion in 2024 [3]. Licensing Agreement - The commercialization rights for HLX14 outside of China and Hong Kong were granted to Organon LLC in June 2022, allowing Fuhong Hanlin to earn milestone payments and sales royalties [4].

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed biosimilar injection of Dexamethasone (HLX14) in two specifications: 60mg/mL and 120mg/1.7mL [2] Group 1 - The biosimilar product HLX14 has been granted a Biologics License Application (BLA) by the FDA [2]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received FDA approval for its biosimilar HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1 - The biosimilar HLX14 is available in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is developed to treat osteoporosis and other indications consistent with the reference drug's label [1]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received FDA approval for its biosimilar drug HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1 - The FDA approved the biologics license application (BLA) for HLX14 in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is a biosimilar of denosumab, developed by the company and its subsidiaries [1] - The drug is aimed at treating osteoporosis and other indications consistent with the reference drug's label [1]

Core Viewpoint - The CAR-T therapy market in China is facing challenges with high costs and limited market penetration, but there is potential for price reductions and increased insurance coverage in the future [2][16]. Group 1: Company Performance - WuXi AppTec reported a revenue of 106.3 million yuan in the first half of 2025, with sales of its CAR-T drug, Regiokyron, amounting to 81 million yuan [2]. - Legend Biotech's CAR-T drug achieved global sales of 439 million USD (approximately 3.1 billion yuan) in Q2 2025, with total sales for the first half reaching 808 million USD (approximately 5.7 billion yuan), marking a year-on-year growth of 100% [3][10]. - CStone Pharmaceuticals reported a revenue of approximately 51 million yuan in the first half of 2025, a year-on-year increase of about 703.8%, primarily driven by CAR-T products [6]. Group 2: Market Challenges - Legend Biotech has reportedly canceled its sales and marketing team in China, focusing instead on more profitable overseas markets due to underwhelming domestic sales [4]. - The high cost of CAR-T treatments remains a significant barrier to market penetration, with prices exceeding 1 million yuan per treatment, making it unaffordable for most patients in China [15][16]. - The lack of a clear commercial path for CAR-T products in China is a common challenge faced by companies in this sector [4]. Group 3: Pricing and Insurance - The pricing of CAR-T products varies, with WuXi AppTec's Regiokyron priced at 1.29 million yuan, while the lowest-priced product, CStone's Nakiokyron, is priced at 999,000 yuan [8][15]. - Efforts are being made to improve insurance coverage for CAR-T therapies, with several companies submitting applications for inclusion in basic medical insurance and commercial insurance directories [16]. - The development of commercial insurance in China is seen as a key factor in enhancing payment capabilities for CAR-T treatments, which could lead to price reductions in the next five years [16][17]. Group 4: Technological Innovations - Recent advancements in CAR-T technology, such as in vivo production methods, are gaining attention and may offer solutions to the high costs associated with traditional CAR-T therapies [18]. - The production cost of CAR-T therapies is significant, with estimates indicating that the material cost for each treatment is around 43,000 USD, highlighting the need for cost-effective production methods [17][18].

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received FDA approval for its biosimilar drug HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1 - The FDA approved the biologics license application (BLA) for HLX14, which comes in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is a biosimilar of denosumab, developed by the company and its subsidiaries [1] - The drug is aimed at treating osteoporosis and other indications consistent with the reference drug's label [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, received FDA approval for its self-developed HLX14 injection, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1: Product Development - The approved HLX14 injection comes in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is aimed at treating osteoporosis and other indications consistent with the reference drug label [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1: Product Approval and Specifications - HLX14 is a biosimilar of denosumab, with two specifications: 60mg/mL and 120mg/1.7mL [1] - The FDA approval allows HLX14 to be used for treating osteoporosis in postmenopausal women and other indications consistent with the reference drug's label [1] Group 2: Regulatory Progress in Other Regions - In May 2024, HLX14's marketing authorization application (MAA) will be accepted by the European Medicines Agency (EMA), with a positive review opinion expected by July 2025 [1] - In September 2024, HLX14's new drug submission (NDS) will be accepted by Health Canada [1]

近日，上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公 司上海复宏汉霖生物技术股份有限公司及其控股子公司（以下合称"复宏汉霖"） 自主研发的 60 mg/mL、120 mg/1.7mL 两项规格的地舒单抗注射液（项目代号：HLX14） 的生物制品许可申请（BLA）获美国 FDA（即美国食品药品监督管理局）批准，本次 获批情况如下： 证券代码：600196 股票简称：复星医药 编号：临 2025-143 上海复星医药（集团）股份有限公司 关于控股子公司获美国 FDA 药品注册批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 | 美国商品名 | 获批适应症 | | --- | --- | | | （1）骨折高风险的绝经后妇女的骨质疏松症治疗； （2）骨折高风险的男性骨质疏松患者的增加骨量治疗； | | | （3）糖皮质激素引起的骨折高风险的男性与女性骨质疏松症的 | | 产品一：BILDYOS®1 | 治疗； | | （60 mg/mL） | （4）接受雄激素剥夺治疗的骨折高风险的非转移性前列腺癌 ...

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，概不對因本公告全部或任何部份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。 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* （於中華人民共和國註冊成立的股份有限公司） （股份代號：02196） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。 茲載列上海復星醫藥（集團）股份有限公司（「本公司」）在上海證券交易所網站刊登的《關於 控股子公司獲美國FDA藥品註冊批准的公告》，僅供參閱。 承董事會命 上海復星醫藥（集團）股份有限公司 董事長 陳玉卿 中國，上海 2025 年9 月1 日 於本公告日期，本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生及王可心先生；本公司之非執行 董事為陳啟宇先生、潘東輝先生及吳以芳先生；本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生及楊玉成先生；以及本公司之職工董事為嚴佳女士 ...