Group 1: Regulatory Actions - The National Healthcare Security Administration (NHSA) has launched a "100-day action" to address prominent issues in medical insurance fund management, aiming to combat fraud and illegal activities related to the resale of medical insurance drugs [1] - The initiative reflects a zero-tolerance approach towards fraudulent practices, which may increase compliance pressure on medical institutions and pharmaceutical companies in the short term, while potentially purifying the industry ecosystem in the long run [1] Group 2: Company Developments - Hanyu Pharmaceutical plans to raise up to 968 million yuan (approximately 136 million USD) through a private placement to fund various projects, including the research and development of Semaglutide [2] - The approval of Lunacanab by XinNuoWei for clinical trials marks the first domestic biosimilar drug for Alzheimer's disease, which could enhance patient accessibility and alleviate financial burdens [3] - Baile Tianheng's ADC dual antibody, Iza-bren, has been included in the breakthrough therapy list by the National Medical Products Administration, which may expedite its market entry and positively impact the company's stock price [4] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for rosacea, filling a gap in the domestic market for innovative treatments in this area [5]

Group 1 - The National Healthcare Security Administration (NHSA) has launched a "100-day action" to crack down on fraudulent medical insurance practices, aiming to eliminate illegal activities such as the resale of returned drugs by designated institutions [1] - This initiative reflects a zero-tolerance approach towards fraud and is expected to increase compliance pressure on medical institutions and pharmaceutical companies in the short term, ultimately helping to purify the industry ecosystem [1] Group 2 - Hanyu Pharmaceutical plans to raise up to 968 million yuan (approximately 136 million USD) through a private placement to fund projects including the development of Semaglutide, which is part of the GLP-1 drug class with significant market potential [2] - If the fundraising is successful, it will accelerate the company's GLP-1 drug development process and enhance its production capacity for peptide raw materials [2] Group 3 - XinNuoWei announced that its subsidiary received approval for clinical trials of Lecanemab, a monoclonal antibody drug for treating Alzheimer's disease, marking it as the first domestic biosimilar of this drug to gain clinical approval [3][4] - The approval of this biosimilar is expected to improve patient accessibility and alleviate financial burdens, as current treatments for Alzheimer's are predominantly high-priced products from multinational companies [4] Group 4 - Baillie Tianheng's ADC dual antibody drug, Iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) for treating advanced or metastatic urothelial carcinoma that has failed previous treatments [5] - This designation is likely to expedite the drug's market entry and could positively impact the company's stock price in the short term [5] Group 5 - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for the treatment of rosacea, a first-class innovative drug in China for this condition [6][7] - The approval of this innovative drug could fill a gap in the domestic market for rosacea treatment, presenting considerable market potential if clinical trials demonstrate its efficacy [7]

Core Viewpoint - The approval of the recombinant anti-human beta-amyloid monoclonal antibody injection, Lunakanai, by the National Medical Products Administration of China marks a significant milestone for the company as it is the first biosimilar of its kind to receive clinical trial permission in China [1] Group 1: Product Information - Lunakanai is a biosimilar to Lecanemab, classified under Category 3.3 for therapeutic biological products, and is intended for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The development of Lunakanai adheres to the relevant research guidelines for biosimilars, ensuring compliance with regulatory standards [1] Group 2: Research Findings - Pharmaceutical and non-clinical research results indicate that Lunakanai is highly similar to the reference drug in terms of quality, safety, and efficacy, which supports the initiation of subsequent clinical studies [1]

（股份代號：1093） （於香港註冊成立之有限公司） 自願公告 侖卡奈單抗注射液在中國獲臨床試驗批准 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 佈，本集團開發的侖卡奈單抗注射液（「該產品」）已獲中華人民共和國國家藥品監督管理局 批 准 ， 可 在 中 國 開 展 臨 床 試 驗 ， 為 國 內 首 個 獲 得 臨 床 許 可 的 侖 卡 奈 單 抗 注 射 液 生 物 類 似 藥。 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。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 該產品是一種重組抗人b澱粉樣蛋白單克隆抗體，為樂意保®的生物類似藥，按照治療用生 物製品3.3類申報，適用於治療由阿爾茨海默病引起的輕度認知障礙和阿爾茨海默病輕度痴 呆。 該產品的研發遵循生物類似藥相關研究指南。藥學及非 ...

Core Viewpoint - New Horizon (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Lecanemab injection, marking it as the first biosimilar of Lecanemab in China [1] Group 1: Product Development - The product is a recombinant anti-human beta-amyloid monoclonal antibody, indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease [1] - The clinical trial approval is based on the adherence to the relevant research guidelines for biosimilars, ensuring the product's quality, safety, and efficacy are highly similar to the reference drug [1] Group 2: Market Position - This approval positions the company as the first in China to obtain clinical licensing for a Lecanemab injection biosimilar, potentially enhancing its competitive edge in the Alzheimer's treatment market [1]

Core Viewpoint - The announcement highlights that New Horizon (300765.SZ) has received approval from the National Medical Products Administration for the clinical trial of its biosimilar drug, Lecanemab injection, which is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] Group 1 - The product is a recombinant anti-human beta-amyloid monoclonal antibody and is classified as a biosimilar to Lecanemab [1] - This marks the first biosimilar Lecanemab injection in China to receive clinical trial approval [1] - The development of the product adheres to the relevant research guidelines for biosimilars, indicating a structured approach to its clinical research [1] Group 2 - Pharmaceutical and non-clinical research results demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Insights - The company reported a 2025 H1 revenue of 101 million yuan, a year-on-year decrease of 12.43%, with a net profit attributable to the parent company of -551 million yuan. However, drug sales revenue reached 100 million yuan, showing a significant year-on-year growth of 53.50%, which is the main growth driver [5][13] - The long-acting G-CSF drug, Mai Li Sheng®, was approved for market release, and a new drug technology license agreement worth 500 million yuan was signed with Qilu Pharmaceutical. Additionally, the company granted CALICO exclusive rights to develop, produce, and commercialize IL-11 targeted therapy products outside Greater China, receiving an upfront payment of 25 million USD, with potential milestone payments up to 571 million USD [5][14] Summary by Sections Financial Performance - In 2025 H1, the company achieved a revenue of 101 million yuan, a decrease of 12.43% year-on-year, while the drug sales revenue was 100 million yuan, increasing by 53.50% [5][13] - The company is expected to see revenues of 677 million, 1.484 billion, and 3.260 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 238.86%, 119.25%, and 119.65% [15][16] Research and Development - The company has increased its R&D expenditure by 21.72% year-on-year, focusing on advancing clinical trials and key registration clinical research phases. As of 2025 H1, the company has 10 innovative drugs and 4 biosimilars in its pipeline, including ADCs and monoclonal antibodies [14] Market Position and Future Outlook - The company is positioned to benefit from the approval of innovative drugs and the gradual market release of biosimilars. The expected net profit attributable to the parent company is projected to improve from -859 million yuan in 2025 to -40 million yuan in 2027 [15][16]

Core Viewpoint - The European Commission has approved two biosimilars of denosumab, BILDYOS and BILPREVDA, developed by Fuhong Hanlin and Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1] Group 1: Product Approval - The approval includes BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), which are biosimilars to PROLIA and XGEVA, respectively, covering all indications approved for the original products in the EU [1] - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1] Group 2: Market Impact - The approval is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1] - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1] Group 3: Strategic Partnership - The approval is a result of the collaboration between Fuhong Hanlin and Organon, which signed a licensing and supply agreement in 2022, granting Organon exclusive commercialization rights for these biosimilars outside of China [2]

Core Viewpoint - The European Commission has approved the marketing authorization for two biosimilars of denosumab, BILDYOS® and BILPREVDA®, developed by Fuhong Hanlin in collaboration with Organon, marking a significant milestone in expanding treatment options for osteoporosis and related conditions in Europe [1][2]. Group 1: Product Approval - The approval includes BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the EU [1]. - With this approval, Fuhong Hanlin now has a total of four products approved in the EU [1]. Group 2: Market Impact - The approval of BILDYOS and BILPREVDA is expected to enhance accessibility to critical bone health treatments for millions of European patients, particularly women who are more affected by osteoporosis [1]. - The launch of these biosimilars supports the sustainability of the European healthcare system by providing more treatment options for conditions related to bone loss [1]. Group 3: Strategic Partnership - The collaboration between Fuhong Hanlin and Organon, established through a licensing and supply agreement in 2022, grants Organon exclusive commercialization rights for these biosimilars outside of China [2]. - This partnership is seen as a significant achievement in meeting the needs of European patients and healthcare systems [1].

复宏汉霖(2696.HK)与Organon(OGN.US)今日联合宣布，欧盟委员会已批准地舒单抗注射液(60 复宏汉霖首席商务发展官兼高级副总裁曹平表示："此次获批是复宏汉霖与Organon强强联合、共同满足 欧洲患者和医疗系统需求的又一重要成果。凭借对科学卓越与产品质量的始终坚守，我们在美国获批的 基础上不断前行，将这些生物类似药治疗方案带给全球更多有需要的患者。" BILDYOS和BILPREVDA的获批是基于一整套全面数据的审查，其中包括结构与功能分析数据、临床药 代动力学数据，以及一项临床对比研究。研究表明，BILDYOS和BILPREVDA在结构、生物活性以及疗 效、安全性和免疫原性特征(蛋白和其他生物药物诱发免疫应答或免疫相关事件的能力)方面与欧盟已批 准的另一种生物药(即"原研产品")高度相似。 mg/mL)BILDYOS®(denosumab)和地舒单抗注射液(120mg/1.7mL)BILPREVDA®(denosumab)的上市许 可，两款产品分别为PROLIA®(地舒单抗)和XGEVA®(地舒单抗)的生物类似药，覆盖原研产品在欧盟已 获批的所有适应症。 ...