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君实生物盘中涨超3% 拓益®2项新增适应症和君适达®纳入国家医保目录
Xin Lang Cai Jing· 2025-12-08 01:48
Core Viewpoint - Junshi Biosciences (01877) has seen a stock price increase of 1.87% to 24 HKD following the announcement of new indications for its products being included in the National Medical Insurance Directory [2][5]. Group 1: Product Developments - Junshi Biosciences announced that its product Toripalimab injection (brand name: Tuoyi®, product code: JS001) has received two new indications, and its product Engreztinib injection (brand name: Junshida®, product code: JS002) has been successfully included in the National Medical Insurance Directory (2025) under the Class B category [2][5]. - The new version of the National Medical Insurance Directory will be officially implemented on January 1, 2026 [2][5]. Group 2: Product Portfolio - As of the announcement date, four commercialized products from the company, including Tuoyi®, Adalimumab injection (brand name: Junmaikang®, product code: UBP1211), Dexamethasone Hydrochloride Tablets (brand name: Mindewi®, product code: VV116/JT001), and Junshida®, have all been included in the National Medical Insurance Directory [2][5]. - Tuoyi® is the only anti-PD-1 monoclonal antibody in the directory that is approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications included [2][5]. - Junshida® is newly included and is the only domestic PCSK9-targeted drug in the new directory for patients intolerant to statins [2][5].
君实生物(688180.SH):拓益新增适应症和君适达纳入国家医保目录
智通财经网· 2025-12-07 08:47
Core Insights - Junshi Biosciences (688180.SH) announced that its product Toripalimab injection (brand name: Tuoyi®, product code: JS001) has received two new indications, and its product Engreztinib injection (brand name: Junshida®, product code: JS002) has been successfully included in the National Medical Insurance Catalog (2025) under Category B, effective January 1, 2026 [1] Group 1 - As of the announcement date, the company has four commercialized products, including Tuoyi®, Adalimumab injection (brand name: Junmaikang®, product code: UBP1211), Dihydrocodeine Bromide tablets (brand name: Mindewi®, product code: VV116/JT001), and Junshida®, all of which have been included in the National Medical Insurance Catalog [1] - Tuoyi® is the only anti-PD-1 monoclonal antibody in the catalog that is approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications in mainland China included in the National Medical Insurance Catalog [1] - Junshida® is newly included in the catalog and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the new version of the catalog [1]
中信证券独家保荐生物科技领先公司旺山旺水成功登陆港交所
Xin Lang Cai Jing· 2025-11-06 05:33
Core Viewpoint - Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. successfully listed on the Hong Kong Stock Exchange, raising approximately HKD 587 million, marking a significant milestone for the company and enhancing its international presence [1][3]. Group 1: Company Overview - Wangshan Wangshui, established in 2013, is a comprehensive biopharmaceutical company focused on discovering, developing, and commercializing innovative small molecule drugs, particularly in the fields of neuropsychiatry, reproductive health, and viral infections [6]. - The company has developed a competitive and diversified pipeline of innovative drug products, with two products in the commercialization stage, four in clinical stages, and three in preclinical stages [3][6]. Group 2: IPO Details - The IPO of Wangshan Wangshui was highly successful, with a subscription rate of 6,238.42 times, ranking second in the healthcare sector and fourth overall among new listings on the Hong Kong Stock Exchange in 2025 [3][5]. - Citic Securities acted as the sole sponsor and played a crucial role in the IPO process, demonstrating its expertise in the biopharmaceutical sector [1][4]. Group 3: Product Development - The product "Mindewei®" received conditional approval from the National Medical Products Administration of China in January 2023 and transitioned to regular approval in January 2025 for the treatment of mild to moderate COVID-19 [6]. - The product "TPN171," marketed as "Angweida®," was approved in July 2025 for the treatment of erectile dysfunction in men [6]. Group 4: Industry Impact - Citic Securities is committed to supporting the health industry and has deepened its involvement in the medical and health sector, leveraging its comprehensive service capabilities to empower the capitalization of Chinese innovative pharmaceutical companies [4][5].
尚未盈利的君实生物:上半年亏损收窄,药品销售收入超10亿元
Xin Jing Bao· 2025-08-28 05:17
Core Viewpoint - Junshi Biosciences reported a significant increase in revenue for the first half of 2025, but the company has not yet achieved profitability, highlighting the challenges of the biopharmaceutical industry, which is characterized by long R&D cycles, high investment, and substantial risks [1][2]. Financial Performance - In the first half of 2025, Junshi Biosciences achieved approximately 1.168 billion yuan in revenue, a year-on-year increase of 48.64%, with drug sales revenue reaching 1.059 billion yuan, up 49.41% [1][2]. - The net loss attributable to shareholders was approximately 413 million yuan, which represents a narrowing of losses compared to the previous year [1][2]. - The company's R&D expenses were about 706 million yuan, reflecting a year-on-year increase of 29.14%, driven by a focus on competitive and innovative R&D projects [3]. Product Pipeline and Innovation - Junshi Biosciences has expanded its innovation scope beyond monoclonal antibodies to include small molecule drugs, antibody-drug conjugates (ADC), bispecific or multispecific antibodies, fusion proteins, nucleic acid drugs, and vaccines [2]. - The company has a product pipeline covering five major therapeutic areas: malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases [2]. - As of the report date, Junshi Biosciences has four commercialized drugs and nearly 30 drug candidates in clinical trials, with over 20 in preclinical development [2]. Cash Flow and Funding - The net cash flow from operating activities showed a reduction in net outflow compared to the previous year, primarily due to increased sales revenue from commercialized drugs and significant technical licensing fees received during the period [2]. - In June 2025, Junshi Biosciences successfully completed a new H-share placement, raising approximately 1.026 billion HKD, with total cash and financial assets amounting to about 3.507 billion yuan at the end of the reporting period [3].
君实生物(688180.SH):近30项在研药物处于临床试验阶段
Ge Long Hui· 2025-06-18 09:18
Core Viewpoint - The company has expanded its innovative research and development from monoclonal antibodies to a broader range of drug types, including small molecules, peptides, antibody-drug conjugates (ADCs), bispecific or multispecific antibodies, fusion proteins, and nucleic acid drugs, focusing on next-generation innovative therapies for cancer and autoimmune diseases [1] Group 1: Product Pipeline and Therapeutic Areas - The company's product pipeline covers five major therapeutic areas: malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases [1] - Currently, the company has four commercialized drugs: Tuoyi® (特瑞普利单抗), Junmai Kang® (君迈康), Mindewi® (民得维), and Junshida® (君适达) [1] - Nearly 30 drug candidates are in clinical trial stages, with over 20 candidates in preclinical development [1] Group 2: Regulatory Approvals and Market Access - The core product Tuoyi® has received approval for 12 indications in mainland China, with 10 of these indications included in the national medical insurance catalog [1] - The company is accelerating the development and market application of late-stage pipeline products, including anti-BTLA monoclonal antibody tifcemalimab (TAB004/JS004), anti-IL-17A monoclonal antibody (JS005), subcutaneous PD-1 monoclonal antibody formulation (JS001sc), and PD-1/VEGF bispecific antibody (JS207) [1] Group 3: Early-stage Pipeline Exploration - The company continues to explore early-stage pipeline products, including anti-Claudin18.2 ADC (JS107), PI3K-α oral small molecule inhibitor (JS105), CD20/CD3 bispecific antibody (JS203), anti-DKK1 monoclonal antibody (JS015), EGFR/HER3 bispecific antibody conjugate (JS212), and PD-1/IL-2 bifunctional antibody fusion protein (JS213) [1]