Core Viewpoint - The approval of the new drug application (NDA) for Masitide (GCG/GLP-1 dual receptor agonist) by the National Medical Products Administration (NMPA) in China marks a significant advancement in the treatment of type 2 diabetes, providing a new option for blood sugar control in adult patients [1][5]. Group 1: Industry Context - China has the highest number of type 2 diabetes patients globally, with approximately 140 million adults affected, accounting for about one-quarter of the world's diabetic population [2]. - The management of diabetes has shifted towards a comprehensive strategy that includes not only blood sugar control but also weight management and the prevention of cardiovascular and renal complications [2]. Group 2: Product Details - Masitide is the first GCG/GLP-1 dual receptor agonist approved for type 2 diabetes, offering benefits in blood sugar control, weight loss, and improvements in cardiovascular, liver, and kidney health [3][5]. - The approval is based on two Phase III clinical studies demonstrating that Masitide outperforms placebo and Dulaglutide 1.5mg in terms of blood sugar control and weight loss, while also improving various metabolic indicators [3][4]. Group 3: Safety and Administration - The safety profile of Masitide is consistent with previous studies of GLP-1 receptor agonists, with no new safety risks identified [4]. - The new injection pen for Masitide features a hidden needle design to reduce injection anxiety and is a single-use device, minimizing contamination risks [4]. Group 4: Future Outlook - The successful launch of Masitide reflects the recognition of its clinical value and safety by regulatory authorities, reinforcing the company's innovation capabilities in metabolic treatments [5]. - The company aims to continue its focus on developing high-quality biopharmaceuticals across various therapeutic areas, including oncology, autoimmune diseases, metabolism, cardiovascular health, and ophthalmology [5].

Core Viewpoint - The announcement indicates that Innovent Biologics has received approval from the National Medical Products Administration (NMPA) in China for the new drug application (NDA) of its dual receptor agonist, Masituzumab injection, for the treatment of blood sugar control in adult patients with type 2 diabetes [1] Group 1 - Innovent Biologics announced the approval of Masituzumab injection for a second indication [1] - The drug is a dual receptor agonist targeting glucagon (GCG) and glucagon-like peptide-1 (GLP-1) [1] - The approval is specifically for use in adult patients with type 2 diabetes [1]

中国经济网北京9月19日讯 康希诺(688185.SH)今日收报79.84元，跌幅2.63%。 康希诺募集资金总额为52.01亿元，扣除发行费用后，募集资金净额为49.79亿元。康希诺最终募集 资金净额较原计划多39.79亿元。康希诺2020年8月6日发布的招股说明书显示，公司计划募集资金10亿 元，分别用于"生产基地二期建设""在研疫苗开发""疫苗追溯、冷链物流体系及信息系统建设""补充流 动资金"。 康希诺上市发行费用为2.21亿元，其中保荐及承销费用2.05亿元。 中信证券投资有限公司（参与跟投的保荐机构相关公司）获配股票数量为49.60万股，占本次发行 总股数的2.00%，跟投金额为1.04亿元。 康希诺于2020年8月13日在上交所科创板上市，发行数量为2480万股，发行价格209.71元/股，保荐 机构（主承销商）为中信证券，保荐代表人为焦延延、马可；联席主承销商为中金公司，副主承销商为 渤海证券。目前该股处于破发状态。 （责任编辑：关婧） ...

Core Viewpoint - The approval of the new drug application for Masitide injection by the NMPA marks a significant advancement in diabetes management in China, being the first GCG/GLP-1 dual receptor agonist approved for type 2 diabetes [1] Company Summary - Sinopharm's Masitide injection has received approval for its second indication, aimed at blood sugar control in adult patients with type 2 diabetes [1] - The drug is expected to provide multiple benefits for the management of type 2 diabetes, including blood sugar control, weight loss, and improvements in heart, liver, and kidney indicators [1] Industry Summary - The approval of Masitide positions it as a pioneering treatment option in the diabetes care market, potentially enhancing disease management for a large population of type 2 diabetes patients in China [1]

Group 1 - The stock of Frontier Biotech (688221.SH) closed at 14.89 yuan, with a decline of 4.18%, currently in a state of breaking issue [1] - Frontier Biotech was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on October 28, 2020, with an issuance of 89.96 million shares, accounting for 25.01% of the total shares post-issuance, at a price of 20.50 yuan per share [1] - The highest stock price recorded on the listing day was 35.53 yuan, marking the peak since its listing [1] Group 2 - The total amount raised by Frontier Biotech during the issuance was 184.418 million yuan, with a net amount of 171.729 million yuan [1] - The company planned to use the raised funds for various projects, including the clinical research of an HIV fusion inhibitor, a combined therapy, a new transdermal analgesic patch, marketing network construction, and to supplement working capital [1] - The total issuance costs (excluding VAT) for the initial public offering were 12.689 million yuan, with underwriting and sponsorship fees amounting to 11.613 million yuan [1] Group 3 - UBSAG, the sponsoring institution, participated in the strategic placement of the issuance, acquiring 2,926,829 shares, which is 3.25% of the total issuance, for an amount of approximately 60 million yuan [2] - The lock-up period for the shares acquired by UBSAG is 24 months, starting from the date of listing on the Shanghai Stock Exchange [2] Group 4 - The actual controller of Frontier Biotech is Dongxie (Xie Dong), who holds American nationality and has permanent residency in China [3] - In a simplified procedure for issuing shares to specific objects, Frontier Biotech issued 14,818,653 shares at a price of 13.51 yuan per share on September 22, 2022, raising a total of approximately 200.2 million yuan [3] - After deducting issuance costs, the net amount raised from this issuance was approximately 195.67 million yuan [3] Group 5 - The total fundraising from the two issuances by Frontier Biotech amounts to approximately 2.044 billion yuan [4]

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。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 瑪仕度肽獲中國國家藥品監督管理局 批准用於成人2型糖尿病患者的血糖控制 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，瑪仕度肽注射液（胰高血糖素[GCG]╱胰高 血糖素樣肽-1[GLP-1]雙受體激動劑）的第二項適應症新藥上市申請（「NDA」）獲 中國國家藥品監督管理局（「NMPA」）批准上市，用於成人2型糖尿病患者的血糖 控制。瑪仕度肽是全球首個獲批的用於2型糖尿病的GCG/GLP-1雙受體激動劑， 有望助力中國廣大2型糖尿病患者人群疾病管理，實現血糖控制、減重及心肝腎 指標多重獲益。 中國2型糖尿病患者人數居世界首位，長期血糖管理及併發症防治需求嚴峻 中國 ...

Core Viewpoint - The company emphasizes its commitment to AI in product development and has established a comprehensive technology innovation platform to enhance its R&D capabilities [1] Group 1: AI Investment and R&D - The company has built a strategic layout consisting of three major research and production bases and an innovation incubation center in Beijing [1] - Multiple innovative vaccine products are in various stages of regulatory approval and clinical trials, including the 15-valent pneumococcal conjugate vaccine and the ACYW135 group meningococcal conjugate vaccine [1] - The company is advancing therapeutic biological products, with liraglutide injection at the application stage and semaglutide injection (for diabetes) having completed phase III clinical trials [1]

Core Viewpoint - Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd. has successfully listed on the Hong Kong Stock Exchange, with a closing price of HKD 42.10, reflecting a significant increase of 106.47% from its opening price of HKD 44.00 [1] Group 1: Company Overview - Jinfang Pharmaceutical is a biopharmaceutical company focused on developing new treatment solutions for tumors, autoimmune diseases, and inflammatory diseases [1] - The company issued a total of 89,240,000 H shares, with 7,760,000 shares allocated for the Hong Kong public offering and 81,480,000 shares for international offering [2][3] Group 2: Financial Details - The offering price was set at HKD 20.39 per share, raising a total of HKD 1,819.60 million, with a net amount of HKD 1,669.92 million after deducting estimated listing expenses of HKD 149.69 million [2][3] - The net proceeds will be used for clinical development of core products GFH925 and GFH375, further development of other pipeline candidates, and general corporate purposes [3] Group 3: Key Investors - Key cornerstone investors include RTW Master Fund, TruMed Health Innovation Fund LP, OrbiMed Genesis Master Fund, and several asset management firms such as UBS Asset Management and 富国基金管理有限公司 [5][6][7] Group 4: Financial Performance - For the fiscal years ending December 31, 2023, and December 31, 2024, Jinfang Pharmaceutical reported revenues of RMB 73.7 million and RMB 104.7 million, respectively, with a loss of RMB 508.3 million and RMB 677.6 million for the same periods [8][9] - The company has incurred significant operating losses primarily due to research and development costs associated with clinical trials, which have exceeded the revenue generated [9][10]

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，临床阶段生物科技公司InxMed Limited（应世生物）正式向港交所递交上市申请，中信证券与建 银国际担任联席保荐人。值得关注的是，递表前一周公司刚刚完成总额3400万美元的C轮融资。C轮融 资由复星医药旗下复健资本领投，比邻星创投、澄翔资本、昆仑资本及老股东恩然创投参与投资。 招股书显示，应世生物于2017年成立，致力于改进目前疗效有限的肿瘤治疗方案。截至递表时，公司的 产品管线包括核心产品FAK抑制剂ifebemtinib、第二代选择性 FAK抑制剂IN10028以及OMTX705、 IN30758、IN30778三款抗体偶联药物 ADC。 费用方面，作为一家尚未有产品上市、零营收的创新药企，研发费用本是应世生物最核心的支出。然而 数据显示，公司研发开支呈现连续下降趋势。2023年，公司研发费用为1.36亿元，2024年降至1亿元。 2025年一季度，研发费用进一步下降，期内研发费用为1621.4万元，同比下降5.8%。而公司行政费用则 逐年走高，2025年一季度行政费用几与研发费用相当。 从产品角度看，应世生物押注的FA ...

公告显示，9MW0813注射液是阿柏西普（艾力雅®）的生物类似药，为VEGFR—1和VEGFR—2胞外区 结合域与人免疫球蛋白Fc段重组形成的融合蛋白，可与VEGF—A和PlGF结合。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）9月19日，迈威生物发布公告称，公司近日收到国家药品 监督管理局核准签发的《受理通知书》，9MW0813注射液的上市许可申请获得受理，用于糖尿病性黄 斑水肿（DME）和新生血管（湿性）年龄相关性黄斑变性（nAMD）。 ...