Core Insights - The conference "2025 Financial Empowerment of the Medical and Health Industry (Guangxi) Innovation Conference" was successfully held in Nanning, focusing on building a closed-loop ecosystem of "technology innovation + capital empowerment + industry landing" to support Guangxi in becoming a healthcare industry hub facing ASEAN [2] - The "2025 China Innovative Drug Industry Investment Blue Book" was jointly released, providing authoritative and practical development trend analysis and investment layout guidance for industry participants, investors, and policymakers [2] Industry Development Background - The demand for innovative drugs is shifting from "curative" to "long-term management" and "precision" due to population aging and chronic diseases [6] - The number of rare diseases is increasing, necessitating the development of effective treatments [6] - AI-driven drug development is shortening research cycles, and innovative biopharmaceutical technologies are flourishing [6] Global Innovative Drug Development Trends - The number of innovative drugs in the oncology field is steadily increasing, with its share rising from 35% in 2020 to 45% in 2024, driven by breakthroughs in targeted therapies and CAR-T cell therapies [8] - From 2015 to 2024, a total of 12,263 innovative drugs are expected to be developed globally, with 9,427 still active by the end of 2024 [10] - China has become the country with the most innovative drugs since 2020, reaching 704 by 2024, surpassing the U.S. [11] China’s Innovative Drug Industry Development - The Chinese innovative drug industry has evolved through four stages: initial stage, combination of imitation and innovation, rise of innovation, and globalization [19] - The policy environment has increasingly focused on supporting innovative drugs, with a systematic policy matrix established to accelerate their transition from laboratory to clinical application [17] Market Size and Financing Trends - The innovative drug market in China is projected to reach CNY 1,620 billion by 2024, with commercial health insurance accounting for only 7.7% of the payment market [25] - The financing landscape has shifted from a focus on quantity to quality, with a notable increase in the proportion of domestic companies' innovative drugs approved in China, rising from under 10% in 2015 to 50% in 2024 [23] Future Opportunities and Challenges - The aging population and the demand for innovative drugs in oncology and chronic diseases are expected to continue growing [69] - The industry faces challenges such as geopolitical tensions, regulatory tightening, and high-risk characteristics of drug development, which typically takes over 10 years and requires substantial investment [71][72]

歌礼制药称，鉴于将GLP-1激动剂类药物从每周滴定放缓至每四周滴定后，其胃肠道耐受性有显著改 善，预期ASC30片在III期研究中每四周滴定时，其胃肠道耐受性将得到进一步提升。计划在2026年第一 季度向美国食品药品监督管理局(FDA)递交这些数据及申请II期临床试验结束会议。 （文章来源：证券时报网） 歌礼制药12月8日宣布，评估口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗肥胖症的13周II期研究 (NCT07002905)取得积极的顶线结果。该研究在美国多个中心开展，共入组125名肥胖受试者或伴有至 少一种体重相关合并症的超重受试者。研究共评估了三个剂量的ASC30口服片(20毫克、40毫克和60毫 克)。在第13周时，与安慰剂相比，三个剂量的ASC30均达到了主要终点，显示出具有统计学显著性(20 毫克、40毫克和60毫克对比安慰剂的p值<0.0001)和临床意义的体重下降。在主要终点(第13周时体重相 对基线的平均百分比变化)上，60毫克ASC30的经安慰剂校正后的平均体重下降高达7.7%。 歌礼制药-B（01672.HK）9日盘中大幅拉升，一度涨超23%，截至发稿，该股涨约18%。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 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、准确性和完整性依法承担法律责任。 近日，科兴生物制药股份有限公司（以下简称"公司"）全资子公司深圳科兴药业有限公司（以下简 称"深圳科兴"）收到国家药品监督管理局（以下简称"国家药监局"）签发的《药物临床试验批准通知 书》，国家药监局批准同意深圳科兴开展"GB10注射液"的临床试验。 现将相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 1、产品名称：GB10注射液 2、受理号：CXSL2500841 3、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，GB10注射液临床试验申请符 合药品注册的有关要求，同意本品开展治疗新生血管性年龄相关性黄斑变性（nAMD）的临床试验。 二、药品相关介绍 临床前数据显示，其生物活性和动物药效均达到国际竞品水平，在激光诱导的猴CNV（脉络膜新生血 管, choroidal neovascularization）药效模型中能够有效抑制眼底血管新生。 GB10注射液是深圳科兴自主研发、拥有全球知识产权的抗V ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [12][14]. Core Insights - The company, Genting Biopharma, focuses on innovative drug and vaccine research, manufacturing, and commercialization, establishing a dual-driven growth model through license-in products and self-developed high-barrier pipelines [3][8]. - Key products include Nefukang (Budesonide) for IgA nephropathy, EVER001 for primary membranous nephropathy, and Aicuo Mod (Etrolizumab) for moderate to severe ulcerative colitis, all showing significant clinical evidence and market potential [9][10][11]. - The company has seen substantial revenue growth, with projected revenues of 1.791 billion, 3.169 billion, and 4.822 billion RMB for 2025-2027, respectively, and a turnaround in profitability expected by 2025 [12][30]. Summary by Sections Company Overview - Genting Biopharma was founded in July 2017 and has developed a diverse product pipeline covering oncology, nephrology, and infectious diseases [18]. - The company has shifted focus towards nephrology and autoimmune diseases, divesting from oncology to enhance resource allocation [18]. Product Pipeline - The product pipeline includes Nefukang, which is the first approved drug for IgA nephropathy globally, and EVER001, a reversible BTK inhibitor targeting primary membranous nephropathy [9][10]. - Aicuo Mod has shown rapid efficacy in inducing clinical remission in ulcerative colitis patients, with a significant mucosal healing rate [11]. Financial Performance - The company achieved a revenue of 707 million RMB in 2024, a 461% increase year-on-year, and expects continued growth with a revenue of 446 million RMB in the first half of 2025 [28][30]. - The net profit is projected to improve from a loss of 376 million RMB in 2025 to a profit of 868 million RMB by 2027, indicating a strong recovery trajectory [12][30]. Market Potential - The chronic kidney disease (CKD) patient population is substantial, with approximately 1.25 billion patients in China, representing a significant market opportunity for the company's nephrology products [32]. - The company’s products are positioned to address unmet medical needs in the nephrology and autoimmune disease sectors, with a focus on innovative treatment approaches [3][8].

Core Insights - Changchun High-tech's subsidiary, Changchun JinSai Pharmaceutical, has two products newly included in the National Medical Insurance Directory: JinSaiZeng (long-acting growth hormone) and MeiShiYa (oral suspension of medroxyprogesterone acetate) [2][3] - JinSaiZeng is the world's first long-acting growth hormone approved in January 2014, with multiple indications beyond primary growth hormone deficiency, including Turner syndrome and idiopathic short stature [2] - MeiShiYa is developed by Bosheng Pharmaceutical and is indicated for appetite loss in AIDS patients and significant weight loss in cancer patients [3] R&D Investment and Strategy - In the first three quarters, Changchun High-tech's R&D expenses increased by 22.96% year-on-year, reaching 1.733 billion yuan, with R&D accounting for 17.68% of total revenue [3] - This increase reflects the company's commitment to R&D and its transition towards becoming an innovative global pharmaceutical company [3] - The approval of clinical trial applications for GenSci142 capsules, aimed at treating bacterial vaginosis, indicates the company's efforts to diversify and optimize its product structure [3]

证券日报网12月8日讯九典制药（300705）在12月8日回答调研者提问时表示，公司目前正在全面转型创 新药研发，采用"多个研发中心+多种药物形式+多种合作模式"策略迅速布局创新药。公司同时在中部 地区和长三角布局创新药研发中心，既利用中部地区丰富的临床资源和研发成本优势，又利用长三角区 域优势，建立双中心的创新药研发平台。平台现有成员40余人，汇聚了从药物设计到临床研究所需各相 关专业的专家及研发团队，核心成员具备多个创新药临床和上市申报获批经验；同时，根据现有临床需 求和未来市场发展潜力，重点布局各类肿瘤和各类慢性疾病相关适应症和治疗领域，以小分子化药、多 肽药物、PDC、ADC等药物形式进行布局。在研发/合作模式上，同时采用引进+合作研发+自研等方 式，一方面通过自主研发构建核心技术壁垒，另一方面积极引进具有竞争力和良好市场前景的项目，加 速创新成果转化，同时，公司重视产学研合作与技术转化，持续优化生产工艺，推动创新药物快速落 地。公司将通过这种方式对创新药管线进行梯次布局，进一步丰富创新药管线，迅速形成自有新药管线 矩阵，强化在创新药领域的核心竞争力。 ...

格隆汇12月8日丨科兴制药(688136.SH)公布，近日，公司全资子公司深圳科兴收到国家药监局签发的 《药物临床试验批准通知书》，国家药监局批准同意深圳科兴开展"GB10注射液"的临床试验。产品名 称：GB10注射液，受理号：CXSL2500841。 GB10注射液是深圳科兴自主研发、拥有全球知识产权的抗VEGF/Ang-2双靶点抗体高浓度眼科专用蛋白 药物制剂。GB10注射液浓度达到140mg/mL，可减少注射体积或提高给药量，延长给药周期，预期实现 每4个月给药一次，极大提高患者依从性。 临床前数据显示，其生物活性和动物药效均达到国际竞品水平，在激光诱导的猴CNV（脉络膜新生血 管, choroidal neovascularization）药效模型中能够有效抑制眼底血管新生。 公司GB10注射液的临床试验获得国家药监局的批准，是公司创新药研发过程中的重要一步，标志着科 兴基于自主技术平台的双抗研发战略取得关键进展，若该药品研发未来实现成功上市，能够为满足市场 需求提供更加多元的产品，有利于丰富公司产品布局，进一步提高公司市场竞争力。 ...

临床前数据显示，其生物活性和动物药效均达到国际竞品水平，在激光诱导的猴CNV（脉络膜新生血 管, choroidal neovascularization）药效模型中能够有效抑制眼底血管新生。 公司GB10注射液的临床试验获得国家药监局的批准，是公司创新药研发过程中的重要一步，标志着科 兴基于自主技术平台的双抗研发战略取得关键进展，若该药品研发未来实现成功上市，能够为满足市场 需求提供更加多元的产品，有利于丰富公司产品布局，进一步提高公司市场竞争力。 GB10注射液是深圳科兴自主研发、拥有全球知识产权的抗VEGF/Ang-2双靶点抗体高浓度眼科专用蛋白 药物制剂。GB10注射液浓度达到140mg/mL，可减少注射体积或提高给药量，延长给药周期，预期实现 每4个月给药一次，极大提高患者依从性。 格隆汇12月8日丨科兴制药(688136.SH)公布，近日，公司全资子公司深圳科兴收到国家药监局签发的 《药物临床试验批准通知书》，国家药监局批准同意深圳科兴开展"GB10注射液"的临床试验。产品名 称：GB10注射液，受理号：CXSL2500841。 ...

Group 1: Investor Relations Activity - The investor relations activity involved a meeting with analysts from Morgan Fund Management, Guolian Minsheng Securities, and Shenzhen Yide Global Fund Management on December 8, 2025 [1] - The meeting was held in the company conference room and included discussions on the company's new drug inclusion in the national medical insurance directory [1] Group 2: New Drug Inclusion - The innovative drug, Olanavir Tablets (brand name: Anruiwei®), was included in the National Medical Insurance Directory on December 7, 2025, following negotiations with the National Healthcare Security Administration [1][3] - Other core products such as Liraglutide Tablets and various capsules were also included in this directory, enhancing their market accessibility [1] Group 3: Drug Characteristics - Olanavir Tablets are the world's first oral drug targeting the PB2 subunit of the RNA polymerase of the influenza A virus, approved for adult patients with uncomplicated influenza [3][4] - The drug demonstrates rapid symptom relief, strong antiviral effects, and low resistance rates, with positive results from clinical trials [4][5] Group 4: Sales and Marketing Strategy - The company plans to enhance marketing through three dimensions: building an academic ecosystem, upgrading data services, and implementing key project practices [8] - The inclusion of Olanavir Tablets in the National Medical Insurance Directory is expected to positively impact market promotion and long-term business development [8] Group 5: Pediatric Development Plans - The company is developing Olanavir Granules for children and adolescents, with ongoing Phase III clinical trials for both adolescents (ages 12-17) and children (ages 2-11) [9][11] - The trials aim to establish a comprehensive treatment matrix for influenza across all age groups [11] Group 6: Other Drug Developments - RAY1225 injection, an innovative dual-agonist drug for type 2 diabetes and obesity, has shown positive results in Phase II clinical trials and is progressing to Phase III trials [12][13] - ZSP1601 tablets, targeting metabolic dysfunction-related fatty liver disease, have completed early clinical trials with promising results and are moving into Phase IIb trials [15][16] Group 7: Research and Development Pipeline - The company is focusing on innovative drug development in respiratory and metabolic diseases, with projects targeting unmet clinical needs [16][18] - Ongoing research includes a new drug for respiratory syncytial virus (RSV) and various GLP-1 receptor agonists, with clinical candidates identified and preclinical studies underway [16][18]

Group 1: Company Overview and Strategy - Hunan Jiutian Pharmaceutical Co., Ltd. is focusing on expanding its market presence through a multi-channel strategy and brand enhancement initiatives, including the launch of the "Jiutian Zhen Tong Xian Sheng" branding campaign on December 6, 2025 [2][3] - The company aims to strengthen its product pipeline by increasing R&D investments and introducing new products, while also leveraging its integrated supply chain to control costs and ensure product quality [3][4] Group 2: Product Specifics and Market Response - The company’s key product, Loxoprofen Sodium Gel Patch, has been selected in the 11th round of national drug centralized procurement at prices of ¥17.88 for 4 patches, ¥26.82 for 6 patches, and ¥35.76 for 8 patches, with a total planned selection of approximately 30.12 million patches [5] - Following the price reduction from centralized procurement, the company anticipates a potential increase in sales volume for Loxoprofen Sodium Gel Patch, contingent on market conditions post-implementation [5] Group 3: Mergers and Acquisitions - The company has acquired a 67% stake in Hunan Nona Pharmaceutical Technology Co., Ltd., which includes 67 drug licenses, enhancing its product offerings and market stability [3][4] - This acquisition is expected to fill potential sales gaps from the centralized procurement of Loxoprofen Sodium Gel Patch and diversify the product range with unique offerings like the Daiwen Moxibustion Patch [3] Group 4: Innovation and R&D Focus - The company is transitioning towards innovative drug development, establishing multiple R&D centers and focusing on various drug forms and cooperative models to expedite the development of new drugs [4][6] - Current R&D efforts are concentrated on oncology and chronic disease treatments, utilizing small molecules, peptides, and other advanced drug forms to build a robust pipeline [4][6] Group 5: Future Product Development - The JIJ02 gel is expected to complete Phase I clinical trials in the first half of 2026, with plans to initiate Phase II trials thereafter [7] - The company is optimistic about the market prospects for Ketoprofen Gel, which was approved in 2023 and included in the national medical insurance directory, and is implementing new sales strategies to enhance market penetration [7]