Core Viewpoint - The company announced that the regulator has accepted a priority review to potentially expand the age range for its Tzield type-1 diabetes drug to include children as young as one year old [1] Group 1 - The priority review indicates a significant step towards making the Tzield drug available for younger patients [1]

Core Viewpoint - The FDA has accepted a supplemental biologic license application for Tzield to expand its age indication to children as young as one year old, aiming to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 T1D [1][2]. Group 1: FDA Review and Study Data - The FDA's priority review highlights the urgent need for innovative therapies like Tzield, which may prevent the progression of T1D by delaying the loss of insulin production [2][3]. - The application is supported by positive interim one-year data from the ongoing PETITE-T1D phase 4 study, which evaluates Tzield's safety and pharmacokinetics in young children [1][4]. - The target action date for the FDA's decision on the application is April 29, 2026 [1]. Group 2: Study Details - The PETITE-T1D study is a phase 4, single-arm, non-randomized, open-label trial designed to assess Tzield's safety and pharmacokinetics in children under eight years diagnosed with stage 2 T1D [4]. - The study has enrolled 23 participants, with a treatment regimen consisting of an intravenous infusion of Tzield once daily for 14 consecutive days, and individual follow-up may last up to 26 months [5]. Group 3: Tzield Overview - Tzield (teplizumab-mzwv) is a CD3-directed monoclonal antibody and the first disease-modifying therapy for autoimmune T1D, initially approved in the US in November 2022 for patients aged eight and older [6]. - Tzield is also approved in several countries, including China, the UK, Canada, and others, for delaying the onset of stage 3 T1D in the same population [6]. - If approved for younger patients, Tzield would be the first therapy to delay the onset of stage 3 T1D in children aged one and older diagnosed with stage 2 T1D [8].

Core Viewpoint - Idorsia Ltd has received marketing authorization from Health Canada for JERAYGO™ (aprocitentan), the first and only endothelin receptor antagonist for treating resistant hypertension in adults [1][11]. Group 1: Product Information - JERAYGO™ is indicated for adult patients with resistant hypertension, defined as uncontrolled blood pressure despite the use of at least three antihypertensive medications from different classes [2][11]. - The recommended starting dose is 12.5 mg orally once daily, which can be increased to 25 mg for patients needing tighter blood pressure control [1]. - Aprocitentan is a dual endothelin receptor antagonist that inhibits the binding of ET-1 to ETA and ETB receptors, representing a new pathway in hypertension treatment [11]. Group 2: Clinical Study Insights - The efficacy of aprocitentan was evaluated in the Phase 3 PRECISION study, which included 730 patients with uncontrolled blood pressure [5][9]. - The primary endpoint was the change in sitting systolic blood pressure (SiSBP) from baseline to Week 4, showing significant reductions compared to placebo [6][9]. - A substantial proportion (at least 90%) of the blood pressure-lowering effect was observed within the first two weeks of treatment [9]. Group 3: Patient Demographics and Health Background - The mean age of patients in the study was 61.7 years, with 34.1% aged 65-74 years and 9.9% aged 75 years or older [7]. - A significant portion of patients had comorbidities, including type 2 diabetes (54.1%), ischemic heart disease (30.8%), and chronic kidney disease (22.2%) [8]. Group 4: Safety and Adverse Reactions - Common adverse reactions reported with aprocitentan included edema/fluid retention (9.1% for 12.5 mg and 18.4% for 25 mg) and decreased hemoglobin (3.7% for 12.5 mg and 1.2% for 25 mg) [10]. - JERAYGO is contraindicated in pregnant women, those breastfeeding, and patients with severe hepatic impairment or hypersensitivity to the active substance [10].

Core Viewpoint - Guolian Minsheng Securities initiates coverage on Baiao Saitu (02315) with a "Buy" rating, highlighting the robust growth across its three main business segments and the positive impact of the "Thousand Mice and Ten Thousand Antibodies" initiative on financial performance [1] Group 1: Model Animals - The company dominates the humanized mouse market with over 1,700 strains, contributing significantly to revenue, with sales and licensing expected to generate 257 million yuan (94% of revenue) by H1 2025 [1] - The sales of model animals are projected to grow at a CAGR of 51.6% from 2022 to 2024, with increasing customer repurchase rates [1] - By 2024, overseas sales of model animals are expected to account for 56.4%, with a mature U.S. subsidiary facilitating order acquisition [1] Group 2: Preclinical CRO Services - The preclinical CRO services segment, which extends from model animals, has an overseas revenue share of 79%, benefiting from a recovering investment environment [2] - The pharmacology and efficacy team operates across Beijing, Haimen, and the U.S., having completed over 6,350 drug evaluation projects for approximately 950 global partners by H1 2025 [2] - Revenue for this segment reached 155 million yuan in H1 2025, reflecting a year-on-year growth of over 90% due to increased client numbers driven by industry growth [2] Group 3: Antibody Molecule Transfer/Authorization - The revenue model based on upfront payments, milestones, and sales sharing allows for significant revenue growth as pipelines advance [3] - The "Thousand Mice and Ten Thousand Antibodies" initiative has created a vast array of antibody combinations, reducing R&D time and uncertainty for pharmaceutical companies [3] - By H1 2025, the company has signed 61 transfer/authorization/co-development projects with renowned pharmaceutical firms, with a projected CAGR of 58.3% for this segment from 2022 to 2024 [3]

Core Viewpoint - The innovative drug sector in China is experiencing significant growth, with a record number of approved innovative drugs and substantial increases in licensing transactions, indicating a strong market potential and investment opportunities in the pharmaceutical industry [1] Industry Summary - As of 2025, China has approved 76 innovative drugs, surpassing the 48 approved in 2024, marking a historical high [1] - The total value of licensing transactions for innovative drugs in China is expected to exceed $130 billion, with over 150 transactions, also a historical high [1] - The pharmaceutical research outsourcing sector is benefiting from a recovery in industry demand, with companies like WuXi AppTec and Hao Yuan Medical showing excellent growth [1] Company Summary - Companies in the innovative drug sector, such as Lepu Medical, Frontier Biotechnologies, and BeiGene, have seen significant stock price increases, with Lepu Medical hitting a 20% limit up and others like Frontier Biotechnologies rising over 13% [1] - The innovative drug industry's core driving factor is the breakthrough in global competitiveness of Chinese pharmaceutical companies, which are gaining recognition for their research capabilities [1] - The demand for CXO and research services within the innovative drug supply chain is expected to continue benefiting from favorable market conditions, leading to sustained performance exceeding expectations [1]

Group 1 - In 2025, Shanghai approved 9 domestic innovative Class 1 drugs and 7 imported innovative drugs, marking a record high. Additionally, 13 innovative medical devices were approved for market entry. Among the 9 domestic drugs, several are global or national firsts [1] - The first domestically developed human-derived long-acting GLP-1 receptor agonist, Eysuparaglutide α injection (brand name: Yinuo Qing), has a half-life of 204 hours, allowing for weekly administration without dose titration [1] - The first recombinant adeno-associated virus (rAAV) vector gene therapy drug, Bopadacogen injection (brand name: Xinjiu Ning), enables long-term self-expression of coagulation factor IX through a single intravenous injection [1] Group 2 - During the "14th Five-Year Plan" period, Shanghai approved a total of 32 domestic Class 1 innovative drugs, including multiple first-in-class products such as Duoglie Aitin tablets and the world's first EGFR-targeted ADC [1] - In the field of innovative medical devices, Shanghai approved 47 Class III products during the "14th Five-Year Plan" period, including the first domestic proton therapy system and the first laparoscopic surgical robot [2] - The Shanghai Municipal Drug Administration plans to shorten the review and approval timelines for eligible innovative drug clinical trials and reduce the review cycle for Class II medical devices, aiming to compress the entire registration cycle to 6 months [2]

海南日报讯(海南日报全媒体记者 王子豪)记者从上海交通大学医学院附属瑞金医院海南医院获 悉，依托博鳌乐城国际医疗旅游先行区"先行先试"政策优势，该院近日成功引入全球创新靶向免疫疗法 ——注射用塔拉妥单抗，成为国内率先实现该药物可及的医疗机构，标志着国内含铂化疗失败的广泛期 小细胞肺癌成人患者，在乐城迎来了与全球同步的治疗新曙光。 此次引进的塔拉妥单抗是一款靶向DLL3的免疫疗法药物，目前已在美国、日本、英国等获批。该 药物采用了创新的T细胞衔接器结构设计，通过同时结合肿瘤细胞上的DLL3蛋白和T细胞上的CD3蛋 白，进而激活T细胞精准杀伤肿瘤细胞，使其有望成为治疗小细胞肺癌的有效疗法之一。 ...

为保障政策落地见效，日前省医保局联合省人社厅印发通知，明确全省定点医疗机构应在2026年2 月底前召开专题药事会，优先配备谈判药品且不受"一品两规"限制，严禁以总额控制、药占比等为由限 制合理用药。 结合特药管理实际，陕西同步联动调整特药管理范围，新增59种、调出6种后，特药管理品种增至 337种。同时，通过强化特药外配处方流转监管，让特药保障更规范、更高效。 作为此次政策的一大创新，国家医保局首设的商保创新药品目录备受关注。该目录纳入的19种药物 均为超出基本医保保障定位、暂未纳入医保目录，但创新程度高、临床价值突出、患者获益明显的创新 药物，推荐商业健康保险、医疗互助等多层次保障体系参考使用。这一举措丰富了保障供给，推动商保 与基本医保错位发展，为构建全方位医疗保障体系奠定基础。 "我们将加强政策培训与宣传解读，主动回应社会关切，确保新版'双目录'平稳落地，让政策红利 真正直达患者，切实减轻群众就医负担。"省医保局相关负责人说。（记者：李旭佳） 1月4日，记者从省医保局获悉：日前，《国家基本医疗保险、生育保险和工伤保险药品目录（2025 年）》以及《商业健康保险创新药品目录（2025年）》已在陕西落地执行 ...

Core Viewpoint - HUTCHMED has initiated the Phase III part of a clinical trial to evaluate a combination therapy for metastatic pancreatic ductal adenocarcinoma (PDAC), which is a highly aggressive cancer with poor survival rates [1][2]. Group 1: Clinical Trial Details - The trial is a multicenter, randomized, open-label, active-controlled Phase II/III study assessing the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer who have not received prior systemic therapy [2]. - A total of 62 patients were enrolled in the Phase II part, with plans to enroll approximately 400 additional patients in the Phase III part [2]. - The primary endpoint for the Phase III part is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2]. Group 2: Phase II Results - As of July 24, 2025, the median PFS for the S+C+AG regimen was 7.20 months compared to 5.52 months for the AG arm, indicating a 50.1% reduction in the risk of progression or death [3]. - The ORR was 67.7% for the S+C+AG arm versus 41.9% for the AG arm, and the DCR was 93.5% compared to 71.0% for the AG arm [3]. - Although overall survival data were immature, a favorable trend was observed with 9 events in the S+C+AG arm and 15 events in the AG arm [3]. Group 3: Drug Information - Surufatinib is a novel oral angio-immuno kinase inhibitor that targets VEGFRs, FGFR, and CSF-1R, promoting the immune response against tumor cells [4]. - Camrelizumab is a humanized monoclonal antibody targeting the PD-1 receptor, approved in China for multiple cancer indications [5]. - HUTCHMED is an innovative biopharmaceutical company focused on the development and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [6].

Group 1 - Crinetics Pharmaceuticals will host a conference call and webcast on January 5, 2026, to provide updates on PALSONIFY™ commercialization and disclose topline results from the Phase 2 trial of atumelnant [1][2] - PALSONIFY™ (paltusotine) is the first once-daily oral treatment approved by the U.S. FDA for adults with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option [4] - Crinetics has a deep pipeline of over 10 disclosed programs, including atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, and CRN09682 for treating SST2 expressing neuroendocrine tumors [4] Group 2 - Crinetics Pharmaceuticals focuses on transforming the treatment of endocrine diseases and related tumors through patient-centered science [3] - The company specializes in discovering, developing, and commercializing novel therapies targeting G-protein coupled receptors (GPCRs) with tailored pharmacology [3]