Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]

Core Points - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., has received the clinical trial approval notice from the National Medical Products Administration for its adsorbed acellular combined vaccine for adults and adolescents [1] Group 1 - The company has made significant progress in vaccine development with the approval of a clinical trial for a new vaccine [1]

（文章来源：证券日报） 证券日报网讯 11月12日晚间，百克生物发布公告称，公司近日收到国家药品监督管理局下发的吸附无 细胞百（二组分）白破联合疫苗（成人及青少年用）的《药物临床试验批准通知书》。 ...

Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of an acellular combined vaccine for adolescents and adults, aimed at preventing whooping cough, diphtheria, and tetanus [1][2] Group 1: Vaccine Approval and Market Context - The approved vaccine is designed for individuals aged 10 and above, stimulating immune response to prevent invasive infections caused by whooping cough, diphtheria, and tetanus [1] - There has been an increasing incidence of whooping cough among adolescents and adults in recent years, prompting the recommendation for vaccination every 10 years in developed countries [1] - Currently, China's immunization program primarily targets infants, with no approved combined vaccine for adolescents and adults [1] Group 2: Technological Advancements and Business Implications - The vaccine developed by Baike Biological utilizes a new acellular technology, replacing the traditional co-purification process, and includes inactivated components of whooping cough toxin, filamentous hemagglutinin, diphtheria toxin, and tetanus toxin [2] - The vaccine's formulation with an aluminum-CpG adjuvant system enhances immune response, offering high purity and consistency [2] - Successful completion of clinical trials and subsequent market approval will enhance the company's vaccine development pipeline, diversify its product offerings, and create new growth opportunities for the company's performance [2]

格隆汇11月12日丨长春高新(000661.SZ)公布,公司子公司百克生物收到国家药监局对其吸附无细胞百 （二组分）白破联合疫苗（成人及青少年用）的《药物临床试验批准通知书》。 本次百克生物获批临床的吸附无细胞百（二组分）白破联合疫苗（成人及青少年用）（以下简称"青少 年及成人百白破疫苗"）是一种可以同时预防青少年及成人百日咳、白喉、破伤风的疫苗。接种对象为 10周岁及以上人群，接种后可刺激机体产生免疫应答，用于预防百日咳、白喉、破伤风引起的侵袭性感 染。 若本次获批的青少年及成人百白破疫苗顺利完成临床试验，并获批上市，将进一步完善公司疫苗研发管 线，丰富公司联合疫苗产品矩阵，有助于公司优化产品结构和主营业务的全面发展，为公众提供更为高 质量的疫苗接种选择，为公司业绩创造新的增长点。 近年来，国内外青少年和成人的百日咳发病率呈现上升趋势，针对这一现象，国外开始应用青少年及成 人接种的百白破疫苗，预防控制该传染病的发生，并普遍推荐青少年和成人每10年接种一次。我国目前 的百日咳、白喉、破伤风的免疫规划主要在婴幼儿阶段，尚未批准用于青少年及成人的百白破疫苗。 目前我国使用的国产百白破疫苗仍为共纯化工艺，而发达国家 ...

Core Viewpoint - Changchun High-tech's subsidiary, Baike Bio, has received approval for clinical trials of an acellular combined vaccine for adolescents and adults, which aims to prevent whooping cough, diphtheria, and tetanus [1] Group 1 - The vaccine is intended for individuals aged 10 years and older [1] - Successful completion of clinical trials and subsequent approval for market launch will enhance the company's vaccine research pipeline [1] - This development will enrich the company's portfolio of combined vaccines, aiding in optimizing product structure and overall business growth [1]

长春高新11月12日公告，公司子公司长春百克生物科技股份公司收到国家药品监督管理局对其吸附无细 胞百（二组分）白破联合疫苗（成人及青少年用）的《药物临床试验批准通知书》，建议批准开展预防 百日咳、白喉、破伤风的临床试验。 ...

每经AI快讯，百克生物（SH 688276，收盘价：23.12元）11月12日晚间发布公告称，长春百克生物科技 股份公司近日收到国家药品监督管理局下发的吸附无细胞百（二组分）白破联合疫苗（成人及青少年 用）的《药物临床试验批准通知书》。 2024年1至12月份，百克生物的营业收入构成为：生物医药占比100.0%。 每经头条（nbdtoutiao）——谁在替王家卫写《繁花》？揭秘影视剧本层层转包"枪手链" （记者 曾健辉） 截至发稿，百克生物市值为96亿元。 ...

百克生物公告，公司近日收到国家药品监督管理局下发的吸附无细胞百（二组分）白破联合疫苗（成人 及青少年用）的《药物临床试验批准通知书》。该疫苗是一种可以同时预防青少年及成人百日咳、白 喉、破伤风的疫苗，接种对象为10周岁及以上人群。若顺利完成临床试验并获批上市，将进一步完善公 司疫苗研发管线，丰富公司联合疫苗产品矩阵，有助于公司优化产品结构和主营业务的全面发展。 ...