Core Viewpoint - Zhifei Biological (300122.SZ) has received a clinical trial application acceptance notice from the National Medical Products Administration for its lyophilized varicella inactivated vaccine developed by its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] Group 1 - The clinical trial acceptance number is CXSL2500962, and the company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center [1] - The lyophilized varicella inactivated vaccine utilizes an innovative inactivation technology route, with both the production cell strains and virus strains being independently developed by the company [1] - This product demonstrates significant safety advantages and is suitable for individuals aged 12 months and older to prevent varicella, providing safer vaccination options for healthy individuals as well as those with immune deficiencies or contraindications [1]

格隆汇11月12日｜长春高新(000661.SZ)公告称，公司子公司百克生物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》。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。若该疫苗顺利 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。 ...

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]

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。 ...

Group 1 - The core point of the article is that Zhifei Biological (SZ 300122) has received approval from the National Medical Products Administration for clinical trials of its acellular combined vaccine for diphtheria, tetanus, and pertussis aimed at adolescents and adults [1] - Zhifei Biological's revenue composition for the year 2024 is projected to be 99.14% from biological products and 0.86% from other businesses [1] - As of the report, Zhifei Biological has a market capitalization of 52.1 billion yuan [1] Group 2 - The chairman of Peking University Pharmaceutical, Xu Xiren, was investigated by the police prior to his arrest, with reports indicating that the group's assets were disposed of and large sums of money are unaccounted for [1]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $98.6 million, which is expected to cover anticipated expenses into the fourth quarter of 2026 [17] - Revenue for Q3 2025 was zero, compared to approximately $2.3 million for Q3 2024, and revenue for the first three quarters of 2025 was zero, compared to approximately $11.1 million for the same period in 2024 [18] - The net loss for Q3 2025 was approximately $24.6 million, compared to a net loss of approximately $12.6 million for Q3 2024, and the net loss for the first three quarters of 2025 was approximately $74.9 million, compared to approximately $33.4 million for the same period in 2024 [19] Business Line Data and Key Metrics Changes - The company has administered over 800 infusions to approximately 150 boys and young men with Duchenne muscular dystrophy, demonstrating a strong and consistent safety profile for deramiocel [8] - The HOPE-3 phase 3 clinical study focuses on non-ambulant individuals, a patient population that has historically had limited clinical research dedicated to it [4] Market Data and Key Metrics Changes - The company is preparing for potential global expansion while closely monitoring evolving U.S. and international pricing policies [15] - The FDA has classified the resubmission of the BLA as Type 2, which means the review period can be up to six months, but there is precedent for faster review times [11] Company Strategy and Development Direction - The company aims to bring forward the first therapy that directly addresses Duchenne muscular dystrophy-associated cardiomyopathy, emphasizing the life-limiting cardiovascular impact of the disease [8] - The company is engaging both neurology and cardiology specialists to ensure an integrated approach to patient care should deramiocel receive approval [15] - The company is advancing its StealthX program under Project NextGen to develop next-generation vaccines for COVID-19 and other infectious threats [16] Management's Comments on Operating Environment and Future Outlook - Management remains highly motivated to achieve approval for deramiocel as early as possible in 2026, well ahead of the September 30, 2026 deadline for priority review voucher eligibility [11] - Management expressed confidence in the potential of deramiocel to stabilize disease progression and preserve both muscle and heart function [12] Other Important Information - The company has published a peer-reviewed paper detailing new mechanistic insights into deramiocel's mechanism of action, reinforcing the biologic rationale for its development program [12] - The San Diego commercial facility is fully operational and preparing for GMP production activities, addressing all CMC-related items cited in the CRL [14] Q&A Session Summary Question: What to expect from the upcoming HOPE-3 data? - The company will release top-line data including primary and key secondary endpoints as soon as available and will host a conference call to explain the implications of the data [22] Question: Are there any statistical changes in the study regarding left ventricular ejection fraction? - The study was always powered to measure ejection fraction, and the results from previous studies provide strong support for this analysis [23] Question: How will the statistical analysis plan handle the primary and secondary endpoints? - The primary endpoint remains the performance of the upper limb, and the analysis will focus on both combined cohorts and specifically on Cohort B [25] Question: What is the FDA's view on cohort B? - The focus on cohort B is due to its importance in addressing manufacturing concerns and ensuring the efficacy data is tied to the approved facility [41] Question: What is the potential for label expansion upon approval? - The company will discuss potential label expansion during conversations with the FDA, contingent on the data outcomes [50]

Investment Rating - The report maintains a "Buy" rating for the company with a target price based on the last closing price of 10.62 [1] Core Insights - The company's revenue for the first three quarters of 2025 reached 1.042 billion yuan, representing a year-on-year increase of 7.38%, while the net profit attributable to shareholders was 161 million yuan, a decrease of 4.85% year-on-year. In Q3 2025 alone, revenue was 423 million yuan, up 17.76% year-on-year, and net profit was 101 million yuan, an increase of 116.40% year-on-year [4][5] - The core products continue to see significant growth, particularly in the swine vaccine segment, with sales of foot-and-mouth disease vaccines increasing by 50% year-on-year, and diarrhea vaccines seeing a 120% increase in revenue. The company is also making steady progress in developing new vaccines, including a novel mRNA vaccine for feline infectious peritonitis [5][7] Financial Performance Summary - The company forecasts revenues of 1.569 billion yuan for 2025, 1.851 billion yuan for 2026, and 2.073 billion yuan for 2027, with net profits projected at 283 million yuan, 320 million yuan, and 335 million yuan respectively. The corresponding EPS for these years is expected to be 0.25 yuan, 0.29 yuan, and 0.30 yuan, with PE ratios of 42.57, 37.67, and 35.91 respectively [5][7][9] - The gross margin is projected to be 54.00% in 2025, with a net profit margin of 18.03% [9]

Core Viewpoint - Chengdu Olin Biological Technology Co., Ltd. has officially launched the Phase III clinical trial of its quadrivalent influenza virus split vaccine (MDCK cells) and completed the enrollment of the first subject, marking a significant milestone in the vaccine's development [1][4]. Group 1: Vaccine Overview - The quadrivalent influenza virus split vaccine (MDCK cells) is designed for individuals aged 6 months and older, aiming to stimulate the immune system to produce antibodies against influenza viruses, thereby preventing influenza outbreaks [1]. - The vaccine is a cell-based influenza vaccine, which allows for higher production yields, more stable product quality, and lower production costs compared to traditional methods [2]. Group 2: Clinical Trial Details - The Phase III clinical trial employs a randomized, blinded, positive-controlled design to further evaluate the efficacy and safety of the quadrivalent influenza virus split vaccine (MDCK cells), providing scientific evidence for regulatory approval [3]. Group 3: Impact on the Company - The quadrivalent influenza virus split vaccine represents a key focus in the company's viral vaccine portfolio, indicating significant progress in vaccine research and development, which will enhance the company's product pipeline and support sustainable growth [4].